Drugs List

Therapeutic Indications

Uses

Ulcerative colitis: induction of remission
Ulcerative colitis: maintenance of remission

Contraindications

Children under 12 years
Moderate renal impairment
Severe hepatic impairment

Precautions and Warnings

Children aged 12 to 18 years
Asthma
Breastfeeding
Coagulopathy
Duodenal ulcer
Hepatic disorder
Mild renal impairment
Peptic ulcer
Pregnancy

Monitor renal function before, at 3 months of treatment, and then annually
During treatment perform blood counts, BUN/creatinine and urine analysis
Monitor digoxin levels in digitalised patients
Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
Discontinue immediately if suspicion of a blood dyscrasia
Maximum duration of high dose therapy for active disease is 12 weeks

Pregnancy and Lactation

Pregnancy

Use balsalazide with caution in pregnancy.

The manufacturer contraindicates balsalazide in pregnancy but other sources state use with caution in pregnancy.

Animal studies on fertility and reproductive function did not reveal adverse effects of balsalazide. Human experience is limited. It is not known if balsalazide crosses the human placenta. The molecular weight is low enough but the very small amounts in the plasma and extensive plasma protein binding suggest that little if any drug crosses to the embryo or foetus.

Mesalamine is the primary active drug produced by metabolism of balsalazide. A study in 2002 concluded that mesalamine is safe to use during pregnancy (Briggs, 2010). The maternal benefits of balsalazide appear to outweigh the unknown risks 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 balsalazide with caution in breastfeeding.

The manufacturer contraindicates balsalazide in pregnancy but other sources state use with caution in pregnancy.

The active metabolite mesalazine has produced adverse effects in nursing infants. Diarrhoea have been reported in infants exposed to mesalamine. If balsalazide is required, it is not a reason to discontinue breastfeeding, but observe the nursing infant for changes in bowel function.

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

Abdominal pain
Acute pancreatitis
Acute renal failure
Agranulocytosis
Allergic alveolitis
Alopecia
Angioedema
Aplastic anaemia
Arthralgia
Blood dyscrasias
Bronchospasm
Cholelithiasis
Diarrhoea
Eosinophilic pneumonia
Exacerbation of colitis
Headache
Hepatitis
Hypersensitivity reactions
Interstitial nephritis
Leucopenia
Lupus erythematosus-like syndrome
Myalgia
Myocarditis
Nausea
Neuropathy
Neutropenia
Pericarditis
Rash
Renal impairment
Thrombocytopenia
Vomiting

Presentation

Capsules containing balsalazide disodium

Drugs List

Therapeutic Indications

Uses

Ulcerative colitis: induction of remission
Ulcerative colitis: maintenance of remission

Dosage

Adults

Children

Contraindications

Children under 12 years
Moderate renal impairment
Severe hepatic impairment

Precautions and Warnings

Children aged 12 to 18 years
Asthma
Breastfeeding
Coagulopathy
Duodenal ulcer
Hepatic disorder
Mild renal impairment
Peptic ulcer
Pregnancy

Monitor renal function before, at 3 months of treatment, and then annually
During treatment perform blood counts, BUN/creatinine and urine analysis
Monitor digoxin levels in digitalised patients
Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
Discontinue immediately if suspicion of a blood dyscrasia
Maximum duration of high dose therapy for active disease is 12 weeks

Pregnancy and Lactation

Pregnancy

Use balsalazide with caution in pregnancy.

The manufacturer contraindicates balsalazide in pregnancy but other sources state use with caution in pregnancy.

Animal studies on fertility and reproductive function did not reveal adverse effects of balsalazide. Human experience is limited. It is not known if balsalazide crosses the human placenta. The molecular weight is low enough but the very small amounts in the plasma and extensive plasma protein binding suggest that little if any drug crosses to the embryo or foetus.

Mesalamine is the primary active drug produced by metabolism of balsalazide. A study in 2002 concluded that mesalamine is safe to use during pregnancy (Briggs, 2010). The maternal benefits of balsalazide appear to outweigh the unknown risks 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 balsalazide with caution in breastfeeding.

The manufacturer contraindicates balsalazide in pregnancy but other sources state use with caution in pregnancy.

The active metabolite mesalazine has produced adverse effects in nursing infants. Diarrhoea have been reported in infants exposed to mesalamine. If balsalazide is required, it is not a reason to discontinue breastfeeding, but observe the nursing infant for changes in bowel function.

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

Abdominal pain
Acute pancreatitis
Acute renal failure
Agranulocytosis
Allergic alveolitis
Alopecia
Angioedema
Aplastic anaemia
Arthralgia
Blood dyscrasias
Bronchospasm
Cholelithiasis
Diarrhoea
Eosinophilic pneumonia
Exacerbation of colitis
Headache
Hepatitis
Hypersensitivity reactions
Interstitial nephritis
Leucopenia
Lupus erythematosus-like syndrome
Myalgia
Myocarditis
Nausea
Neuropathy
Neutropenia
Pericarditis
Rash
Renal impairment
Thrombocytopenia
Vomiting

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: July 2014

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

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.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Summary of Product Characteristics: Colazide 750mg capsules. Almirall Limited. May 2013.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 21 June 2017

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
Balsalazide Last revised: April 1, 2014
Last accessed: July 15, 2014