CLARITHROMYCIN- clarithromycin tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

CLARITHROMYCIN

Sammensætning:

CLARITHROMYCIN 500 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 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) - Mycoplasma pneumoniae , Streptococcus pneumoniae , Chlamydophila pneumoniae Clarithromycin tablets, USP 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 ther

Produkt oversigt:

Clarithromycin tablets, USP are supplied as white to off-white oval film-coated tablets in the following packaging sizes: 250 mg tablets: (imprinted in blue with the “S39” on one side) 500 mg tablets: (debossed with the “S4” on one side) 55700-535-20 55700-535-30 Store clarithromycin tablets, USP at controlled room temperature 20° to 25°C (68° to 77°F) in a well-closed container.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

CLARITHROMYCIN- CLARITHROMYCIN TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLARITHROMYCIN TABLETS, USP SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLARITHROMYCIN
TABLETS, USP.
CLARITHROMYCIN TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Serious Adverse Reactions with Concomitant
Use with Other Drugs (5.4)
10/2015
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 7–14 days
(2.2)
_H. pylori_ eradication (in combination with lansoprazole/amoxicillin,
omeprazole/amoxicillin, or omeprazole):
clarithromycin 500 mg every 8 or 12 hours for 10–14 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 renal impairment with concomitant atazanavir
or ritonavir-contain