Drugs List

Therapeutic Indications

Uses

Multidrug-resistant tuberculosis: combination treatment

Para-aminosalicylic acid is indicated as part of a combination regimen for multidrug-resistant tuberculosis when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.

Contraindications

Neonates under 1 month
Severe renal impairment

Precautions and Warnings

Breastfeeding
Hepatic impairment
Peptic ulcer
Pregnancy
Renal impairment

Consult national/regional policy on the use of anti-infectives
Must be used as part of combination therapy
Discontinue if hepatitis develops
Discontinue if hypersensitivity reactions occur
Advise patient that empty granule shells may be observed in stools

Pregnancy and Lactation

Pregnancy

Use para-aminosalicylic acid with caution in pregnancy.

Briggs suggests, if possible, it is best to avoid para-aminosalicylic acid in the first trimester. The manufacturer suggests para-aminosalicylic acid should only be given in pregnancy if clearly needed.

At the time of writing, there are limited data available on the use of para-aminosalicylic acid in pregnant women. Studies in animals have shown some embryologic toxicity.

The molecular weight (approximately 153) is low enough to expect passage to the foetus.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use para-aminosalicylic acid with caution in breastfeeding.

The Drugs and Lactation Database (LactMed) suggests para-aminosalicylic acid is not expected to cause any adverse effects in breastfed infants, especially those older than 2 months. Breastfed infants should be monitored for jaundice, gastrointestinal disturbances, hypokalaemia, thrombocytopenia, haemolysis and hypokalaemia. The manufacturer suggests breastfeeding mothers should not breastfeed during treatment because para-aminosalicylic acid is excreted into breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Agranulocytosis
Anorexia
Bloating
Crystalluria
Cytolytic hepatitis
Diarrhoea
Dizziness
Gastrointestinal bleeding
Giddiness
Haemolytic anaemia
Headache
Hyperprothrombinaemia
Hypersensitivity reactions
Hypoglycaemia
Hypothyroidism
Increase in alkaline phosphatase
Increase in serum transaminases
Jaundice
Leucopenia
Malabsorption
Metallic taste
Methaemoglobinaemia
Nausea
Pain
Peptic ulceration
Peripheral neuropathy
Purpura
Rash
Soft faeces
Thrombocytopenia
Urticaria
Vestibular disorders
Visual disturbances
Vomiting
Weight loss

Presentation

Oral formulations of para-aminosalicylic acid.

Drugs List

Therapeutic Indications

Uses

Multidrug-resistant tuberculosis: combination treatment

Para-aminosalicylic acid is indicated as part of a combination regimen for multidrug-resistant tuberculosis when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.

Dosage

Adults

Elderly

Children

Additional Dosage Information

Contraindications

Neonates under 1 month
Severe renal impairment

Precautions and Warnings

Breastfeeding
Hepatic impairment
Peptic ulcer
Pregnancy
Renal impairment

Consult national/regional policy on the use of anti-infectives
Must be used as part of combination therapy
Discontinue if hepatitis develops
Discontinue if hypersensitivity reactions occur
Advise patient that empty granule shells may be observed in stools

Pregnancy and Lactation

Pregnancy

Use para-aminosalicylic acid with caution in pregnancy.

Briggs suggests, if possible, it is best to avoid para-aminosalicylic acid in the first trimester. The manufacturer suggests para-aminosalicylic acid should only be given in pregnancy if clearly needed.

At the time of writing, there are limited data available on the use of para-aminosalicylic acid in pregnant women. Studies in animals have shown some embryologic toxicity.

The molecular weight (approximately 153) is low enough to expect passage to the foetus.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use para-aminosalicylic acid with caution in breastfeeding.

The Drugs and Lactation Database (LactMed) suggests para-aminosalicylic acid is not expected to cause any adverse effects in breastfed infants, especially those older than 2 months. Breastfed infants should be monitored for jaundice, gastrointestinal disturbances, hypokalaemia, thrombocytopenia, haemolysis and hypokalaemia. The manufacturer suggests breastfeeding mothers should not breastfeed during treatment because para-aminosalicylic acid is excreted into breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Counselling

Advise patients to swallow granules immediately after mixing with orange juice, tomato juice, apple sauce or yoghurt whilst the granules are still intact. The granules will not dissolve. If adding to orange or tomato juice swirl the contents to re-suspend the granules should they sink. Drink at once ensuring the granules are not left in the glass, any leftover granules should be swallowed immediately by adding a small amount of liquid. Doses smaller than the contents of one sachet (4 g) should be measured using the dosing spoon. Granules should not be crushed or chewed.

Advise patients the empty granule shell may be seen in the stools.

Side Effects

Agranulocytosis
Anorexia
Bloating
Crystalluria
Cytolytic hepatitis
Diarrhoea
Dizziness
Gastrointestinal bleeding
Giddiness
Haemolytic anaemia
Headache
Hyperprothrombinaemia
Hypersensitivity reactions
Hypoglycaemia
Hypothyroidism
Increase in alkaline phosphatase
Increase in serum transaminases
Jaundice
Leucopenia
Malabsorption
Metallic taste
Methaemoglobinaemia
Nausea
Pain
Peptic ulceration
Peripheral neuropathy
Purpura
Rash
Soft faeces
Thrombocytopenia
Urticaria
Vestibular disorders
Visual disturbances
Vomiting
Weight loss

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: September 2014

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summary of Product Characteristics: Granupas 4 g gastro-resistant tablets. Lucane Pharma. Revised May 2014.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Aminosalicylic Acid. Last revised: 16th January, 2014.
Last accessed: 18th September, 2014.