Crixan

Crixan

clarithromycin

Manufacturer:

Ranbaxy

Distributor:

DKLL
Full Prescribing Info
Contents
Clarithromycin.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Clarithromycin exerts its antibacterial action by binding to the 50S ribosomal subunit of susceptible bacteria and suppresses protein synthesis. It is active against a wide variety of aerobic and anaerobic gram-positive and gram-negative organisms. The 14-hydroxy metabolites of clarithromycin also has antimicrobial activity.
Microbiology: Antibacterial Spectrum: Clarithromycin is usually active against the following organisms in vitro: Gram-Positive Bacteria: Staphylococcus aureus (methicillin susceptible), Streptococcus pyogenes (group A β-haemolytic streptococci), α-haemolytic streptococci (viridans group), Streptococcus (Diplococcus) pneumoniae, Streptococcus agalactiae, Listeria monocytogenes.
Gram-Negative Bacteria: Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoeae, Legionella pneumophila, Bordetella pertussis, Helicobacter pylori.
Mycoplasma: Mycoplasma pneumoniae.
Other Organisms: Chlamydia trachomatis, Mycobacterium avium, Mycobacterium leprae.
Anaerobes: Macrolides-susceptible Bacteroides fragilis, Clostridium perfringens, Peptococcus and Peptostreptococcus spp, Propionibacterium acnes.
Indications/Uses
Treatment of infections caused by one or more susceptible organisms:
Upper Respiratory Tract Infections: Sinusitis and pharyngitis.
Lower Respiratory Tract Infections: Pneumonia, bronchitis.
Disseminated mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare.
Skin and skin structure infections.
Dosage/Direction for Use
Adults: Usual Dose: 250 mg twice daily for 7 days.
Severe Infections: 500 mg twice daily for 6-14 days.
Eradication of H. pylori: Recommended Dose: 500 mg 3 times a day for 14 days.
Renal Impairment: Dosage adjustments are required in patients with severe renal impairment.
Creatinine Clearance <30 mL/min: 250 mg once daily for mild to moderately severe infections and 250 mg twice daily in more severe infections.
Contraindications
Patients with a previous history of hypersensitivity to clarithromycin and other macrolides.
Special Precautions
General: Clarithromycin is principally excreted by the liver and kidney. Caution should be exercised in administering clarithromycin to patients with impaired hepatic and renal function. Prolonged or repeated use of clarithromycin may result in an overgrowth of nonsusceptible bacteria or fungi. If superinfection occurs, clarithromycin should be discontinued and appropriate therapy instituted.
Use in pregnancy & lactation: The safety of clarithromycin during pregnancy and breastfeeding of infants has not been established. Clarithromycin should, thus, not be used during pregnancy or lactation unless the benefit outweighs the risk. Clarithromycin is secreted in the breast milk.
Use In Pregnancy & Lactation
Use in pregnancy & lactation: The safety of clarithromycin during pregnancy and breastfeeding of infants has not been established. Clarithromycin should, thus, not be used during pregnancy or lactation unless the benefit outweighs the risk. Clarithromycin is secreted in the breast milk.
Side Effects
Clarithromycin is generally well-tolerated. Side effects include nausea, vomiting, diarrhoea, abdominal pain, stomatitis and headache.
Drug Interactions
Theophylline levels should be monitored in patients who are administered with clarithromycin, as increased serum theophylline levels and potential theophylline toxicity may occur during concomitant administration of the 2 drugs.
The use of clarithromycin in patients receiving warfarin may result in a potentiation of the effects of warfarin. Prothrombin time should be frequently monitored in these patients.
The effects of digoxin may be potentiated with concomitant administration of clarithromycin.
Simultaneous oral administration of clarithromycin tablets and zidovudine to HIV-infected adult patients may result in decreased steady-state zidovudine concentrations.
Storage
Store below 25°C. Protect from moisture.
MIMS Class
ATC Classification
J01FA09 - clarithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Tab (film-coated) 250 mg x 10 x 10's. 500 mg x 5 x 14's.
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