To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should
be used only to treat or prevent infections that are proven or strongly
suspected to be caused by bacteria.
Description
Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an
analog of ampicillin, with a broad spectrum of bactericidal activity against
many gram-positive and gram-negative microorganisms. Chemically it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo
[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally
as: The amoxicillin molecular formula is C16H19N3O5S • 3H2O, and the molecular weight is 419.45.
Capsules, tablets and powder for oral suspension of amoxicillin are intended
for oral administration. Capsules Each amoxicillin capsule, with yellow opaque cap and body,
contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is
imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule
is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive
ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin,
black ferric oxide; Capsule contents - cellulose microcrystalline and magnesium
stearate.
Meets USP Dissolution Test 2.
Clinical Pharmacology
Dose*
AUC0-∞ (mcg.hr./mL)
Cmax (mcg/mL)â€
Amoxicillin
amoxicillin(±S.D.)
amoxicillin(±S.D.)
400 mg (5 mL of suspension)
17.1 (3.1)
5.92 (1.62)
400 mg (chewable tablet)
17.9 (2.4)
5.18 (1.64)
* Administered at the start of a light meal.†Mean values of 24 normal volunteers. Peak concentrations occurred
approximately 1 hour after the dose. Amoxicillin is stable in the presence of gastric acid and is
rapidly absorbed after oral administration. The effect of food on the absorption
of amoxicillin from the tablets and suspension has been partially investigated.
The 400 mg and 875 mg formulations have been studied only when administered at
the start of a light meal. However, food effect studies have not been performed
with the 200 mg and 500 mg formulations. Amoxicillin diffuses readily into most
body tissues and fluids, with the exception of brain and spinal fluid, except
when meninges are inflamed. The half-life of amoxicillin is 61.3 minutes. Most
of the amoxicillin is excreted unchanged in the urine; its excretion can be
delayed by concurrent administration of probenecid. In blood serum, amoxicillin
is approximately 20% protein-bound.
Orally administered doses of 250 mg and 500 mg of amoxicillin capsules result
in average peak blood levels 1 to 2 hours after administration in the range of
3.5 mcg/mL to 5 mcg/mL and 5.5 mcg/mL to 7.5 mcg/mL, respectively.
Mean amoxicillin pharmacokinetic parameters from an open, two-part,
single-dose crossover bioequivalence study in 27 adults comparing 875 mg of
Amoxicillin tablets with 875 mg of amoxicillin and clavulanate potassium showed
that the 875 mg tablet of amoxicillin produces an AUC0-∞
of 35.4 ± 8.1 mcg∙hr/mL and a Cmax of 13.8 ± 4.1 mcg/mL.
Dosing was at the start of a light meal following an overnight fast.
Oral administration of single doses of amoxicillin 400 mg chewable tablets
and 400 mg/5 mL suspension to 24 adult volunteers yielded the following
pharmacokinetic data:
Orally administered doses of amoxicillin suspension, 125 mg/5 mL and 250 mg/5
mL, result in average peak blood levels 1 to 2 hours after administration in the
range of 1.5 mcg/mL to 3 mcg/mL and 3.5 mcg/mL to 5 mcg/ mL, respectively.
Detectable serum levels are observed up to 8 hours after an orally
administered dose of amoxicillin. Following a 1 gram dose and utilizing a
special skin window technique to determine levels of the antibiotic, it was
noted that therapeutic levels were found in the interstitial fluid.
Approximately 60% of an orally administered dose of amoxicillin is excreted in
the urine within 6 to 8 hours.
Microbiology
Amoxicillin is similar to ampicillin in its bactericidal action
against susceptible organisms during the stage of active multiplication. It acts
through the inhibition of biosynthesis of cell wall mucopeptide. Amoxicillin has
been shown to be active against most strains of the following microorganisms,
both in vitro and in clinical infections as described
in the INDICATIONS AND USAGE
section.
