CLARITHROMYCIN tablet, film coated, extended release

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Actavis Pharma, Inc.

INN (nume internaţional):

CLARITHROMYCIN

Compoziție:

CLARITHROMYCIN 500 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 adults) - Mycoplasma pneumoniae, Streptococcus pneumoniae , Chlamydophila pneumoniae (in adults) Clarithromycin extended-release tablets are indicated only for acute maxillary

Rezumat produs:

Clarithromycin Extended-release Tablets USP are supplied as yellow, film coated, oval shaped, unscored tablets debossed with  and “777” on one side. Bottles of 60 (NDC 0591-2805-60). 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.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

CLARITHROMYCIN- CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE
ACTAVIS PHARMA, 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
clarithromycin (4.3)
Co