Amoxicillin and Clavulanate Potassium Extended Release (Page 6 of 6)

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^a n/N = patients with pathogen eradicated or presumed eradicated/total number of patients.^b Confidence limits calculated using exact probabilities.^c S. pneumoniae strains with penicillin MICs of ≥ 2 mcg/mL are considered resistant to penicillin.^d Includes one patient each with S. pneumoniae penicillin MICs of 8 and 16 mcg/mL in the Intent‑To‑Treat group only.

15 REFERENCES

1. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-third Informational Supplement, CLSI document M100-S23. CLSI document M100-S23, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2013.

2. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard ‑ Ninth Edition. CLSI Document M7‑A9 Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.

3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard ‑ Eleventh Edition. CLSI Document M2‑A11. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.

16 HOW SUPPLIED/STORAGE AND HANDLING

Amoxicillin and Clavulanate Potassium Extended Release Tablets: Each white, oval film‑coated bilayer scored tablet, debossed with AUGMENTIN XR, contains amoxicillin trihydrate and amoxicillin sodium equivalent to a total of 1,000 mg of amoxicillin and clavulanate potassium equivalent to 62.5 mg of clavulanic acid.

NDC 43598‑220‑28 Bottles of 28 (7 day Extended Release pack)

NDC 43598‑220‑40 Bottles of 40 (10 day Extended Release pack)

Storage

Dispense in original container

Store tablets at or below 25°C (77°F).

Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

17.1 Information for Patients

Counsel patients to take Amoxicillin and Clavulanate Potassium Extended Release Tablets every 12 hours with a low fat 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.

Patients should be counseled that antibacterial drugs, including Amoxicillin and Clavulanate Potassium Extended Release Tablets, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Amoxicillin and Clavulanate Potassium Extended Release Tablet 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 and Clavulanate Potassium Extended Release Tablets or other antibacterial drugs in the future.

Counsel patients that diarrhea is a common problem caused by antibacterials, and it usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, 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 their last dose of the antibacterial. If diarrhea is severe or lasts more than 2 or 3 days, patients should contact their physician. Discard any unused medicine.

Patients should be aware that Amoxicillin and Clavulanate Potassium Tablets contain a penicillin class drug product that can cause allergic reactions in some individuals.

AUGMENTIN XR and AUGMENTIN are registered trademarks of GlaxoSmithKline and are licensed to Dr. Reddy’s Laboratories, Inc.

MAALOX is a registered trademark of Novartis Consumer Health, Inc.

CLINITEST is a registered trademark of Miles, Inc.

Manufactured by:

Dr. Reddy’s Laboratories Tennessee LLC,

Bristol, TN 37620

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

Principal Display Panel

NDC 43598-220-28

7 day Extended Release Pack

Amoxicillin and Clavulanate Potassium

Extended Release Tablets

Amoxicillin, 1000 MG

Clavulanic Acid, 62.5 MG ,

as clavulanate potassium

28 Scored Tablets

Rx only

1000mg/62.5 mg

Store at or below 25^o C (77^o F).

Dispense in original container; advise patients to keep in closed container.

Each tablet contains 1000 mg amoxicillin and 62.5 mg clavulanic acid as clavulanate potassium.

Dosage: Take 2 tablets every 12 hours at start of a meal.

See prescribing information.Use only if inner seal is intact.

Mfd. By: Dr. Reddy’s Laboratories Tennessee LLC.

Bristol, TN 37620

I0513

150035308

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

Principal Display Panel

NDC 43598-220-40

10 day Extended Release Pack

Amoxicillin and Clavulanate Potassium

Extended Release Tablets

Amoxicillin, 1000 MG

Clavulanic Acid, 62.5 MG ,

as clavulanate potassium

40 Scored Tablets

Rx only

1000mg/62.5 mg

Store at or below 25^o C (77^o F).

Dispense in original container; advise patients to keep in closed container.

Each tablet contains 1000 mg amoxicillin and 62.5 mg clavulanic acid as clavulanate potassium.

Dosage: Take 2 tablets every 12 hours at start of a meal.

See prescribing information.Use only if inner seal is intact.

Mfd. By: Dr. Reddy’s Laboratories Tennessee LLC.

Bristol, TN 37620

I0513

150035307

AMOXICILLIN AND CLAVULANATE POTASSIUM EXTENDED RELEASE amoxicillin and clavulanate potassium tablet, film coated, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-220 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 562.5 mg AMOXICILLIN SODIUM (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 437.5 mg CLAVULANATE POTASSIUM (CLAVULANIC ACID) CLAVULANIC ACID 62.5 mg

Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE SILICON DIOXIDE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS SODIUM STARCH GLYCOLATE TYPE A POTATO Titanium Dioxide Xanthan Gum

Product Characteristics Color WHITE Score 2 pieces Shape OVAL Size 22mm Flavor Imprint Code AUGMENTIN;XR Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43598-220-40 40 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:43598-220-28 28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA050785 09/11/2003

Labeler — Dr. Reddy’s Laboratories Inc (802315887)

Registrant — Dr. Reddy’s Laboratories Inc. DBA Dr. Reddy’s Laboratories Tennessee LLC (967940441)

Establishment
Name	Address	ID/FEI	Operations
Dr. Reddy’s laboratories DBA Dr. Reddy’s Laboratories Tennessee LLC		967940441	manufacture (43598-220)

Establishment
Name	Address	ID/FEI	Operations
Beecham Pharmaceuticals (PTE) Limited		595132580	api manufacture (43598-220), analysis (43598-220)

Establishment
Name	Address	ID/FEI	Operations
SmithKline Beecham Limited		214482031	api manufacture (43598-220), analysis (43598-220)

Establishment
Name	Address	ID/FEI	Operations
Smithkline Beecham Limited		233662381	api manufacture (43598-220), analysis (43598-220)

Revised: 01/2014 Dr. Reddy’s Laboratories Inc