Helicobacter pylori
1Staphylococci which are susceptible to amoxicillin but resistant to
methicillin/oxacillin should be considered as resistant to
amoxicillin.Susceptibility TestsDilution Techniques Quantitative methods are used to determine antimicrobial minimum
inhibitory concentrations (MICs). These MICs provide estimates of the
susceptibility of bacteria to antimicrobial compounds. The MICs should be
determined using a standardized procedure. Standardized procedures are based on
a dilution method1 (broth or agar) or equivalent with
standardized inoculum concentrations and standardized concentrations of ampicillin powder. Ampicillin is sometimes used to predict
susceptibility of S. pneumoniae to amoxicillin;
however, some intermediate strains have been shown to be susceptible to
amoxicillin. Therefore, S. pneumoniae susceptibility
should be tested using amoxicillin powder. The MIC values should be interpreted
according to the following criteria:
A report of "Susceptible" indicates that the pathogen is likely to be
inhibited if the antimicrobial compound in the blood reaches the concentrations
usually achievable. A report of "Intermediate" indicates that the result should
be considered equivocal, and, if the microorganism is not fully susceptible to
alternative, clinically feasible drugs, the test should be repeated. This
category implies possible clinical applicability in body sites where the drug is
physiologically concentrated or in situations where high dosage of drug can be
used. This category also provides a buffer zone, which prevents small
uncontrolled technical factors from causing major discrepancies in
interpretation. A report of "Resistant" indicates that the pathogen is not
likely to be inhibited if the antimicrobial compound in the blood reaches the
concentrations usually achievable; other therapy should be selected.
Standardized susceptibility test procedures require the use of laboratory
control microorganisms to control the technical aspects of the laboratory
procedures. Standard ampicillin powder should provide
the following MIC values:
Microorganism
MIC Range (mcg/mL)
E. coli
ATCC 25922
2 to 8
E. faecalis
ATCC 29212
0.5 to 2
H. influenzae
ATCC 49247*
2 to 8
S. aureus
ATCC 29213
.25 to 1
*This quality control range is applicable to only H.
influenzae ATCC 49247 tested by a broth microdilution procedure using
HTM.1 Using amoxicillin to determine susceptibility:
Microorganism
MIC Range (mcg/ml)
S. pneumoniae
ATCC 49619*
0.03 to .12
*This quality control range is applicable to only S.
pneumoniae ATCC 49619 tested by the broth microdilution procedure using
cation-adjusted Mueller-Hinton broth with 2-5% lysed horse blood.
2 Staphylococci which are susceptible to amoxicillin but resistant to
methicillin/oxacillin should be considered as resistant to amoxicillin. 3 These interpretive standards are applicable only to broth microdilution
susceptibility tests using cation-adjusted Mueller-Hinton broth with 2-5% lysed
horse blood.4 These interpretive standards are applicable only to broth microdilution test
with H. influenzae using Haemophilus Test Medium (HTM).1
Diffusion Techniques Quantitative methods that require measurement of zone diameters
also provide reproducible estimates of the susceptibility of bacteria to
antimicrobial compounds. One such standardized procedure2
requires the use of standardized inoculum concentrations. This procedure uses
paper disks impregnated with 10 mcg ampicillin to test the susceptibility of
microorganisms, except S. pneumoniae, to amoxicillin.
Interpretation involves correlation of the diameter obtained in the disk test
with the MIC for ampicillin.
Reports from the laboratory providing results of the standard single-disk
susceptibility test with a 10 mcg ampicillin disk should be interpreted
according to the following criteria:
NOTE: For streptococci (other than β-hemolytic
streptococci and S. pneumoniae), an ampicillin MIC
should be determined.
S. pneumoniae
S. pneumoniae should be tested using a 1 mcg
oxacillin disk. Isolates with oxacillin zone sizes of ≥ 20 mm are susceptible to
amoxicillin. An amoxicillin MIC should be determined on isolates of S. pneumoniae with oxacillin zone sizes of ≤ 19 mm.
Interpretation should be as stated above for results using dilution
techniques.
