Prevention of gastric and duodenal ulceration during NSAID treatment.
Composition:
1 tabl contains 200 μg of misoprostol.
Action:
Prostaglandin E1 analogue, which accelerates the healing of peptic ulcers and regression of their symptoms. The drug protects the mucous membrane of the stomach and duodenum in the mechanism of inhibition of basic, stimulated and nocturnal secretion of hydrochloric acid and reduction of the volume and proteolytic activity of gastric juice, as well as by increasing the secretion of bicarbonate and mucus. After oral administration, the drug is rapidly absorbed from the gastrointestinal tract. The maximum plasma concentration of the active metabolite (misoprostol acid) occurs after 30 min. T0,5 Misoprostol acid is 20-40 min. There is no accumulation of this metabolite in the plasma after repeated administration of 400 μg 2 times a day.
Contraindications:
Hypersensitivity to the active substance, other prostaglandins or any of the excipients. Do not use in pregnant women and women planning pregnancy.
Precautions:
It must not be used in pre-menopausal women unless the patient requires NSAIDs and is at high risk of developing ulcer complications due to these medicines. It is recommended that in these patients misoprostol should be used only if the patient: uses effective contraception and is advised about the risks associated with taking this medicine during pregnancy. The drug is used cautiously in conditions such as cerebrovascular disease, ischemic heart disease or severe form of peripheral vascular disease, including hypertension in which hypotension can contribute to the occurrence of serious complications. Patients predisposed to diarrhea (eg in inflammatory bowel diseases) should take misoprostol with food, and avoid antacids in the stomach. Carefully use in patients for whom dehydration can be dangerous. There is no evidence that the product adversely affects Glucose metabolism in healthy volunteers or in patients with diabetes mellitus. The use of misoprostol in children for the treatment of gastric and / or duodenal ulceration, including those resulting from NSAID treatment, has not been evaluated so far.
Pregnancy and lactation:
Misoprostol is contraindicated during pregnancy and in women planning pregnancy, as it increases the tension and contractility of the uterus muscle in pregnant women, which may result in partial or complete expulsion of the fetal egg, embryo or fetus. The use of the preparation during pregnancy was associated with the occurrence of congenital malformations. During the treatment, effective methods of contraception should be used. Do not use during breast-feeding.
Orally. Adults: the recommended dose is 400-800 μg / day in 2 or 4 divided doses. The NSAID treatment should be continued while taking the drug. If indicated, the drug should be taken concurrently with NSAIDs until the end of NSAID therapy. Take different doses of the drug during breakfast and / or main meals and at bedtime.
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