Composition :

Each tablet PROSTER® contains Misoprostol 200 mcg


Pharmacology :

Misoprostol is a synthetic analog of prostaglandin E1 which has an antisecretory effect and protects the gastric mucosa. Its antisecretory effect is a direct effect on specific prostaglandin receptors on the surface gastric parietal cells. The protection effects of mucosal against harmful substances arise in inhibiting doses as well as doses that affect minimal secretion of acids.

Antisecretory activitY:

  • Effects on acid secretion: Misoprostol inhibits acid secretion during the day and night and is caused by stimulation by histamine, pentagastrin and coffee. This antisecretory effect can be observed up to 5 ½ hours after administration of Misoprostol
  • Effects on pepsin secretion and gastric fluid volume: Misoprostol causes a moderate decrease in pepsin and gastric fluid levels in basal conditions, but not during stimulation conditions
  • Effects on serum gastrin: Misoprostol has no persistent effect on fasting level or on increase in serum gastrin after meals
  • Effects on intrinsic factor secretion: With pentagastrin as a stimulant expenditure intrinsic factor is not affected by giving Misoprostol 100 μg
  • Mucosal protection activity: Misoprostol has the property of strengthening the integrity of the gastroduodenal mucosal barrier from the effects of the destroyer. This includes stimulation of duodenal bicarbonate secretion and gastric mucus production. Misoprostol also maintains hemodynamic mucosa


Pharmacokinetic :

With oral administration, Misoprostol is rapidly absorbed in which peak plasma levels of active metabolites (Misoprostol Acid) occur within 30 minutes. The drug is further metabolized through the fatty acid oxidation system (oxidation of β and Ω) present in various tissues of the body. The elimination half-life of Misoprostol Acid is 20-40 minutes. The half-life of plasma elimination from Misoprostol’s additional metabolite is 1 ½ hours. 73% of oral doses were excreted in urine by 15% through feces within the first 24 hours. Serum protein binding of Misoprostol Acid ranges from 80-90% and does not depend on therapeutic levels. There is no accumulation of Misoprostol in erythrocytes.


Indication :

Misoprostol is indicated for prevention of gastric ulcers induced by administration of NSAIDs (including aspirin) in patients at high risk of complications from gastric ulcers such as elderly patients and patients with concomittant debilating disease, patients at high risk of gastric ulcers such as patients with a history of ulcers. Misoprostol should be given during NSAID therapy prescribed by the Doctor


Dosage and Administration :

  • The recommended dose of Misoprostol in adults for prevention of gastric ulcers induced by NSAID administration is 200 mcg 4 times per day, administered with food. If the dose is intolerable, it can be given at a dose of 100 mcg. Misoprostol should be given during prescription NSAID by Doctor with food and at bedtime
  • Impaired renal function: no adjustment dosage of Misoprostol is required in patients with impaired renal function, but the dose can be decreased if a dose of 200 mcg can not be tolerated by the patient


Presentation and Registration Number:

PROSTER® Tablet Box 3 strips @ 10 tablets; DKL1108017210A1




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