As with standard dilution techniques, disk diffusion susceptibility test
procedures require the use of laboratory control microorganisms. The 10 mcg
ampicillin disk should provide the following zone
diameters in these laboratory test quality control strains:
Microorganism
Zone Diameter (mm)
E. coli
ATCC 25922
16 to 22
H. influenzae
ATCC 49247*
13 to 21
S. aureus
ATCC 25923
27 to 35
*This quality control range is applicable to only H.
influenzae ATCC 49247 tested by a disk diffusion procedure using
HTM.2 Using 1 mcg oxacillin disk:
Microorganism
Zone Diameter (mm)
S. pneumoniae
ATCC 49619*
8 to 12
*This quality control range is applicable to only S.
pneumoniae ATCC 49619 tested by a disk diffusion procedure using
Mueller-Hinton agar supplemented with 5% sheep blood and incubated in 5% CO2.5 Staphylococci which are susceptible to amoxicillin but resistant to
methicillin/oxacillin should be considered as resistant to amoxicillin. 6 These interpretive standards are applicable only to disk diffusion
susceptibility tests with H. influenzae using Haemophilus Test Medium (HTM).2
Susceptibility Testing for Helicobacter pylori
In vitro susceptibility testing
methods and diagnostic products currently available for determining minimum
inhibitory concentrations (MICs) and zone sizes have not been standardized,
validated, or approved for testing H. pylori
microorganisms.
Culture and susceptibility testing should be obtained in patients who fail
triple therapy. If clarithromycin resistance is found, a
nonclarithromycin-containing regimen should be used.
Indications And Usage
Amoxicillin is indicated in the treatment of infections due to
susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms
in the conditions uled below:
Infections of the ear, nose, and throat - due to
Streptococcus spp. (α- and β-hemolytic strains only),
S. pneumoniae, Staphylococcus spp., or H. influenzae.
Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E.
faecalis.
Infections of the skin and skin structure - due to
Streptococcus spp. (α- and β-hemolytic strains only),
Staphylococcus spp., or E.
coli
Infections of the lower respiratory tract - due to
Streptococcus spp. (α- and β-hemolytic strains only),
S. pneumoniae, Staphylococcus spp., or H. influenzae.
Gonorrhea, acute uncomplicated (ano-genital and urethral
infections) - due to N. gonorrhoeae (males and
females).
H. pylori eradication to reduce the risk of
duodenal ulcer recurrence Triple TherapyAmoxicillin/clarithromycin/lansoprazole Amoxicillin, in combination with clarithromycin plus lansoprazole
as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1
year history of a duodenal ulcer) to eradicate H.
pylori. Eradication of H. pylori has been
shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.) Dual TherapyAmoxicillin/lansoprazole Amoxicillin, in combination with lansoprazole delayed-release
capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1
year history of a duodenal ulcer) who are either allergic or
intolerant to clarithromycin or in whom resistance to clarithromycin is known or
suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori
has been shown to reduce the risk of duodenal ulcer recurrence. (See
CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should
be used only to treat or prevent infections that are proven or strongly
suspected to be caused by susceptible bacteria. When culture and susceptibility
information are available, they should be considered in selecting or modifying
antibacterial therapy. In the absence of such data, local epidemiology and
susceptibility patterns may contribute to the empiric selection of therapy.
Indicated surgical procedures should be performed.
Contraindications
A history of allergic reaction to any of the penicillins is a contraindication.
Warnings
SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC)
REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. ALTHOUGH
ANAPHYLAXIS IS MORE FREQUENT FOLLOWING PARENTERAL THERAPY, IT HAS OCCURRED IN
PATIENTS ON ORAL PENICILLINS. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN
INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF
SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A
HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS
WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY WITH AMOXICILLIN,
CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO
PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS,
AMOXICILLIN SHOULD BE DISCONTINUED AND APPROPRIATE THERAPY INSTITUTED. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT
WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING
INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.
Pseudomembranous colitis has been reported with nearly all
antibacterial agents, including amoxicillin, and may range in severity from mild
to life-threatening. Therefore, it is important to consider this diagnosis in
patients who present with diarrhea subsequent to the administration of
antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and
may permit overgrowth of clostridia. Studies indicate that a toxin produced by
Clostridium difficile is a primary cause of
"antibiotic-associated colitis."
