SANDOZ A NOVARTIS DIVISION
Clarithromycin is indicated in: Lower respiratory tract infection: acute and chronic bronchitis and pneumonia; Upper respiratory tract infection: sinusitis and pharyngitis, Community-acquired pneumonia, atypical pneumonia; Skin and soft tissue infection; Adjunct in the treatment of duodenal ulcers to eradicate of H. pylori
Clarithromycin acts by inhibiting microsomal protein synthesis in susceptible organisms mainly by binding to the donor site on the 50S sub- unit of the bacterial ribosome and preventing translocation to that site. Clarithromycin is active against most Gram-positive bacteria and Chlamydia, some Gram-negative bacteria and Mycoplasmas. Clarithromycin8s activity is the same as, or greater than, that of erythromycin in vitro against most Gram-positive bacteria. Clarithromycin is more acid stable than erythromycin and therefore, is better tolerated. Clarithromycin has twice the activity of erythromycin against H. influenzae. Most species of Gram-negative bacteria are resistant to clarithromycin because of failure to penetrate to the target.
Adults: Pharyngitis/Tonsillitis: 250 mg for 10 days Acute maxillary sinusitis: 500 mg for 14 days Chronic bronchitis: 250 - 500 mg for 7-14 days Pneumonia: 250 mg for 7-14 days Uncomplicated skin and skin structure infections: 250 mg for 7-14 days Community-acquired upper and lower respiratory tract infections: 250 - 500 mg for 5-14 days Children: Body weight under 8 kg: 7.5 mg/kg twice daily Body weight of 8-11 kg (1-2 years): 62.5 mg twice daily Body weight of 12-19 kg (3-6 years): 125 mg twice daily Body weight of 20-29 kg (7-9 years): 187.5 mg twice daily Body weight of 30-40 kg (10-12 years): 250 mg twice daily Eradication of H. pylori in patients with duodenal ulcers: Triple Therapy: Clarithromycin (500mg) twice daily and lansoprazole 30mg twice daily should be given with amoxycillin 1000mg twice daily. Triple Therapy: Clarithromycin (500mg) twice daily and lansoprazole 30mg twice daily should be given with metronidazole 400mg twice daily. Triple Therapy: Clarithromycin (500mg) twice daily and omeprazole 40mg daily should be given with amoxycillin 1000mg twice daily or metronidazole 400mg twice daily. Triple Therapy: Clarithromycin (500mg) twice daily should be given with amoxycillin 1000mg twice daily and omeprazole 20mg daily. Dual Therapy: The usual dose of Clarithromycin is 500mg three times daily for 14 days. Clarithromycin should be administered with oral omeprazole 40mg once daily. The pivotal study was conducted with omeprazole 40mg once daily for 28 days. Supportive studies have been conducted with omeprazole 40mg once daily for 14 days. This may be given with or without meals.
Theophylline: Concomitant use of clarithromycin who are receiving theophylline may be associated with an increase in serum theophylline concentrations. Terfenadine: Clarithromycin may alter the metabolism of terfenadine. Carbamazepine: Clarithromycin may increase area under the serum concentration-time curve (AUC) for carbamazepine and decreased peak serum concentration and AUC for carbamazepine.
Hypersensitive to Clarithromycin, Erythromycin or any of the macrolide antibiotics. Patients receiving terfenadine who have pre-existing cardiac abnormalities or electrolyte disturbances.
The most frequent and common adverse reactions related to clarithromycin therapy for both adult and peadiatric populations are abdominal pain, diarrhoea, nausea, vomiting and taste perversion. These adverse reactions are usually mild in intensity and are consistent with the known safety profile of macrolide antibiotics. There was no significant difference in the incidence of these gastrointestinal adverse reactions during clinical trials between the patient population with or without pre-existing mycobacterial infections.
Clarithromycin is not recommended for pregnant women. Breast milk from mothers receiving Clarithromycin should not be given to infants until treatment is completed.
Symptoms: Ingestion of large amounts of Clarithromycin can be expected to produce gastrointestinal symptoms. Symptoms of overdose may largely correspond to the profile of side effects. Management: There is no specific antidote on overdose. Serum levels of Clarithromycin can not be reduced by haemodialysis or peritoneal dialysis.
Caution should be taken in administering this antibiotic 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. Pharmaceutical precaution Clarithromycin tablet should be stored in a cool and dry place and away from sunlight.
Store in a cool and dry place, protected from light.