CLARITHROMYCIN tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Wockhardt USA LLC.

INN (International Nazwa):

CLARITHROMYCIN

Skład:

CLARITHROMYCIN 250 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 (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 tablets, USP 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 and pediatric patients) Clarithromycin tablets, USP are indicated for the treatment of mild to mo

Podsumowanie produktu:

Clarithromycin tablets, USP 250 mg are supplied as white oval film-coated tablets debossed with W954 on one side and other side plain. Bottles of 60 Tablets (NDC 64679-954-01) Clarithromycin tablets, USP 500 mg are supplied as white oval film-coated tablets debossed with W949 on one side and other side plain. Bottles of 60 Tablets (NDC 64679-949-01) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a light, light-resistant container as defined in the USP.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

CLARITHROMYCIN- CLARITHROMYCIN TABLET, FILM COATED
WOCKHARDT USA LLC.
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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)
6/2017
Warnings and Precautions, All-Cause Mortality in Patients With
Coronary Artery Disease Years After clarithromycin Exposure (5.5)
6/2017
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)
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 to 14
days (2.2)
_H. pylori _eradication (in combination with lansoprazole/amoxicillin,
omeprazole/amoxicillin, or omeprazole):
Clarithromycin 500 mg every 8 or 12 hours for 10 to 14 days. See full
prescribing information (FPI) for additional
information. (2.3)
Pediatric Patients: Clarithromycin 15 mg/kg/day divided every 12 hours
for 10 days (2.4)
Mycobacterial Infections: Clarithromycin 500 mg every 12 hours;
clarithromycin 7.5 mg/kg up to 500 mg every 12
hours in pediatric patients (2.5)
Reduce dose in moderate re