Iselpin 1 Gm Tablet
Each tablet contains 1g of sucralfate.
Sucralfate (Iselpin) is a white, amorphous powder which is soluble in strong acids and alkalis but practically insoluble in water and in alcohol. It is a basic, aluminum complex of sucrose octasulfate.
Sucralfate is a-D-glucopyranoside, ?-D-fructofuranosyl, octakis (hydrogen sulfate), aluminum complex. Its molecular formula is C12HmAl16OnS8 (m and n are approximately 54 and 75, respectively, resulting in an average molecular weight of about 2086 daltons).
Indications / Uses :
Treatment of gastric and duodenal ulcer and chronic gastritis.
It is also indicated for the relapse prophylaxis of gastric and duodenal ulcer, and treatment of reflux esophagitis, and the prophylaxis of stress ulcer.
Should be taken on an empty stomach: Take 1 hr before each meal & at bedtime.
Known hypersensitivity to sucralfate or to any of the excipients of Iselpin. Patients receiving dialysis (long-term administration of Iselpin may result in aluminum accumulation and toxicity. Aluminum toxicity has been implicated in encephalopathy and osteomalacia).
Special Precautions :
Do not administer intravenously: Sucralfate (Iselpin) must not be administered intravenously. Inadvertent intravenous administration of insoluble sucralfate and its insoluble excipients may induce fatal complications including pulmonary and cerebral emboli. Other severe complications including aluminum intoxication are reported after intravenous administration.
Chronic Renal Impairment: Sucralfate is not recommended for use in individuals on dialysis.
Sucralfate should be administered carefully in patients with chronic impairment of renal function. Small amounts of aluminum are absorbed through the gastrointestinal tract and aluminum may accumulate. Aluminum osteodystrophy, osteomalacia, encephalopathy and anemia have been reported in patients with chronic renal impairment. For patients with impairment of renal function (chronic renal failure) laboratory testing eg, aluminum phosphate, calcium and alkaline phosphatase is recommended to be periodically performed due to excretion impairment.
Swallowing Difficulty: At the time of taking sucralfate tablets, aspiration may occur in patients with swallowing difficulty.
Effect on the Ability to Drive and Operate Machinery: The pharmacodynamic profile of sucralfate does not indicate that the effect on the ability drive and use machines are expected.