Complete SPL Sections#
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
1 INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, Amoxicillin Tablets, USP should be used only to treat infections that are proven or strongly suspected to be caused by 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 Tablets, USP are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of the designated bacteria in the conditions listed below:
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
Tablets: 875 mg. Each tablet contains 875 mg amoxicillin as the trihydrate. Each film-coated, capsule-shaped, pink tablet is scored on one side and imprinted WW951 on the other side.
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
Amoxicillin is contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or to other β-lactam antibiotics (e.g., penicillins and cephalosporins).
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions [see Warnings and Precautions (5.1)] CDAD [see Warnings and Precautions (5.2)]
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
10 OVERDOSAGE
OVERDOSAGE SECTION
In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. 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. Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin1. 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.
11 DESCRIPTION
DESCRIPTION SECTION
Formulations of Amoxicillin Tablets, USP contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-zabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S•3H2O and the molecular weight is 419.45. Tablets: Each film coated tablet contains 875 mg amoxicillin as the trihydrate. Each film-coated, capsule shaped, pink tablet is scored on one side and imprinted WW951 on the other side. Inactive ingredients: carmine, colloidal silicone dioxide, crospovidone, FD&C Rws #40 Lake, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolized, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
14 CLINICAL STUDIES
CLINICAL STUDIES SECTION
15 REFERENCES
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.
16 HOW SUPPLIED
HOW SUPPLIED SECTION
Amoxicillin Tablets, USP 875 mg: Each film-coated tablet contains 875 mg amoxicillin as the trihydrate. Film-coated, capsule-shaped, pink tablet is scored on one side and imprinted WW951 on the other side. Store at 20°-25°C (68°-77°F ) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child resistant closure.
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Distributed by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 USA Manufactured by: Hikma Pharmaceuticals P.O. Box 182400 Amman 11118 – Jordan Revised February 2015
Principal Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 10544-434-20 Amoxicillin Tablets, USP 875mg Rx Only 20 Tablets
