Amoxicillin and Clavulanate Oral Suspension

Name: Amoxicillin and Clavulanate Oral Suspension

Indications and Usage for Amoxicillin and Clavulanate Oral Suspension

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium for Oral Suspension, USP and other antibacterial drugs, Amoxicillin and Clavulanate Potassium for Oral Suspension should be used only to treat 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.

Amoxicillin and Clavulanate Potassium for Oral Suspension, USP is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenza (including beta-lactamase–producing strains), or M. catarrhalis (including beta-lactamase–producing strains) characterized by the following risk factors:

▪∙ antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following:

  • age 2 years or younger
  • daycare attendance

[see CLINICAL PHARMACOLOGY, Microbiology (12.4)]

NOTE: Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Amoxicillin and Clavulanate Potassium for Oral Suspension is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC ≥ 4 mcg/mL. Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S. pneumoniae (penicillin MIC ≤ 2 mcg/mL) and the beta-lactamase–producing organisms listed above.

Dosage Forms and Strengths

Powder for Oral Suspension:

  • 600 mg/42.9 mg per 5 mL: Orange-flavored powder for oral suspension ( each 5 mL of reconstituted suspension contains 600 mg amoxicillin and 42.9 mg of clavulanic acid as the potassium salt).

Contraindications

Serious Hypersensitivity Reactions

Amoxicillin and Clavulanate Potassium for Oral Suspension is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins).

Cholestatic Jaundice/Hepatic Dysfunction

Amoxicillin and Clavulanate Potassium for Oral Suspension is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with treatment with amoxicillin/clavulanate potassium.

Overdosage

Following overdosage, patients have experienced primarily gastrointestinal symptoms including stomach and abdominal pain, vomiting, and diarrhea. Rash, hyperactivity, or drowsiness has also been observed in a small number of patients.

In the case of overdosage, discontinue Amoxicillin and Clavulanate Potassium for Oral Suspension, 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 overdosage of less than 250 mg/kg of amoxicillin is not associated with significant clinical symptoms and does not require gastric emptying.4

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 both amoxicillin and clavulanate. Both amoxicillin and clavulanate are removed from the circulation by hemodialysis.

How Supplied/Storage and Handling

How Supplied

Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 600 mg/42.9 mg per 5 mL:   

Each 5 mL of reconstituted orange-flavored suspension contains 600 mg amoxicillin trihydrate and 42.9 mg clavulanic acid as the potassium salt.

NDC 60432-070-50 ........ 50 mL bottle

NDC 60432-070-75 ........ 75 mL bottle

NDC 60432-070-00 ........ 100 mL bottle

NDC 60432-070-46 ........ 125 mL bottle

NDC 60432-070-47 ........ 150 mL bottle

NDC 60432-070-48 ........ 200 mL bottle

Storage

Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Store dry powder for oral suspension at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature].

Dispense in original container.

Patient Counseling Information

Take Amoxicillin and Clavulanate Potassium for Oral Suspension every 12 hours with a meal or snack to reduce the possibility of gastrointestinal upset. If diarrhea develops and is severe or lasts more than 2 or 3 days, call your doctor.

Counsel patients that antibacterial drugs, including Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL, should only be used to treat bacterial infections. Antibacterial drugs do not treat viral infections (e.g., the common cold). When Amoxicillin and Clavulanate Potassium for Oral Suspension is prescribed to treat a bacterial infection, tell patients 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 and Clavulanate Potassium for Oral Suspension or other antibacterial drugs in the future.

Counsel patients that diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patient 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 antibacterial drug. If this occurs, patients should contact their physician as soon as possible.

Keep suspension refrigerated. Shake well before using. When dosing a child with the suspension (liquid) of amoxicillin and clavulanate potassium for oral suspension, use a dosing spoon or medicine dropper. Be sure to rinse the spoon or dropper after each use. Bottles of suspension of Amoxicillin and Clavulanate Potassium for Oral Suspension may contain more liquid than required. Follow your doctor's instructions about the amount to use and the days of treatment your child requires. Discard any unused medicine.

Counsel patients that Amoxicillin and Clavulanate Potassium for Oral Suspension contains a penicillin class drug product that can cause allergic reactions in some individuals.

Counsel patients with phenylketonuria: Each 5 mL of the 600 mg/42.9 mg per 5 mL suspension of Amoxicillin and Clavulanate Potassium for Oral Suspension contains 7 mg phenylalanine.

CLINITEST is a registered trademark of Miles, Inc.

CLINISTIX is a registered trademark of Bayer Corporation.

Product No.: 8070

Made in India

Manufactured By: Cipla Ltd. at Medispray Laboratories Pvt. Ltd.

Kundaim Goa, India

Manufactured For: Wockhardt USA, LLC

Parsippany, NJ 07054

28070

REV. 10-16

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