4-Aminosalicylic acid

Therapeutic Indications

4-Aminosalicylic acid is indicated for:

Multi-drug resistant tuberculosis

Irrespective of gender only Adults (18 years old or older)

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, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 4 g three times per day

Multi-drug resistant tuberculosis

Irrespective of gender only Infants (40 days - 1 year old) , Children (1 year - 12 years old) , Adolescents (12 years - 18 years old)

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, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 150 mg/kg per day, divided in two intakes

Contraindications

Active ingredient 4-Aminosalicylic acid is contraindicated in the following cases:

Severe renal disease

No gender/age discrimination

Patients with severe renal impairment should not receive para-aminosalicylic acid. Patients with severe renal disease will accumulate the inactive acetyl metabolite of paraaminosalicylic acid.

Lactation

No gender/age discrimination

Aminosalicylic acid is excreted in human milk. There is insufficient information on the effects of aminosalicylic acid in newborns/infants. Aminosalicylic acid should not be used during breast-feeding.

Pregnancy

No gender/age discrimination

There are no or limited amount of data from the use of aminosalicylic acid in pregnant women. Studies in animals have shown some reproductive toxicity. Aminosalicylic acid is not recommended during pregnancy and in women of childbearing potential not using contraception.

Literature reports on aminosalicylic acid in pregnant women always report co-administration of other medicinal products. As there are no adequate and well controlled studies of aminosalicylic acid in humans, aminosalicylic acid should be given to a pregnant woman only if clearly needed.

Diphenylhydramine

No gender/age discrimination

Diphenylhydramine decreases the gastrointestinal absorption of para-aminosalicylic acid, and should not be administered concomitantly.