(nitroglycerin 0.6 mg) Dailymed
IMPRINT: N 6
SHAPE: round
COLOR: white
All Imprints
frovatriptan succinate 2.5 mg - e 2 5 round white
dipyridamole 75 mg - 19 round orange
aspirin 325 mg - aspirin 44 249 round white
valsartan 80 mg - 7432 tv round pink
calcium fluoride 30 [hp_x] - round white
captopril 100 mg - w 905 round white
levodopa 50 mgentacapone 200 mgcarbidopa 12.5 mg - w782 round brown
calcium acetate 667 mg - p113 round white
lithium carbonate 300 mg - ww 300 round white
cyclophosphamide 25 mg - 54 639 round blue
methylphenidate hydrochloride 10 mg - ciba 3 round green
desloratadine 5 mg - 5 round blue
carvedilol 25 mg - zc42 round white
iloperidone 8 mg - 8 round white
glyburide 2.5 mg - cor 124 round yellow
bismuth subsalicylate 262 mg - rh046 round pink
moexipril hydrochloride 7.5 mg - apo moe 7 5 round white
- r221 round orange
venlafaxine hydrochloride 50 mg - ip 303 round orange
pseudoephedrine hydrochloride 30 mg - tcl016 round red
donepezil hydrochloride 5 mg - i 24 round white
methadone hydrochloride 5 mg - u41 round white
donepezil hydrochloride 10 mg - i 21 round yellow
amlodipine besylate 2.5 mgatorvastatin calcium trihydrate 20 mg - pfizer cdt 252 round white
chlorpheniramine maleate 4 mg - 44 194 round yellow
tamoxifen citrate 20 mg - m 274 round white
hydrochlorothiazide 50 mg - h 3 round orange
pitavastatin calcium 4.18 mg - 4 kc round white
venlafaxine hydrochloride 25 mg - 6147 v round orange
docusate sodium 50 mgsennosides a and b 8.6 mg - tcl081 round orange
quinidine gluconate 324 mg - mp 66 round white
oxycodone hydrochloride 7.5 mgacetaminophen 325 mg - watson 933 round white
cyclobenzaprine hydrochloride 5 mg - tl 211 round orange
trihexyphenidyl hydrochloride 2 mg - 5971 v round white
lamotrigine 50 mg - h009 round orange
rabeprazole sodium 20 mg - 107 round yellow
carbamazepine 200 mg - t 200 mg round pink
enalapril maleate 5 mghydrochlorothiazide 12.5 mg - apo 5 12 5 round red
diclofenac sodium 100 mg - r 717 round yellow
minoxidil 10 mg - dan 5643 10 round white
acetaminophen 500 mg - ap 013 round white
levonorgestrel 0.1 mgethinyl estradiol 0.02 mg - b 965 round pink
clonazepam 0.5 mg - 832 teva round yellow
oxcarbazepine 300 mg - 54 515 round orange
fludrocortisone acetate 0.1 mg - 7033 round white
atovaquone 250 mgproguanil hydrochloride 100 mg - gx cm3 round pink
lamotrigine 50 mg - lamictal xr 50 round green
maprotiline hydrochloride 75 mg - 9 2 m round white
candesartan cilexetil 4 mg - acf 004 round white
memantine hydrochloride 5 mg - m5 v round white
lamotrigine 150 mg - lam 150 apo round yellow
acarbose 50 mg - precose 50 round white
docusate sodium 50 mgsennosides 8.6 mg - tcl 131 round purple
dextroamphetamine saccharate 3.75 mgamphetamine aspartate monohydrate 3.75 mgdextroamphetamine sulfate 3.75 mgamphetamine sulfate 3.75 mg - b 777 1 5 round orange
paroxetine hydrochloride hemihydrate 25 mg - gsk 25 round pink
bupropion hydrochloride 100 mg - wellbutrin 100 round red
memantine hydrochloride 10 mg - m10 x round white
dextroamphetamine saccharate 2.5 mgamphetamine aspartate monohydrate 2.5 mgdextroamphetamine sulfate 2.5 mgamphetamine sulfate 2.5 mg - 1 0 dp round blue
nifedipine 60 mg - 60 adalat cc round pink
lisinopril 10 mghydrochlorothiazide 12.5 mg - lh1 m round white
alprazolam 1 mg - cor 188 round yellow
liothyronine sodium 50 ug - 50 223 round white
venlafaxine hydrochloride 75 mg - 6150 v round orange
metoprolol tartrate 50 mg - c 74 round pink
prednisone 10 mg - west ward 473 round white
trandolapril 2 mg - fx round yellow
pitavastatin calcium 1 mg - 1 kc round white
dextroamphetamine saccharate 3.125 mgamphetamine aspartate monohydrate 3.125 mgdextroamphetamine sulfate 3.125 mgamphetamine sulfate 3.125 mg - 12 5 d p round orange
benztropine mesylate 2 mg - b 1116 round white
chlorpheniramine maleate 12 mg - chlorphen 12 round orange
lisinopril 10 mg - ww 267 round pink
paroxetine hydrochloride hemihydrate 37.5 mg - gsk 37 5 round blue
naproxen 250 mg - 93 147 round red
morphine sulfate 60 mg - m ms 60 round orange
hydrocodone bitartrate 7.5 mgibuprofen 200 mg - 3585 v round white
warfarin sodium 2 mg - ig w 2 round purple
galantamine hydrobromide 12 mg - janssen g 12 round brown
methazolamide 50 mg - eff 20 round white
simvastatin 10 mg - sv 10 round pink
norethindrone 1 mgethinyl estradiol 0.035 mg - b 949 round yellow
potassium chloride 600 mg - ktab round yellow
famciclovir 250 mg - 8118 93 round white
progesterone 100 mg - sv round orange
isosorbide dinitrate 10 mg - gg26 round white
flecainide acetate 50 mg - an 641 round white
buspirone hydrochloride 10 mg - teva 54 round white
topiramate 50 mg - apo tp 50 round yellow
simvastatin 40 mg - sv 40 round pink
isosorbide dinitrate 5 mg - bpi 152 round pink
- b 247 round brown
clonazepam 0.25 mg - b 95 1 4 round white
prednisolone sodium phosphate 30 mg - ora 30 round white
nifedipine 30 mg - m 475 round pink
alendronate sodium 5 mg - 93 5140 round white
chloroquine phosphate 250 mg - 0115 2790 round white
acarbose 25 mg - precose 25 round white
bumetanide 1 mg - e 129 round yellow
levomefolate calcium 0.451 mg - m round orange
flavoxate hydrochloride 100 mg - 58 round white
verapamil hydrochloride 80 mg - watson 343 round white
desipramine hydrochloride 10 mg - 68 7 round blue
levonorgestrel 0.15 mgethinyl estradiol 0.02 mg - tv 076 round pink
atenolol 25 mg - 787 teva round white
dipyridamole 75 mg - c83 round white
hydrocortisone 10 mg - cp 332 round white
desipramine hydrochloride 75 mg - e 722 round blue
citalopram hydrobromide 10 mg - mx31 round orange
lamotrigine 150 mg - taro lmt 150 round white
- 54-980 round blue
topiramate 25 mg - ig 278 round white
hydroxyzine hydrochloride 50 mg - tv 309 round white
cefuroxime axetil 250 mg - w 921 round white
acarbose 25 mg - 54 311 round white
lamotrigine 100 mg - j 246 round white
sennosides a and b 8.6 mg - gpi w2 round brown
metformin hydrochloride 500 mg - h 102 round white
olanzapine 5 mg - m oe1 round yellow
zolpidem tartrate 12.5 mg - a1 round yellow
bupropion hydrochloride 100 mg - g 2442 round yellow
- dan 5540 round white
hydromorphone hydrochloride 4 mg - m 4 round white
phytonadione 5 mg - aton 405 mephyton round yellow
nifedipine 30 mg - 30 adalat cc round pink
tramadol hydrochloride 200 mg - 200 er round white
cinchona officinalis bark 30 [hp_c]coffea arabica fruit 6 [hp_c]strychnos nux-vomica seed 30 [hp_c]matricaria chamomilla flowering top oil 6 [hp_c]artemisia cina flower 30 [hp_c] - none round white
paroxetine hydrochloride hemihydrate 10 mg - zc 15 round white
hydralazine hydrochloride 50 mg - par 028 round orange
benazepril hydrochloride 10 mg - apo be 10 round yellow
propafenone hydrochloride 225 mg - 5125 v round white
eszopiclone 1 mg - 93 e7 round blue
carbinoxamine maleate 4 mg - bp 605 round white
metronidazole 250 mg - 3969 wpi round white
oxybutynin chloride 10 mg - g342 round pink
ethinyl estradiol 0.01 mg - b 556 round yellow
hydrochlorothiazide 6.25 mgbisoprolol fumarate 2.5 mg - ul l round yellow
metoprolol tartrate 100 mg - re 76 round white
aripiprazole 30 mg - tv 7583 round pink
ropinirole hydrochloride 2 mg - 54 231 round orange
- west-ward 248 round yellow
acetaminophen 300 mgcodeine phosphate 15 mg - 2 m round white
calcium carbonate 750 mg - fc round green
levocetirizine dihydrochloride 5 mg - 161 h round white
glipizide 2.5 mg - wpi 900 round orange
torsemide 20 mg - pa 917 round white
olanzapine 7.5 mg - m 335 round white
metformin hydrochloride 500 mg - andrx 674 500 round white
norethindrone acetate 1.5 mgethinyl estradiol 30 ug - b 978 round pink
azathioprine 50 mg - 54 043 round yellow
bupropion hydrochloride 100 mg - apo bup 100 round purple
estradiol 0.5 mg - watson 528 round white
olanzapine 20 mg - tv u4 20 round yellow
levonorgestrel 1.5 mg - g00 round white
nitazoxanide 500 mg - alinia 500 round yellow
zolmitriptan 5 mg - f11 round white
paroxetine hydrochloride hemihydrate 30 mg - m n3 round blue
doxazosin mesylate 8 mg - n 598 8 round white
hydrochlorothiazide 50 mg - 3572 v round orange
levonorgestrel 0.075 mgethinyl estradiol 0.040 mg - dp 511 round white
glipizide 10 mg - 10 round white
norethindrone acetate 1 mgethinyl estradiol 20 ug - b 711 round pink
imipramine hydrochloride 50 mg - par 56 round green
repaglinide 1 mg - p241 round yellow
felodipine 2.5 mg - 450 plendil round green
ciprofloxacin hydrochloride 250 mg - cr 250 round white
pravastatin sodium 10 mg - teva 771 round pink
prednisone 20 mg - tl175 round pink
ethinyl estradiol 0.01 mg - dp 457 round yellow
calcium carbonate 420 mg - az 036 round white
alprazolam 0.5 mg - cor 187 round white
haloperidol 0.5 mg - mylan 351 round orange
midodrine hydrochloride 5 mg - g 422 round orange
carvedilol 12.5 mg - zc41 round white
metformin hydrochloride 850 mg - andrx 675 850 round white
desipramine hydrochloride 25 mg - e 19 round blue
olanzapine 5 mg - tv u1 5 round yellow
felodipine 10 mg - 452 plendil round red
flecainide acetate 50 mg - rx794 round white
fosinopril sodium 40 mg - 202 ig round white
rabeprazole sodium 20 mg - aciphex 20 round yellow
zolpidem tartrate 5 mg - m z1 round purple
metoprolol succinate 100 mg - a ms round white
leucovorin calcium 15 mg - 54 650 round yellow
amoxapine 50 mg - dan 50 5714 round orange
clozapine 100 mg - clozaril 100 round yellow
leucovorin calcium 25 mg - 54 013 round yellow
tramadol hydrochloride 300 mg - 300 er round white
tolterodine tartrate 2 mg - dt round white
doxycycline 50 mg - lci 1335 round yellow
minoxidil 10 mg - 10 mp 89 round white
aspirin 81 mg - az 013 round orange
lorazepam 2 mg - 242 2 watson round white
trandolapril 4 mg - tn4 round white
propranolol hydrochloride 60 mg - 54 85 v round pink
dimethicone 80 mgcalcium carbonate 750 mg - dr round pink
prochlorperazine maleate 10 mg - tl115 round green
dexamethasone 1.5 mg - 54 943 round pink
ranitidine hydrochloride 150 mg - gg 705 round pink
sodium fluoride 0.5 mg - sci 1007 round white
prednisone 5 mg - westward 475 round white
alprazolam 2 mg - sp 324 2 round white
pioglitazone hydrochloride 15 mg - actos 15 round white
aspirin 162 mgacetaminophen 110 mgsalicylamide 152 mgcaffeine 32.4 mg - fr2 round orange
meloxicam 7.5 mg - zc 25 round yellow
metolazone 2.5 mg - m 172 round orange
amlodipine besylate 5 mgolmesartan medoxomil 40 mg - c75 round white
ondansetron hydrochloride 8 mg - r 154 round yellow
diclofenac sodium 75 mgmisoprostol 200 ug - 0398 round white
sitagliptin phosphate 100 mg - 277 round brown
acarbose 25 mg - e71 round white
albuterol sulfate 4 mg - mp 88 round white
topiramate 50 mg - omn 50 round yellow
dextroamphetamine saccharate 5 mgamphetamine aspartate monohydrate 5 mgdextroamphetamine sulfate 5 mgamphetamine sulfate 5 mg - e 401 round orange
trifluoperazine hydrochloride 2 mg - m t4 round white
oxycodone hydrochloride 20 mg - op 20 round pink
citalopram hydrobromide 10 mg - 206 ig round yellow