After the diagnosis of pseudomembranous colitis has been established,
appropriate therapeutic measures should be initiated. Mild cases of
pseudomembranous colitis usually respond to drug discontinuation alone. In
moderate-to-severe cases, consideration should be given to management with
fluids and electrolytes, protein supplementation, and treatment with an
antibacterial drug clinically effective against C. difficile
colitis.
Precautions
General The possibility of superinfections with mycotic or bacterial
pathogens should be kept in mind during therapy. If superinfections occur,
amoxicillin should be discontinued and appropriate therapy instituted.
Prescribing amoxicillin in the absence of a proven or strongly suspected
bacterial infection or a prophylactic indication is unlikely to provide benefit
to the patient and increases the risk of the development of drug-resistant
bacteria.
Information For Patients
Amoxicillin may be taken every 8 hours or every 12 hours,
depending on the strength of the product prescribed.
Patients should be counseled that antibacterial drugs including amoxicillin
should only be used to treat bacterial infections. They do not treat viral
infections (e.g., the common cold). When amoxicillin is prescribed to treat a
bacterial infection, patients should be told that although it is common to feel
better early in the course of therapy, the medication should be taken exactly as
directed. Skipping doses or not completing the full course of therapy may: (1)
decrease the effectiveness of the immediate treatment, and (2) increase the
likelihood that bacteria will develop resistance and will not be treatable by
amoxicillin or other antibacterial drugs in the future.
Laboratory Tests
As with any potent drug, periodic assessment of renal, hepatic,
and hematopoietic function should be made during prolonged therapy.
All patients with gonorrhea should have a serologic test for syphilis at the
time of diagnosis. Patients treated with amoxicillin should have a follow-up
serologic test for syphilis after 3 months.
Drug Interactions
Probenecid decreases the renal tubular secretion of amoxicillin.
Concurrent use of amoxicillin and probenecid may result in increased and
prolonged blood levels of amoxicillin.
Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere
with the bactericidal effects of penicillin. This has been demonstrated in vitro; however, the clinical significance of this
interaction is not well documented.
Drug/laboratory Test Interactions
High urine concentrations of ampicillin may result in
false-positive reactions when testing for the presence of glucose in urine using
Clinitest®, Benedict's Solution, or Fehling's Solution.
Since this effect may also occur with amoxicillin, it is recommended that
glucose tests based on enzymatic glucose oxidase reactions (such as
Clinistix®) be used.
Following administration of ampicillin to pregnant women, a transient
decrease in plasma concentration of total conjugated estriol,
estriol-glucuronide, conjugated estrone, and estradiol has been noted. This
effect may also occur with amoxicillin.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Longterm studies in animals have not been performed to evaluate carcinogenic
potential. Studies to detect mutagenic potential of amoxicillin alone have not
been conducted; however, the following information is available from tests on a
4:1 mixture of amoxicillin and potassium clavulanate. Amoxicillin and potassium
clavulanate was non-mutagenic in the Ames bacterial mutation assay, and the
yeast gene conversion assay. Amoxicillin and potassium clavulanate was weakly
positive in the mouse lymphoma assay, but the trend toward increased mutation
frequencies in this assay occurred at doses that were also associated with
decreased cell survival. Amoxicillin and potassium clavulanate was negative in
the mouse micronucleus test, and in the dominant lethal assay in mice. Potassium
clavulanate alone was tested in the Ames bacterial mutation assay and in the
mouse micronucleus test, and was negative in each of these assays. In a
multi-generation reproduction study in rats, no impairment of fertility or other
adverse reproductive effects were seen at doses up to 500 mg/kg (approximately 3
times the human dose in mg/m2).
Pregnancy
Teratogenic EffectsPregnancy Category B Reproduction studies have been performed in mice and rats at
doses up to 10 times the human dose and have revealed no evidence of impaired
fertility or harm to the fetus due to amoxicillin. There are, however, no
adequate and well-controlled studies in pregnant women. Because animal
reproduction studies are not always predictive of human response, this drug
should be used during pregnancy only if clearly needed.
