Formulary
Mesalazine: Indications, Dosing, Side Effects and Interactions
Mesalazine clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 9 min read
Mesalazine: Indications, Dosing, Side Effects and Interactions
Mesalazine clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Treatment of acute attack of mild to moderate ulcerative colitis affecting the rectosigmoid region**
- **Child** (By Rectum): 12-17 years 1 g once daily, dose to be administered at bedtime.
**Treatment of acute attack of mild to moderate ulcerative colitis, affecting the descending colon**
- **Adult** (By Rectum): 2 g once daily for 4-6 weeks, to be administered into the rectum.
**Treatment of mild to moderate ulcerative colitis, acute attack**
- **Child** (By Mouth): 5-17 years (body-weight 40 kg and above) 0.5-1 g 3 times a day.
- **Adult** (By Mouth): 0.5-1 g 3 times a day.
**Maintenance of remission of ulcerative colitis and Crohn's ileo-colitis**
- **Adult** (By Mouth): 1.2-2.4 g once daily, alternatively 1.2-2.4 g daily in divided doses.
**Maintenance of remission of ulcerative colitis**
- **Child** (By Mouth): 5-17 years (body-weight 40 kg and above) 500 mg 3 times a day.
- **Adult** (By Mouth): 500 mg 3 times a day.
**Maintenance of remission of Crohn's ileo-colitis**
- **Adult** (By Mouth): Up to 2.4 g daily in divided doses.
**Treatment of acute attack of mild to moderate ulcerative colitis and maintenance of remission**
- **Adult** (By Rectum): 0.75-1.5 g daily in divided doses, last dose to be administered at bedtime.
**Treatment of mild to moderate ulcerative proctitis, acute attack,Maintenance of remission of ulcerative proctitis**
- **Adult** (By Rectum): 1 g once daily, to be administered preferably at bedtime.
**Treatment of acute attack of mild to moderate ulcerative colitis or maintenance of remission**
- **Adult** (By Rectum): 2 g once daily, dose to be administered at bedtime.
**Treatment of acute attack, ulcerative proctitis**
- **Adult** (By Rectum): 1 g daily for 2-4 weeks.
**Maintenance, ulcerative proctitis**
- **Adult** (By Rectum): 1 g daily.
**Treatment of mild ulcerative colitis affecting sigmoid colon and rectum**
- **Child** (By Rectum): 12-17 years 2 g once daily, dose to be administered into the rectum at bedtime, alternatively 2 g daily in 2 divided doses.
- **Adult** (By Rectum): 2 g once daily, dose to be administered into the rectum at bedtime, alternatively 2 g daily in 2 divided doses.
**Treatment of acute attack of mild to moderate ulcerative colitis affecting the rectum**
- **Adult** (By Rectum): 0.5-1 g 2-3 times a day, to be given using 500 mg suppositories, dose to be adjusted according to response, alternatively 1 g once daily, to be given using 1 g suppositories preferably at bedtime.
**Treatment of acute attack of mild to moderate ulcerative colitis affecting the rectosigmoid region for Asacol foam enema**
- **Child 12-17 years** (By rectum): 1 g daily for 4-6 weeks, to be administered into the rectum.
**Treatment of acute attack of mild to moderate ulcerative colitis, affecting the descending colon for Asacol foam enema**
- **Child 12-17 years** (By rectum): 2 g once daily for 4-6 weeks, to be administered into the rectum.
**Treatment of mild to moderate ulcerative colitis, acute attack for Asacol MR 400mg tablets**
- **Child 12-17 years** (By mouth): 800 mg 3 times a day.
**Maintenance of remission of ulcerative colitis and Crohn's ileo-colitis for Asacol MR 400mg tablets**
- **Child 12-17 years** (By mouth): 400-800 mg 2-3 times a day.
**Treatment and maintenance of remission of ulcerative colitis affecting the rectosigmoid region for Asacol suppositories**
- **Child 12-17 years** (By rectum): 250-500 mg 3 times a day, last dose to be administered at bedtime.
**Treatment of mild to moderate ulcerative colitis, acute attack for Octasa MR 400mg and 800mg tablets**
- **Child 6-17 years (body-weight up to 40 kg)** (By mouth): Initially 30-50 mg/kg daily in divided doses, increased if necessary up to 75 mg/kg daily in divided doses.