trazodone hydrochloride 100 mg - pliva 434 round white
zolmitriptan 2.5 mg - zomig 25 round yellow
desipramine hydrochloride 50 mg - e 721 round blue
dextroamphetamine saccharate 7.5 mgamphetamine aspartate monohydrate 7.5 mgdextroamphetamine sulfate 7.5 mgamphetamine sulfate 7.5 mg - e 404 round orange
trazodone hydrochloride 100 mg - apo t100 round white
hydralazine hydrochloride 100 mg - hp 4 round pink
meclizine hydrochloride 25 mg - m mcz 25 round white
levetiracetam 250 mg - m 613 round white
alendronate sodium 35 mg - 637 round white
dexamethasone 0.5 mg - 54 299 round yellow
carbidopa 25 mglevodopa 100 mg - apo 25 100 round yellow
norethindrone 0.5 mgethinyl estradiol 0.035 mg - b 941 round yellow
irbesartan 75 mg - m in1 round white
calcium ascorbate 50 mgcalcium threonate 50 mgcholecalciferol 6 ug.alpha.-tocopherol acetate, dl- 3.5 [iu]pyridoxine hydrochloride 2 mgfolic acid 1 mgcalcium carbonate 250 mgferrous fumarate 40 mgmagnesium oxide 50 mgzinc oxide 15 mgcupric oxide 2 mg - tl014 round grey
hydromorphone hydrochloride 2 mg - p 2 round orange
norethindrone acetate 1 mgethinyl estradiol .02 mg - 93 912 round white
sodium starch glycolate type a corn 3.61 mgpovidone k30 5.415 mgstearic acid 1.805 mgacetaminophen 324.9 mgstarch, corn 25.27 mg - 325 round white
megestrol acetate 20 mg - par 289 round white
propranolol hydrochloride 40 mg - 54 84 v round green
tinidazole 250 mg - tm 250 round pink
lisinopril 40 mg - 3761 round white
escitalopram oxalate 10 mg - 11 36 round white
amitriptyline hydrochloride 75 mg - m 37 round blue
medroxyprogesterone acetate 2.5 mg - g3740 round orange
amlodipine besylate 5 mgvalsartan 160 mghydrochlorothiazide 25 mg - tv 7037 round yellow
trihexyphenidyl hydrochloride 2 mg - dan dan 5335 round white
amitriptyline hydrochloride 100 mg - 2105 v round red
acarbose 100 mg - e73 round white
norethindrone 1 mgethinyl estradiol 0.035 mg - b 943 round orange
lorazepam 2 mg - mylan 777 round white
bisoprolol fumarate 5 mghydrochlorothiazide 6.25 mg - b 50 round pink
oxycodone hydrochloride 15 mg - m 15 round green
repaglinide 1 mg - 745 c round yellow
butalbital 50 mgacetaminophen 325 mgcaffeine 40 mg - lci 1695 round blue
aripiprazole 30 mg - a 011 30 round pink
levonorgestrel 0.15 mgethinyl estradiol 0.03 mg - b 555 round blue
glipizide 10 mg - glipizide xl 10 round white
olanzapine 2.5 mg - m 157 round orange
promethazine hydrochloride 50 mg - zc03 round white
zolmitriptan 5 mg - zomig 5 round pink
acetaminophen 300 mgcodeine phosphate 30 mg - 3 tv 150 round white
nadolol 80 mgbendroflumethiazide 5 mg - kpi 284 corzide 80 5 round white
lamotrigine 200 mg - lamictal xr 200 round blue
albuterol sulfate 2 mg - m 255 round white
bupropion hydrochloride 75 mg - wellbutrin 75 round yellow
carisoprodol 350 mg - dan 5513 round white
hydrochlorothiazide 50 mg - 112 s g round white
cyclophosphamide 50 mg - 54 980 round blue
benztropine mesylate 0.5 mg - cor 143 round white
norethindrone acetate 1 mgethinyl estradiol 20 ug - b 977 round yellow
perindopril erbumine 2 mg - d 5 7 round white
propranolol hydrochloride 10 mg - pliva 467 round orange
pramipexole dihydrochloride 0.25 mg - p2 round blue
amitriptyline hydrochloride 100 mg - gg461 round orange
ropinirole 2 mg - 93 5285 round pink
olanzapine 10 mg - lilly 4117 round white
trihexyphenidyl hydrochloride 2 mg - w 4 round white
repaglinide 0.5 mg - p240 round white
nifedipine 30 mg - eln 30 round brown
trandolapril 4 mg - lu h03 round red
warfarin sodium 10 mg - ig w 10 round white
bismuth subsalicylate 262 mg - ap 045 round pink
ropinirole hydrochloride 4 mg - m re4 round brown
dipyridamole 25 mg - 17 round orange
lithium carbonate 450 mg - 224 g breakline round yellow
estradiol 1 mgnorethindrone acetate 0.5 mg - novo 288 round white
venlafaxine hydrochloride 75 mg - 759 round
enalapril maleate 10 mg - elp 10 round brown
carvedilol 25 mg - g41 25 round white
metoprolol tartrate 50 mg - 477 round white
pitavastatin calcium 2 mg - 2 kc round white
folic acid 1 mg - ig 210 round yellow
meloxicam 7.5 mg - 7 5 round yellow
bupropion hydrochloride 100 mg - a 171 round yellow
chlorpromazine hydrochloride 25 mg - gg476 25 round orange
carbidopa 25 mglevodopa 250 mg - m c53 round green
pramipexole dihydrochloride 0.125 mg - 91 round white
dimenhydrinate 50 mg - 0111 v round white
chlorpromazine hydrochloride 200 mg - gg457 200 round orange
ranitidine hydrochloride 150 mg - apo ran 150 round pink
tramadol hydrochloride 50 mg - m t7 round white
citalopram hydrobromide 40 mg - 208 ig round white
carvedilol 6.25 mg - zc40 round white
labetalol hydrochloride 200 mg - cl38 200 round white
diclofenac potassium 50 mg - 93 948 round orange
fosinopril sodium 20 mg - 201 ig round white
clonazepam 0.125 mg - b 94 1 8 round white
carisoprodol 350 mg - 2410 v round white
candesartan cilexetil 8 mg - acg 008 round pink
risperidone 0.25 mg - 93 221 round yellow
tamoxifen citrate 10 mg - m 144 round white
pyridostigmine bromide 60 mg - mestinon v 60 round white
carbidopa 25 mglevodopa 100 mg - apo 131 round brown
citalopram hydrobromide 10 mg - a 05 round orange
spironolactone 100 mg - searle 1031 aldactone 100 round orange
glipizide 10 mg - 9200 teva round white
nisoldipine 17 mg - sci 501 round yellow
promethazine hydrochloride 25 mg - an 521 round white
olanzapine 7.5 mg - lilly 4116 round white
spironolactone 100 mg - 58 82 v round white
oxycodone hydrochloride 10 mg - op 10 round white
propranolol hydrochloride 80 mg - 54 86 v round yellow
amiodarone hydrochloride 100 mg - as 100 round yellow
levonorgestrel 0.050 mgethinyl estradiol 0.030 mg - dp 510 round pink
mebendazole 100 mg - 93 107 round orange
sennosides a and b 8.6 mg - az217 round brown
estradiol valerate 2 mgdienogest 3 mg - dh round yellow
amlodipine besylate 2.5 mgatorvastatin calcium trihydrate 10 mg - r 407 round white
meloxicam 15 mg - m 89 round yellow
nifedipine 60 mg - b 60 round red
methocarbamol 500 mg - west ward 290 round white
metformin hydrochloride 850 mg - bms 6070 850 round white
aspirin 81 mg - heart round yellow
aripiprazole 15 mg - a 009 15 round yellow
clomiphene citrate 50 mg - watson 781 round white
olanzapine 2.5 mg - c 45 round yellow
dexmethylphenidate hydrochloride 5 mg - 93 5276 round yellow
quinapril hydrochloride 20 mg - lu f03 round yellow
ethynodiol diacetate 1 mgethinyl estradiol 35 ug - b 14 round yellow
griseofulvin 500 mg - ortho 214 round white
cefprozil 250 mg - 93 1077 round orange
felodipine 5 mg - e137 round pink
propranolol hydrochloride 10 mg - mylan 182 10 round orange
eltrombopag olamine 25 mg - gs nx3 25 round orange
clonazepam 2 mg - b 98 2 round white
allopurinol 300 mg - m 71 round white
estradiol 0.5 mg - e 3 m round white
spironolactone 50 mg - mp 542 round white
- 3m tr 50 round white
metoprolol tartrate 100 mg - c 75 round blue
pioglitazone hydrochloride 15 mg - 31 h round white
salsalate 500 mg - bp 507 round yellow
bethanechol chloride 50 mg - lci 1329 round yellow
codeine phosphate 15 mgacetaminophen 300 mg - 2063 v 2 round white
methimazole 5 mg - bp 655 round white
tolterodine tartrate 1 mg - to round white
atovaquone 62.5 mgproguanil hydrochloride 25 mg - gx cg7 round pink
lamotrigine 200 mg - l124 round white
levonorgestrel 0.15 mgethinyl estradiol 0.03 mg - b 992 round pink
metoclopramide hydrochloride 10 mg - teva 2203 round white
venlafaxine hydrochloride 37.5 mg - 6148 v round orange
irbesartan 150 mghydrochlorothiazide 12.5 mg - 54 857 round red
diclofenac sodium 100 mg - dx 41 round pink
risedronate sodium monohydrate 35 mg - teva 7389 round orange
ethinyl estradiol 0.01 mg - tv 077 round yellow
aspirin 325 mg - aspirin 44157 round white
ropinirole hydrochloride 2 mg - 975 hh round pink
nilutamide 150 mg - 168d round white
carbidopa 25 mglevodopa 100 mg - 93 293 teva round yellow
doxycycline 100 mg - i63 round orange
testosterone 30 mg - a round white
benazepril hydrochloride 20 mg - lotensin 20 round pink
simvastatin 40 mg - rx792 round red
trifluoperazine hydrochloride 5 mg - gg55 5 round purple
albuterol sulfate 4 mg - v 4 round green
metformin hydrochloride 500 mg - a 12 round white
topiramate 200 mg - ig 281 round pink
quinidine sulfate 200 mg - dan dan 5438 round white
doxycycline 50 mg - i61 round orange
metformin hydrochloride 500 mg - 574 round white
carbamazepine 100 mg - taro 16 round white
hydrochlorothiazide 50 mg - hp 46 round white
trifluoperazine hydrochloride 5 mg - m t5 round purple
imipramine hydrochloride 50 mg - v13 lu round brown
lamotrigine 25 mg - taro lmt 25 round white
aripiprazole 10 mg - 10 18 round white
propranolol hydrochloride 80 mg - dan 5557 80 round yellow
benztropine mesylate 0.5 mg - b 1114 round white
hydrochlorothiazide 12.5 mglisinopril 10 mg - ww 62 round blue
aspirin 81 mg - 81 round yellow
doxazosin mesylate 1 mg - m d9 round white
mitotane 500 mg - bl l1 round white
lamotrigine 100 mg - par 563 round brown
cetirizine hydrochloride 5 mgpseudoephedrine hydrochloride 120 mg - 5029 5 120 round white
linagliptin 5 mg - d5 round red
estradiol 2 mg - watson 488 round green
bumetanide 2 mg - e 130 round brown
lamotrigine 25 mg - lmt 25 round white
alprazolam 2 mg - r 87 round pink
nifedipine 60 mg - ku 261 round pink
norethindrone acetate 1.5 mgethinyl estradiol 0.03 mg - watson 631 round green
doxycycline hyclate 100 mg - dan 5553 round orange
carvedilol 6.25 mg - m c32 round white
atenolol 100 mg - z 67 round white
demeclocycline hydrochloride 150 mg - an 54 round red
risperidone 0.5 mg - 93 225 round red
bethanechol chloride 50 mg - bcl 50 832 round yellow
bisacodyl 5 mg - tcl 003 round orange
bupropion hydrochloride 150 mg - 141 round white
morphine sulfate 30 mg - m 30 round purple
azilsartan kamedoxomil 80 mg - asl 80 round white
dextroamphetamine sulfate 10 mg - 953 10 b round pink
neomycin sulfate 500 mg - zynova 01 round white
quetiapine fumarate 100 mg - apo que 100 round yellow
quetiapine fumarate 200 mg - apo que 200 round white
finasteride 5 mg - ig 412 round blue
clonidine hydrochloride 0.1 mg - 241 round pink
glipizide 5 mg - gxl 5 round white
- deltasone 20 round orange
guaifenesin 600 mg - l498 round white
amlodipine besylate 5 mg - m a9 round blue
desipramine hydrochloride 10 mg - 341 round white
captopril 12.5 mg - w 7 round white
diclofenac sodium 100 mg - m 355 round yellow
metoprolol tartrate 100 mg - 93 734 round blue
anastrozole 1 mg - adx1 round white
haloperidol 10 mg - mylan 334 round green
imipramine hydrochloride 50 mg - gg 42 round green
desipramine hydrochloride 75 mg - gg166 round white
chlorpromazine hydrochloride 200 mg - 832 200 round brown
adefovir dipivoxil 10 mg - 3 round white
dipyridamole 50 mg - c82 round white
methimazole 10 mg - bp 656 round white
montelukast sodium 5 mg - 54 741 round pink
ramelteon 8 mg - tak ram 8 round orange
fluvastatin sodium 80 mg - lescol xl 80 round yellow
hyoscyamine sulfate 0.125 mg - pad h round white
azilsartan kamedoxomil 40 mgchlorthalidone 12.5 mg - ac 40 12 5 round red
