AMOXICILLIN tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Dr Reddys Laboratories Inc

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN ANHYDROUS 500 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

AMOXICILLIN- AMOXICILLIN TABLET, FILM COATED
AMOXICILLIN- AMOXICILLIN POWDER, FOR SUSPENSION
DR REDDYS LABORATORIES INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR AMOXICILLIN.
AMOXICILLIN CAPSULES, TABLETS, AND POWDER FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1974
RECENT MAJOR CHANGES
Indications and Usage, Gonorrhea
(1.5)..................................................... Removed
9/2015
Dosage and Administration, Gonorrhea (2.1)
..............................................Removed 9/2015
INDICATIONS AND USAGE
AMOXICILLIN is 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 – 1.4)
In combination for treatment of H. pylori infection and duodenal ulcer
disease. (1.5)
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. (1.6)
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)
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