Brand name: Asacol
Active ingredient (generic name): Mesalamine- Mesalazine
Manufacturer: Tillotts Pharma AG
Importer: Rossen Darman
Pharmacotherapeutic group: anti-inflammatory
Pharmaceutical form: 4 g in 100 ml Enema
Mesalazine is one of the two components of sulphasalazine, the other being sulphapyridine. It is the latter which is responsible for the majority of the side effects associated with sulphasalazine therapy whilst Mesalazine is known to be the active moiety in the treatment of ulcerative colitis.
Pharmacokinetic:
The enema is intended to deliver mesalazine directly to the proposed site of action in the colon and rectum. Asacol half life is 3 hours and it is defecated from bowel.
Asacol enema is indicated for the treatment of mild to moderate proctitis and proctosigmoiditis.
Dosage and administration:
Adult dose is 1g, 2g or 4g daily for maximum 8 weeks. It should be administered at night after defecation.
Adverse reaction:
The side effects are predominantly gastrointestinal, including nausea, diarrhoea and abdominal pain. Headache has also been reported.
There have been rare reports of leucopenia, neutropenia, agranulocytosis, aplastic anaemia and thrombocytopenia, alopecia, peripheral neuropathy, pancreatitis, abnormalities of hepatic function and hepatitis, myocarditis and pericarditis, allergic and fibrotic lung reactions, lupus erythematosus-like reactions and rash (including urticaria), interstitial nephritis and nephrotic syndrome with oral mesalazine treatment, usually reversible on withdrawal. Renal failure has been reported. Mesalazine-induced nephrotoxicity should be suspected in patients developing renal dysfunction during treatment.
Contraindication:
Use in the elderly should be cautious and subject to patients having normal renal function and it is prohibited in children under two years old.
Renal disorder: Mesalazine is excreted rapidly by the kidney, mainly as its metabolite, N-acetyl-5-aminosalicylic acid. Asacol should be used with extreme caution in patients with confirmed mild to moderate renal impairment. Patients on mesalazine should have renal function monitored. Treatment with mesalazine should be discontinued if renal function deteriorates.
Serious blood dyscrasias have been reported very rarely with mesalazine. Haematological investigations should be performed if the patient develops unexplained bleeding, bruising, purpura, anemia, fever or sore throat. Treatment should be stopped if there is suspicion or evidence of blood dyscrasias.
Pharmacokinetic interactions
Concurrent use of other known nephrotoxic agents, such as NSAIDs and azathioprine, may increase the risk of renal reactions.
Pregnancy and lactation:
No information is available with regard to teratogenicity; however, negligible quantities of mesalazine are transferred across the placenta and are excreted in breast milk following sulphasalazine therapy. Use of 'Asacol' during pregnancy should be with caution, and only if the potential benefits are greater than the possible hazards. 'Asacol' should, unless essential, be avoided by nursing mothers.
Storage temperature:
Store in room temperature (15-25 C), in a dry place, protected from direct sunlight
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