clonazepam 0.5 mg - r 33 round pink
zidovudine 300 mg - 54 777 round white
lovastatin 20 mg - 20 round orange
moexipril hydrochloride 15 mg - g 208 round brown
desogestrel 0.15 mgethinyl estradiol 0.02 mg - dp 021 round white
bupropion hydrochloride 100 mg - e over 410 round blue
fosinopril sodium 40 mg - ig 202 round white
pilocarpine hydrochloride 5 mg - lan 1313 round white
hydrocodone bitartrate 7.5 mgibuprofen 200 mg - 5161 round white
bisoprolol fumarate 5 mghydrochlorothiazide 6.25 mg - e 704 round red
moexipril hydrochloride 7.5 mg - g 209 round pink
hydrocortisone 5 mg - cp 331 round white
olanzapine\ 7.5 mg - 7654 round white
metoprolol tartrate 100 mg - m 47 round blue
propranolol hydrochloride 20 mg - dan 5555 20 round blue
lisinopril 20 mghydrochlorothiazide 25 mg - lh3 m round green
spironolactone 100 mg - an 515 round brown
thioridazine hydrochloride 100 mg - mp 160 round yellow
ascorbic acid 100 mgthiamine mononitrate 1.5 mgriboflavin 1.7 mgniacinamide 20 mgpyridoxine hydrochloride 10 mgfolic acid 1 mgcobalamin 6 ugbiotin 300 ugcalcium pantothenate 10 mgzinc citrate 50 mg - h round yellow
glycopyrrolate 1 mg - k 400 round white
allopurinol 100 mg - zyloprim 100 round white
norethindrone acetate 1 mgethinyl estradiol 0.02 mg - pd 915 round white
doxazosin mesylate 2 mg - m d10 round pink
acetazolamide 125 mg - t52 round white
ribavirin 200 mg - zc19 round pink
clozapine 100 mgaspartame 12.4 mg - a08 round yellow
bisoprolol fumarate 5 mghydrochlorothiazide 6.25 mg - m 503 round blue
estropipate 3 mg - watson 416 round blue
dimethicone 125 mg - ap 040 round white
hydrocortisone 20 mg - ww 254 round white
haloperidol 2 mg - mylan 214 round orange
desipramine hydrochloride 100 mg - e 736 round blue
phenobarbital 16.2 mg - 5011 v round white
aripiprazole 15 mg - ari 15 apo round yellow
ciprofloxacin hydrochloride 250 mg - y101 round white
alprazolam 0.5 mg - r 83 round white
- 3m tr 100 round white
desmopressin acetate 0.2 mg - 0 2 37 av round white
naproxen 250 mg - ip188 250 round white
amlodipine besylate 2.5 mgatorvastatin calcium trihydrate 40 mg - pfizer cdt 254 round white
clobazam 5 mg - lu 5 round white
propafenone hydrochloride 225 mg - mp 512 round white
nifedipine 30 mg - b 30 round red
atovaquone 250 mgproguanil hydrochloride 100 mg - 404 g round pink
buprenorphine hydrochloride 2 mgnaloxone hydrochloride dihydrate 0.5 mg - 154 round white
lisinopril 20 mghydrochlorothiazide 12.5 mg - a 28 round yellow
torsemide 5 mg - pa 915 round white
penicillin v potassium 250 mg - gg949 pvk250 round white
chlorambucil 2 mg - gx eg3 l round brown
pioglitazone hydrochloride 45 mg - actos 45 round white
trazodone hydrochloride 100 mg - mp 114 round white
ketoconazole 200 mg - janssen nizoral round white
prednisone 20 mg - dan dan 5443 round orange
norethindrone 0.5 mgethinyl estradiol 0.035 mg - b 951 round yellow
hydroxyzine hydrochloride 25 mg - 3616 v round green
atenolol 50 mg - d 22 round white
finasteride 5 mg - h 37 round blue
propafenone hydrochloride 150 mg - 5124 v round white
allopurinol 300 mg - n021 round orange
metolazone 5 mg - 644 5 round blue
clopidogrel bisulfate 75 mg - apo cl 75 round pink
morphine sulfate 30 mg - m ms 30 round purple
codeine sulfate 60 mg - 60 54 412 round white
zinc acetate 2 [hp_x]zinc gluconate 2 [hp_x] - rd round red
primidone 50 mg - lan 1301 round white
lamotrigine 150 mg - j 247 round white
simvastatin 5 mg - ll c01 round brown
promethazine hydrochloride 25 mg - gg 225 round white
dimenhydrinate 50 mg - 44 198 round white
simvastatin 40 mg - ll c04 round red
doxycycline hyclate 20 mg - mp 573 round white
potassium chloride 600 mg - kc 8 round blue
chlorpromazine hydrochloride 50 mg - sz 203 round brown
- dp 519 round green
amlodipine besylate 10 mg - s25 round white
alendronate sodium 5 mg - m a6 round white
risperidone 4 mg - p 403 round white
- b 343 round pink
quetiapine fumarate 100 mg - 93 8162 round orange
guanfacine hydrochloride 1 mg - watson 444 round pink
hydrocortisone 5 mg - cortef 5 round white
acyclovir 400 mg - m 253 round white
mirtazapine 45 mg - m 545 round brown
norethindrone 0.75 mgethinyl estradiol 0.035 mg - b 942 round blue
amlodipine besylate 10 mgolmesartan medoxomil 20 mg - c74 round orange
methylphenidate hydrochloride 20 mg - dan 20 5884 round orange
betaxolol hydrochloride 20 mg - e39 round white
thyroid, porcine 15 mg - a tc round brown
busulfan 2 mg - gx ef3 m round white
solifenacin succinate 5 mg - 150 round yellow
perindopril erbumine 8 mg - d 5 9 round white
risperidone 2 mg - 93 7241 round orange
bumetanide 0.5 mg - e 128 round green
terbinafine hydrochloride 250 mg - lamisil 250 round yellow
midodrine hydrochloride 10 mg - e 149 round
isosorbide mononitrate 10 mg - 10 ku 106 round white
levothyroxine sodium 25 ug - synthroid 25 round orange
metformin hydrochloride 500 mg - 397 round white
hydrochlorothiazide 50 mg - westward 257 round orange
dextroamphetamine saccharate 5 mgamphetamine aspartate monohydrate 5 mgdextroamphetamine sulfate 5 mgamphetamine sulfate 5 mg - 2 0 dp round orange
topiramate 50 mg - m t12 round white
bupropion hydrochloride 150 mg - e over 415 round purple
liothyronine sodium 50 ug - kpi 117 round white
baclofen 10 mg - lci 1330 round white
dexmethylphenidate hydrochloride 2.5 mg - 93 5275 round blue
amiodarone hydrochloride 200 mg - as 200 round yellow
carbidopa 10 mglevodopa 100 mg - r 538 round blue
aripiprazole 20 mg - ari 20 apo round white
metronidazole 250 mg - 93 851 round white
bicalutamide 50 mg - bcm 50 round white
prednisone 20 mg - west ward 477 round red
acetaminophen 325 mgchlorpheniramine maleate 4 mgphenylephrine hydrochloride 10 mg - xl3 forte round yellow
iloperidone 12 mg - 12 round white
losartan potassium 25 mg - 11 round white
sumatriptan succinate 25 mg - m s4 round white
cyclobenzaprine hydrochloride 10 mg - pliva 563 round yellow
losartan potassium 100 mghydrochlorothiazide 25 mg - 54 557 round yellow
glycopyrrolate 2 mg - 3181 v round white
glipizide 5 mg - 9201 teva round white
bupropion hydrochloride 100 mg - m 435 round blue
aminocaproic acid 500 mg - vp 045 round white
metformin hydrochloride 850 mg - sg 106 round white
valsartan 160 mghydrochlorothiazide 12.5 mg - m v22 round orange
labetalol hydrochloride 100 mg - watson 605 round brown
guanfacine hydrochloride 3 mg - 853 round yellow
bupropion hydrochloride 150 mg - wellbutrin xl 150 round white
losartan potassium 100 mg - sz 214 round pink
citalopram hydrobromide 10 mg - rdy 342 round brown
erythromycin stearate 250 mg - es round pink
propranolol hydrochloride 80 mg - mylan 185 80 round yellow
metolazone 5 mg - zaroxolyn 5 round blue
glycopyrrolate 2 mg - horizon 205 round white
terbinafine hydrochloride 250 1 - 209 ig round white
bupropion hydrochloride 150 mg - m bu1 round green
risperidone 0.5 mg - sz z1 round pink
carbidopa 25 mglevodopa 250 mg - r 540 round blue
simvastatin 40 mg - a 03 round pink
phenazopyridine hydrochloride 200 mg - 612 round brown
doxycycline 75 mg - lci 1535 round yellow
- 405 n round pink
terbutaline sulfate 5 mg - lci 1311 round white
ketoconazole 200 milligram in 1 tablet - ket 200 apo round white
nadolol 80 mg - 80 z 4237 round white
bisoprolol fumarate 5 mg - m 523 round purple
nifedipine 90 mg - b 90 round yellow
clonazepam 1 mg - r 34 round yellow
donepezil hydrochloride 5 mg - teva 738 round white
amlodipine besylate 5 mgvalsartan 160 mg - tv j2 round yellow
cilostazol 100 mg - m c42 round white
cilostazol 50 mg - e 123 round white
diltiazem hydrochloride 30 mg - m 23 round white
ropinirole hydrochloride 8 mg - m re8 round red
enalapril maleate 2.5 mg - t 2 round yellow
morphine sulfate 15 mg - abg 15 round blue
benazepril hydrochloride 10 mg - e 53 round orange
amiloride hydrochloride 5 mghydrochlorothiazide 50 mg - 555 483 barr round yellow
desipramine hydrochloride 25 mg - 342 round blue
paroxetine hydrochloride hemihydrate 25 mg - m p4 round purple
clonidine hydrochloride 0.2 mg - r128 round orange
glipizide 10 mg - wpi 845 round white
bisoprolol fumarate 10 mg - 93 5271 round white
- b 944 round white
amitriptyline hydrochloride 50 mg - 2103 v round brown
venlafaxine hydrochloride 50 mg - zc 66 round orange
bethanechol chloride 25 mg - pliva 325 round yellow
toremifene citrate 60 mg - to 60 round white
leflunomide 10 mg - hp 43 round white
oxycodone hydrochloride 5 mg - 4810 v round white
amitriptyline hydrochloride 75 mg - 2104 v round orange
guaifenesin 400 mg - 44 532 round blue
labetalol hydrochloride 200 mg - 4365 teva round white
risperidone 0.5 mg - m r5 round brown
meclizine hydrochloride 25 mg - 21g round pink
nadolol 20 mg - kpi 232 corgard 20 round blue
ropinirole hydrochloride 2 mg - cor 204 round pink
lovastatin 20 mg - cti 142 round white
thioridazine hydrochloride 10 mg - mp 12 round yellow
clozapine 25 mg - c 7 m round orange
propafenone hydrochloride 150 mg - gs tf5 round white
melphalan 2 mg - gx eh3 a round white
dicyclomine hydrochloride 20 mg - m d6 round blue
lithium carbonate 300 mg - 54 452 round white
enalapril maleate 20 mg - m e18 round blue
acetaminophen 300 mgcodeine phosphate 30 mg - 3 m round white
bupropion hydrochloride 200 mg - 738 round white
amitriptyline hydrochloride 100 mg - m 38 round orange
primaquine phosphate 15 mg - w p97 round pink
estradiol 1 mg - watson 487 round grey
aripiprazole 20 mg - a 010 20 round white
eletriptan hydrobromide 40 mg - rep40 pfizer round orange
dexamethasone 2 mg - 54 662 round white
digoxin 250 ug - lanoxin x3a round white
fluvoxamine maleate 100 mg - e 157 round brown
lisinopril 5 mg - m l23 round orange
propranolol hydrochloride 20 mg - mylan 183 20 round blue
thioridazine hydrochloride 50 mg - m 59 50 round orange
doxazosin mesylate 1 mg - apo 093 round white
flecainide acetate 50 mg - b 859 round white
doxycycline hyclate 100 mg - ww 112 round orange
dicyclomine hydrochloride 20 mg - lan 1282 round blue
lisinopril 20 mg - w 941 round yellow
triamterene 75 mghydrochlorothiazide 50 mg - watson 348 round yellow
ondansetron 4 mg - z4 round white
propranolol hydrochloride 60 mg - mylan pr60 60 round purple
mirtazapine 30 mg - 93 7304 round white
dronabinol 10 mg - um round orange
nystatin 500000 [usp'u] - mp 83 round brown
risperidone 3 mg - sz z5 round pink
bupropion hydrochloride 200 mg - wpi 3385 round white
lisinopril 2.5 mg - watson 405 round white
lovastatin 10 mg - 926 teva round orange
oxybutynin chloride 5 mg - m o 5 round green
- 633 round white
topiramate 50 mg - ig 279 round yellow
meperidine hydrochloride 100 mg - 382 b round white
azilsartan kamedoxomil 40 mg - asl 40 round white
lovastatin 40 mg - 635 round yellow
bethanechol chloride 5 mg - bcl 5 832 round white
alendronate sodium 70 mg - 638 round white
bupropion hydrochloride 100 mg - wellbutrin sr 100 round blue
nadolol 80 mg - sz467 round white
bupropion hydrochloride 150 mg - a 133 round yellow
- 54-639 round blue
