AMOXICILLIN tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)

Available from:

Blenheim Pharmacal, Inc.

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN ANHYDROUS 875 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: – due to Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. – due to Escherichia coli , Proteus mirabilis , or

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN- AMOXICILLIN TABLET, COATED
BLENHEIM PHARMACAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE, SEE
FULL PRESCRIBING INFORMATION FOR
AMOXICILLIN TABLETS, USP.
AMOXICILLIN TABLETS, USP, FOR ORAL ADMINISTRATION
RX ONLY
INITIAL U.S. APPROVAL: 1974
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF AMOXICILLIN AND OTHER
ANTIBACTERIAL DRUGS, AMOXICILLIN SHOULD BE USED ONLY TO TREAT
INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED
TO BE CAUSED BY BACTERIA.
INDICATIONS AND USAGE
Amoxicillin Tablets, USP are a penicillin-class antibacterial
indicated for treatment of infections due to susceptible strains of
designated microorganisms. (1)
Infections of the ear, nose, throat, genitourinary tract, skin and
skin structure, and lower respiratory tract. (1.1 – 1.5)
In combination for treatment of _H. pylori _infection and duodenal
ulcer disease. (1.6, 1.7)
(1)
DOSAGE AND ADMINISTRATION
In adults, 750-1750 mg/day in divided doses every 8-12 hours. In
Pediatric Patients > 3 Months of Age, 20-45
mg/kg/day in divided doses every 8-12 hours. Refer to full prescribing
information for specific dosing regimens. (2.1,
2.2, 2.3)
Treatment of gonorrhea is 3 grams as a single oral dose. (2.1)
The upper dose for neonates and infants ≤ 3 months is 30 mg/kg/day
divided every 12 hours. (2.2)
Dosing for _H. pylori _Infection: Triple therapy: 1 gram amoxicillin,
500 mg clarithromycin, and 30 mg lansoprazole, all
given twice daily (every 12 hours) for 14 days. Dual therapy: 1 gram
amoxicillin and 30 mg lansoprazole, each given
three times daily (every 8 hours) for 14 days. (2.3)
Reduce the dose in patients with severe renal impairment (GFR <30
mL/min). (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 875 mg (3)
CONTRAINDICATIONS
History of a serious hypersensitivity reaction (e.g., anaphylaxis or
Stevens-Johnson syndrome) to amoxicillin or to
other beta-lactams (e.g., penicillins or cephalosporins). (4).
WARNINGS AND PRECAUTIONS