CLARITHROMYCIN- clarithromycin tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Preferred Pharmaceuticals Inc.

INN (International Name):

CLARITHROMYCIN

Sammensetning:

CLARITHROMYCIN 500 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Clarithromycin 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 tablets 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 tablets are indicated [see Indications and Usage (1.9)] for the treatment of mild to moderate infections caused by susceptible isolates due to: Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Streptococcus pyogenes as an alternative in individuals who cannot use first line therapy. Clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococ

Produkt oppsummering:

Clarithromycin tablets, USP 500 mg are white, oval-shaped, film-coated tablets, debossed GG C9 on one side and plain on the reverse side, and are supplied as follows: NDC 68788-6425-1 in bottles of 14 tablets NDC 68788-6425-2 in bottles of 20 tablets NDC 68788-6425 -8 in bottles of 28 tablets NDC 68788-6425-3 in bottles of 30 tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as described in the USP. Protect from light.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CLARITHROMYCIN- CLARITHROMYCIN TABLET
PREFERRED PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLARITHROMYCIN TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLARITHROMYCIN
TABLETS.
CLARITHROMYCIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Acute Hypersensitivity Reactions (5.1)
Warnings and Precautions, All-Cause Mortality in Patients With
Coronary Artery Disease Years After
Clarithromycin Exposure (5.5)
06/2017
06/2017
INDICATIONS AND USAGE
Clarithromycin is a macrolide antimicrobial indicated for mild to
moderate infections caused by designated, susceptible
bacteria in the following:
•
•
•
•
•
•
•
•
Limitations of Use
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of clarithromycin and other
antibacterial drugs, clarithromycin tablets 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
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
•
WARNINGS AND PRECAUTIONS
•
Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1)
Acute Maxillary Sinusitis (1.2)
Community-Acquired Pneumonia (1.3)
Pharyngitis/Tonsillitis (1.4)
Uncomplicated Skin and Skin Structure Infections (1.5)
Acute Otitis Media in Pediatric Patients (1.6)
Treatment and Prophylaxis of Disseminated Mycobacterial Infections
(1.7)
_Helicobacter pylori_ Infection and Duodenal Ulcer Disease in Adults
(1.8)
Adults: clarithromycin tablets 250 mg or 500 mg every 12 hours for
7–14 days (2.2)
_H. pylori_ eradication (in combination with lansoprazole/amoxicillin,
omeprazole/amoxicillin, or omeprazole):
clarithromycin tablets 500 mg every 8 or 12 hours for 10–14 days.
See full prescribing information (FPI) for additional
information. (2.3)
Pediatric Patients: clarithromycin 15 mg/kg/day divided every 12 hours
f