saxagliptin hydrochloride 5 mg - 5 4215 round pink
- dp 331 round green
medroxyprogesterone acetate 10 mg - provera 10 round white
metformin hydrochloride 500 mg - i45 round white
furosemide 80 mg - lasix 80 round white
clarithromycin 250 mg - 54 271 round white
methazolamide 25 mg - eff 21 round white
levonorgestrel 90 ugethinyl estradiol 20 ug - 295 watson round white
hydrochlorothiazide 25 mg - d 27 round pink
mirtazapine 15 mg - tz 1 round white
venlafaxine hydrochloride 225 mg - os304 round white
lisinopril 40 mg - rx535 round yellow
imatinib mesylate 100 mg - nvr sa round yellow
aspirin 325 mg - t round orange
lisinopril 20 mghydrochlorothiazide 12.5 mg - lh2 m round yellow
hydrocortisone 20 mg - cortef 20 round white
oxycodone hydrochloride 5 mgacetaminophen 325 mg - endo 602 round white
atenolol 50 mgchlorthalidone 25 mg - m 63 round white
metoclopramide hydrochloride 5 mg - bl 92 round white
amlodipine besylate 2.5 mg - 2108 v round white
ropinirole hydrochloride 4 mg - 977 hh round brown
phenylephrine hydrochloride 5 mg - fr4 round pink
clonidine hydrochloride 0.2 mgchlorthalidone 15 mg - m 27 round yellow
risperidone 1 mg - m r11 round white
amoxicillin 200 mgclavulanate potassium 28.5 mg - ggn2 round pink
flavoxate hydrochloride 100 mg - e58 round white
aspirin 81 mg - l467 round orange
hydroxyzine hydrochloride 50 mg - pa 309 round white
levonorgestrel 0.15 mgethinyl estradiol 0.03 mg - tv 074 round purple
donepezil hydrochloride 5 mg - 5 aricept round white
carbamazepine 100 mg - t 100 mg round yellow
bupropion hydrochloride 150 mg - g 2444 round yellow
clozapine 25 mg - clozaril 25 round yellow
phenobarbital 64.8 mg - 5013 v round white
benztropine mesylate 2 mg - cor 145 round white
tranylcypromine sulfate 10 mg - 250 k round pink
darifenacin 15 mg - df 15 round orange
olmesartan medoxomil 20 mgamlodipine besylate 5 mghydrochlorothiazide 12.5 mg - c51 round orange
escitalopram oxalate 5 mg - f 53 round white
fenofibrate 50 mg - fh 50 round white
enalapril maleate 2.5 mg - m e15 round white
diclofenac sodium 75 mg - cti 103 round white
amitriptyline hydrochloride 50 mg - gg431 round brown
hydroxyzine hydrochloride 25 mg - m h25 round blue
cyclobenzaprine hydrochloride 5 mg - m 771 round blue
glipizide 5 mg - mylan g1 round white
alendronate sodium 5 mg - a 5 round white
mirtazapine 30 mg - tz 2 round white
glipizide 2.5 mg - gxl 2 5 round blue
oxybutynin chloride 15 mg - ku 272 round white
calcium carbonate 750 mg - as round
dextroamphetamine saccharate 1.25 mgamphetamine aspartate monohydrate 1.25 mgdextroamphetamine sulfate 1.25 mgamphetamine sulfate 1.25 mg - 5 dp round white
finasteride 1 mg - 714 round red
donepezil hydrochloride 10 mg - 10 aricept round yellow
- tolinase 100 round white
nisoldipine 25.5 mg - m ne 25 round orange
desipramine hydrochloride 10 mg - e 29 round white
- 428 round orange
amitriptyline hydrochloride 50 mg - m 36 round brown
metformin hydrochloride 500 mg - e 213 round white
prednisone 5 mg - dan dan 5052 round white
donepezil hydrochloride 10 mg - x 12 round yellow
quetiapine fumarate 100 mg - seroquel 100 round yellow
ciprofloxacin hydrochloride 250 mg - p 250 round white
diclofenac potassium 50 mg - gg977 round white
amiloride hydrochloride anhydrous 5 mg - par 117 round yellow
escitalopram oxalate 20 mg - 251 ig round white
famotidine 20 mg - m f1 round yellow
lamotrigine 150 mg - l123 round white
lorazepam 0.5 mg - 240 0 5 watson round white
timolol maleate 10 mg - m 221 round green
bupropion hydrochloride 300 mg - wpi 3332 round white
fexofenadine hydrochloride 180 mg - 93 7253 round orange
flavoxate hydrochloride 100 mg - g 181 round white
bupropion hydrochloride 100 mg - 736 round white
metoprolol tartrate 25 mg - c 73 round white
naproxen sodium 220 mg - 220 round blue
atenolol 50 mg - 93 752 teva round white
oxybutynin chloride 10 mg - ku 271 round white
tiagabine hydrochloride 4 mg - c 404 round yellow
hydralazine hydrochloride 25 mg - pliva 327 round orange
famotidine 40 mg - cti 122 round white
norethindrone 1 mgethinyl estradiol 0.035 mg - b 342 round white
carbamazepine 200 mg - 109 teva round white
- dan 5552 round white
amantadine hydrochloride 100 mg - 832 amt round orange
lovastatin 40 mg - 40 round orange
clopidogrel bisulfate 75 mg - r 196 round white
glipizide 10 mg - apo glp 10 round white
pioglitazone hydrochloride 30 mg - teva 7272 round white
prochlorperazine maleate 5 mg - gg952 5 round yellow
rifaximin 200 mg - sx round pink
labetalol hydrochloride 300 mg - e118 round white
sertraline hydrochloride 25 mg - s 21 round white
flecainide acetate 100 mg - 54070 round white
chlorothiazide 250 mg - westward 209 round white
atenolol 100 mgchlorthalidone 25 mg - tenoretic 117 round white
diltiazem hydrochloride 30 mg - marion 1771 round green
acamprosate calcium 333 mg - 435 round white
escitalopram oxalate 20 mg - ig 251 round white
bupropion hydrochloride 200 mg - a161 round red
escitalopram oxalate 5 mg - ig 249 round white
prasugrel hydrochloride 5 mg - s77 round pink
bupropion hydrochloride 300 mg - a102 round white
hyoscyamine sulfate 0.125 mg - 644 round white
venlafaxine hydrochloride 37.5 mg - y02 round pink
escitalopram oxalate 10 mg - 5851 10 round white
levothyroxine sodium 0.175 mg - jsp 563 round purple
metoclopramide hydrochloride 5 mg - tv 2204 round white
acetaminophen 500 mg - fr1 round white
hyoscyamine sulfate 0.12 mgsodium phosphate, monobasic, monohydrate 40.8 mgphenyl salicylate 36.2 mgmethenamine 81.6 mgmethylene blue 10.8 mg - 293 round purple
chlorpheniramine maleate 4 mgphenylephrine hydrochloride 10 mg - 44 525 round white
demeclocycline hydrochloride 300 mg - an 55 round red
calcium acetate 667 mg - cyp910 round white
naltrexone hydrochloride 50 mg - b 50 902 round white
hydralazine hydrochloride 50 mg - pliva 328 round orange
promethazine hydrochloride 25 mg - z c 0 2 round white
pioglitazone hydrochloride 30 mgmetformin hydrochloride 1000 mg - 4833x 30 1000 round white
meprobamate 400 mg - 591 a round white
adefovir dipivoxil 10 mg - gilead 10 round white
propranolol hydrochloride 80 mg - pliva 471 round yellow
clonazepam 2 mg - 834 teva round white
fluphenazine hydrochloride 10 mg - gg490 round brown
indapamide 1.25 mg - m 69 round pink
diclofenac sodium 100 mg - gg 904 round pink
metformin hydrochloride 1000 mg - g 45 1000 round white
benztropine mesylate 2 mg - 2327 v round white
eszopiclone 3 mg - s193 round blue
trospium chloride 20 mg - l 1 round yellow
midodrine hydrochloride 10 mg - mh 3 m round white
captopril 25 mg - ww 172 round white
meperidine hydrochloride 50 mg - 381 b round white
nifedipine 30 mg - ku 260 round pink
chloroquine phosphate 500 mg - cn500 round white
venlafaxine hydrochloride 100 mg - y05 round pink
acetaminophen 300 mgcodeine phosphate 60 mg - 4 93 350 round white
risedronate sodium 150 mg - apo ris 150 round blue
lamotrigine 200 mg - lamictal 200 round white
glipizide 5 mg - wpi 844 round orange
olanzapine 5 mg - apo ola 5 round white
cyproheptadine hydrochloride 4 mg - par 043 round white
nifedipine 60 mg - eln 60 round brown
carvedilol 3.125 mg - g round white
ibuprofen 200 1 - ibu 200 round brown
bethanechol chloride 10 mg - an 572 round white
levonorgestrel 0.15 mgethinyl estradiol 0.025 mg - tv 075 round pink
naproxen sodium 275 mg - nps 275 round blue
fosinopril sodium 10 mghydrochlorothiazide 12.5 mg - i 3 round white
levothyroxine sodium 125 ug - synthroid 125 round brown
metoclopramide hydrochloride 5 mg - wpi 2228 round green
sumatriptan succinate 50 mg - sa 50 round white
venlafaxine hydrochloride 25 mg - 9 3 199 round orange
terbinafine hydrochloride 250 mg - c134 round white
acetazolamide 250 mg - lan 1050 round white
exemestane 25 mg - 2858 round white
anastrozole 1 mg - m 34 round white
desloratadine 5 mg - m d17 round red
olmesartan medoxomil 40 mgamlodipine besylate 10 mghydrochlorothiazide 12.5 mg - c55 round red
demeclocycline hydrochloride 150 mg - c 115 round pink
letrozole 2.5 mg - 54 753 round white
sumatriptan succinate 50 mg - m s7 round white
repaglinide 2 mg - 747 c round pink
prochlorperazine maleate 5 mg - 93 9643 round yellow
folic acid 1 mg - 3162 v round yellow
midodrine hydrochloride 10 mg - us 10 213 round purple
felodipine 2.5 mg - mp 771 round green
ropinirole hydrochloride 12 mg - m re12 round green
hydroxyzine hydrochloride 10 mg - 3615 v round orange
labetalol hydrochloride 200 mg - watson 606 round white
- b 143 round white
paroxetine hydrochloride hemihydrate 12.5 mg - m p3 round white
albuterol sulfate 2 mg - mp 47 round white
donepezil hydrochloride 10 mg - zf 15 round white
imipramine hydrochloride 10 mg - mp 4 round yellow
timolol maleate 5 mg - m 55 round green
amlodipine besylate 10 mg - z 5 round white
anastrozole 1 mg - teva a10 round white
morphine sulfate 30 mg - abg 30 round purple
bupropion hydrochloride 100 mg - wpi 858 round white
medroxyprogesterone acetate 5 mg - 555 873 b round white
furosemide 20 mg - 54 840 round white
hydroxyzine hydrochloride 10 mg - a 75 round white
hydroxychloroquine sulfate 200 mg - ww28 round white
hydroxyzine hydrochloride 10 mg - k 10 round white
captopril 100 mg - m c4 round white
morphine sulfate 15 mg - e652 15 round blue
dicyclomine hydrochloride 20 mg - ww 27 round blue
trihexyphenidyl hydrochloride 5 mg - dan dan 5337 round white
nifedipine 90 mg - 90 adalat cc round pink
orphenadrine citrate 100 mg - nl4 round white
desogestrel 0.15 mgethinyl estradiol 0.025 mg - b 335 round pink
amlodipine besylate 10 mgolmesartan medoxomil 40 mg - c77 round red
pilocarpine hydrochloride 7.5 mg - lci 1407 round blue
nifedipine 30 mg - m ne 30 round white
amlodipine besylate 5 mg - 2109 v round white
progesterone 100 mg - ak round pink
oxybutynin chloride 5 mg - 4853 v round blue
amlodipine besylate 2.5 mg - 237 ig round white
lovastatin 60 mg - 60 round orange
pravastatin sodium 40 mg - apo pra 40 round green
promethazine hydrochloride 50 mg - gg 235 round pink
hydrochlorothiazide 25 mg - lci 1413 round orange
diclofenac sodium 50 mg - gg738 round brown
amitriptyline hydrochloride 25 mg - gg44 round green
zafirlukast 10 mg - r 625 round pink
clonidine hydrochloride 0.2 mg - mp 658 round white
acarbose 25 mg - p210 25 round white
- deltasone 2.5 round pink
lisinopril 20 mghydrochlorothiazide 12.5 mg - rx537 round yellow
desipramine hydrochloride 50 mg - norpramin 50 round green
diclofenac sodium 75 mg - r 551 round white
drospirenone 3 mgethinyl estradiol 0.03 mg - do round yellow
nitroglycerin 0.6 mg - n 6 round white
nitroglycerin 0.4 mg - n 4 round white
nitroglycerin 0.3 mg - n 3 round white
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1 Indications And Usage
Edluar (zolpidem tartrate) sublingual tablet is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
The clinical trials performed with Zolpidem tartrate in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment [see Clinical Studies (14)].
