Pentasa 1 gm/sachet (Microgranules)

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 of Mesalamine 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 for active disease
• Recommended dosage for adults: 2 gm mesalazine once daily for maintenance treatment
• Safety and efficacy in children below 6 years of age not established
• For children 6 years of age and older: individual dosage based on weight, divided doses, maximum dose not exceed 4 g/day
• Granules must not be chewed, to be taken with water or orange juice, or with yogurt

Interaction

• Concurrent use of other known 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 the potential risk to the fetus
• Caution advised when administered to a nursing mother

Precautions & Warnings

• Patients with pyloric stenosis may have prolonged gastric retention of Mesalamine tablets
• Renal impairment, including minimal change nephropathy and acute and chronic interstitial nephritis reported in patients taking Mesalamine
• Caution when using Mesalamine in patients with known renal dysfunction or history of renal disease
• Reports of hepatic failure in patients with pre-existing liver disease who have been administered Mesalamine
• Exercise caution when administering Mesalamine to patients with liver impairment

Use in Special Populations

• Geriatrics: caution should be taken to closely monitor blood cell counts during Mesalamine therapy
• Elderly patients more likely to have decreased renal function, care should be taken when prescribing Pentasa therapy
• Paediatric: Safety and effectiveness not established

Overdose Effects

• No specific antidote for Mesalamine overdose
• Treatment for suspected acute severe toxicity should be symptomatic and supportive
• Consider pH dependent delayed-release product when treating a suspected overdose

Therapeutic Class

• Aminosalicylates

Storage Conditions

• Store below 30°C
• Protect from light and moisture
• Keep all medicines out of the reach of children

Related Brands

• Pentasa 2 gm/sachet (Microgranules) - ferring-pharmaceuticals-ltd