Labor And Delivery
Oral ampicillin-class antibiotics are poorly absorbed during labor. Studies in
guinea pigs showed that intravenous administration of ampicillin slightly
decreased the uterine tone and frequency of contractions but moderately
increased the height and duration of contractions. However, it is not known
whether use of amoxicillin in humans during labor or delivery has immediate or
delayed adverse effects on the fetus, prolongs the duration of labor, or
increases the likelihood that forceps delivery or other obstetrical intervention
or resuscitation of the newborn will be necessary.
Nursing Mothers
Penicillins have been shown to be excreted in human milk. Amoxicillin use by
nursing mothers may lead to sensitization of infants. Caution should be
exercised when amoxicillin is administered to a nursing woman.
Pediatric Use
Because of incompletely developed renal function in neonates and young infants,
the elimination of amoxicillin may be delayed. Dosing of amoxicillin should be
modified in pediatric patients 12 weeks or younger (≤3 months). (See DOSAGE AND ADMINISTRATION: Neonates and
Infants.)
Geriatric Use
An analysis of clinical studies of amoxicillin was conducted to
determine whether subjects aged 65 and over respond differently from younger
subjects. Of the 1,811 subjects treated with capsules of amoxicillin, 85% were less than 60 years old, 15% were ≥ 61 years old and 7% were ≥ 71 years old. This
analysis and other reported clinical experience have not identified differences
in responses between the elderly and younger patients, but a greater sensitivity
of some older individuals cannot be ruled out.
This drug is known to be substantially excreted by the kidney, and the risk
of toxic reactions to this drug may be greater in patients with impaired renal
function. Because eldery patients are more likely to have decreased renal
function, care should be taken in dose selection, and it may be useful to
monitor renal function.
Adverse Reactions
have previously demonstrated hypersensitivity to penicillins and in those with a
history of allergy, asthma, hay fever, or urticaria. The following adverse
reactions have been reported as associated with the use of penicillins:
Gastrointestinal: Nausea, vomiting, diarrhea, and
hemorrhagic/pseudomembranous colitis.
Onset of pseudomembranous colitis symptoms may occur during or after
antibiotic treatment. (See WARNINGS.)
Hypersensitivity Reactions: Serum sickness-like
reactions, erythematous maculopapular rashes, erythema multiforme,
Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis,
acute generalized exanthematous pustulosis, hypersensitivity vasculitis and
urticaria have been reported.
NOTE: These hypersensitivity reactions may be
controlled with antihistamines and, if necessary, systemic corticosteroids.
Whenever such reactions occur, amoxicillin should be discontinued unless, in the
opinion of the physician, the condition being treated is lifethreatening and
amenable only to amoxicillin therapy.
Liver: A moderate rise in AST (SGOT) and/or ALT
(SGPT) has been noted, but the significance of this finding is unknown. Hepatic
dysfunction including cholestatic jaundice, hepatic cholestasis and acute
cytolytic hepatitis have been reported.
Renal: Crystalluria has also been reported (See OVERDOSAGE).
Hemic and Lymphatic Systems: Anemia, including
hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia,
leukopenia, and agranulocytosis have been reported during therapy with
penicillins. These reactions are usually reversible on discontinuation of
therapy and are believed to be hypersensitivity phenomena.
Central Nervous System: Reversible hyperactivity,
agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or
dizziness have been reported rarely.
Miscellaneous: Tooth discoloration (brown, yellow, or
gray staining) has been rarely reported. Most reports occurred in pediatric
patients. Discoloration was reduced or eliminated with brushing or dental
cleaning in most cases. Combination Therapy with Clarithromycin and
Lansoprazole In clinical trials using combination therapy with amoxicillin
plus clarithromycin and lansoprazole, and amoxicillin plus lansoprazole, no
adverse reactions peculiar to these drug combinations were observed. Adverse
reactions that have occurred have been limited to those that had been previously
reported with amoxicillin, clarithromycin, or lansoprazole. Triple TherapyAmoxicillin/Clarithromycin/Lansoprazole The most frequently reported adverse events for patients who
received triple therapy were diarrhea (7%), headache (6%), and taste perversion
(5%). No treatment-emergent adverse events were observed at significantly higher
rates with triple therapy than with any dual therapy regimen. Dual TherapyAmoxicillin/Lansoprazole The most frequently reported adverse events for patients who
received amoxicillin three times daily plus lansoprazole three times daily dual
therapy were diarrhea (8%) and headache (7%). No treatment-emergent adverse
events were observed at significantly higher rates with amoxicillin three times
daily plus lansoprazole three times daily dual therapy than with lansoprazole
alone.
