Drugs List

Therapeutic Indications

Uses

Oral treatment of mild active ulcerative colitis and maintenance of remission.

Administration

For oral administration.

Olsalazine taken on an empty stomach may sometimes lead to loose stools or diarrhoea. By taking the drug at the end of a meal, this may be avoided.

Capsules can be opened and contents sprinkled on food.

Contraindications

Severe renal impairment

Children under 2 years

Hypersensitivity to salicylates

Precautions and Warnings

Olsalazine should be used with caution in patients with moderate renal impairment.

It is recommended to monitor patients with impaired renal or hepatic function.

For patients with baseline renal impairment, treatment with olsalazine should only be initiated if the benefits outweigh the risks. Renal function should be monitored before starting olsalazine, every 3 months for the first year, every 6 months for the next 4 years, and annually after 5 years of treatment. Treatment should be discontinued if renal functions deteriorates.

Patients suffering from severe allergy or asthma should be observed for signs of worsening of these conditions.

Serious blood dyscrasias have been reported very rarely with olsalazine. Haematological investigations should be performed if the patient develops unexplained bleeding, bruising, purpura, anaemia, fever or sore throat. Treatment should be stopped if there is a suspicion or evidence of a blood dyscrasia.

Patients should be instructed how to recognise the sings of haematotoxicity and should be advised to contact their physicians immediately if the symptoms develop.

Children under 18 years - see ' Dosage - Children' section

Pregnancy - see 'Pregnancy' section

Breastfeeding - see 'Lactation' section

Pregnancy and Lactation

Pregnancy

Use with caution in pregnancy.

Reproductive studies in rats have revealed reduced foetal weights, retarded ossifications, and immaturity of the foetal visceral organs with doses 5 - 20 times the recommended dose of a weight basis.

There are no adequate or well-controlled studies in pregnant women and at the time of writing no reports of its use have been located.

In inflammatory bowel disease, symptoms and activity are linked to pregnancy outcomes, active disease being associated with low birth weights, higher rates of spontaneous abortion, prematurity and perinatal complications.

Although Schaefer concludes that olsalazine may be used in pregnancy if necessary, both Schaefer and Briggs suggest that the 5-aminosalicylic acid derivative of choice is mesalazine due to the greater body of evidence concerning its use.

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 14-17 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

Olsalazine is excreted into human milk although only a small percentage of an oral dose to the mother is absorbed. Nursing infants of women being treated with olsalazine should be closely observed for changes in stool consistency although there are a very few reports of adverse effects with the 5-aminosalicylic acid derivatives.

Schaefer suggests that olsalazine may be used during breastfeeding, however the manufacturer recommends its use only if the benefit of the treatment outweighs the risks.

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

Diarrhoea
Headache
Nausea
Dyspepsia
Arthralgia
Rash
Blood dyscrasias
Leucopenia
Neutropenia
Aplastic anaemia
Pancytopenia
Thrombocytopenia
Anaemia
Haemolytic anaemia
Vomiting
Exacerbation of colitis
Hypersensitivity reactions
Urticaria
Acute pancreatitis
Hepatitis
Myocarditis
Pericarditis
Interstitial lung disease
Eosinophilia
Fibrosing alveolitis
Agranulocytosis
Methaemoglobinaemia
Renal impairment
Interstitial nephritis
Nephrotic syndrome
Myalgia
Skin reactions
Lupus erythematosus-like syndrome
Stevens-Johnson syndrome
Alopecia
Peripheral neuropathy
Palpitations
Tachycardia
Dizziness
Paraesthesia
Blurred vision
Photosensitivity
Pruritus
Angioneurotic oedema
Serum bilirubin increased
Dyspnoea
Elevation of liver enzymes
Pyrexia
Upper abdominal pain
Depression

Presentation

Capsules containing olsalazine sodium 250mg

Tablets containing olsalazine sodium 500mg

Drugs List

Therapeutic Indications

Uses

Oral treatment of mild active ulcerative colitis and maintenance of remission.

Dosage

Adults

Children

Patients with Renal Impairment

Patients with Hepatic Impairment

Administration

For oral administration.

Olsalazine taken on an empty stomach may sometimes lead to loose stools or diarrhoea. By taking the drug at the end of a meal, this may be avoided.

Capsules can be opened and contents sprinkled on food.

