AMOXICILLIN capsule

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Preferred Pharmaceuticals Inc.

INN (Alþjóðlegt nafn):

AMOXICILLIN

Samsetning:

AMOXICILLIN ANHYDROUS 250 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species. (α- and   β-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae . Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis , or Enterococcus faecalis . Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli . Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneum

Vörulýsing:

Amoxicillin Capsules, USP contains 250 mg amoxicillin USP as the trihydrate. 250 mg Capsule Blue/Pink size “1” hard gelatin capsule filled with white to off white granular powder and imprinted with “A44” on pink body with black ink.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

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.
•
•
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
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
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 RISING HEALTH, LLC
AT 1-833-395-
6928 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
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 amoxicillin,
500 mg clarithromycin, and 30 mg