API

Mesalazine (1gm)

Drug classification

Anti-inflammatory agent; specific subclass: aminosalicylate (5-aminosalicylic acid derivative).

Dosage form

Rectal enema containing 1 gram mesalazine per unit.

API strength per dosage

Dose

Pentasa 1g enema is typically administered once daily at bedtime for adults with mild to moderate distal ulcerative colitis. Safety and efficacy in children are not established. Use with caution in renal or hepatic impairment; monitor renal function before and during treatment. Discontinue if renal function deteriorates. Always follow local prescribing guidelines.

Mechanism of action

Mesalazine (mesalamine) in Pentasa enema acts locally in the colonic mucosa, inhibiting cyclooxygenase and lipoxygenase pathways, thereby reducing prostaglandin and leukotriene synthesis. This decreases inflammation by suppressing inflammatory cytokine production and scavenging free radicals, resulting in reduced mucosal inflammation in ulcerative colitis.

Indications

Treatment of Ulcerative colitis

Side effects

Rectal discomfort Flatulence Headache Vomiting Diarrhea Nausea Abdominal pain Rash

Pregnancy category

Mesalazine should be used during pregnancy only if clearly needed; limited data suggest low risk, but potential benefits must outweigh possible risks.

Precautions

History of hypersensitivity to salicylates, renal impairment, hepatic impairment, blood dyscrasias, monitor renal function before and during treatment, monitor liver function, assess for signs of acute intolerance (cramping, abdominal pain, bloody diarrhea, rash, fever), discontinue if severe adverse reactions occur, use caution in elderly.

Contraindications

Hypersensitivity to mesalazine, salicylates, or any excipients; severe liver impairment; severe renal impairment; existing gastric or duodenal ulcers; hemorrhagic diathesis; children under 2 years of age.