Edluar (zolpidem tartrate) sublingual tablet is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate has been shown to decrease sleep latency for up to 35 days in controlled clinical studies. (1 )
2 Dosage And Administration
The dose of Edluar should be individualized.
- Adult dose: 10 mg once daily immediately before bedtime. (
2.1 ) Edluar sublingual tablet should be placed under the tongue, where it will disintegrate. The tablet should not be swallowed and the tablet should not be taken with water. (2.4 )- Elderly/Debilitated patients/Hepatic impairment: 5 mg once daily immediately before bedtime. (
2.2 )- Downward dosage adjustment may be necessary when used with CNS depressants. (
2.3 )- Edluar should not be administered with or immediately after a meal. (
2.4 )2.1 Dosage in adults
The recommended dose for Edluar for adults is 10 mg once daily immediately before bedtime. The total Edluar daily dose should not exceed 10 mg.2.2 Special populations
Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of Edluar in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].2.3 Use with CNS depressants
Dosage adjustment may be necessary when Edluar is combined with other CNS-depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].2.4 Administration
The effect of Edluar may be slowed by ingestion with or immediately after a meal. Edluar should not be given with or immediately after a meal.
Edluar sublingual tablet should be placed under the tongue, where it will disintegrate. The tablet should not be swallowed and the tablet should not be taken with water.
3 Dosage Forms And Strengths
Edluar is available in 5 mg and 10 mg strength tablets for sublingual administration. Tablets are not scored.
Edluar 5 mg sublingual tablets are round white, flat-faced, bevel-edged, with debossed on one side.
Edluar 10 mg sublingual tablets are round white, flat-faced, bevel-edged, with debossed on one side.
5 mg and 10 mg sublingual tablets. Tablets not scored. (3 )
4 Contraindications
Edluar is contraindicated in patients with known hypersensitivity to zolpidem tartrate or to any of the inactive ingredients in the formulation. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.2) and Description (11)].
Known hypersensitivity to zolpidem tartrate or to any of the inactive ingredients in the formulation. (4 )
5 Warnings And Precautions
- Need to evaluate for co-morbid diagnosis. Reevaluate if insomnia persists after 7 to 10 days of use. (
5.1 )- Severe anaphylactic and anaphylactoid reactions: angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur. (
5.2 )- Abnormal thinking, behaviour changes and complex behaviors: May include "sleep-driving" and hallucinations. Immediately evaluate any new onset behavioural changes. (
5.3 )- Depression: Worsening of depression or, suicidal thinking may occur. Prescribe the least amount feasible to avoid intentional overdose. (
5.3 ,5.6 )- Withdrawal effects: Symptoms may occur with rapid dose reduction or discontinuation. (
5.4 ,9.3 )- CNS depressant effects: Use can impair alertness and motor coordination. If used in combination with other CNS depressants, dose reductions may be needed due to additive effects. Do not use with alcohol. (
2.3 ,5.5 )- Elderly/debilitated patients: Use lower dose due to impaired motor, cognitive performance after repeated exposure, and increased sensitivity. (
2.2 ,5.6 )- Patients with hepatic impairment, mild to moderate COPD, impaired drug metabolism or hemodynamic responses, mild to moderate sleep apnea: Use with caution and monitor closely. (
5.6 )5.1 Need to evaluate for co-morbid diagnoses
Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including zolpidem tartrate.5.2 Severe anaphylactic and anaphylactoid reactions
Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zolpidem tartrate. Some patients have had additional symptoms such as dyspnea, throat closing or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the throat, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with Edluar should not be rechallenged with the drug.5.3 Abnormal thinking and behavioral changes
A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of sedative/hypnotics. Some of these changes may be characterized by decreased inhibition (e.g. aggressiveness and extroversion that seemed out of character), similar to effects produced by alcohol and other CNS depressants. Visual and auditory hallucinations have been reported as well as behavioral changes such as bizarre behavior, agitation and depersonalization. In controlled trials, <1% of adults with insomnia who received zolpidem tartrate reported hallucinations. In a clinical trial, 7.4% of pediatric patients with insomnia associated with attention-deficit/hyperactivity disorder (ADHD), who received zolpidem reported hallucinations [see Use in Specific Populations (8.4)].
Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported with sedative-hypnotics, including zolpidem tartrate. These events can occur in sedative-hypnotic-naive as well as in sedative-hypnotic-experienced persons. Although behaviors such as "sleep-driving" may occur with Edluar alone at therapeutic doses, the use of alcohol and other CNS depressants with Edluar appears to increase the risk of such behaviors, as does the use of Edluar at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of Edluar should be strongly considered for patients who report a "sleep-driving" episode. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with "sleep-driving", patients usually do not remember these events. Amnesia, anxiety and other neuro-psychiatric symptoms may occur unpredictably.
In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides), has been reported in association with the use of sedative/hypnotics.
It can rarely be determined with certainty whether a particular instance of the abnormal behaviors uled above is drug-induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.5.4 Withdrawal effects
Following rapid dose decrease or abrupt discontinuation of sedative/hypnotics, there have been reports of signs and symptoms similar to those associated with withdrawal from other CNS-depressant drugs [see Drug Abuse and Dependence (9)].5.5 CNS depressant effects
Edluar, like other sedative/hypnotic drugs, has CNS-depressant effects. Due to the rapid onset of action, Edluar should be ingested immediately prior to going to bed. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness or motor coordination such as operating machinery or driving a motor vehicle after ingesting the drug, including potential impairment of the performance of such activities that may occur the day following ingestion of Edluar. Zolpidem tartrate showed additive effects when combined with alcohol and should not be taken with alcohol. Patients should also be cautioned about possible combined effects with other CNS-depressant drugs. Dosage adjustments of Edluar may be necessary when Edluar is administered with such agents because of the potentially additive effects.5.6 Special populations
Use in the elderly and/or debilitated patients:
Impaired motor and/or cognitive performance after repeated exposure or unusual sensitivity to sedative/hypnotic drugs is a concern in the treatment of elderly and/or debilitated patients. Therefore, the recommended Edluar dosage is 5 mg in the elderly and/or debilitated patients [see Dosage and Administration (2.2) and Geriatric Use (8.5)] to decrease the possibility of side effects. These patients should be closely monitored.Use in patients with concomitant illness:
Clinical experience with zolpidem tartrate in patients with concomitant systemic illness is limited. Caution is advisable in using Edluar in patients with diseases or conditions that could affect metabolism or hemodynamic responses. Although studies did not reveal respiratory depressant effects at hypnotic doses of zolpidem tartrate in normal subjects or in patients with mild to moderate chronic obstructive pulmonary disease (COPD), a reduction in the Total Arousal Index together with a reduction in lowest oxygen saturation and increase in the times of oxygen desaturation below 80% and 90% was observed in patients with mild-to-moderate sleep apnea when treated with zolpidem tartrate (10 mg) when compared to placebo. Since sedative/hypnotics have the capacity to depress respiratory drive, precautions should be taken if Edluar is prescribed to patients with compromised respiratory function. Edluar should be used with caution in patients with sleep apnea syndrome or myasthenia gravis. Post-marketing reports of respiratory insufficiency following treatment with zolpidem tartrate, most of which involved patients with pre-existing respiratory impairment, have been received.
Data in end-stage renal failure patients repeatedly treated with zolpidem tartrate did not demonstrate drug accumulation or alterations in pharmacokinetic parameters. No dosage adjustment of Edluar in renally impaired patients is required; however, these patients should be closely monitored [see Clinical Pharmacology (12.3)].
A study in subjects with hepatic impairment treated with zolpidem tartrate did reveal prolonged elimination in this group; therefore, treatment with Edluar should be initiated with 5 mg in patients with hepatic compromise, and they should be closely monitored [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)].Use in patients with depression:
As with other sedative/hypnotic drugs, Edluar should be administered with caution to patients exhibiting signs or symptoms of depression. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional over-dosage is more common in this group of patients; therefore, the least amount of drug that is feasible should be prescribed for the patient at any one time.Pediatric patients:
Edluar is not recommended for use in children. Safety and effectiveness of Edluar have not been established in pediatric patients below the age of 18. In an 8-week study in pediatric patients (aged 6-17 years) with insomnia associated with ADHD, an oral solution of zolpidem did not decrease sleep latency compared to placebo. Hallucinations were reported in 7.4% of the pediatric patients who received zolpidem; none of the pediatric patients who received placebo reported hallucinations [see Use in Specific Populations (8.4)].
6 Adverse Reactions
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
- Most commonly observed adverse events using zolpidem tartrate were:
          -Short-term (<10 nights): Drowsiness, dizziness and diarrhea;
          -Long-term (28-35 nights): Dizziness and drugged feelings (6.1 )6.1 Clinical trials experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating incidence rates.Associated with discontinuation of treatment:
Approximately 4% of 1,701 patients who received zolpidem tartrate at all doses (1.25 to 90 mg) in U.S. premarketing clinical trials discontinued treatment because of an adverse reaction. Reactions most commonly associated with discontinuation from U.S. trials were daytime drowsiness (0.5%), dizziness (0.4%), headache (0.5%), nausea (0.6%), and vomiting (0.5%).
Approximately 4% of 1,959 patients who received zolpidem tartrate at all doses (1 to 50 mg) in similar foreign trials discontinued treatment because of an adverse reaction. Reactions most commonly associated with discontinuation from these trials were daytime drowsiness (1.1%), dizziness/vertigo (0.8%), amnesia (0.5%), nausea (0.5%), headache (0.4%), and falls (0.4%).
Data from a clinical study in which selective serotonin reuptake inhibitor (SSRI)-treated patients were given zolpidem tartrate revealed that four of the seven discontinuations during double-blind treatment with zolpidem (n=95) were associated with impaired concentration, continuing or aggravated depression, and manic reaction; one patient treated with placebo (n=97) was discontinued after an attempted suicide.Most commonly observed adverse reactions in controlled trials:
During short-term treatment (up to 10 nights) with zolpidem tartrate at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically significant differences from placebo-treated patients were drowsiness (reported by 2% of zolpidem patients), dizziness (1%), and diarrhea (1%). During longer-term treatment (28 to 35 nights) with zolpidem tartrate at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically significant differences from placebo-treated patients were dizziness (5%) and drugged feelings (3%).Adverse reactions observed at an incidence of ≥1% in controlled trials:
The following tables enumerate treatment-emergent adverse event frequencies that were observed at an incidence equal to 1% or greater among patients with insomnia who received zolpidem tartrate and at a greater incidence than placebo in U.S. placebo-controlled trials. Events reported by investigators were classified utilizing a modified World Health Organization (WHO) dictionary of preferred terms for the purpose of establishing event frequencies. The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice, in which patient characteristics and other factors differ from those that prevailed in these clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigators involving related drug products and uses, since each group of drug trials is conducted under a different set of conditions. However, the cited figures provide the physician with a basis for estimating the relative contribution of drug and nondrug factors to the incidence of side effects in the population studied.
