Clarimax^®

Clarimax^® is a preparation of Clarithromycin which is a semi-synthetic macrolide antibiotic. It exerts its antibacterial action by binding to the SOS ribosomal subunit of susceptible bacteria resulting in inhibition of protein synthesis.

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Clarithromycin is indicated for the treatment of-

• Acute bacterial exacerbation of chronic bronchitis in adults
• Acute maxillary sinusitis
• Community-acquired pneumonia
• Pharyngitis or tonsillitis
• Uncomplicated skin and skin structure infections
• Acute otitis media in pediatric patients
• Treatment and prophylaxis of disseminated mycobacterial infections
• Helicobacter pylori infection and duodenal ulcer disease in adults

Route of administration: Clarimax^® should be taken in oral route. It may be given with or should be taken in oral route. It may be given with or without meals.
Adults:

Acute bacterial exacerbation of chronic bronchitis: 250 mg to 500 mg every 12 hours for 7 to 14 days.

Acute maxillary sinusitis: 500 mg every 12 hours for 14 days.
Community-acquired pneumonia: 250 mg every 12 hours for 7 to 14 days.
Pharyngitis or tonsillitis: 250 mg every 12 hours for 10 days.
Uncomplicated skin and skin structure infections: 250 mg every 12 hours for 7 to 14 days.
Treatment and prophylaxis of disseminated Mycobacterium avium disease:
500 mg every 12 hours until the patient is considered at low risk of disseminated infection.
Combination dosing regimens for H. pylori infection:

Triple therapy: Clarithromycin/lansoprazole/amoxicillin
The recommended adult dosage is 500 mg clarithromycin, 30 mg lansoprazole and 1 g amoxicillin, all given every 12 hours for 10 or 14 days.

Triple therapy: Clarithromycin/omeprazole/amoxicillin
The recommended adult dosage is 500 mg clarithromycin, 20 mg omeprazole and 1 g amoxicillin; all given every 12 hours for 10 or 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 or 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: Clarithromycin/omeprazole
The recommended adult dosage is 500 mg clarithromycin given every 8 hours and 40 mg omeprazole given once every morning for 14 days. An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Children: The recommended daily dosage is 15 mg/kg/day divided every 12 hours for 10 days. For treatment and prophylaxis of mycobacterial infections in pediatric patients, the recommended dose is 7.5 mg/kg every 12 hours up to 500 mg every 12 hours.

Renal and hepatic impairment: Clarithromycin is principally excreted via the liver and kidney. Clarithromycin may be administered without dosage adjustment to patients with hepatic impairment and normal renal function. However, in the presence of severe renal impairment with or without coexisting hepatic impairment, decreased dosage or prolonged dosing intervals may be appropriate.

Pregnancy: Clarithromycin is not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate.

Lactation: The development and health benefits of breastfeeding should be considered along with the mother's clinical need for clarithromycin and any potential adverse effects on the breastfed child from clarithromycin or from the underlying maternal condition.

Use in children and adolescents
The safety and effectiveness of clarithromycin have been established for the treatment of pharyngitis or tonsillitis, community-acquired pneumonia, acute maxillary sinusitis, acute otitis media, uncomplicated skin and skin structure infections in pediatric patients 6 months and older. The safety and effectiveness of clarithromycin have been established for the prevention of disseminated Mycobacterium avium complex (MAC) disease in pediatric patients 20 months and older with advanced HIV infection. The safety of clarithromycin has not been studied in MAC patients under the age of 20 months. Safety and effectiveness of clarithromycin in pediatric patients under 6 months of age have not been established.

Clarithromycin should be discontinued if severe acute hypersensitivity reactions occur. Clarithromycin should be avoided in patients with known QT prolongation or receiving drugs known to prolong the QT interval, ventricular arrhythmia, hypokalemia or hypomagnesemia, significant bradycardia or taking Class IA or Ill antiarrhythmics. It should be discontinued if signs and symptoms of hepatitis occur. There is an increased risk of all-cause mortality one year or more after the end of treatment in patients with coronary artery disease. Balancing this potential risk with the treatment benefits should be considered when prescribing clarithromycin in these patients. If diarrhea occurs, the patient should be evaluated for C/ostridium difficile associated diarrhea (COAD). Exacerbation of myasthenia gravis has been reported in patients receiving clarithromycin therapy.

The most common side effects include abdominal pain, diarrhea, nausea, vomiting and dysgeusia.

Clarithromycin is contraindicated in patients with known hypersensitivity to clarithromycin, erythromycin, any of the macrolide antibacterial drugs or any other components of this product. It is also contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with prior use of clarithromycin.

Drug interaction with medication: Clarithromycin is contraindicated when co-administration with HMG-CoA reductase inhibitors (e.g., lovastatin and simvastatin), gastroprokinetic agents (e.g., cisapride), ergot alkaloids (e.g., ergotamine and dihydroergotamine), antipsychotics (e.g., pimozide and quetiapine) and anti-gout agents (e.g., colchicine). Antiarrhythmics drugs (e.g., disopyramide, quinidine, dofetilide, amiodarone, sotalol and procainamide) are not recommended to use with clarithromycin.

Drug interaction with food and others:  Not applicable. 

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Store in a cool (below 30^oC) and dry place protected from light. Keep away from the reach of children.

Clarimax^® 250 tablet: Each coated tablet contains Clarithromycin USP 250 mg.

Clarimax^® 500 tablet: Each coated tablet contains Clarithromycin USP 500 mg.

Clarimax^® 250 tablet: Carton of 10 tablets in blister pack.

Clarimax^® 500 tablet: Carton of 7 tablets in blister pack.