CLARITHROMYCIN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clarithromycin tablets, USP 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, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to

Product summary:

NDC: 63629-8222-1: 20 Tablets in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLARITHROMYCIN- CLARITHROMYCIN TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
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 USP, 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 Concomitant
Use with Other Drugs
(5.4)
9/2019
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)
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)
Limitations of Use
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 250 mg or 500 mg every 12 hours for 7–14 days
(2.2)Adults:Adults:
clarithromycin 250 mg or 500 mg every 12 hours for 7–14 days
(2.2)Adults:
_H. pylori_ eradication (in combination with lansoprazole/amoxicillin,
omeprazole/amoxicillin, or
omeprazole): clarithromycin 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 ever