Generic Name: Mesalazine [5-aminosalicylic acid] 400mg Manufacturer/Distributor: Sun Pharmaceutical (Bangladesh) Ltd.
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Indications
Pharmacology
Mesalamine's mode of action is uncertain, but it appears to be topical rather than systemic in nature. In individuals with chronic inflammatory bowel disease, mucosal synthesis of Arachidonic Acid metabolites is enhanced, both through cyclooxygenase pathways, such as prostanoids, and through lipoxygenase pathways, such as leukotrienes and hydroxy eicosatetraenoic acids. Mesalamine reduces inflammation in the colon by reducing prostaglandin synthesis and blocking cyclooxygenase.
Dosage & Administration
Ulcerative colitis-
Adults:
Active disease: Individual dosage, up to 4 gm mesalazine once daily or divided into 2-4 doses.
Maintenance treatment: Individual dosage. Recommended dosage, 2 gm mesalazine once daily.
Pediatrics: The safety and efficacy in children below 6 years of age have not been established. There is only limited documentation for an effect in children (age 6-18 years).
Children 6 years of age and older:
Active disease: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day (maximum adult dose).
Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed 2 g/day (recommended adult dose).
It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg, and the normal adult dose to those above 40 kg.
Interaction
Other recognized nephrotoxic agents, such as NSAIDs and Azathioprine, may enhance the risk of renal responses when taken together.
Contraindications
Hypersensitivity to salicylates or any other formulation component.
Side Effects
Headache, nausea, dizziness, asthenia, dyspepsia, vomiting, pruritus, and other side effects are frequently observed.
Pregnancy & Lactation
It should only be used during pregnancy if the possible benefit outweighs the risk to the fetus. When provided to a nursing mother, caution is suggested.
Precautions & Warnings
Mesalamine pills may be retained in the stomach for longer in patients with pyloric stenosis, delaying the release of Mesalamine into the colon. Renal impairment has been recorded in Mesalamine users, including minimal change nephropathy and acute and chronic interstitial nephritis. Mesalamine should be used with caution in patients who have known renal failure or a history of renal disease. Renal function should be checked prior to the start of treatment and subsequently at regular intervals throughout treatment. Hepatic failure has been reported in patients who had a pre-existing liver illness and were given Mesalamine. Caution is advised.
Storage Conditions
Keep the temperature below 30°C and away from light and moisture. Keep out of children's reach..
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