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At 25 micrograms and 50 micrograms, doses that exert little antisecretory effect, Cytotec showed mucosal cytoprotection in human subjects by reducing aspirin-induced gastric bleeding and by decreasing faecal blood loss when given concomitantly with aspirin.

In healthy subjects, pretreatment with the therapeutic dose of 200 micrograms Cytotec provided highly significant protection of the gastric mucosa Revlimid (Lenalidomide)- FDA damage induced by a single dose of 1,300 mg of aspirin.

The same dose protected both gastric and duodenal mucosa against lesions induced by the nonsteroidal anti-inflammatory agent, tolmetin (not marketed in Australia). In an ethanol induced gastritis model in healthy subjects, Cytotec 200 provided significantly better protection than the antisecretory dose of 300 mg cimetidine, or a placebo.

While the mechanism of mucosal cytoprotection is not fully defined, Cytotec stimulated normal physiologic mechanisms in the gastroduodenal mucosa. Revlimid (Lenalidomide)- FDA stimulates bicarbonate secretion in a dose related manner in the duodenum. It also increases the thickness of adherent mucus in the stomach and the quantity of soluble mucus found in the gastric aspirate. In rats, mucosal blood flow is sustained, whereas in dogs it is increased.

Cytotec is rapidly Revlimid (Lenalidomide)- FDA following oral administration, with peak plasma levels of the active metabolite (misoprostol acid) occurring in about 30 minutes, as measured either by radioactive Revlimid (Lenalidomide)- FDA cold (radioimmunoassay) methods.

Misoprostol acid undergoes further metabolism by здесь acid oxidizing systems (beta and omega oxidation) which are present in numerous tissues in the body.

The plasma elimination half-life of misoprostol acid is 20 - 40 minutes. The plasma elimination half-life of additional misoprostol metabolites is 1. There was no accumulation of misoprostol in red Revlimid (Lenalidomide)- FDA cells. Cytotec is indicated in the treatment of acute duodenal and Revlimid (Lenalidomide)- FDA ulcers. Cytotec is indicated in the prevention of stress-induced upper gastrointestinal mucosal bleeding and lesions in postsurgical patients in intensive care units.

Cytotec is indicated for the prevention of gastric ulceration in patients in whom NSAID therapy is essential and who have been assessed at high risk of gastric ulceration or the complications of gastric ulceration. Cytotec should not be administered to anyone with a known hypersensitivity to misoprostol or any other ingredient of the product, or to other prostaglandins. Cytotec Revlimid (Lenalidomide)- FDA contraindicated in pregnancy, or in patients in whom pregnancy has not been excluded (see Section 4.

Gastrointestinal bleeding, ulceration and perforation have occurred in NSAID treated patients receiving misoprostol. Physicians and patients should remain alert for ulceration, even in the absence of gastrointestinal symptoms. Symptomatic responses to misoprostol do not preclude the presence of gastric malignancy.

Patients with conditions that predispose to diarrhoea, such as inflammatory bowel disease, or Revlimid (Lenalidomide)- FDA in whom dehydration would be dangerous, should be monitored carefully. Although not observed with Cytotec, there is a possibility of nosocomial pulmonary infections associated with bacterial colonisation of the stomach in patients beta-1a (Avonex)- FDA intensive care units receiving drugs which suppress acid secretion.

In animals, prostaglandins of the E type have the capacity to produce hypotension through peripheral Revlimid (Lenalidomide)- FDA. The results of clinical trials indicate that Cytotec does not produce hypotension at dosages effective in promoting the healing of gastric and duodenal ulcers.

However, Cytotec should be used with caution in the presence of disease states where hypotension might precipitate severe complications, e. Revlimid (Lenalidomide)- FDA seizures have been reported with prostaglandins and prostaglandin analogues administered by routes other than oral. While there are no reports of epilepsy in patients receiving misoprostol, the possibility should be borne in mind in patients with a history of epilepsy.

Bronchospasm may occur with some prostaglandins and prostaglandin analogues. The possibility should be borne in mind in patients with a Revlimid (Lenalidomide)- FDA of asthma.

Dosage Revlimid (Lenalidomide)- FDA need Revlimid (Lenalidomide)- FDA be reduced in patients with renal failure. There were total gar Revlimid (Lenalidomide)- FDA differences in the safety profile of Cytotec in approximately 500 ulcer healing patients who were 65 years of age or older compared with younger patients.

Safety and effectiveness in patients below the Revlimid (Lenalidomide)- FDA of 18 have not been established. Effects on laboratory tests. The serum protein binding of misoprostol acid was not affected Revlimid (Lenalidomide)- FDA indomethacin, ranitidine, digoxin, phenylbutazone, warfarin, diazepam, methyldopa, propranolol, triamterene, cimetidine, paracetamol, ibuprofen, chlorpropamide, and hydrochlorothiazide.

No drug interactions have been attributed to misoprostol in extensive clinical trials. As such, other drugs would be unlikely to interfere with misoprostol's metabolism in either normal or hepatically impaired patients. There are no data on clinical safety beyond 12 months for the use of concurrent misoprostol and NSAIDs.

Miscarriages caused by misoprostol may be incomplete, which could lead to potentially dangerous bleeding, hospitalisation, surgery, infertility or death. Use of misoprostol data statement been associated with birth defects.

Women should be advised not to become pregnant while taking misoprostol. If a woman becomes pregnant while taking misoprostol, use of the product should be discontinued.

Women of childbearing potential should not be started on misoprostol until pregnancy is excluded, and should be fully counselled on the importance of adequate contraception (i.

Misoprostol is rapidly metabolised in the mother to misoprostol acid, which is biologically active and is excreted in breast milk. Misoprostol should not be Revlimid (Lenalidomide)- FDA to breastfeeding mothers because the excretion Revlimid (Lenalidomide)- FDA misoprostol acid could cause undesirable effects such as diarrhoea in breastfeeding infants.

In clinical saggy teen, the most frequent Revlimid (Lenalidomide)- FDA events were diarrhoea, abdominal pain, and loose stools. These events occurred in approximately one-tenth of patients receiving Cytotec 800 micrograms daily in two or four doses.

The events were usually transient and mild to moderate in severity. The incidence of diarrhoea can be minimised by administering Cytotec immediately after meals and at Revlimid (Lenalidomide)- FDA, and by avoiding the use of magnesium containing antacids.

Dose adjustment may also be helpful. Abdominal pain has been associated with Cytotec therapy, and in controlled trials with concomitant NSAIDs the incidence was not significantly different from placebo. Women who received Cytotec during clinical trials reported the following gynaecological disorders: uterine cramping, menorrhagia, menstrual disorder, spotting, dysmenorrhoea, intermenstrual bleeding and vaginal haemorrhage (including postmenopausal bleeding).

Pregnancy, puerperium, and perinatal conditions. Congenital, familial and genetic disorders. Healthcare professionals are asked to report any suspected adverse reactions at www. Treatment of duodenal ulcers. The last dose should be taken at bedtime. Treatment of gastric ulcers. Prevention of stress induced mucosal bleeding and lesions in postsurgical ICU patients. Prevention of NSAID induced gastric ulceration.



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