The following table was derived from a pool of 11 placebo-controlled short-term U.S. efficacy trials involving zolpidem in doses ranging from 1.25 to 20 mg. The table is limited to data from doses up to and including 10 mg, the highest dose recommended for use.
TABLE 1: Incidence of Treatment-Emergent Adverse Experiences in Placebo-Controlled Clinical Trials with zolpidem tartrate lasting up to 10 nights (Percentage of patients reporting) Body System/Adverse Event* Zolpidem tartrate(≤ 10 mg)(n=685) Placebo(n=473) *Reactions reported by at least 1% of patients treated with oral zolpidem and at a greater frequency than placebo. Central and Peripheral Nervous System Headache 7 6 Drowsiness 2 - Dizziness 1 - Gastrointestinal System Diarrhea 1 -
The following table was derived from a pool of three placebo-controlled long-term efficacy trials involving oral zolpidem. These trials involved patients with chronic insomnia who were treated for 28 to 35 nights with zolpidem at doses of 5, 10, or 15 mg. The table is limited to data from doses up to and including 10 mg, the highest dose recommended for use. The table includes only adverse events occurring at an incidence of at least 1% for zolpidem patients.
TABLE 2: Incidence of Treatment-Emergent Adverse Experiences in Placebo-Controlled Clinical Trials with zolpidem tartrate lasting up to 35 nights (Percentage of patients reporting) Body System/Adverse Event* Zolpidem tartrate(≤ 10 mg)(n=152) Placebo(n=161) *Reactions reported by at least 1% of patients treated with oral zolpidem and at a greater frequency than placebo. Autonomic Nervous System Dry mouth 3 1 Body as a Whole Allergy 4 1 Back pain 3 2 Influenza-like symptoms 2 - Chest pain 1 - Cardiovascular System Palpitation 2 - Central and Peripheral Nervous System Drowsiness 8 5 Dizziness 5 1 Lethargy 3 1 Drugged feeling 3 - Lightheadedness 2 1 Depression 2 1 Abnormal dreams 1 - Amnesia 1 - Sleep disorder 1 - Gastrointestinal System Diarrhea 3 2 Abdominal pain 2 2 Constipation 2 1 Respiratory System Sinusitis 4 2 Pharyngitis 3 1 Skin and Appendages Rash 2 1 Dose relationship for adverse reactions associated with oral zolpidem:
There is evidence from dose comparison trials suggesting a dose relationship for many of the adverse reactions associated with oral zolpidem use, particularly for certain CNS and gastrointestinal adverse events.Oral tissue-related adverse reactions to Edluar:
The effect of chronic daily administration of Edluar on oral tissue was evaluated in a 60-day open-label study in 60 insomniac patients. One patient developed transient sublingual erythema, and another transient paresthesia of the tongue.Adverse event incidence across the entire preapproval oral zolpidem database: Zolpidem was administered to 3,660 subjects in clinical trials throughout the U.S., Canada, and Europe. Treatment-emergent adverse events associated with clinical trial participation were recorded by clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals experiencing treatment-emergent adverse events, similar types of untoward events were grouped into a smaller number of standardized event categories and classified utilizing a modified World Health Organization (WHO) dictionary of preferred terms.
The frequencies presented, therefore, represent the proportions of the 3,660 individuals exposed to zolpidem, at all doses, who experienced an event of the type cited on at least one occasion while receiving zolpidem. All reported treatment-emergent adverse events are included, except those already uled in the table above of adverse events in placebo-controlled studies, those coding terms that are so general as to be uninformative, and those events where a drug cause was remote. It is important to emphasize that, although the events reported did occur during treatment with zolpidem, they were not necessarily caused by it.
Adverse events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in greater than 1/100 subjects; infrequent adverse events are those occurring in 1/100 to 1/1,000 patients; rare events are those occurring in less than 1/1,000 patients.
Autonomic nervous system: Infrequent: increased sweating, pallor, postural hypotension, syncope. Rare: abnormal accommodation, altered saliva, flushing, glaucoma, hypotension, impotence, increased saliva, tenesmus.
Body as a whole: Frequent: asthenia. Infrequent: edema, falling, fever, malaise, trauma.
Rare: allergic reaction, allergy aggravated, anaphylactic shock, face edema, hot flashes, increased ESR, pain, restless legs, rigors, tolerance increased, weight decrease.
Cardiovascular system: Infrequent: cerebrovascular disorder, hypertension, tachycardia.
Rare: angina pectoris, arrhythmia, arteritis, circulatory failure, extrasystoles, hypertension aggravated, myocardial infarction, phlebitis, pulmonary embolism, pulmonary edema, varicose veins, ventricular tachycardia.
Central and peripheral nervous system: Frequent: ataxia, confusion, euphoria, headache, insomnia, vertigo. Infrequent: agitation, anxiety, decreased cognition, detached, difficulty concentrating, dysarthria, emotional lability, hallucination, hypoesthesia, illusion, leg cramps, migraine, nervousness, paresthesia, sleeping (after daytime dosing), speech disorder, stupor, tremor. Rare: abnormal gait, abnormal thinking, aggressive reaction, apathy, appetite increased, decreased libido, delusion, dementia, depersonalization, dysphasia, feeling strange, hypokinesia, hypotonia, hysteria, intoxicated feeling, manic reaction, neuralgia, neuritis, neuropathy, neurosis, panic attacks, paresis, personality disorder, somnambulism, suicide attempts, tetany, yawning.
Gastrointestinal system: Frequent: dyspepsia, hiccup, nausea. Infrequent: anorexia, constipation, dysphagia, flatulence, gastroenteritis, vomiting. Rare: enteritis, eructation, esophagospasm, gastritis, hemorrhoids, intestinal obstruction, rectal hemorrhage, tooth caries.
Hematologic and lymphatic system: Rare: anemia, hyperhemoglobinemia, leukopenia, lymphadenopathy, macrocytic anemia, purpura, thrombosis.
Immunologic system: Infrequent: infection. Rare: abscess herpes simplex herpes zoster, otitis externa, otitis media.
Liver and biliary system: Infrequent: abnormal hepatic function, increased SGPT. Rare: bilirubinemia, increased SGOT.
Metabolic and nutritional: Infrequent: hyperglycemia, thirst. Rare: gout, hypercholesteremia, hyperlipidemia, increased alkaline phosphatase, increased BUN, periorbital edema.
Musculoskeletal system: Frequent: arthralgia, myalgia. Infrequent: arthritis. Rare: arthrosis, muscle weakness, sciatica, tendinitis.
Reproductive system: Infrequent: menstrual disorder, vaginitis. Rare: breast fibroadenosis, breast neoplasm, breast pain.
Respiratory system: Frequent: upper respiratory infection. Infrequent: bronchitis, coughing, dyspnea, rhinitis. Rare: bronchospasm, epistaxis, hypoxia, laryngitis, pneumonia.
Skin and appendages: Infrequent: pruritus. Rare: acne, bullous eruption, dermatitis, furunculosis, injection-site inflammation, photosensitivity reaction, urticaria.
Special senses: Frequent: diplopia, vision abnormal. Infrequent: eye irritation, eye pain, scleritis, taste perversion, tinnitus. Rare: conjunctivitis, corneal ulceration, lacrimation abnormal, parosmia, photopsia.
Urogenital system: Infrequent: urinary tract infection. Infrequent: cystitis, urinary incontinence. Rare: acute renal failure, dysuria, micturition frequency, nocturia, polyuria, pyelonephritis, renal pain, urinary retention.
7 Drug Interactions
For details of drug interactions, please refer to Clinical Pharmacology (12.3).
- CNS-depressants: Enhanced CNS-depressant effects with combination use.
- Use with alcohol causes additive psychomotor impairment. (
7.1 ,12.3 )- Imipramine: Decreased alertness observed with combination use. (
7.1 ,12.3 )- Chlorpromazine: Impaired alertness and psychomotor performance observed with combination use. (
7.1 ,12.3 )- Rifampin: Combination use decreases exposure to, and effect of zolpidem. (
7.2 ,12.3 )- Ketoconazole: Combination use increases exposure to, and effect of zolpidem. (
7.2 ,12.3 )7.1 CNS-active drugs
Any drug with CNS-depressant effects could potentially enhance the CNS-depressant effects of zolpidem.
Imipramine in combination with zolpidem produced an additive effect of decreased alertness. Similarly, chlorpromazine in combination with zolpidem produced an additive effect of decreased alertness and psychomotor performance. These drugs did not show any significant pharmacokinetic interaction.
A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem. The lack of a drug interaction following single-dose administration does not predict a lack following chronic administration.
An additive effect on psychomotor performance between alcohol and oral zolpidem was demonstrated [see Warnings and Precautions: CNS depressant effects (5.5)]. Concomitant administration of zolpidem and sertraline increased zolpidem Cmax (43%) and decreased Tmax (53%), whether or not these changes alter the pharmacodynamic effect of zolpidem is unknown.7.2 Drugs that affect drug metabolism via cytochrome P450
Some compounds known to inhibit CYP3A may increase exposure to zolpidem. The effect of inhibitors of other P450 enzymes has not been carefully evaluated.
Co-administration of multiple doses of rifampin and a single dose of zolpidem tartrate (20 mg) given 17 hours after the last dose of rifampin showed significant reductions of the AUC (73%), Cmax (58%), and T1/2 (36%) of zolpidem together with significant reductions in the pharmacodynamic effects of zolpidem tartrate.
Co-administration of a single dose of zolpidem tartrate with 4 doses of ketoconazole, a potent CYP3A4 inhibitor increased Cmax of zolpidem (30%) and the total AUC of zolpidem (70%) compared to zolpidem alone and prolonged the elimination half-life (30%) along with an increase in the pharmacodynamic effects of zolpidem. Consideration should be given to using a lower dose of zolpidem when ketoconazole and zolpidem are given together. Patients should be advised that use of Edluar with ketoconazole may enhance the sedative effects.7.3 Drug-laboratory test interactions
Zolpidem is not known to interfere with commonly employed clinical laboratory tests. In addition, clinical data indicate that zolpidem does not cross-react with benzodiazepines, opiates, barbiturates, cocaine, cannabinoids, or amphetamines in two standard urine drug screens.
8 Use In Specific Populations
- Pregnancy: Based on animal data, zolpidem may cause fetal harm. (
8.1 )- Nursing mothers: Zolpidem is excreted in human milk. (
8.3 )- Pediatric use: Safety and effectiveness not established. Hallucinations (incidence rate 7.4%) and other psychiatric and/or nervous system adverse reactions were observed frequently in a study of pediatric patients with Attention-Deficit/Hyperactivity Disorder. (
5.6 ,8.4 )8.1 Pregnancy
Pregnancy Category C:
There are no adequate and well-controlled studies of Edluar in pregnant women. Edluar should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Studies to assess the effects on children whose mothers took zolpidem during pregnancy have not been conducted. There is a published case report documenting the presence of zolpidem in human umbilical cord blood. Children born to mothers taking sedative-hypnotic drugs may be at some risk for withdrawal symptoms from the drug during the postnatal period. In addition, neonatal flaccidity has been reported in infants born to mothers who received sedative-hypnotic drugs during pregnancy.
Administration of zolpidem to pregnant rats and rabbits resulted in adverse effects on offspring development at doses greater than the maximum recommended human dose (MRHD) of 10 mg/day (8 mg/day zolpidem base); however, teratogenicity was not observed.
When zolpidem was administered at oral doses of 4, 20, and 100 mg base/kg (approximately 5, 24, and 120 times the MRHD on a mg/m2 basis) to pregnant rats during the period of organogenesis, dose-related decreases in fetal skull ossification occurred at all but the lowest dose, which is approximately 5 times the MRHD on a mg/m2 basis. In rabbits treated during organogenesis with zolpidem at oral doses of 1, 4, and 16 mg base/kg (approximately 2.5, 10, and 40 times the MRHD on a mg/m2 basis), increased embryo-fetal death and incomplete fetal skeletal ossification occurred at the highest dose. The no-effect dose for embryo-fetal toxicity in rabbits is approximately 10 times the MRHD on a mg/m2 basis. Administration of zolpidem to rats at oral doses of 4, 20, and 100 mg base/kg (approximately 5, 24, and 120 times the MRHD on a mg/m2 basis) during the latter part of pregnancy and throughout lactation produced decreased offspring growth and survival at all but the lowest dose, which is approximately 5 times the MRHD on a mg/m2 basis.8.2 Labor and delivery
Edluar has no established use in labor and delivery [see Pregnancy (8.1)].8.3 Nursing mothers
Zolpidem is excreted into human milk. Studies in lactating mothers indicate that the t1/2 of zolpidem is similar to that in non-lactating women (2.6 ± 0.3 hours). The effect of zolpidem on the nursing infant is not known. Caution should be exercised when Edluar is administered to a nursing mother.8.4 Pediatric use
Safety and effectiveness of Edluar have not been established in pediatric patients below the age of 18.
