AMOXICILLIN capsule

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Preferred Pharmaceuticals, Inc.

INN（国际名称）:

AMOXICILLIN

组成:

AMOXICILLIN ANHYDROUS 500 mg

处方类型:

PRESCRIPTION DRUG

授权状态:

Abbreviated New Drug Application

产品特点

AMOXICILLIN- AMOXICILLIN CAPSULE
PREFERRED PHARMACEUTICALS, INC.
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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.
AMOXICILLIN CAPSULES, FOR ORAL USE
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 capsules are a penicillin-class antibacterial indicated
for treatment of infections due to susceptible strains of
designated microorganisms.
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To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin capsules and other
antibacterial drugs, amoxicillin capsules should be used only to treat
infections that are proven or strongly suspected to be
caused by bacteria. (1.6)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
THE MOST COMMON ADVERSE REACTIONS (> 1%) OBSERVED IN CLINICAL TRIALS
OF AMOXICILLIN CAPSULES, TABLETS OR ORAL
SUSPENSION WERE DIARRHEA, RASH, VOMITING, AND NAUSEA. (6.1)TO REPORT
SUSPECTED ADVERSE REACTIONS,
CONTACT AUROBINDO PHARMA USA, INC. AT 1-866-850-2876 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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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)
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)
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 amoxicil