AMOXICILLIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

STAT Rx USA LLC

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN ANHYDROUS 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN - AMOXICILLIN CAPSULE
STAT RX USA LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN CAPSULES SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR AMOXICILLIN CAPSULES, USP.
AMOXICILLIN CAPSULES, USP
INITIAL U.S. APPROVAL: 1974
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin capsules, USP and
other antibacterial drugs, amoxicillin capsules, USP should be used
only to treat infections that are proven or strongly
suspected to be caused by bacteria. (1)
INDICATIONS AND USAGE
Amoxicillin capsules, USP are a penicillin-class antibacterial
indicated for treatment of infections due to susceptible strains
of designated microorganisms.
Infections of the ear, nose, throat, genitourinary tract, skin and
skin structure, and lower respiratory tract. (1.1, 1.2, 1.3,
1.4, 1.5)
In combination for treatment of _H. pylori _infection and duodenal
ulcer disease. (1.6, 1.7)
DOSAGE AND ADMINISTRATION
In adults, 750 to 1750 mg/day in divided doses every 8 to 12 hours. In
Pediatric Patients > 3 Months of Age, 20 to 45
mg/kg/day in divided doses every 8 to 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
Capsules: 250 mg and 500 mg (3)
CONTRAINDICATIONS
History of a serious hypersensitivity reaction (e.g., anaphylaxis or
Stevens-Johnson syndrome) to amoxicillin capsules
or to other beta-lactams (