GMP Certified / Misoprostol Tablets 200mcg

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Product name:
Misoprostol Tablets 200mcg

Character:
White/quasi-white, hexagonal tablet, notched on both sides and engraved with 'SEARLE 1461' on one side. Each tablet contains misoprostol 0.2mg.

Indications:
Misoprostol tablets, indicated for the treatment of duodenal and gastric ulcers, including duodenal and gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAID) in arthritis patients, to ensure that they can continue to be treated with NSAID. It can also be used to prevent ulcers caused by the use of NSaids.

Adverse reactions:
Diarrhea and abdominal pain are dose-dependent, usually occur early in treatment, and are generally self-limiting. Rare cases of severe diarrhea resulting in severe dehydration have been reported.
Taking no more than 0.2mg in a single dose with food, and avoiding antacids containing magnesium if needed, can reduce the risk of diarrhea.
When non-steroidal anti-inflammatory drugs (NSAID) were administered at the same time, the types of adverse events associated with Sikfed were similar.
Clinical Trials:
In clinical trials, more than 15,000 patients and subjects received at least one dose of misoprostol. Adverse reactions mainly involve the digestive system.
Diarrhea and abdominal pain are dose-dependent, usually occur early in treatment, and are generally self-limiting. Rare cases of severe diarrhea resulting in severe dehydration have been reported.
The characteristics of the 1% adverse effects were similar to those in short - to medium-term (lasting 4-12 weeks) and long-term (up to 1 year) clinical trials.
The safety of long-term (more than 12 weeks) administration of misoprostol has been demonstrated in several studies in which patients continued to receive misoprostol for up to 1 year. Safety includes the absence of adverse or abnormal changes in gastric mucosal morphology as determined by gastric biopsy.

Pharmacology and toxicology:
This product is an analogue of natural prostaglandin E1, which can promote the healing of peptic ulcers or relieve symptoms. The protective effect of this product on gastric and duodenal mucosa is to reduce the amount of gastric acid secreted, reduce the activity of proteolytic enzyme in gastric juice, and increase the secretion of bicarbonate and mucous by inhibiting the secretion of basic, irritating and nocturnal gastric acid.
In animal trials (dogs, rats, mice) with single and multiple doses at several times the clinically recommended therapeutic dose, toxicological findings are consistent with the known pharmacological effects of prostaglandin E. The main symptoms are diarrhea, vomiting, dilated pupils, tremors and high fever. It has also been found to cause hyperplasia of gastric mucosa in dogs, rats, and mice. In rats and dogs, the hyperplasia was reversible when the drug was discontinued after one year. Histological biopsies of the stomach were performed 1 year after medication and no adverse tissue changes were found. There were no significant findings on reproduction, teratogenicity and perinatal toxicology in rats and rabbits. When the dose exceeds 100 times the human dose, the implantation rate is found to be reduced and the development of the young is delayed. It can be concluded that misoprostol has no obvious effect on reproduction, teratogenicity and fetal toxicity, and does not affect the development of rat pups before and after the perinatal period.
In a set of studies that assessed the likelihood of mutagenicity, consisting of six extracellular analyses and one intracellular test, misoprostol was negative. Carcinogenicity studies in rats and mice showed no carcinogenic risk.

Storage:
Store in dry, below 30ºC.