For more information on adverse reactions with clarithromycin or
lansoprazole, refer to their package inserts, ADVERSE
REACTIONS.
Overdosage
In case of overdosage, discontinue medication, treat
symptomatically, and institute supportive measures as required. If the
overdosage is very recent and there is no contraindication, an attempt at emesis
or other means of removal of drug from the stomach may be performed. A
prospective study of 51 pediatric patients at a poison-control center suggested
that overdosages of less than 250 mg/kg of amoxicillin are not associated with
significant clinical symptoms and do not require gastric emptying.3
Interstitial nephritis resulting in oliguric renal failure has been reported
in a small number of patients after overdosage with amoxicillin.
Crystalluria, in some cases leading to renal failure, has also been reported
after amoxicillin overdosage in adult and pediatric patients. In case of
overdosage, adequate fluid intake and diuresis should be maintained to reduce
the risk of amoxicillin crystalluria.
Renal impairment appears to be reversible with cessation of drug
administration. High blood levels may occur more readily in patients with
impaired renal function because of decreased renal clearance of amoxicillin.
Amoxicillin may be removed from circulation by hemodialysis.
Dosage And Administration
Capsules, tablets and oral suspensions of amoxicillin may be
given without regard to meals. The 400 mg suspension and the 875 mg tablet have
been studied only when administered at the start of a light meal. However, food
effect studies have not been performed with the 200 mg and 500 mg
formulations. Neonates and Infants Aged ≤12 Weeks (≤3 Months) Due to incompletely developed renal function affecting
elimination of amoxicillin in this age group, the recommended upper dose of
amoxicillin is 30 mg/kg/day divided q12h.
Infection
Severity*
Usual Adult Dose
Usual Dose for children over 3 monthsâ€
Ear/Nose/Throat
Mild/Moderate
500 mg every 12 hours or 250 mg every 8 hours
25 mg/kg/day in divided doses every 12 hours
or
20 mg/kg/day in divided doses every 8 hours
Severe
875 mg every 12 hours or 500 mg every 8 hours
45 mg/kg/day in divided doses every 12 hours
or
40 mg/kg/day in divided doses every 8 hours
Lover Respiratory Tract
Mild/Moderate or Severe
875 mg every 12 hours or 500 mg every 8 hours
45 mg/kg/day in divided doses every 12 hours
or
40 mg/kg/day in divided doses every 8 hours
Skin/Skin Structure
Mild/Moderate
500 mg every 12 hours or 250 mg every 8 hours
25 mg/kg/day in divided doses every 12 hours
or
20 mg/kg/day in divided doses every 8 hours
Severe
875 mg every 12 hours or 500 mg every 8 hours
45 mg/kg/day in divided doses every 12 hours
or
40 mg/kg/day in divided doses every 8 hours
Genitourinary Tract
Mild/Moderate
500 mg every 12 hours or 250 mg every 8 hours
25 mg/kg/day in divided doses every 12 hours
or
20 mg/kg/day in divided doses every 8 hours
Severe
875 mg every 12 hours or 250 mg every 8 hours
45 mg/kg/day in divided doses every 12 hours
or
40mg/kg/day in divided doses every 8 hours
Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females
3 grams as single oral dose
NOTE: SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER2 YEARS, DO NOT USE THIS REGIMINE IN THESE CASES.
*Dosing for infections caused by less susceptible organisms should follow the
recommendations for severe infections.†The children's dosage is intended for individuals whose weight is less than
40 kg. Children weighing 40 kg or more should be dosed according to the adult
recommendations After reconstitution, the required amount of suspension should be
placed directly on the child's tongue for swallowing. Alternate means of
administration are to add the required amount of suspension to formula, milk,
fruit juice, water, ginger ale, or cold drinks. These preparations should then
be taken immediately. To be certain the child is receiving full dosage, such
preparations should be consumed in entirety.
