CLARITHROMYCIN for suspension

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Sandoz Inc

INN (nume internaţional):

CLARITHROMYCIN

Compoziție:

CLARITHROMYCIN 125 mg in 5 mL

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Clarithromycin is 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 is 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 is indicated [see Indications and Usage (1.9) ] for the treatment of mild to moderate infections caused by susceptible isolates due to: Clarithromycin is 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 is indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Staphylococcus aureus , or Streptococcus pyogenes . Cl

Rezumat produs:

Clarithromycin for oral suspension, USP is supplied in the following strengths and sizes: Total Volume After Constitution Clarithromycin Concentration After Constitution Clarithromycin Contents Per Bottle NDC 50 mL 125 mg/5 mL 1250 mg 0781-6022-52 100 mL 125 mg/5 mL 2500 mg 0781-6022-46 50 mL 250 mg/5 mL 2500 mg 0781-6023-52 100 mL 250 mg/5 mL 5000 mg 0781-6023-46 Store clarithromycin for oral suspension below 25°C (77°F) in a well-closed container [see USP Controlled Room Temperature]. Do not refrigerate clarithromycin suspension.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

CLARITHROMYCIN- CLARITHROMYCIN FOR SUSPENSION
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLARITHROMYCIN FOR
ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
CLARITHROMYCIN FOR ORAL SUSPENSION.
CLARITHROMYCIN FOR ORAL SUSPENSION, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Contraindications (4) 05/2023
Drug Interactions (7) 05/2023
INDICATIONS AND USAGE
Clarithromycin is a macrolide antimicrobial indicated for mild to
moderate infections caused by
designated, susceptible bacteria in the following:
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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
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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)
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-containing
regimens and in severe renal impairment (2.6)
Granules for Oral Suspension: 125 mg/5 mL and 250 mg/5 mL (3)
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.