Clarimax 250 mg (Tablet)

Indications

• 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

Pharmacology

• Inhibition of microsomal protein synthesis
• Binding to the donor site on the 50S subunit of the bacterial ribosome
• Prevention of translocation to the donor site
• Activity against most Gram-positive bacteria and Chlamydia
• Activity against some Gram-negative bacteria and Mycoplasmas
• Twice the activity of Erythromycin against H. influenzae
• More acid-stable than Erythromycin
• Resistance of most species of Gram-negative bacteria to Clarithromycin

Dosage & Administration

• Dosage regimen for different indications in adults
• Combination dosing regimens for H. pylori infection
• Recommended daily dosage for children
• Administration in renal and hepatic impairment

Interaction

• Contraindication with certain medications
• Contraindication with HMG-CoA reductase inhibitors
• Contraindication with gastroprokinetic agents
• Contraindication with ergot alkaloids
• Avoidance with drugs known to prolong the QT interval

Contraindications

• Known hypersensitivity to clarithromycin or macrolide antibacterial drugs
• History of cholestatic jaundice or hepatic dysfunction associated with prior use of clarithromycin

Side Effects

• Nausea
• Vomiting
• Diarrhoea
• Abdominal pain
• Stomatitis
• Glossitis
• Headache
• Allergic reactions
• Taste perversion
• Transient central nervous system side effects

Pregnancy & Lactation

• Use in neonates and children
• Precaution for breast milk from mothers receiving Clarithromycin
• Limited experience in the treatment of pregnant patients

Precautions & Warnings

• Discontinuation in case of severe acute hypersensitivity reactions
• Avoidance in patients with known QT prolongation
• Increased risk of all-cause mortality in patients with coronary artery disease
• Evaluation for Clostridium difficile associated diarrhea if diarrhea occurs

Use in Special Populations

• Safety and effectiveness in pediatric patients 6 months and older
• Established treatment for various pediatric infections
• Not studied in pediatric patients under 6 months of age
• Safety of Clarimax in MAC patients under the age of 20 months not established

Overdose Effects

• Gastro-intestinal symptoms
• Altered mental status
• Paranoid behaviour
• Hypokalemia
• Hypoxemia
• Prompt elimination of unabsorbed drug
• Supportive measures

Therapeutic Class

• Macrolides

Storage Conditions

• Store in a cool and dry place
• Protected from light & moisture
• Reconstituted suspension must be used within specified timeframes
• Keep out of reach of children

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