Cozycol 800

Indications

Cozycol serves the following purposes:

• Treating mild to moderately active Ulcerative Colitis and Crohn’s Disease.
• Maintaining remission of Ulcerative Colitis.
• Maintaining remission of Crohn’s disease.

Pharmacology

The precise mechanism of Mesalamine’s action remains unclear, yet it seems to operate topically rather than systemically. Patients with chronic inflammatory bowel disease exhibit increased mucosal production of Arachidonic Acid metabolites through pathways like cyclooxygenase (prostanoids) and lipoxygenase (leukotrienes and hydroxyeicosatetraenoic acids). Mesalamine reduces inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.

Dosage

For Ulcerative colitis:

• Adults:
  • Active disease: Customized dosage up to 4 gm mesalazine once daily or split into 2-4 doses.
  • Maintenance treatment: Tailored dosage; recommended 2 gm mesalazine once daily.
• Pediatrics: Safety and efficacy for children below 6 years are not established. Limited evidence suggests effectiveness in children aged 6-18 years.
  • Children 6 years and older:
    • Active disease: Individualized dosage, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses, not exceeding 4 g/day.
    • Maintenance treatment: Individualized dosage, starting with 15-30 mg/kg/day in divided doses, not exceeding 2 g/day (recommended adult dose).

Administration

The granules should not be chewed. Empty the sachet onto the tongue and wash down with water or orange juice. Alternatively, consume the entire sachet contents with yogurt immediately.

Interactions

Concurrent use of other nephrotoxic agents like NSAIDs and Azathioprine may increase renal reaction risks.

Contraindications

Hypersensitivity to salicylates or any other component of the formulation.

Side Effects

Common adverse events include headache, nausea, dizziness, asthenia, dyspepsia, vomiting, and pruritus.

Pregnancy & Lactation

Administer during pregnancy only if benefits outweigh fetal risks. Caution is advised during nursing.

Precautions & Warnings

Exercise caution in patients with pyloric stenosis, renal impairment, or hepatic dysfunction. Monitor renal and hepatic function regularly. Geriatric patients (65 years or older) and elderly individuals should undergo close blood cell count monitoring during therapy.

Overdose Effects

No specific antidote for Mesalamine overdose exists. Symptomatic and supportive treatment is recommended, considering its pH-dependent delayed-release nature.

Therapeutic Class

Aminosalicylates

Storage Conditions

Store below 30°C, protected from light and moisture, and out of reach of children.