Rith 125 mg/5 ml (Powder for Suspension)

Indications

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

Pharmacology

• Inhibits microsomal protein synthesis
• Binds to the donor site on the 50S subunit of the bacterial ribosome
• Prevents translocation to the donor site
• Active against most Gram-positive bacteria and Chlamydia
• Active against some Gram-negative bacteria and Mycoplasmas
• Twice the activity of Erythromycin against H. influenzae
• More acid-stable than Erythromycin
• Better tolerated than Erythromycin

Dosage & Administration

• Dosage for acute bacterial exacerbation of chronic bronchitis in adults
• Dosage for acute maxillary sinusitis in adults
• Dosage for community-acquired pneumonia in adults
• Dosage for pharyngitis or tonsillitis in adults
• Dosage for uncomplicated skin and skin structure infections in adults
• Dosage for treatment and prophylaxis of disseminated Mycobacterium avium disease
• Dosage for H. pylori infection in adults
• Dosage for pediatric patients
• Dosage for patients with renal and hepatic impairment

Interaction

• Contraindicated with HMG-CoA reductase inhibitors
• Contraindicated with gastroprokinetic agents
• Contraindicated with ergot alkaloids
• Contraindicated with antipsychotics
• Contraindicated with anti-gout agents
• Not recommended with antiarrhythmics drugs

Contraindications

• Known hypersensitivity to clarithromycin
• 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

• Safety in neonates and children
• Recommendation regarding breast milk

Precautions & Warnings

• Discontinue if severe acute hypersensitivity reactions occur
• Avoid in patients with known QT prolongation
• Avoid in patients receiving drugs known to prolong the QT interval
• Avoid in patients with ventricular arrhythmia
• Avoid in patients with hypokalemia or hypomagnesemia
• Avoid in patients with significant bradycardia
• Discontinue if signs and symptoms of hepatitis occur
• 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
• Effectiveness for prevention of disseminated Mycobacterium avium complex (MAC) disease in pediatric patients

Overdose Effects

• Expected gastro-intestinal symptoms with large amount ingestion
• Adverse reactions accompanying overdosage should be treated
• Rith serum levels not significantly affected by haemodialysis or peritoneal dialysis

Therapeutic Class

• Macrolides

Storage Conditions

• Store in a cool and dry place
• Protected from light & moisture
• Reconstituted suspension must be used within 7-14 days
• Keep out of reach of children

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