- **Child 6-17 years (body-weight 40 kg and above)** (By mouth): 2.4 g once daily, alternatively 2.4-4 g daily in divided doses.
**Maintenance of remission of ulcerative colitis and Crohn's ileo-colitis for Octasa MR 400mg and 800mg tablets**
- **Child 6-17 years (body-weight up to 40 kg)** (By mouth): 15-30 mg/kg daily in divided doses.
- **Child 6-17 years (body-weight 40 kg and above)** (By mouth): 1.2-2 g once daily, alternatively 1.2-2 g daily in divided doses.
**Treatment of mild to moderate ulcerative colitis, acute attack for Pentasa granules**
- **Child 5-17 years (body-weight up to 40 kg)** (By mouth): 10-20 mg/kg 3 times a day.
- **Child 5-17 years (body-weight 40 kg and above)** (By mouth): 1-2 g twice daily, alternatively 2-4 g daily in 3-4 divided doses.
**Maintenance of remission of ulcerative colitis for Pentasa granules**
- **Child 5-17 years (body-weight up to 40 kg)** (By mouth): 7.5-15 mg/kg twice daily, alternatively 15-30 mg/kg daily in 3 divided doses.
- **Child 5-17 years (body-weight 40 kg and above)** (By mouth): 2 g once daily.
**Treatment of acute attack of mild to moderate ulcerative colitis affecting the rectosigmoid region for Pentasa retention enema**
- **Child 12-17 years** (By rectum): 1 g once daily, dose to be administered at bedtime.
**Treatment of acute attack, ulcerative proctitis for Pentasa suppositories**
- **Child 12-17 years** (By rectum): 1 g daily for 2-4 weeks.
**Maintenance, ulcerative proctitis for Pentasa suppositories**
- **Child 12-17 years** (By rectum): 1 g daily.
**Treatment of mild to moderate ulcerative colitis, acute attack for Pentasa tablets**
- **Child 5-17 years (body-weight up to 40 kg)** (By mouth): 10-20 mg/kg 3 times a day.
- **Child 5-17 years (body-weight 40 kg and above)** (By mouth): 1-2 g twice daily, alternatively 2-4 g daily in 3 divided doses.
**Maintenance of remission of ulcerative colitis for Pentasa tablets**
- **Child 5-17 years (body-weight up to 40 kg)** (By mouth): 7.5-15 mg/kg twice daily, alternatively 15-30 mg/kg daily in 3 divided doses.
- **Child 5-17 years (body-weight 40 kg and above)** (By mouth): 2 g once daily.
**Treatment of acute attack of mild to moderate ulcerative colitis or maintenance of remission for Salofalk enema**
- **Child 12-17 years** (By rectum): 2 g once daily, dose to be administered at bedtime.
**Treatment of mild to moderate ulcerative colitis, acute attack for Salofalk granules**
- **Child 5-17 years (body-weight up to 40 kg)** (By mouth): 30-50 mg/kg once daily, dose preferably given in the morning, alternatively 10-20 mg/kg 3 times a day.
- **Child 5-17 years (body-weight 40 kg and above)** (By mouth): 1.5-3 g once daily, dose preferably given in the morning, alternatively 0.5-1 g 3 times a day.
**Maintenance of remission of ulcerative colitis for Salofalk granules**
- **Child 5-17 years (body-weight up to 40 kg)** (By mouth): 7.5-15 mg/kg twice daily, alternatively 15-30 mg/kg daily in 3 divided doses.
- **Child 5-17 years (body-weight 40 kg and above)** (By mouth): 500 mg 3 times a day.
**Treatment of mild ulcerative colitis affecting sigmoid colon and rectum for Salofalk rectal foam**
- **Child 12-17 years** (By rectum): 2 g once daily, dose to be administered into the rectum at bedtime, alternatively 2 g daily in 2 divided doses.
**Treatment of acute attack of mild to moderate ulcerative colitis affecting the rectum, sigmoid colon, and descending colon for Salofalk suppositories**
- **Child 12-17 years** (By rectum): 0.5-1 g 2-3 times a day, to be given using 500 mg suppositories, dose to be adjusted according to response.
