AMOXICILLIN (Page 4 of 4)

NONCLINICAL TOXICOLOGY SECTION

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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. Amoxicillin and clavulanic acid mixture was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. Amoxicillin and clavulanic acid mixture 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. Amoxicillin and clavulanic acid mixture 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 2 times the 3 g human dose based on body surface area).

CLINICAL STUDIES SECTION

14.1 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Randomized, double-blind clinical studies performed in the United States in patients with H. pylori and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within 1 year) evaluated the efficacy of lansoprazole in combination with amoxicillin capsules and clarithromycin tablets as triple 14-day therapy, or in combination with amoxicillin capsules as dual 14-day therapy, for the eradication of H. pylori. Based on the results of these studies, the safety and efficacy of 2 different eradication regimens were established:

Triple Therapy: Amoxicillin 1 gram twice daily/clarithromycin 500 mg twice daily/lansoprazole 30 mg twice daily (see Table 6).

Dual Therapy: Amoxicillin 1 gram three times daily/lansoprazole 30 mg three times daily (see Table 7). All treatments were for 14 days. H. pylori eradication was defined as 2 negative tests (culture and histology) at 4 to 6 weeks following the end of treatment. Triple therapy was shown to be more effective than all possible dual therapy combinations. Dual therapy was shown to be more effective than both monotherapies. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

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REFERENCES SECTION

  1. 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.
  2. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – 8th ed. CLSI Document M7-A8, Vol. 29, No.2. CLSI, Wayne, PA, Jan. 2009.
  3. Clinical and Laboratory Standards Institute (CLSI). Performance Standard for Antimicrobial Disk Susceptibility Tests; Approved Standard – 10th ed. CLSI Document M2-A10, Vol. 29, No. 1. CLSI, Wayne, PA, 2009.
  4. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing: 21st Informational Supplement. Approved Standard CLSI Document M100-S21 CLSI, Wayne, PA, January 2011.

HOW SUPPLIED SECTION

Amoxicillin for Oral Suspension, USP: Each 5 mL of reconstituted bubble-gum-flavored pink suspension contains 200 mg or 400 mg amoxicillin as the trihydrate.

200 mg/5 mL

50 mL Bottle NDC 65862-070-50

75 mL Bottle NDC 65862-070-75

100 mL Bottle NDC 65862-070-01

400 mg/5 mL

50 mL Bottle NDC 65862-071-50

75 mL Bottle NDC 65862-071-75

100 mL Bottle NDC 65862-071-01

Store dry powder 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

INFORMATION FOR PATIENTS SECTION

17.1 Information for Patients.

  • Patients should be advised that amoxicillin may be taken every 8 hours or every 12 hours, depending on the dose 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.
  • Patients should be counseled that diarrhea is a common problem caused by antibiotics, and it 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 their last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
  • Patients should be aware that amoxicillin contains a penicillin class drug product that can cause allergic reactions in some individuals.

CLINITEST® is a registered trademark of Siemens Medical Solutions Diagnostics, and Ames Company, Inc.

CLINISTIX® is a registered trademark of Bayer Healthcare Llc, and Ames Company, Inc.

CLOtest® is a registered trademark of Kimberly-Clark Worldwide, Inc.

Manufactured for:

Aurobindo Pharma USA, Inc.

2400 Route 130 North

Dayton, NJ 08810

Manufactured by:

Aurobindo Pharma Limited

Hyderabad-500 072, India

Revised: 12/2012

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 200 mg/5 mL (50 mL Bottle)

NDC 65862-070-50

Amoxicillin for Oral Suspension, USP

200 mg/5 mL

50 mL when reconstituted

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

401
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01920
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AMOXICILLIN amoxicillin powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-401(NDC:65862-071)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 400 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE
TRISODIUM CITRATE DIHYDRATE
SODIUM BENZOATE
EDETATE DISODIUM
FD&C RED NO. 3
XANTHAN GUM
SILICON DIOXIDE
Product Characteristics
Color pink Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61919-401-32 100 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065334 01/01/2014
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin and clavulanate potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-019(NDC:66685-1002)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 500 mg
CLAVULANATE POTASSIUM (CLAVULANIC ACID) CLAVULANIC ACID 125 mg
Inactive Ingredients
Ingredient Name Strength
TALC
TRIETHYL CITRATE
POLYSORBATE 80
TITANIUM DIOXIDE
CROSCARMELLOSE SODIUM
ETHYLCELLULOSES
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
Product Characteristics
Color white Score no score
Shape OVAL Size 13mm
Flavor Imprint Code 500125;AMC
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61919-019-20 20 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065117 01/21/2021
Labeler — DIRECT RX (079254320)
Establishment
Name Address ID/FEI Operations
DIRECT RX 079254320 relabel (61919-401), relabel (61919-019)

Revised: 01/2021 DIRECT RX

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