Clariwin

Clariwin

clarithromycin

Manufacturer:

Micro Labs

Distributor:

Zizawa Healthcare
Full Prescribing Info
Contents
Clarithromycin.
Description
Clarithromycin is erythromycin 6-O-methyl-6-O-methylerythromycin.
Action
Macrolide antibiotic.
Pharmacology: Clarithromycin exerts its antibacterial action by binding to the 50S ribosomal subunit of susceptible organisms and inhibiting protein synthesis.
Microbiology: Clarithromycin is active in vitro against a variety of aerobic and anaerobic gram-positive and gram-negative organisms as well as most Mycobacterium avium complex (MAC) organisms.
Gram-positive aerobes: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes.
Gram-negative aerobes: Haemophilus influenzae, Moraxella (Branhamella) catarrhalis.
Other aerobes: Mycoplasma pneumoniae.
Mycobacteriae: Mycobacterium avium complex (MAC) consisting of Mycobacterium avium and Mycobacterium intracellulare.
Pharmacokinetics: Clarithromycin is rapidly absorbed from the gastrointestinal tract after oral administration. The absolute bioavailability of clarithromycin 250 mg was approximately 50%. Food slightly delays both the onset of clarithromycin absorption and the formation of the antimicrobially active metabolite, 14-OH clarithromycin, but does not affect the extent of bioavailability. Therefore, clarithromycin may be given without regard to meals.
Indications/Uses
Treatment of upper and lower respiratory tract infections, pharyngitis/tonsillitis due to Streptococcus pyogenes, acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, pneumonia, uncomplicated skin and skin structure infections.
Dosage/Direction for Use
Upper Respiratory Tract Infection: 250-500 mg for 10-14 days.
Lower Respiratory Tract Infection: 250 mg for 7-14 days.
Uncomplicated Skin and Skin Structure Infections: 250 mg for 7-14 days.
Overdosage
Studies on overdosage not available.
Contraindications
Patients with known hypersensitivity to clarithromycin, erythromycin or any of the macrolide antibiotics.
Special Precautions
General: In the presence of severe renal impairment with or without coexisting hepatic impairment, decreased dosage or prolonged dosing intervals may be appropriate. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including macrolides and may range in severity from mild to severe.
Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Clarithromycin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate.
Use in lactation: It is not known whether clarithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when clarithromycin is administered to a nursing woman.
Use in children: Safety and effectiveness of clarithromycin in children <6 months have not been established.
Use In Pregnancy & Lactation
Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Clarithromycin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Clarithromycin should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate.
Use in lactation: It is not known whether clarithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when clarithromycin is administered to a nursing woman.
Side Effects
Diarrhoea, nausea, abnormal taste, dyspepsia, abdominal pain/discomfort and headache.
Drug Interactions
Clarithromycin use in patients who are receiving theophylline may be associated with increased serum theophylline concentrations. Clarithromycin may increase carbamazepine concentrations. Active metabolite of terfenadine was 3-fold higher when co-administered with clarithromycin. Concomitant administration of erythromycin and digoxin has been reported to result in elevated digoxin level.
Storage
Keep in a cool, dry place.
MIMS Class
ATC Classification
J01FA09 - clarithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Tab 250 mg x 1 x 10's. 500 mg (film-coated) x 1 x 10's.
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