Cozycol 800 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 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

• Adult dosage: up to 4 gm mesalazine once daily or divided into 2-4 doses
• Pediatric dosage: starting with 30-50 mg/kg/day in divided doses
• Granules must not be chewed
• Contents of the sachet should be emptied onto the tongue and washed down with water or orange juice
• Store below 30 0 C
• Keep all medicines out of the reach of children

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 are headache, nausea, dizziness, asthenia, dyspepsia, vomiting, pruritus etc.

Pregnancy & Lactation

• Should be given in pregnancy only if the 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 has been reported in patients taking Mesalamine
• Caution should be exercised 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

Use in Special Populations

• Caution should be taken to closely monitor blood cell counts during Mesalamine therapy in patients who are 65 years or older
• Care should be taken when prescribing Cozycol therapy to elderly patients who are more likely to have decreased renal function
• Safety and effectiveness not established in pediatric population

Overdose Effects

• No specific antidote for Mesalamine overdose
• Treatment for suspected acute severe toxicity should be symptomatic and supportive
• Prevention of further gastrointestinal tract absorption, correction of fluid-electrolyte imbalance, maintenance of adequate renal function

Therapeutic Class

• Aminosalicylates

Related Brands

• Pentasa 2 gm/sachet (Microgranules) - ferring-pharmaceuticals-ltd
• Pentasa 1 gm/sachet (Microgranules) - ferring-pharmaceuticals-ltd