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Cytotek 200mcg #60 tablets

Cytotek 200mcg #60 tablets
Pharmacological group: anti-ulcer drugs
Country: Great Britain
Manufacturer: Piramal Helskea Uk Lim. Pfizer
Generic – compare analogues: Misoprostolum
Dispensing form: Group II prescription


Cytotek 200mcg #60 tablets

Cytotec  annotation


White/off-white hexagonal tablet, scored on both sides, debossed with SEARLE 1461 on one side. Each tablet contains 200 micrograms of misoprostol.

Pharmacological properties
Cytotec is a naturally occurring prostaglandin E1 analog that promotes healing and asymptomatic relief of peptic ulcers. Cytotek protects the gastroduodenal mucosa by inhibiting basal, forced and nocturnal acid secretion and by reducing the volume of gastric secretion, proteolytic activity of gastric juice and increasing bicarbonate and mucous secretion.

Cytotec is indicated for the treatment of duodenal ulcers and gastric ulcers, including those caused by NSAIDs, in patients who are at risk for arthritis while continuing treatment with NSAIDs. In addition, Cytotec can be used for the prevention of ulcers caused by non-steroidal anti-inflammatory drugs.

Administration rules and dosages
healing of duodenal ulcer, gastric ulcer and peptic ulcer caused by non-steroidal anti-inflammatory drugs; 800 mcg daily in 2 or 4 divided doses at breakfast and/or each main meal and at bedtime. Initial treatment is prescribed for at least 4 weeks, even if symptomatic relief is achieved sooner. Ulcers will heal in 4 weeks in most patients, but treatment should be continued for up to 8 weeks if necessary. If the ulcer recurs, treatment must be continued. Prevention of peptic ulcer caused by non-steroidal anti-inflammatory drugs – 200 mcg twice a day, three times a day or four times a day. If necessary, the treatment should be continued. Dosage is selected individually, taking into account the clinical condition of each patient.
the elderly
Usual doses can be used
Kidney failure
According to the available data, no dose adjustment is necessary in patients with renal failure.
Liver disorders
Cytotec is metabolized by the fatty acid oxidation systems present in the organs of the whole body. Because of this, liver failure probably does not significantly affect its metabolism and plasma levels.
The use of Cytotek has not yet been evaluated in the treatment of peptic ulcer and peptic ulcer caused by non-steroidal anti-inflammatory drugs.

Side effects
Gastrointestinal system: Diarrhea has been observed, sometimes acute and prolonged and may require withdrawal of the drug. It can be minimized by using a single dose of no more than 200 mcg with food and predominantly when an antacid is needed, by avoiding the use of magnesium containing antacids.
Abdominal pain with associated dyspepsia or diarrhea may occur after misoprostol treatment. Other gastrointestinal effects include: dyspepsia, flatulence, nausea and vomiting.
Female reproductive system: Menorrhagia, vaginal bleeding and intermenstrual bleeding in pre- and post-menopausal women.
Other adverse effects: Skin rash has been reported. Dizziness has rarely been noted.
The nature of side effects associated with Cytotek is similar to the simultaneous use of non-steroidal anti-inflammatory drugs.

Cytotec is contraindicated in pregnant women and women who are planning to become pregnant, as it increases uterine tone and contractility in pregnant women, which can lead to partial or complete expulsion of the products of conception. It is also contraindicated in patients with increased sensitivity to prostaglandins.

Pregnancy and lactation
See contraindications
It is not known whether the active metabolite of Cytotec is excreted in human milk. Because of this, the appointment of Cytotek is not recommended during breastfeeding.

Special instructions
Use in pre-menopausal women (see also Contraindications): Cytotec should not be used in pre-menopausal women unless the patient requires non-steroidal anti-inflammatory treatment and is at risk of complications from non-steroidal anti-inflammatory drug-induced ulcers.
Cytotec is indicated for such patients only if the patient:
• Implements effective contraceptive measures.
• It has been recommended that there is a high risk of taking Cytotec if you are pregnant (see Contraindications)
Special precautions
According to the results of clinical studies, Cytotec does not cause hypotension at doses that are effective in promoting the healing of gastric and duodenal ulcers. Nevertheless, Cytotec is used with caution in the presence of such diseases, when hypotension accelerates serious complications, for example, cerebrovascular disease, coronary artery disease or acute peripheral vascular disease, including hypertension.
There are no data on whether Cytotec causes side effects related to glucose metabolism in volunteers or in diabetic patients.

Additional information
Cytotec at multiple recommended therapeutic doses induced gastric mucosal hyperplasia in animals. This characteristic response to E prostaglandins returns to normal when the compound is withdrawn. Histological examination of gastric biopsies in patients taken before and one year after treatment with misoprostol did not reveal any adverse tissue reactions related to misoprostol. Cytotec inhibition of gastric secretion is achieved by a combination of local and systemic effects. Cytotec is rapidly absorbed after oral administration, and peak plasma levels of the active metabolite (misoprostolic acid) occur in approximately 30 minutes. The plasma half-life of misoprostol is 20-40 minutes. Accumulation of misoprostolic acid in plasma is not observed after repeated doses of 400 mcg 2 times a day.

In case of overdose, there may be an increase in pharmacological effects. In case of overdose, it is necessary to carry out symptomatic and maintenance treatment. According to clinical studies, patients tolerated 1200 mcg daily for 3 months without significant side effects.

Interaction with other drugs
Cytotec is predominantly metabolized by fatty acid oxidizing systems and does not have a side effect on the microsomal mixed-function oxidase (P450) enzyme system of the liver. Specific studies did not reveal any clinically significant pharmacokinetic interactions with antipyrine, diazepam, and propranolol. According to extensive clinical studies, drug interactions related to Cytotec were not detected. Additional data revealed no clinically significant pharmacokinetic or pharmacodynamic interactions with nonsteroidal anti-inflammatory drugs such as aspirin, diclofenac, and ibuprofen.

Storage conditions and terms
Store in a dry place below 30°C (86°F).

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