Cyclo/Gaba 10/300 Pack (gabapentin 300 mg) Dailymed

4 Contraindications

Gabapentin is contraindicated in patients who havedemonstrated hypersensitivity to the drug or its ingredients.

7 Drug Interactions

• Morphine increases gabapentin concentrations; dose adjustment may be needed ( 5.4, 7.2)

7.1 Other Antiepileptic Drugs

Gabapentin is not appreciably metabolized nor does it interfere with the metabolism of commonly coadministered antiepileptic drugs [see Clinical Pharmacology (12.3)] .

7.2 Opioids

Hydrocodone

Coadministration of gabapentin with hydrocodone decreases hydrocodone exposure [see Clinical Pharmacology (12.3)]. The potential for alteration in hydrocodone exposure and effect should be considered when gabapentin is started or discontinued in a patient taking hydrocodone.

Morphine

When gabapentin is administered with morphine, patients should be observed for signs of central nervous system (CNS) depression, such as somnolence, sedation and respiratory depression [see Clinical Pharmacology (12.3)] .

7.3 Maalox (aluminum hydroxide, magnesium hydroxide)

The mean bioavailability of gabapentin was reduced by about 20% with concomitant use of an antacid (Maalox ^®) containing magnesium and aluminum hydroxides. It is recommended that gabapentin be taken at least 2 hours following Maalox administration [see Clinical Pharmacology (12.3)] .

7.4 Drug/Laboratory Test Interactions

Because false positive readings were reported withthe Ames N-Multistix SG ^® dipstick test for urinary protein whengabapentin was added to other antiepileptic drugs, the more specificsulfosalicylic acid precipitation procedure is recommended to determine thepresence of urine protein.

9 Drug Abuse And Dependence

9.1 Controlled Substance

Gabapentin is not a scheduled drug.

9.2 Abuse

Gabapentin does not exhibit affinity for benzodiazepine, opiate (mu, delta or kappa), or cannabinoid 1 receptor sites. A small number of postmarketing cases report gabapentin misuse and abuse. These individuals were taking higher than recommended doses of gabapentin for unapproved uses. Most of the individuals described in these reports had a history of poly-substance abuse or used gabapentin to relieve symptoms of withdrawal from other substances. When prescribing gabapentin carefully evaluate patients for a history of drug abuse and observe them for signs and symptoms of gabapentin misuse or abuse (e.g. development of tolerance, self-dose escalation, and drug-seeking behavior).

9.3 Dependence

There are rare postmarketing reports of individuals experiencing withdrawal symptoms shortly after discontinuing higher than recommended doses of gabapentin used to treat illnesses for which the drug is not approved. Such symptoms included agitation, disorientation and confusion after suddenly discontinuing gabapentin that resolved after restarting gabapentin. Most of these individuals had a history of poly-substance abuse or used gabapentin to relieve symptoms of withdrawal from other substances. The dependence and abuse potential of gabapentin has not been evaluated in human studies.

10 Overdosage

A lethal dose of gabapentin was not identified in mice and rats receiving single oral doses as high as 8000 mg/kg. Signs of acute toxicity in animals included ataxia, labored breathing, ptosis, sedation, hypoactivity, or excitation.

Acute oral overdoses of gabapentin up to 49 grams have been reported. In these cases, double vision, slurred speech, drowsiness, lethargy, and diarrhea were observed. All patients recovered with supportive care. Coma, resolving with dialysis, has been reported in patients with chronic renal failure who were treated with gabapentin.

Gabapentin can be removed by hemodialysis. Although hemodialysis has not been performed in the few overdose cases reported, it may be indicated by the patients clinical state or in patients with significant renal impairment.

If overexposure occurs, call your poison control center at 1-800-222-1222.

12 Clinical Pharmacology

12.1 Mechanism of Action

The precise mechanisms by which gabapentin producesits analgesic and antiepileptic actions are unknown. Gabapentin is structurallyrelated to the neurotransmitter gamma-aminobutyric acid (GABA) but has noeffect on GABA binding, uptake, or degradation. In vitro studies haveshown that gabapentin binds with high-affinity to the α2δ subunit ofvoltage-activated calcium channels; however, the relationship of this bindingto the therapeutic effects of gabapentin is unknown.

13 Nonclinical Toxicology

14 Clinical Studies

16 How Supplied/storage And Handling

Gabapentincapsules USP is supplied as follows:

100 mgcapsules:

White hardgelatin capsules imprinted “216” on body with blue ink, available in:

Bottles of 100:NDC 67877-222-01

Bottles of 500:NDC 67877-222-05

Bottles of1000: NDC 67877-222-10

300 mg capsules:

Yellow hardgelatin capsules imprinted “215” on body with blue ink, available in:

Bottles of 100:NDC 67877-223-01

Bottles of 500:NDC 67877-223-05

Bottles of1000: NDC 67877-223-10

400 mgcapsules:

Orange hardgelatin capsules imprinted “214” on body with blue ink, available in:

Bottles of 100:NDC 67877-224-01

Bottles of 500:NDC 67877-224-05

Bottles of1000: NDC 67877-224-10

Storage

Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature] .

17 Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity

Prior to initiation of treatment with gabapentin, instruct patients that a rash or other signs or symptoms of hypersensitivity (such as fever or lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately [see Warnings and Precautions (5.1)] .

Anaphylaxis and Angioedema

Advise patients to discontinue gabapentin and seek medical care if they develop signs or symptoms of anaphylaxis or angioedema [ see Warnings and Precautions (5.2 )].

Dizziness and Somnolence and Effects on Driving and Operating Heavy Machinery

Advise patients that gabapentin may cause dizziness, somnolence, and other symptoms and signs of CNS depression. Other drugs with sedative properties may increase these symptoms. Accordingly, although patients’ ability to determine their level of impairment can be unreliable, advise them neither to drive a car nor to operate other complex machinery until they have gained sufficient experience on gabapentin to gauge whether or not it affects their mental and/or motor performance adversely. Inform patients that it is not known how long this effect lasts [see Warnings and Precautions (5.3 ) and Warnings and Precautions (5.4 )] .

Suicidal Thinking and Behavior

Counsel the patient, their caregivers, and families that AEDs, including gabapentin, may increase the risk of suicidal thoughts and behavior. Advise patients of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Instruct patients to report behaviors of concern immediately to healthcare providers [see Warnings and Precautions (5.6 )] .

 

Use in Pregnancy

Instruct patients to notify their physician if they become pregnant or intend to become pregnant during therapy, and to notify their physician if they are breast feeding or intend to breast feed during therapy [see  Use in Specific Populations (8.1) and ( 8.3 )] .

Encourage patients to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 [see Use in Specific Populations (8.1 )] .

This product’s label may have been updated. For full prescribing information, please visit www.dailymed.nlm.nih.gov.

Manufactured by:

Alkem Laboratories Limited

ALKEM HOUSE, Lower Parel,

Mumbai – 400 013, INDIA

Distributed by:

Ascend Laboratories, LCC

Montvale, NJ 07645 PT 1702-03