In an 8-week controlled study, 201 pediatric patients (aged 6-17 years) with insomnia associated with attention-deficit/hyperactivity disorder (90% of the patients were using psychoanaleptics) were treated with an oral solution of zolpidem (n=136), or placebo (n=65). Zolpidem did not significantly decrease latency to persistent sleep, compared to placebo, as measured by polysomnography after 4 weeks of treatment. Psychiatric and nervous system disorders comprised the most frequent (>5%) treatment-emergent adverse reactions observed with zolpidem versus placebo and included dizziness (23.5% vs. 1.5%), headache (12.5% vs. 9.2%), and hallucinations (7.4% vs. 0%) [see Warnings and Precautions (5.6)]. Ten patients on zolpidem (7.4%) discontinued treatment due to an adverse reaction.8.5 Geriatric use
A total of 154 patients in U.S. controlled clinical trials and 897 patients in non-U.S. clinical trials who received oral zolpidem were ≥60 years of age. For a pool of U.S. patients receiving zolpidem tartrate at doses of ≤10 mg or placebo, there were three adverse events occurring at an incidence of at least 3% for zolpidem and for which the zolpidem incidence was at least twice the placebo incidence (i.e., they could be considered drug-related).
Adverse Event Zolpidem Placebo Dizziness 3% 0% Drowsiness 5% 2% Diarrhea 3% 1%
A total of 30/1,959 (1.5%) non-U.S. patients receiving zolpidem tartrate reported falls, including 28/30 (93%) who were ≥70 years of age. Of these 28 patients, 23 (82%) were receiving zolpidem doses >10 mg. A total of 24/1,959 (1.2%) non-U.S. patients receiving zolpidem reported confusion, including 18/24 (75%) who were ≥70 years of age. Of these 18 patients, 14 (78%) were receiving zolpidem doses >10 mg.
The dose of Edluar in elderly patients is 5 mg to minimize adverse effects related to impaired motor and/or cognitive performance and unusual sensitivity to sedative/hypnotic drugs [see Dosage and Administration (2), Warnings and Precautions (5), Clinical Pharmacology (12) and Clinical Studies (14)].
9 Drug Abuse And Dependence
9.1 Controlled substance
Edluar contains the same active substance, zolpidem tartrate, as zolpidem tartrate oral tablets and is classified as a Schedule IV controlled substance by federal regulation.9.2 Abuse
Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug effects over time. Tolerance may occur to both desired and undesired effects of drugs and may develop at different rates for different effects.
Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, using a multidisciplinary approach, but relapse is common.
Studies of abuse potential in former drug abusers found that the effects of single doses of zolpidem tartrate 40 mg were similar, but not identical, to diazepam 20 mg, while zolpidem tartrate 10 mg was difficult to distinguish from placebo.
Because persons with a history of addiction to, or abuse of, drugs or alcohol are at increased risk for misuse, abuse, and addiction of Edluar, they should be monitored carefully when receiving Edluar or any other hypnotic.9.3 Dependence
Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist.
Sedative/hypnotics have produced withdrawal signs and symptoms following abrupt discontinuation. These reported symptoms range from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, and convulsions. The following adverse events which are considered to meet the DSM-III-R criteria for uncomplicated sedative/hypnotic withdrawal were reported during U.S. clinical trials following placebo substitution occurring within 48 hours following last zolpidem tartrate treatment: fatigue, nausea, flushing, lightheadedness, uncontrolled crying, emesis, stomach cramps, panic attack, nervousness, and abdominal discomfort. These reported adverse events occurred at an incidence of 1% or less. However, available data cannot provide a reliable estimate of the incidence, if any, of dependence during treatment at recommended doses. Post-marketing reports of abuse, dependence and withdrawal have been received.
10 Overdosage
10.1 Signs and symptoms
In postmarketing experience of overdose with zolpidem tartrate alone, or in combination with CNS-depressant agents, impairment of consciousness ranging from somnolence to coma, cardiovascular and/or respiratory compromise, and fatal outcomes have been reported.10.2 Recommended treatment
Based on data obtained for zolpidem tartrate, general symptomatic and supportive measures for overdose with Edluar should be used along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Zolpidem's sedative hypnotic effect was shown to be reduced by flumazenil and therefore may be useful; however, flumazenil administration may contribute to the appearance of neurological symptoms (convulsions). As in all cases of drug overdose, respiration, pulse, blood pressure, and other appropriate signs should be monitored and general supportive measures employed. Hypotension and CNS depression should be monitored and treated by appropriate medical intervention. Sedating drugs should be withheld following zolpidem overdosage, even if excitation occurs. The value of dialysis in the treatment of overdosage has not been determined, although hemodialysis studies in patients with renal failure receiving therapeutic doses have demonstrated that zolpidem is not dialyzable.
As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of hypnotic drug product overdosage.
11 Description
Edluar (zolpidem tartrate) sublingual tablet is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for sublingual administration.
Chemically, zolpidem tartrate is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure:
Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88.
Each Edluar tablet includes the following inactive ingredients: mannitol, colloidal silicon dioxide, silicified microcrystalline cellulose, croscarmellose sodium, saccharin sodium, and magnesium stearate.
12 Clinical Pharmacology
12.1 Mechanism of action
Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties. It interacts with a GABA-BZ receptor complex and shares some of the pharmacological properties of the benzodiazepines. In contrast to the benzodiazepines, which non-selectively bind to and activate all BZ receptor subtypes, zolpidem in vitro binds the BZ1 receptor preferentially with a high affinity ratio of the α1/α5 subunits. This selective binding of zolpidem on the BZ1 receptor is not absolute, but it may explain the relative absence of myorelaxant and anticonvulsant effects in animal studies as well as the preservation of deep sleep (stages 3 and 4) in human studies of zolpidem tartrate at hypnotic doses.12.3 Pharmacokinetics
Absorption:
Edluar (zolpidem tartrate) sublingual tablet is bioequivalent to Ambien® tablets (Sanofi-Aventis) with respect to Cmax and AUC. Similar to zolpidem tartrate oral tablets, Edluar sublingual tablet results in a pharmacokinetic profile characterized by rapid absorption.
Following administration of single 10 mg Edluar, in 18 (18-65 years of age) healthy adult subjects, the mean peak concentration (Cmax) of zolpidem was 106 ng/mL (range: 52 to 205 ng/ml) occurring at a median time (Tmax) of 82 minutes (range: 30-180 min).
A food-effect study in 18 healthy volunteers compared the pharmacokinetics of Edluar 10 mg when administered while fasting or within 20 minutes after a high fat meal. The mean AUC and Cmax were decreased by 20% and 31%, respectively, while median Tmax was prolonged by 28% (from 82 to 105 min). The half-life remained unchanged. These results suggest that, for faster sleep onset, Edluar should not be administered with or immediately after a meal.
Distribution:
Based on data obtained with oral zolpidem, the total protein binding was found to be 92.5 ± 0.1% and remained constant, independent of concentration between 40 and 790 ng/mL.
Metabolism:
Based on data obtained with oral zolpidem, zolpidem is converted to inactive metabolites that are eliminated primarily by renal excretion.
Elimination:
When Edluar was administered as a single 5 or 10 mg dose in healthy adult subjects, the mean zolpidem elimination half-life was 2.85 hours (range: 1.57-6.73 hr) and 2.65 hours (range: 1.75 to 3.77 hr) respectively.Special populations
Elderly:
In the elderly, the dose for Edluar should be 5 mg [see Warnings and Precautions (5) and Dosage and Administration (2)]. This recommendation is based on several studies with zolpidem tartrate in which the mean Cmax, T1/2, and AUC were significantly increased when compared to results in young adults. In one study of eight elderly subjects (>70 years), the means for Cmax, T1/2, and AUC significantly increased by 50% (255 vs 384 ng/mL), 32% (2.2 vs 2.9 hr), and 64% (955 vs 1,562 ng·hr/mL), respectively, as compared to younger adults (20 to 40 years) following a single 20 mg oral dose. Zolpidem did not accumulate in elderly subjects following nightly oral dosing of 10 mg for 1 week.
Hepatic impairment:
The pharmacokinetics of zolpidem tartrate in eight patients with chronic hepatic insufficiency were compared to results in healthy subjects. Following a single 20-mg oral zolpidem tartrate dose, mean Cmax and AUC were found to be two times (250 vs 499 ng/mL) and five times (788 vs 4,203 ng·hr/mL) higher, respectively, in hepatically-compromised patients. Tmax did not change. The mean half-life in cirrhotic patients of 9.9 hr (range: 4.1 to 25.8 hr) was greater than that observed in normals of 2.2 hr (range: 1.6 to 2.4 hr). Dosing with Edluar should be modified accordingly in patients with hepatic insufficiency [see Dosage and Administration (2.2) and Warnings andPrecautions (5.6)].
Renal impairment:
The pharmacokinetics of zolpidem tartrate were studied in 11 patients with end-stage 4 renal failure (mean ClCr = 6.5 ± 1.5 mL/min) undergoing hemodialysis three times a week, who were dosed with zolpidem tartrate 10 mg orally each day for 14 or 21 days. No statistically significant differences were observed for Cmax, Tmax, half-life, and AUC between the first and last day of drug administration when baseline concentration adjustments were made. On day 1, Cmax was 172 ± 29 ng/mL (range: 46 to 344 ng/mL). After repeated dosing for 14 or 21 days, Cmax was 203 ± 32 ng/mL (range: 28 to 316 ng/mL). On day 1, Tmax was 1.7 ± 0.3 hr (range: 0.5 to 3.0 hr); after repeated dosing Tmax was 0.8 ± 0.2 hr (range: 0.5 to 2.0 hr). This variation is accounted for by noting that last-day serum sampling began 10 hours after the previous dose, rather than after 24 hours. This resulted in residual drug concentration and a shorter period to reach maximal serum concentration. On day 1, T1/2 was 2.4 ± 0.4 hr (range: 0.4 to 5.1 hr). After repeated dosing, T1/2 was 2.5 ± 0.4 hr (range: 0.7 to 4.2 hr). AUC was 796 ± 159 ng·hr/mL after the first dose and 818 ± 170 ng·hr/mL after repeated dosing. Zolpidem was not hemodialyzable. No accumulation of unchanged drug appeared after 14 or 21 days. Zolpidem pharmacokinetics were not significantly different in renally-impaired patients. No dosage adjustment of Edluar is necessary in patients with compromised renal function.Drug interactions
CNS-active drugs:
Since the systematic evaluations of zolpidem in combination with other CNS-active drugs have been limited, careful consideration should be given to the pharmacology of any CNS-active drug to be used with zolpidem. Any drug with CNS-depressant effects could potentially enhance the CNS-depressant effects of zolpidem.
Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs. Imipramine in combination with zolpidem produced no pharmacokinetic interaction other than a 20% decrease in peak levels of imipramine, but there was an additive effect of decreased alertness. Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance.
A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem. The lack of a drug interaction following single-dose administration does not predict a lack following chronic administration.
An additive effect on psychomotor performance between alcohol and oral zolpidem was demonstrated [see Warnings and Precautions: CNS depressant effects (5.5)].
A single-dose interaction study with zolpidem tartrate10 mg and fluoxetine 20 mg at steady-state levels in male volunteers did not demonstrate any clinically significant pharmacokinetic or pharmacodynamic interactions. When multiple doses of zolpidem and fluoxetine at steady state the concentrations were evaluated in healthy females, increase in the zolpidem half-life (17%) was observed. There was no evidence of an additive effect in psychomotor performance.
Following five consecutive nightly doses of oral zolpidem tartrate10 mg in the presence of sertraline 50 mg (17 consecutive daily doses, at 7:00 am, in healthy female volunteers), zolpidem Cmax was significantly higher (43%) and Tmax was significantly decreased (53%). Pharmacokinetics of sertraline and N-desmethylsertraline were unaffected by zolpidem.
Drugs that affect drug metabolism via cytochrome P450:
Some compounds known to inhibit CYP3A may increase exposure to zolpidem. The effect of inhibitors of other P450 enzymes has not been carefully evaluated.
A randomized, double-blind, crossover interaction study in ten healthy volunteers between itraconazole (200 mg once daily for 4 days) and a single dose of zolpidem tartrate (10 mg) given 5 hours after the last dose of itraconazole resulted in a 34% increase in AUC0-∞ of zolpidem tartrate. There were no significant pharmacodynamic effects of zolpidem on subjective drowsiness, postural sway, or psychomotor performance.
A randomized, placebo-controlled, crossover interaction study in eight healthy female subjects between five consecutive daily doses of rifampin (600 mg) and a single dose of zolpidem tartrate (20 mg) given 17 hours after the last dose of rifampin showed significant reductions of the AUC (73%), Cmax (58%), and T1/2 (36 %) of zolpidem together with significant reductions in the pharmacodynamic effects of zolpidem tartrate.
