CLARITHROMYCIN tablet, film coated, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

CLARITHROMYCIN

Sammensetning:

CLARITHROMYCIN 500 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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: - Haemophilus influenzae (in adults) - Haemophilus parainfluenzae (in adults) - Moraxella catarrhalis (in adult

Produkt oppsummering:

Clarithromycin Extended-release Tablets USP are supplied as yellow, film coated, oval shaped, unscored tablets debossed with   and “777” on one side. Bottles of 14 (NDC 43063-565-14). 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.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CLARITHROMYCIN- CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE
PD-RX 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
RECENT MAJOR CHANGES
Contraindications, Lomitapide, Lovastatin, and Simvastatin ( 4.5)
9/2019
Warnings and Precautions, QT Prolongation ( 5.2)
11/2018
Warnings and Precautions, Serious Adverse Reactions Due to
9/2019
Concomitant Use with Other Drugs ( 5.4)
Warnings and Precautions, Embryo-Fetal Toxicity ( 5.7)
12/2018
INDICATIONS AND USAGE
Clarithromycin is a macrolide antimicrobial indicated for mild to
moderate infections caused by
designated, susceptible bacteria in the following:
Acute Bacterial Exacerbation of Chronic Bronchitis in Adults ( 1.1)
Acute Maxillary Sinusitis ( 1.2)
Community-Acquired Pneumonia ( 1.3)
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
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)
DOSAGE FORMS AND STRENGTHS
Extended-release Tablets: 500 mg ( 3)
CONTRAINDICATIONS
Hypersensitivity to clarithromycin or any macrolide drug ( 4.1)
Cisapride and pimozide ( 4.2)
History of cholestatic jaundice/hepatic dysfunction with use of
cla