Mesacol 400 mg (Tablet (Delayed Release))

Indications

• Treatment of mild to moderately active Ulcerative Colitis & Crohn's Disease
• Maintenance of remission of Ulcerative Colitis
• Maintenance of remission of Crohn's disease

Pharmacology

• Mechanism of action is unknown
• Appears to be topical rather than systemic
• Diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon

Dosage & Administration

• Recommended dosage for adults: up to 4 gm mesalazine once daily or divided into 2-4 doses
• Recommended maintenance dosage for adults: 2 gm mesalazine once daily
• Recommended dosage for children 6 years and older: 30-50 mg/kg/day in divided doses
• Maximum dose for children: 75 mg/kg/day in divided doses

Interaction

Concurrent use of nephrotoxic agents such as NSAIDs and Azathioprine may increase the risk of renal reactions

Contraindications

Hypersensitivity to salicylates or any other component of the formulation

Side Effects

• Commonly reported adverse events: headache, nausea, dizziness, asthenia, dyspepsia, vomiting, pruritus

Pregnancy & Lactation

Should be given in pregnancy only if potential benefit justifies potential risk to the fetus. Caution is advised when administered to a nursing mother

Precautions & Warnings

• Patients with pyloric stenosis may have prolonged gastric retention of Mesalamine tablets
• Renal impairment and hepatic failure reported in patients taking Mesalamine
• Caution in patients with known renal dysfunction or history of renal disease
• Caution when administering to patients with liver impairment

Use in Special Populations

• Geriatrics: Close monitoring of blood cell counts during Mesalamine therapy
• Elderly: Careful prescribing due to decreased renal function
• Pediatric: Safety and effectiveness not established

Overdose Effects

No specific antidote for Mesalamine overdose. Symptomatic and supportive treatment is recommended

Therapeutic Class

Aminosalicylates

Storage Conditions

Store below 30°C. Protect from light and moisture. Keep out of reach of children

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