Mesalazine oral enteric coated
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Enteric coated tablets of mesalazine.
Crohn's disease - maintenance of remission
Ulcerative colitis: induction of remission
Ulcerative colitis: maintenance of remission
The release characteristics of enteric-coated preparations of mesalazine vary and should not be considered interchangeable.
Dosage should be individually determined on the clinical requirements of the patient.
Dosage recommendations vary according to brand: consult product literature for more information.
1.5g to 4g once daily or in divided doses.
When using the highest dose (4g), the effect of the treatment should be evaluated at eight weeks.
Maintenance of remission
1.5g to 3g once daily or in divided doses.
Children aged 6 to 18 years
Active disease: 30 to 50mg/kg/day in divided doses with a maximum dose of 75mg/kg/day. The total dose should not exceed 3g/day.
Maintenance treatment: 15 to 30mg/kg/day in divided doses. The total dose should not exceed 1.5g/day.
It is suggested that half the adult dose may be given to children up to a body weight of 40kg; and a normal adult dose to those above 40kg.
In children below 40kg, it is preferable to use mesalazine preparations of lower strength.
The following alternative dosing schedules may be suitable:
Acute attack in children aged 5 to 18 years and body-weight over 40kg: 0.5g to 1g three times daily.
Acute attack in children aged 5 to 18 years and body-weight under 40kg: 10mg/kg to 20mg/kg three times daily.
Maintenance of remission in children aged 5 to 18 years and body-weight over 40kg: 500mg three times daily.
Maintenance of remission in children aged 5 to 18 years and body-weight under 40kg: 7.5mg/kg to 15mg/kg twice a day. Total dose may alternatively be given in 3 divided doses.
Children under 5 years
Renal impairment - glomerular filtration rate below 20ml/minute
Severe hepatic impairment
Precautions and Warnings
Children aged 5 to 18 years
Restricted sodium intake
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
History of myocarditis
History of pericarditis
Renal impairment - glomerular filtration rate 20-50ml/minute
Some formulations contain aspartame - caution in phenylketonuria
Some formulations contain more than 1mmol (23mg) sodium per dose
Not all available brands are licensed for all indications
Not all available brands/formulations are licensed for use in children
Restore electrolyte & fluid balance in case of dehydration
Some formulations contain lactose
Some formulations contain sucrose
Delivery characteristics of e-c preps may vary and are not interchangeable
Ensure patient has adequate fluid intake
Blood counts should be performed before and periodically during treatment
Monitor hepatic function before treatment and regularly during treatment
Monitor renal function prior to initiating treatment
Elderly: Monitor renal function and consider dose modification
Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
Monitor patients with bronchial asthma
Monitor renal function especially during the initial phase of treatment
Advise patient to report unexplained fever, sore throat, bruising, bleeding
Drug-induced cardiac hypersensitivity[myocarditis & pericarditis] may occur
Suspect drug-induced nephrotoxicity if renal impairment occurs with therapy
May affect results of some laboratory tests
Discontinue if myocarditis or pericarditis occurs
Discontinue if renal function deteriorates
Discontinue if severe hypersensitivity reactions occur
Discontinue if severe skin reaction occurs
Discontinue immediately if suspicion of a blood dyscrasia
Avoid concurrent use of lactulose
Advise patients that empty tablet/capsule may be observed in stools
Haematological investigations are generally recommended within 14 days of initiation of therapy and with 2 to 3 repeat tests at intervals of 4 weeks. If the results are normal, tests are recommended quarterly.
The enteric coated tablet may be excreted undissolved in the stool in patients who have undergone bowel resection/bowel surgery in the ileocoecal region with removal of the ileocoecal valve, due to the excessively rapid intestinal passage.
Pregnancy and Lactation
Use mesalazine with caution during pregnancy.
The manufacturers recommends mesalazine is not used in pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. One manufacturer states that blood disorders (leucopenia, thrombocytopenia, anaemia) have been reported in neonates of mothers being treated with mesalazine and recommends use with caution.
Although mesalazine acts within the gastrointestinal tract, systemic absorption occurs with up to 50% of the dose being absorbed after oral administration.
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. Most authors conclude that mesalazine does not further increase the risk of adverse pregnancy outcomes. There is one report of renal insufficiency in an infant exposed after long term use of a high dose (2g to 4g, orally) of mesalazine.
Schaefer states that mesalazine is the drug of choice for chronic inflammatory bowel disease during pregnancy. Inflammatory markers and haematology should be monitored regularly. Dosage should be as required for optimal disease control.
Use mesalazine with caution during breastfeeding.
The manufacturer advises that mesalazine is excreted in breast milk in small quantities while its metabolite N-acetyl-5-aminosalicyclic acid is excreted in larger amounts. There have been a number of reported cases of diarrhoea in the nursing infant which were considered to be due to a possible hypersensitivity reaction. The manufacturer recommends that if the infant develops diarrhoea, breast feeding should be discontinued.
Abnormal liver function tests
Allergic lung reactions
Benign intracranial hypertension
Bone marrow depression
Discolouration of urine
Elevated amylase levels
Exacerbation of colitis
Increase of liver transaminases
Lupus erythematosus-like syndrome
Respiratory tract infection
Serum bilirubin increased
Toxic epidermal necrolysis
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 ).
Last Full Review Date: July 2018
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Salcrozine 500mg gastro-resistant tablets. Faes Farma, S.A. Revised April 2022.
Summary of Product Characteristics: Salcrozine 1000mg gastro-resistant tablets. Faes Farma, S.A. Revised March 2022.
Summary of Product Characteristics: Salofalk 250mg tablets. Dr. Falk Pharma UK Ltd. Revised October 2017.
Summary of Product Characteristics: Salofalk 500mg gastro-resistant tablets. Dr. Falk Pharma UK Ltd. Revised October 2017.
Summary of Product Characteristics: Salofalk 1g gastro-resistant tablets. Dr Falk Pharma UK Ltd. Revised June 2018.
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 7 October 2022.
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