Cotrimoxazole 400/80 Stella (10 blisters x 10 tablets/box)

Indications

Acute otitis media, chronic or recurrent urinary tract infections (UTIs) or prostatitis, respiratory tract infections, gastrointestinal infections, brucellosis, cholera, plague, Pneumocystis jiroveci (Pneumocystis carinii) pneumonia, toxoplasmosis.

Contraindications

• Known hypersensitivity to any of the active substances or excipients.
• Patients with marked hepatic damage, severe renal impairment.
• Patients with documented megaloblastic anemia to folate deficiency.
• Pregnancy and lactation.
• Infants younger than 2 months of age.

Compositon/Ingredients

Dosage and administration

• Dosage of cotrimoxazole is expressed in terms of the trimethoprim content.
• Acute otitis media in children 2 months of age or older: 8 mg/kg daily, in 2 divided doses, in 10 days.
• Chronic or recurrent urinary tract infections (UTIs) or prostatitis: Adults: 2 tablets x twice daily x 10 – 14 days (chronic or recurrent UTIs) or x 3 – 6 months (prostatitis). Prevention of chronic or recurrent UTIs: adults: ½-1 tablets, daily or 3 times/week, in 3 – 6 months; children 2 months of age or older: 8 mg/kg daily in 2 divided doses.
• Respiratory tract infections adults: 2 tablets, twice daily in 14 days.
• Gastrointestinal infections by Shigella: Adults: 2 tablets, twice daily, children: 8 mg/kg daily in 2 divided doses, in 5 days.
• Brucellosis: Children: 10 mg/kg daily (maximum 480 mg daily) in 2 divided doses, in 4 – 6 weeks.
• Cholera: Adults: 2 tablets, twice daily in 3 days, children: 4 – 5 mg/kg x twice daily in 3 days, in conjunction with fluid and electrolyte replacement.
• Plague: Prevention: Adults: 4-8 tablets daily in 2 divided doses, in 7 days; children 2 months of age or older: 8 mg/kg daily in 2 divided doses, in 7 days.
• Pneumocystis jiroveci (Pneumocystis carinii) pneumonia (PCP): Adults and children 2 months of age or older: 15 – 20 mg/kg daily in 3-4 divided doses, in 14 – 21 days. Primary and secondary prevention: In HIV infected adults and adolescents: 1-2 tablets, once daily; children, including HIV-infected children: 150 mg/m² in 2 divided doses, 3 consecutive days each week.
• Toxoplasmosis: Primary prophylaxis in adults and adolescents: 1-2 tablets once daily. Primary prophylaxis in HIV-infected children: 150 mg/m² daily, in 2 divided doses.
• Renal impairment: Clcr < 15 ml/min (not recommend); Clcr: 15 – 30 ml/min (½ the usual regimen).

Precaution

• Pharyngitis caused by S. Pyogenes (should not use).
• Patients with impaired renal function, elderly, chronic alcoholics, receiving anticonvulsants, malnourished patients, malabsorption syndrome, severe allergy or bronchial asthma, or with glucose-6-phosphate-dehydrogenase deficiency.
• Patients should be cautioned maintain adequate fluid intake to prevent stone formation.
• Regular blood counts and urinalyses and renal-function tests should be carried out in patients receiving prolonged treatment.
• Patients should be aware of how they react to Cotrimoxazole 400/80 before driving or operating machinery.

Storage

Store at temperature below 30°C, protect from light.