**Treatment of mild to moderate ulcerative colitis, acute attack for Salofalk tablets**
- **Child 5-17 years (body-weight up to 40 kg)** (By mouth): 10-20 mg/kg 3 times a day.
- **Child 5-17 years (body-weight 40 kg and above)** (By mouth): 0.5-1 g 3 times a day.
**Maintenance of remission of ulcerative colitis for Salofalk tablets**
- **Child 5-17 years (body-weight up to 40 kg)** (By mouth): 7.5-15 mg/kg twice daily, alternatively 15-30 mg/kg daily in 3 divided doses.
- **Child 5-17 years (body-weight 40 kg and above)** (By mouth): 500 mg 3 times a day.
Cautions
Elderly (in adults); maintain adequate fluid intake; pulmonary disease
Contraindications
With oral use Blood clotting abnormalities
Side effects
Common or very common Arthralgia; cough; diarrhoea; dizziness; fever; gastrointestinal discomfort; headache; leucopenia; myalgia; nausea; proteinuria; skin reactions; vomiting Uncommon Alopecia; depression; dyspnoea; face oedema; pancreatitis; paraesthesia; photosensitivity reaction; tachycardia; thrombocytopenia; vertigo Rare or very rare Agranulocytosis; angioedema; blood disorder; bone marrow disorders; cardiac inflammation; hepatic disorders; interstitial lung disease; lupus-like syndrome; nephritis tubulointerstitial; nephrotic syndrome; neutropenia; peripheral neuropathy; renal impairment; respiratory disorders Frequency not known Cholelithiasis; eosinophilia; haematuria; haemolytic anaemia; oligozoospermia (reversible); severe cutaneous adverse reactions (SCARs); ulcerative colitis aggravated Side-effects, further information A blood count should be performed and the drug stopped immediately if there is suspicion of a blood dyscrasia. Side-effects For mesalazine General side-effects: Rare or very rare Anaemia; constipation; drug fever; hypersensitivity; nephritis; pulmonary fibrosis Frequency not known Nephrolithiasis Specific side-effects: Common or very common With oral use Asthenia; gastrointestinal disorders; hypertension; pain With rectal use Flatulence Uncommon With oral use Chest pain; drowsiness; ear pain; hypotension; laryngeal pain; tremor Rare or very rare With oral use Pericardial effusion Frequency not known With oral use Condition aggravated; increased risk of infection; intracranial pressure increased (rare in children); ketonuria; minimal change disease; weight decreased With rectal use Idiopathic intracranial hypertension Side-effects, further information Discontinue immediately if symptoms of acute intolerance syndrome occur such as cramping, abdominal pain, bloody diarrhoea, fever, severe headache, and rash. Worsening abdominal pain and diarrhoea may be difficult to distinguish from an exacerbation of inflammatory bowel disease.
Interactions
**Other interactions (7):**
- 'Asacol' tablets should not be given with lactulose or similar preparations, which lower stool pH and may prevent release of mesalazine.
- Concurrent use of other known nephrotoxic agents, such as NSAIDs and azathioprine, may increase the risk of renal reactions (see section 4.4).
- The hypoglycaemic effect of sulfonylureas may be enhanced when administered with aminosalicylates (oral antidiabetics may be displaced from the binding sites of plasma proteins).
- Concomitant treatment with mesalazine may increase the risk of myelosuppression in patients receiving azathioprine, thioguanine or 6-mercaptopurine.
- The concurrent use of mesalazine with azathioprine, thioguanine or 6-mercaptopurine may increase the risk for blood dyscrasia.
- If concomitant use of mesalazine and azathioprine, thioguanine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts.
Pregnancy
Negligible quantities cross placenta.
Breast feeding
Diarrhoea reported in breast-fed infants, but negligible amounts of mesalazine detected in breast milk. Monitoring in breast feeding Monitor breast-fed infant for diarrhoea.
Hepatic impairment
Manufacturer advises caution in mild to moderate impairment; avoid in severe impairment.
Renal impairment
Use with caution in mild to moderate impairment (risk of toxicity including crystalluria); avoid in severe impairment. M
Medicinal forms
Tablet,Tablet,Granules,Suppository
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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