Amoxicillin and Clavulanate Potassium (Page 6 of 6)

15 REFERENCES

• 1.Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard -Ninth Edition. CLSI document M07-A9, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.

• 2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fourth Informational Supplement , CLSI document M100-S24, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2014.
• 3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Eleventh Edition. CLSI document M02-A11, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.
• 4. 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.

16 HOW SUPPLIED/STORAGE AND HANDLING

Amoxicillin and Clavulanate Potassium for Oral Suspension, USP

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

75 mL bottle

125 mL bottle

200 mL bottle

STORAGE

Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Store dry powder for oral suspension at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. Dispense in original container.

17 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 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.

The brands listed are the registered trademarks of their respective owners and are not trademarks of Sandoz Inc.

Repackaged by:

Aidarex Pharmaceuticals, LLC

Corona, CA 92880

Manufactured in Slovenia by

Lek Pharmaceuticals d.d. for

Sandoz Inc., Princeton, NJ 08540

Rev.: March 2015

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Repackaged by:

Aidarex Pharmaceuticals, LLC

Corona, CA 92880

NDC 53217-0359

Amoxicillin and

Clavulanate Potassium

For Oral Suspension, USP

*600 mg/42.9 mg per 5 mL

*When reconstituted, each 5 mL contains

AMOXICILLIN, 600 mg as the trihydrate

CLAVULANIC ACID, 42.9 mg as

clavulanate potassium

Rx only

75 mL (when reconstituted)

SANDOZ

53217-0359_AMOX-CLAV-POT_600MG_42-9MG_5ML

AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin and clavulanate potassium suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53217-359(NDC:0781-6139) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 600 mg in 5 mL CLAVULANATE POTASSIUM (CLAVULANIC ACID) CLAVULANIC ACID 42.9 mg in 5 mL

Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM CITRIC ACID MONOHYDRATE SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE SACCHARIN SODIUM SODIUM CITRATE XANTHAN GUM CARAMEL ORANGE RASPBERRY

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:53217-359-01 75 mL in 1 BOTTLE, DISPENSING None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065358 01/11/2018

Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 08/2018 Aidarex Pharmaceuticals LLC