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Klarix (Clarithromycin)
Therapeutic Group: Anti Bacterial
Presentation

Klarix 250: Each film coated tablet contains Clarithromycin USP 250 mg.

Klarix 500: Each film coated tablet contains Clarithromycin USP 500 mg.

Klarix 60 ml granules for suspension: After reconstitution according to direction, each 5 ml suspension contains Clarithromycin USP 125 mg.

Descriptions
Clarithromycin is a macrolide antibiotic. It acts by inhibiting microsomal protein synthesis by binding to the 50S subunit of the bacterial ribosome. Clarithromycin is active against most gram-positive bacteria, Chlamydia, some gram-negative bacteria and Mycoplasmas.
Indications
• LRTIs for example, acute and chronic bronchitis and pneumonia.

• URTIs for example, 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
Dosage & Administration
Clarithromycin may be given with or without meals.
Adults (12 years or above):
250 mg twice daily for 7 days. Dose may be increased to 500 mg twice daily for up to 14 days in pneumonia or severe infections.

Combination therapy for H. pylori infection:
Clarithromycin 500 mg (two 250 mg tablets or one 500 mg tablet) twice daily in combination with Amoxicillin 1000 mg twice daily and Omeprazole 20 mg twice daily should be continued for 10 days.

Children:
The usual recommended daily dosage is 15 mg/kg in 2 divided doses for 10 days.

Approximate Calculation of dose:
1. For 9kg body weight 2.5ml 12 hourly for 10 days
2. For 17kg body weight 5ml 12 hourly for 10 days
3. For 25kg body weight 7.5ml 12 hourly for 10 days
4. For 33kg body weight 10ml 12 hourly for 10 days

Direction for reconstitution of suspension:
Shake the bottle to loosen granules. Add 35 ml of boiled and cooled water with the help of the supplied cup, to the dry granules of the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the granules is in suspension.
Note: Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator.
Side Effects
The most frequently reported events in adults taking Clarithromycin were diarrhoea (3%), nausea (3%), abnormal taste (3%), dyspepsia (2%), abdominal pain/discomfort (2%), headache (2%) and oral monilia.
Precautions
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.
Contraindications
Hypersensitive to Clarithromycin, Erythromycin or any of the macrolide antibiotics. Patients receiving terfenadine who have pre-existing cardiac abnormalities or electrolyte disturbances.
Use in Pregnancy & Lactation
Clarithromycin is not recommended for pregnant women. Breast milk from mothers receiving Clarithromycin should not be given to infants until treatment is completed. Clarithromycin may be used in neonates and children in appropriate doses.
Drug Interaction
Concomitant use of Clarithromycin who are receiving Theophylline may be associated with an increase in serum Theophylline concentrations. Clarithromycin may alter the metabolism of Terfenadine. The effects of digoxin may be potentiated with concomitant administration of Clarithromycin. Clarithromycin resulted in decrease in serum levels of Rifabutin, followed by an increased risk of uveitis.
Overdose
Signs & 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.
Commercial Packaging
Klarix 250: Each box contains 1 blister strip of 10 tablets.
Klarix 500: Each box contains 2 blister strips of 3 tablets.
Klarix 60 ml granules for suspension: Bottle containing dry granules for 60 ml suspension.
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