A randomized double-blind crossover interaction study in twelve healthy subjects showed that co-administration of a single 5 mg dose of zolpidem tartrate with ketoconazole, a potent CYP3A4 inhibitor, given as 200 mg twice daily for 2 days increased Cmax of zolpidem (30%) and the total AUC of zolpidem (70%) compared to zolpidem alone and prolonged the elimination half-life (30Â %) along with an increase in the pharmacodynamic effects of zolpidem. Consideration should be given to using a lower dose of zolpidem when ketoconazole and zolpidem are given together. Patients should be advised that use of Edluar with ketoconazole may enhance the sedative effects.
Other drugs with no interactions with zolpidem:
A study involving cimetidine/zolpidem tartrate and ranitidine/zolpidem tartrate combinations revealed no effect of either drug on the pharmacokinetics or pharmacodynamics of zolpidem.
Zolpidem tartrate had no effect on digoxin pharmacokinetics and did not affect prothrombin time when given with warfarin in normal subjects.
13 Nonclinical Toxicology
13.1 Carcinogenesis, mutagenesis, impairment of fertility
Carcinogenesis:
Zolpidem was administered to mice and rats for 2 years at dietary dosages of 4, 18, and 80 mg base/kg. In mice, these doses are ≈2.5, 10, and 50 times the maximum recommended human dose (MRHD) of 10 mg/day (8 mg zolpidem base) on mg/m2 basis. In rats, these doses are ≈5, 20, and 100 times the MRHD on a mg/m2 basis. No evidence of carcinogenic potential was observed in mice. In rats, renal tumors (lipoma, liposarcoma) were seen at the mid- and high doses.Mutagenesis:
Zolpidem was negative in in vitro (bacterial reverse mutation, mouse lymphoma, and chromosomal aberration) and in vivo (mouse micronucleus) genetic toxicology assays.Impairment of fertility:
Oral administration of zolpidem (doses of 4, 20, and 100 mg base/kg or ≈5, 24, and 120 times the MRHD on a mg/m2 basis) to rats prior to and during mating, and continuing in females through postpartum day 25, resulted in irregular estrus cycles and prolonged precoital intervals. The no-effect dose for these findings is ≈24 times the MRHD on a mg/m2 basis. There was no impairment of fertility at any dose tested.
14 Clinical Studies
14.1 Chronic insomnia
Zolpidem was evaluated in two controlled studies for the treatment of patients with chronic insomnia (most closely resembling primary insomnia, as defined in the APA Diagnostic and Statistical Manual of Mental Disorders, DSM-IVâ„¢). Adult outpatients with chronic insomnia (n = 75) were evaluated in a double-blind, parallel group, 5-week trial comparing two doses of zolpidem tartrate and placebo. On objective (polysomnographic) measures of sleep latency and sleep efficiency, zolpidem 10 mg was superior to placebo on sleep latency for the first 4 weeks and on sleep efficiency for weeks 2 and 4. Zolpidem was comparable to placebo on number of awakenings at both doses studied.
Adult outpatients (n=141) with chronic insomnia were also evaluated, in a double-blind, parallel group, 4-week trial comparing two doses of zolpidem and placebo. Zolpidem 10 mg was superior to placebo on a subjective measure of sleep latency for all 4 weeks, and on subjective measures of total sleep time, number of awakenings, and sleep quality for the first treatment week.
Increased wakefulness during the last third of the night as measured by polysomnography has not been observed in clinical trials with zolpidem tartrate.14.2 Transient insomnia
Normal adults experiencing transient insomnia (n = 462) during the first night in a sleep laboratory were evaluated in a double-blind, parallel group, single-night trial comparing two doses of zolpidem tartrate oral tablets (7.5 and 10 mg) and placebo. Both zolpidem doses were superior to placebo on objective (polysomnographic) measures of sleep latency, sleep duration, and number of awakenings.
Normal elderly adults (mean age 68) experiencing transient insomnia (n = 35) during the first two nights in a sleep laboratory were evaluated in a double-blind, crossover, 2-night trial comparing four doses of zolpidem (5, 10, 15 and 20 mg) and placebo. All zolpidem doses were superior to placebo on the two primary PSG parameters (sleep latency and efficiency) and all four subjective outcome measures (sleep duration, sleep latency, number of awakenings, and sleep quality).14.3 Studies pertinent to safety concerns for sedative/hypnotic drugs
Next-day residual effects:
Next-day residual effects of zolpidem tartrate were evaluated in seven studies involving normal subjects. In three studies in adults (including one study in a phase advance model of transient insomnia) and in one study in elderly subjects, a small but statistically significant decrease in performance was observed in the Digit Symbol Substitution Test (DSST) when compared to placebo. Studies of zolpidem tartrate in non-elderly patients with insomnia did not detect evidence of next-day residual effects using the DSST, the Multiple Sleep Latency Test (MSLT), and patient ratings of alertness.Rebound effects:
There was no objective (polysomnographic) evidence of rebound insomnia at recommended doses seen in studies evaluating sleep on the nights following discontinuation of zolpidem tartrate. There was subjective evidence of impaired sleep in the elderly on the first post-treatment night at doses of zolpidem tartrate above the recommended elderly dose of 5 mg.Memory impairment:
Controlled studies in adults utilizing objective measures of memory yielded no consistent evidence of next-day memory impairment following the administration of zolpidem tartrate. However, in one study involving zolpidem doses of 10 and 20 mg, there was a significant decrease in next-morning recall of information presented to subjects during peak drug effect (90 minutes post-dose), i.e., these subjects experienced anterograde amnesia. There was also subjective evidence from adverse event data for anterograde amnesia occurring in association with the administration of zolpidem tartrate, predominantly at doses above 10 mg.Effects on sleep stages:
In studies that measured the percentage of sleep time spent in each sleep stage, zolpidem tartrate has generally been shown to preserve sleep stages. Sleep time spent in stages 3 and 4 (deep sleep) was found comparable to placebo with only inconsistent, minor changes in REM (paradoxical) sleep at the recommended dose.
16 How Supplied/storage And Handling
16.1 How supplied
Edluar is supplied as sublingual tablets in two dosage strengths. Tablets are not scored.
Edluar 5 mg sublingual tablets are round white tablets, flat-faced, bevel-edged with debossed on one side and supplied as:
NDC Number        Size
42447-112-01Â Â Â Â Â buler pack of 10
42447-112-03Â Â Â Â Â buler pack of 30
42447-112-10Â Â Â Â Â buler pack of 100
The buler packs consist of aluminum/aluminum Child Resistant Control (CRC) bulers.
Edluar 10 mg sublingual tablets are round white tablets, flat-faced, bevel-edged with debossed on one side and supplied as:
NDC Number        Size
42447-122-01Â Â Â Â Â buler pack of 10
42447-122-03Â Â Â Â Â buler pack of 30
42447-122-10Â Â Â Â Â buler pack of 100
The buler packs consist of aluminum/aluminum Child Resistant Control (CRC) bulers.16.2 Storage and handling
Store at controlled room temperature 20-25°C (68-77°F). Protect from light and moisture.
17 Patient Counseling Information
Prescribers or other healthcare professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with sedative-hypnotics, should counsel them in its appropriate use, and should instruct them to read the accompanying Medication Guide [see Medication Guide (17.4)].17.1 Severe anaphylactic and anaphylactoid reactions
Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with zolpidem. Describe the signs/symptoms of these reactions and advise patients to seek medical attention immediately if any of them occur.17.2 Sleep-driving and other complex behaviors
There have been reports of people getting out of bed after taking a sedative-hypnotic and driving their cars while not fully awake, often with no memory of the event. If a patient experiences such an episode, it should be reported to his or her doctor immediately, since "sleep-driving" can be dangerous. This behavior is more likely to occur when Edluar is taken with alcohol or other central nervous system depressants [see Warnings and Precautions (5.3)]. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with "sleep-driving", patients usually do not remember these events.
In addition, patients should be advised to report all concomitant medications to the prescriber. Patients should be instructed to report events such as sleep-driving and other complex behaviors immediately to the prescriber.17.3 Administration instructions
Patients should be counseled to take Edluar right before they get in bed and only when they are able to stay in bed a full night (7-8 hours) before being active again. Edluar tablets should not be taken with or immediately after a meal. Advise patients NOT to take Edluar when drinking alcohol. Edluar sublingual tablet should be placed under the tongue, where it will disintegrate. The tablet should not be swallowed and the tablet should not be taken with water.17.4 Medication guide
Medication Guide
Edluarâ„¢ [ED'-loo-ahr]
(zolpidem tartrate sublingual tablets)
Read this Medication Guide Edluar before you start taking Edluar and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.
What is the most important information I should know about Edluar?
After taking Edluar, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with Edluar. Reported activities include:
- driving a car ("sleep-driving")
- making and eating food
- talking on the phone
- having sex
- sleep-walking.
Call your doctor right away if you find out that you have done any of the above activities after taking Edluar.
Important
Take Edluar exactly as prescribed
- Do not take more Edluar than prescribed.
- Take Edluar right before you get in bed, not sooner.
Do not take Edluar if you:
- drink alcohol
- take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take Edluar with your other medicines.
- cannot get a full night's sleep
What is Edluar?
Edluar is a sedative-hypnotic (sleep) medicine. Edluar is used in adults for the short-term treatment of a sleep problem called insomnia. A symptom of insomnia includes:
- trouble falling asleep
Edluar is not for children.
Edluar is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep Edluar in a safe place to prevent misuse and abuse. Selling or giving away Edluar may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
Who should not take Edluar?
Do not take Edluar if you have had an allergic reaction to zolpidem (Ambien®, Ambien CR™, ZolpiMist™, Edluar™).
Some signs of allergic reaction may be swelling of the face, a feeling of the throat closing, or difficulty breathing shortly after taking Zolpidem.
Do not take Edluar if you are allergic to anything in it.
See the end of this Medication Guide for a complete ul of ingredients in Edluar.
Edluar may not be right for you. Before starting Edluar, tell your doctor about all of your health conditions, including if you:
- have a history of depression, mental illness or, suicidal thoughts
- have a history of drug or alcohol abuse or addiction
- have kidney or liver disease
- have lung disease or breathing problems
- are pregnant, planning to become pregnant, or breastfeeding
Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects.
Do not take Edluar with other medicines that can make you sleepy.
Know the medicines you take. Keep a ul of your medicines with you to show your doctor and pharmacist each time you get a new medicine.
How should I take Edluar?
- Take Edluar exactly as prescribed. Do not take more Edluar than prescribed for you.
- Take Edluar right before you get into bed.
- Do not take Edluar unless you are able to stay in bed a full night (7-8 hours) before you must be active again.
- For faster sleep onset, Edluar should NOT be taken with or right after a meal.
- Do not use the tablet if the seal on the childproof buler pack is broken, or if the buler holding the tablet is broken.
- To open the buler pack, separate the individual bulers at the perforations. Peel off the top layer of paper, and push the tablet through the foil.
- Place the tablet under the tongue, where it will disintegrate. Do not swallow or take with water.
- Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.
- If you take too much Edluar or overdose, call your doctor or poison control center right away, or get emergency treatment.
What are the possible side effects of Edluar?
Serious side effects of Edluar include:
- getting out of bed while not being fully awake and do an activity that you do not know you are doing. (See "What is the most important information I should know about Edluar?")
- abnormal thoughts and behavior Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, suicidal thoughts or actions.
- memory loss
- anxiety
- severe allergic reactionsSymptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking Edluar.
Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using Edluar.
The most common side effects of Edluar are:
- drowsiness
- dizziness
- diarrhea
- "drugged feelings"
- fatigue
- headache
You may still feel drowsy the next day after taking Edluar.
Do not drive or do any dangerous activities after taking Edluar until you feel fully awake.
After you stop taking a sleep medicine, you may have symptoms for 1 to 2 days such as:
trouble sleeping, nausea, flushing, lightheadedness, uncontrolled crying, vomiting, stomach cramps, panic attack, nervousness, and stomach area pain
These are not all the side effects of Edluar. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Edluar?
- Store Edluar between 68° and 77°F (20° to 25°C). Protect from light and moisture.
- Keep Edluar and all medicines out of reach of children.
General Information about Edluar
- Medicines are sometimes prescribed for purposes other than those uled in a Medication Guide.
- Do not use Edluar for a condition for which it was not prescribed.
- Do not share Edluar with other people, even if you think they have the same symptoms that you have. It may harm them and it is against the law.
This Medication Guide summarizes the most important information about Edluar.
If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Edluar that is written for healthcare professionals.
For more information about Edluar, call Meda Pharmaceuticals at 1-800-526-3840.
What are the ingredients in Edluar?
Active Ingredient: zolpidem tartrate
Inactive Ingredients: mannitol, colloidal silicon dioxide, silicified microcrystalline cellulose, croscarmellose sodium, saccharin sodium, and magnesium stearate.
Rx Only
This Medication Guide has been approved
by U.S. Food and Drug Administration.
Orexo AB, Sweden
March 2009
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
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