Active Ingredient: 4-Aminosalicylic acid
4-Aminosalicylic acid is indicated for use as part of an appropriate combination regimen for multi-drug resistant tuberculosis in adults and paediatric patients from 28 days of age and older when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
150 mg per kg of body weight
75 mg per kg of body weight 2 time(s) per day every day for 730 day(s)
The optimal dose regimen in children is uncertain. Limited pharmacokinetic data suggest no substantial difference between adults and children.
For infants, children and adolescents the dosage will be adapted to the patient’s weight at 150 mg/kg per day, divided in two intakes. A dosing spoon is provided to measure small doses below 4 g for young children.
The safety and efficacy of para-aminosalicylic acid in neonates have not been established. No data are available.
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