Generic
Mesalazine
2 brands available in the market
At a glance
Mesalazine is an anti-inflammatory medicine used for ulcerative colitis and Crohn's disease. It reduces inflammation by blocking the production of inflammatory chemical mediators in the intestines.
Description
Mesalazine is considered to be the active moiety of sulfasalazine. The mechanism of action is uncertain, but may be due to its ability to inhibit local chemical mediators of the inflammatory response, especially leukotriene synthesis in the GI mucosa. Action may be topical in terminal ileum and colon rather than systemic. It diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.
Indications
- Mild to moderately active ulcerative colitis - treatment and maintenance of remission
- Crohn's disease - maintenance of remission
Therapeutic class
Aminosalicylates
Pharmacological class
Anti-inflammatory
Pharmacology
Mesalazine reduces mucosal production of arachidonic acid metabolites, blocking both cyclooxygenase and lipoxygenase pathways, reducing prostaglandin production in the colon to decrease inflammation.
Mechanism of action
Reduces inflammation by blocking production of inflammatory chemical mediators in the intestines.
Dosage
Adult Dose (Oral):
- Ulcerative colitis (active): Up to 4 g/day in 2-4 divided doses, 6 weeks
- Ulcerative colitis (maintenance): 2 g/day in divided doses
- Crohn's disease (maintenance): 1.2-2.4 g/day in divided doses
Children (5-12 years): Active: 15-20 mg/kg (max 1 g) 3 times daily; Maintenance: 10 mg/kg (max 500 mg) 2-3 times daily
Administration
- Swallow tablet whole; do not chew, crush or break
- Take with food
- Granules: Empty onto tongue and swallow with water/orange juice, or mix with yogurt
Missed dose
If you miss a dose, take it as soon as you remember; skip if it's almost time for next dose; do not double the dose.
Side effects
Common Side Effects:
- Headache
- Nausea, vomiting
- Diarrhea
- Abdominal pain
- Flatulence
- Pruritus
- Hair loss
- Asthenia, dyspepsia
Precautions & warnings
- Pyloric stenosis may cause delayed gastric retention
- Caution in renal dysfunction (nephropathy, interstitial nephritis)
- Caution in liver disease (hepatic failure reported)
- Consult doctor during pregnancy and lactation
Contraindications
- Hypersensitivity to salicylates or any components
- Severe renal impairment (CrCl <20 mL/min)
- Severe hepatic impairment
- Children under 2 years
Drug interactions
- Do not give with lactulose or other pH-lowering drugs (prevents mesalazine release)
- May decrease digoxin absorption
- Increased risk of renal reactions with NSAIDs and azathioprine
Food interactions
Caution with alcohol; consult your doctor (risk of stomach upset and bleeding).
Use in pregnancy
Use in Pregnancy: Mesalazine may be unsafe during pregnancy (Category C); animal studies have shown harmful effects on the fetus. Use only if benefits outweigh risks.
Pregnancy Category: C — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Mesalazine is probably unsafe during breastfeeding; may pass into breast milk; monitor baby for diarrhea.
Pediatric use
Safety not established in children under 2 years; doses established for children 5-12 years.
Geriatric use
Monitor blood cell counts closely in patients 65 years and older (higher risk of decreased renal function).
Renal / hepatic impairment
Renal Impairment: Caution in kidney disease; avoid if CrCl <20 mL/min; monitor renal function regularly.
Hepatic Impairment: Caution in liver disease; dose adjustment may be needed.
Overdose effects
Overdose: prevent GI absorption, correct fluid/electrolyte balance, maintain renal function; no specific antidote.
Storage conditions
Store below 30°C, away from light and moisture; keep out of reach of children.
Chemical structure
Mesalazine