CLARITHROMYCIN- clarithromycin tablet, film coated, extended release

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

CLARITHROMYCIN (UNII: H1250JIK0A) (CLARITHROMYCIN - UNII:H1250JIK0A)

Fáanlegur frá:

Preferred Pharmaceuticals Inc.

INN (Alþjóðlegt nafn):

CLARITHROMYCIN

Samsetning:

CLARITHROMYCIN 500 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Clarithromycin extended-release tablets are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae [see Indications and Usage (1.9)] . Clarithromycin extended-release tablets (in adults) are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae [see Indications and Usage (1.9)] . Clarithromycin extended-release tablets are indicated [see Indications and Usage (1.9)] for the treatment of mild to moderate infections caused by susceptible isolates due to: Clarithromycin extended-release tablets are indicated only for acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, and community-acquired pneumonia in adults. The efficacy and safety of clarithromycin extended-release tablets in treating other infections for which

Vörulýsing:

Clarithromycin Extended-release Tablets USP are supplied as yellow, film coated, oval shaped, unscored tablets debossed with  and “777” on one side. Bottles of 20 Tablets NDC #68788-6887-2 Bottles of 30 Tablets NDC #68788-6887-3 Bottles of 60 Tablets NDC #68788-6887-6 Bottles of 90 Tablets NDC #68788-6887-9 Bottles of 100 Tablets NDC #68788-6887-1 Store clarithromycin extended-release tablets USP at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

CLARITHROMYCIN- CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE
PREFERRED PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLARITHROMYCIN EXTENDED-RELEASE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CLARITHROMYCIN EXTENDED-
RELEASE TABLETS.
CLARITHROMYCIN EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
Clarithromycin is a macrolide antimicrobial indicated for mild to
moderate infections caused by designated, susceptible
bacteria in the following:
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Limitations of Use
Clarithromycin extended-release tablets are indicated only for acute
bacterial exacerbation of chronic bronchitis, acute
maxillary sinusitis, and community-acquired pneumonia in adults. (1.9)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of clarithromycin and other
antibacterial drugs, clarithromycin should be used only to treat or
prevent infections that are proven or strongly suspected
to be caused by bacteria. (1.9)
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
Most frequent adverse reactions for both adult and pediatric
populations in clinical trials: abdominal pain, diarrhea, nausea,
Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1)
Acute Maxillary Sinusitis (1.2)
Community-Acquired Pneumonia (1.3)
Adults: Clarithromycin extended-release tablets 1 gram every 24 hours
for 7 to 14 days (2.2)
Reduce dose in moderate renal impairment with concomitant atazanavir
or ritonavir-containing regimens and in
severe renal impairment (2.6)
Extended-release Tablets: 500 mg (3)
Hypersensitivity to clarithromycin or any macrolide drug (4.1)
Cisapride, pimozide, lovastatin/simvastatin,
ergotamine/dihydroergotamine (4.2, 4.5, 4.6)
History of cholestatic jaundice/hepatic dysfunction with use of
clarithromycin (4.3)
Colch