Contraindications

Severe renal impairment

Children under 2 years

Hypersensitivity to salicylates

Precautions and Warnings

Olsalazine should be used with caution in patients with moderate renal impairment.

It is recommended to monitor patients with impaired renal or hepatic function.

For patients with baseline renal impairment, treatment with olsalazine should only be initiated if the benefits outweigh the risks. Renal function should be monitored before starting olsalazine, every 3 months for the first year, every 6 months for the next 4 years, and annually after 5 years of treatment. Treatment should be discontinued if renal functions deteriorates.

Patients suffering from severe allergy or asthma should be observed for signs of worsening of these conditions.

Serious blood dyscrasias have been reported very rarely with olsalazine. Haematological investigations should be performed if the patient develops unexplained bleeding, bruising, purpura, anaemia, fever or sore throat. Treatment should be stopped if there is a suspicion or evidence of a blood dyscrasia.

Patients should be instructed how to recognise the sings of haematotoxicity and should be advised to contact their physicians immediately if the symptoms develop.

Children under 18 years - see ' Dosage - Children' section

Pregnancy - see 'Pregnancy' section

Breastfeeding - see 'Lactation' section

Pregnancy and Lactation

Pregnancy

Use with caution in pregnancy.

Reproductive studies in rats have revealed reduced foetal weights, retarded ossifications, and immaturity of the foetal visceral organs with doses 5 - 20 times the recommended dose of a weight basis.

There are no adequate or well-controlled studies in pregnant women and at the time of writing no reports of its use have been located.

In inflammatory bowel disease, symptoms and activity are linked to pregnancy outcomes, active disease being associated with low birth weights, higher rates of spontaneous abortion, prematurity and perinatal complications.

Although Schaefer concludes that olsalazine may be used in pregnancy if necessary, both Schaefer and Briggs suggest that the 5-aminosalicylic acid derivative of choice is mesalazine due to the greater body of evidence concerning its use.

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 14-17 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

Olsalazine is excreted into human milk although only a small percentage of an oral dose to the mother is absorbed. Nursing infants of women being treated with olsalazine should be closely observed for changes in stool consistency although there are a very few reports of adverse effects with the 5-aminosalicylic acid derivatives.

Schaefer suggests that olsalazine may be used during breastfeeding, however the manufacturer recommends its use only if the benefit of the treatment outweighs the risks.

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

Effects on Ability to Drive and Operate Machinery

The ability to drive or operate machinery may be affected by side effects, especially dizziness and blurred vision.

Counselling

Advise patients that dizziness and blurred vision have been reported as side effects. If affected, they should not drive or operate machinery.

Advise patient to report any unexplained bleeding, bruising, purpura, sore throat, fever or malaise that occurs during treatment.

Side Effects

Diarrhoea
Headache
Nausea
Dyspepsia
Arthralgia
Rash
Blood dyscrasias
Leucopenia
Neutropenia
Aplastic anaemia
Pancytopenia
Thrombocytopenia
Anaemia
Haemolytic anaemia
Vomiting
Exacerbation of colitis
Hypersensitivity reactions
Urticaria
Acute pancreatitis
Hepatitis
Myocarditis
Pericarditis
Interstitial lung disease
Eosinophilia
Fibrosing alveolitis
Agranulocytosis
Methaemoglobinaemia
Renal impairment
Interstitial nephritis
Nephrotic syndrome
Myalgia
Skin reactions
Lupus erythematosus-like syndrome
Stevens-Johnson syndrome
Alopecia
Peripheral neuropathy
Palpitations
Tachycardia
Dizziness
Paraesthesia
Blurred vision
Photosensitivity
Pruritus
Angioneurotic oedema
Serum bilirubin increased
Dyspnoea
Elevation of liver enzymes
Pyrexia
Upper abdominal pain
Depression

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 ).

Shelf Life and Storage

Store at room temperature in a dry place.

Further Information

Last Full Review Date: May 2012

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.

Summary of Product Characteristics: Olsalazine Sodium Capsules 250mg. Atnahs Pharma UK Ltd. Revised May 2021.

Summary of Product Characteristics: Olsalazine Sodium Tablets 500mg. Atnahs Pharma UK Ltd. Revised May 2021.

The Renal Drug Handbook. Fifth Edition (2019) ed. Ashley, C. and Dunleavy, A. Radcliffe Publishing Ltd, London.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 August 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
Olsalazine. Last revised: January 04, 2011
Last accessed: May 23, 2012