Amoxicillin Extended Release Tablets

Name: Amoxicillin Extended Release Tablets

Dosage forms and strengths

775 mg blue film-coated, oval-shaped tablets printed with “MB-111” on one side in black edible ink.

Contraindications

Amoxicillin Extended-Release Tablets is contraindicated in patients with known serious hypersensitivity to amoxicillin or to other drugs in the same class or patients who have demonstrated anaphylactic reactions to beta-lactams.

Use in specific populations

Pregnancy

Teratogenic Effects. Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (12.5 and 25 times the human dose in mg/m2) 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

The safety and effectiveness of Amoxicillin Extended-Release Tablets in pediatric patients 12 years of age and older have been established based on results of a clinical trial that included adults and pediatric patients (12 years and older). [see Clinical Studies (14)] Sixty-three (21%) of the study participants were pediatric patients 12 years of age and older. There were no significant differences in treatment response or adverse reactions from adults.

The safety and effectiveness of Amoxicillin Extended-Release Tablets in pediatric patients younger than 12 years has not been established.

Geriatric Use

Clinical studies with Amoxicillin Extended-Release Tablets did not include a sufficient number of patients aged 65 years and over to determine whether they respond differently from younger patients. Other reported clinical experiences with amoxicillin have not yet 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 kidneys, and the risk of adverse 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.

Renal Impairment

Amoxicillin Extended-Release Tablets have not been studied in patients with renal impairment; however, a reduction of amoxicillin dose is generally recommended for patients with severe renal impairment. Therefore, Amoxicillin Extended-Release Tablets is not recommended for use in patients with severe renal impairment (CrCl <30 mL/min) or patients on hemodialysis.

Overdosage

In case of overdose, discontinue medication, treat symptomatically, and institute supportive measures as required. If the overdose 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.

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.

For additional information about overdose treatment, call a poison control center (1-800-222-1222).

Clinical studies

In a randomized, parallel-group, multi-center, double-blind, double-dummy study in adults and pediatrics (age ≥ 12 years) with tonsillitis and/or pharyngitis secondary to S. pyogenes, Amoxicillin Extended-Release Tablets 775 mg QD for 10 days was non-inferior to penicillin VK 250 mg QID for 10 days.

Using strict evaluability and microbiologic response criteria 4-8 days post-therapy, the following bacteriological eradication rates and statistical outcomes in the per-protocol (PPb) and modified intent-to-treat (mITT) populations were obtained (Table 3). The mITT population included all randomized patients with a positive throat culture for S. pyogenes at baseline. The PPb population included mITT patients who had post-therapy cultures, were compliant with treatment, and didn't have major protocol violations.

Table 3. Bacteriological Eradication Rates in Patients with Tonsillitis and/or Pharyngitis
Study Population Amoxicillin Extended-Release Tablets Penicillin VK Rate Difference 95% CI (%)
PPb 198/233
(85.0%)
191/229
(83.4%)
1.6 (-5.1, 8.2)
mITT 204/256
(79.7%)
206/264
(78.0%)
1.7 (-5.4, 8.7)

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Review Date: October 4, 2017

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