All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS – Laboratory
Tests.)
Larger doses may be required for stubborn or severe infections. General It should be recognized that in the treatment of chronic urinary
tract infections, frequent bacteriological and clinical appraisals are
necessary. Smaller doses than those recommended above should not be used. Even
higher doses may be needed at times. In stubborn infections, therapy may be
required for several weeks. It may be necessary to continue clinical and/or
bacteriological followup for several months after cessation of therapy. Except
for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours
beyond the time that the patient becomes asymptomatic or evidence of bacterial
eradication has been obtained. It is recommended that there be at least 10 days'
treatment for any infection caused by Streptococcus pyogenes
to prevent the occurrence of acute rheumatic fever. H. pylori Eradication to
Reduce the Risk of Duodenal Ulcer RecurrenceTriple TherapyAmoxicillin/clarithromycin/lansoprazole The recommended adult oral dose is 1 gram amoxicillin, 500 mg
clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14
days. (See INDICATIONS AND
USAGE
.) Dual TherapyAmoxicillin/lansoprazole The recommended adult oral dose is 1 gram amoxicillin and 30 mg
lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE
.)
Please refer to clarithromycin and lansoprazole full prescribing information
for CONTRAINDICATIONS
and WARNINGS
, and for information
regarding dosing in elderly and renally impaired patients. Dosing Recommendations for Adults with Impaired Renal
Function Patients with impaired renal function do not generally require a
reduction in dose unless the impairment is severe. Severely impaired patients
with a glomerular filtration rate of less than 30 mL/minute should not receive the 875
mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute
should receive 500 mg or 250 mg every 12 hours, depending on the severity of the
infection. Patients with a less than 10 mL/minute glomerular filtration rate
should receive 500 mg or 250 mg every 24 hours, depending on severity of the
infection.
Hemodialysis patients should receive 500 mg or 250 mg every 24 hours,
depending on severity of the infection. They should receive an additional dose
both during and at the end of dialysis.
There are currently no dosing recommendations for pediatric
patients with impaired renal function.
Directions for Mixing Oral Suspension Prepare suspension at time of dispensing as follows: Tap bottle
until all powder flows freely. Add approximately 1/3 of the total amount of
water for reconstitution (see table below) and shake
vigorously to wet powder. Add remainder of the water and again shake
vigorously.
125 mg/5 mL
Bottle Size
Amount of Water Required for
Reconstitution
80 mL
55 mL
100 mL
68 mL
150 mL
102 mL
  Each teaspoonful (5 mL) will contain 125 mg
amoxicillin.
200 mg/5 mL
Bottle Size
Amount of Water Required for
Reconstitution
50 mL
34 mL
75 mL
51 mL
100 mL
68 mL
  Each teaspoonful (5 mL) will contain 200 mg
amoxicillin.
250 mg/5 mL
Bottle Size
Amount of Water Required for
Reconstitution
80 mL
55 mL
100 mL
68 mL
150 mL
102 mL
  Each teaspoonful (5 mL) will contain 250 mg
amoxicillin.
400 mg/5 mL
Bottle Size
Amount of Water Required for
Reconstitution
50 mL
34 mL
75 mL
51 mL
100 mL
68 mL
  Each teaspoonful (5 mL) will contain 400 mg
amoxicillin.
NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep
bottle tightly closed. Any unused portion of the reconstituted suspension must
be discarded after 14 days. Refrigeration preferable, but not required.
How Supplied
Amoxicillin Capsules, USP, for oral administration,
contain 250 mg or 500 mg amoxicillin as the trihydrate and are supplied as:
500 mg: yellow, opaque, hard gelatin capsules
imprinted AMOX 500 on one side and GG 849 on the other side.NDC 67296-0220-5....................................................
bottles of 40
Store capsules at
20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Dispense in a tight
container.
