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How is Amoxicillin Supplied

October 14th, 2009 No comments

Amoxicillin Capsules, USP contains 250 mg or 500 mg Amoxicillin as the trihydrate.

250 mg Capsule

Blue/Pink size “1” hard gelatin capsule filled with white to off white granular powder and imprinted with “A44” on pink body with black ink.
 
Bottles of 20                                              NDC 65862-016-20
Bottles of 100                                             NDC 65862-016-01
Bottles of 500                                             NDC 65862-016-05

500 mg Capsule

Blue/Pink size “0EL” hard gelatin capsule filled with white to off white granular powder and imprinted with “A45” on pink body with black ink.
 
Bottles of 20                                              NDC 65862-017-20
Bottles of 100                                             NDC 65862-017-01
Bottles of 500                                             NDC 65862-017-05

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
 
Dispense in a tight container.

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Amoxicillin Overdosage

October 14th, 2009 No comments

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.

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Amoxicillin adverse reactions

October 14th, 2009 No comments

As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to Amoxicillin 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 Amoxicillin:

Infections and Infestations
Mucocutaneous candidiasis.

Amoxicillin Gastrointestinal adverse reactions
Nausea, vomiting, diarrhea, black hairy tongue, and hemorrhagic/pseudomembranous colitis.
 
Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.

Amoxicillin Hypersensitivity Adverse Reactions
Anaphylaxis
 
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 life-threatening and amenable only to Amoxicillin therapy.

Amoxicillin Liver adverse reactions
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.

Amoxicillin Renal adverse reactions
Crystalluria has also been reported.

Amoxicillin Hemic and Lymphatic Systems adverse reactions
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.

Amoxicillin Central Nervous System adverse reactions
Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness have been reported rarely.

Amoxicillin Miscellaneous adverse reactions
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.

Amoxicillin Combination Therapy with Clarithromycin and Lansoprazole adverse reactions 
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.

Amoxicillin Triple Therapy adverse reactions
Amoxicillin/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.

Amoxicillin Dual Therapy adverse reactions 
Amoxicillin/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.

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Amoxicillin precautions

October 13th, 2009 No comments

Amoxicillin general precautions

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.
 
A high percentage of patients with mononucleosis who receive ampicillin develop an erythematous skin rash. Thus, ampicillin-class antibiotics should not be administered to patients with mononucleosis.
 
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.
 
Amoxicillin 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.

Amoxicillin 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.

Amoxicillin Carcinogenesis, Mutagenesis, Impairment of Fertility precautions

Long-term 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 (AUGMENTIN). AUGMENTIN was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. AUGMENTIN 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. AUGMENTIN 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).

Amoxicillin 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.
 
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

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Amoxicillin drug interactions precautions

October 12th, 2009 No comments

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.
 
In common with other antibiotics, Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

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Amoxicillin pregnancy precautions

October 12th, 2009 No comments

Teratogenic Effects
Pregnancy 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.

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Amoxicillin Labor and Delivery precautions

October 12th, 2009 No comments

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.

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Amoxicillin nursing mothers precautions

October 12th, 2009 No comments

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.

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Amoxicillin pediatric use precautions

October 12th, 2009 No comments

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).

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Amoxicillin geriatric use precautions

October 12th, 2009 No comments

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 <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 elderly 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.

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