Generic
Mesalazine [5-aminosalicylic acid]
11 brands available in the market
At a glance
Mesalazine [5-aminosalicylic acid] is an anti-inflammatory medicine used for inflammatory bowel disease (IBD), particularly ulcerative colitis and Crohn's disease. It reduces inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.
Description
The mechanism of action of Mesalamine is unknown, but appears to be topical rather than systemic. Mucosal production of arachidonic acid metabolites, both through cyclooxygenase and lipoxygenase pathways, is increased in patients with chronic inflammatory bowel disease. Mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.
Indications
- Inflammatory bowel disease (IBD) - ulcerative colitis and Crohn's disease
- 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
Mesalamine blocks cyclooxygenase and inhibits prostaglandin production in the colon to reduce inflammation. It reduces mucosal production of arachidonic acid metabolites.
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 (once daily or in 2-4 divided doses)
- Ulcerative colitis (maintenance): 2 g/day (once daily)
Children (6-18 years):
- Active: 30-50 mg/kg/day in divided doses; max 75 mg/kg/day (up to 4 g/day)
- Maintenance: 15-30 mg/kg/day in divided doses; max 2 g/day
- Children up to 40 kg: half adult dose; above 40 kg: adult dose
Administration
- Swallow tablet whole; do not chew, crush or break
- May be taken with or without food (taking with food may reduce stomach upset)
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 take two doses at the same time.
Side effects
Common Side Effects:
- Stomach upset
- Nausea
- Diarrhea
- Headache
- Vomiting
- Abdominal pain
- Skin rash
Precautions & warnings
- Pyloric stenosis may cause delayed gastric retention
- Caution in renal dysfunction (nephropathy, interstitial nephritis)
- Caution in liver disease
- Consult doctor during pregnancy and lactation
- Monitor blood cell counts in patients 65 years and older
Contraindications
- Hypersensitivity to salicylates or any components
Drug interactions
- Increased risk of renal reactions with NSAIDs and azathioprine
Food interactions
Alcohol may increase risk of stomach upset and bleeding; avoid alcohol while taking Mesalazine.
Use in pregnancy
Use in Pregnancy: Mesalazine crosses the placenta and may cause fetal harm; use only if benefits outweigh risks.
Pregnancy Category: C — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Mesalazine passes into breast milk; caution is advised.
Pediatric use
Safety and efficacy not established in children under 6 years; doses established for children 6-18 years (weight-based).
Geriatric use
Elderly patients are more likely to have decreased renal function; monitor blood cell counts.
Renal / hepatic impairment
Renal Impairment: Caution in kidney disease; dose adjustment may be needed; monitor renal function regularly.
Hepatic Impairment: Caution in liver disease; dose adjustment may be needed.
Overdose effects
No specific antidote for overdose; symptomatic and supportive treatment (prevent GI absorption, fluid/electrolyte balance, renal function).
Storage conditions
Store below 30°C, away from light and moisture; keep out of reach of children.
Chemical structure
Mesalazine [5-aminosalicylic acid]