Clinical Studies
H. pylori Eradication to
Reduce the Risk of Duodenal Ulcer Recurrence Randomized, double-blind clinical studies performed in the United
States in patients with H. pylori and duodenal ulcer
disease (defined as an active ulcer or history of an ulcer within 1 year)
evaluated the efficacy of lansoprazole in combination with amoxicillin capsules
and clarithromycin tablets as triple 14 day therapy, or in combination with
amoxicillin capsules as dual 14 day therapy, for the eradication of H. pylori. Based on the results of these studies, the
safety and efficacy of 2 different eradication regimen were established:
Dual Therapy: Amoxicillin 1 gram three
times daily/lansoprazole 30 mg three times daily.
All treatments were for 14 days. H. pylori
eradication was defined as 2 negative tests (culture and histology) at 4
to 6 weeks following the end of treatment.
Triple therapy was shown to be more effective than all possible dual therapy
combinations. Dual therapy was shown to be more effective than both
monotherapies. Eradication of H. pylori has been
shown to reduce the risk of duodenal ulcer recurrence.
Triple Therapy
Triple Therapy
Study
valuable Analysis*
Intent-to-Treat Analysisâ€
Study 1
92‡
86‡
[80.0-97.7]
[73.3-93.5]
(n=48)
(n=55)
Study 2
86§
83§
[75.7-93.5]
[72.0-90.8]
(n=66)
(n=70)
* This analysis was based on evaluable patients with confirmed duodenal ulcer
(active or within 1 year) and H. pylori infection at
baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest®, (Delta West Ltd., Bentley, Australia), histology and/or
culture. Patients were included in the analysis if they completed the study.
Additionally, if patients dropped out of the study due to an adverse event
related to the study drug, they were included in the analysis as failures of
therapy.†Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a
confirmed duodenal ulcer (active or within 1 year). All dropouts were included
as failures of therapy.‡ (p less than 0.05) versus lansoprazole/amoxicillin and lansoprazole/clarithromycin
dual therapy.§ (p less than 0.05) versus clarithromycin/amoxicillin dual therapy.
H. pylori Eradication Rates – Dual Therapy (amoxicillin/lansoprazole) Percent of Patients Cured [95% Confidence Interval] (Number of Patients)
Dual Therapy
Dual Therapy
Study
valuable Analysis*
Intent-to-Treat Analysisâ€
Study 1
77‡
70‡
[62.5-77.5]
[56.8-81.2]
(n=51)
(n=60)
Study 2
86§
61§
[51.9-77.5]
[48.5-72.9]
(n=58)
(n=67)
*This analysis was based on evaluable patients with confirmed duodenal ulcer
(active or within 1 year) and H. pylori infection at
baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest®, histology and/or culture. Patients were included in the
analysis if they completed the study. Additionally, if patients dropped out of
the study due to an adverse event related to the study drug, they were included
in the analysis as failures of therapy.†Patients were included in the analysis if they had documented H. pylori infection at baseline as defined above and had a
confirmed duodenal ulcer (active or within 1 year). All dropouts were included
as failures of therapy.‡ (p less than 0.05) versus lansoprazole alone.§ (p less than 0.05) versus lansoprazole alone or amoxicillin alone.
References
National Committee for Clinical Laboratory Standards. Methods for Dilution
Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically – Fourth
Edition; Approved Standard. NCCLS Document M7-A4, Vol. 17, No. 2. NCCLS, Wayne,
PA, January 1997.
National Committee for Clinical Laboratory Standards. Performance Standards
for Antimicrobial Disk Susceptibility Tests – Sixth Edition; Approved Standard.
NCCLS Document M2-A6, Vol. 17, No. 1. NCCLS, Wayne, PA, January 1997.
Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of
penicillin and cephalosporin ingestions in children less than six years of age.
Vet Hum Toxicol. 1988;30:66-67.
CLINITEST® is a registered trademark of
Miles, Inc.CLINISTIX® is a registered trademark of
Bayer Corporation.CLOtest® is a registered trademark
of Kimberly-Clark Corporation.
Revised 02-2007
Manufactured in Austria by Sandoz GmbHfor Sandoz Inc., Princeton, NJ
08540
Package Label.principal Display Panel
copy of label
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"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."
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"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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