Presentation and Status in Health Basket
28 X 200 mcg
Adults: Use in treatment of gastric and duodenal ulcers, including those associated with NSAID use; and treatment of erosive gastritis associated with peptic ulcer disease: The recommended total daily dose is 800 micrograms per day in two or four divided doses taken with breakfast and / or each main meal and at bedtime. Treatment should be given initially for at least 4 weeks even if symptomatic relief has been achieved sooner. In most patients ulcers will be healed in 4 weeks but treatment may be continued for up to 8 weeks if required. If the ulcer relapses further treatment courses may be given.
Use in Prevention of ulcers, erosions and hemorrhagic lesions in patients maintained on NSAID therapy: The recommended total daily dose is 400 micrograms to 800 micrograms in two to four devided doses. NSAIDs should be taken according to the schedule prescribed by the physician. When appropriate, misoprostol tablets should be taken simultaneously with NSAIDs. Misoprostol should be taken for the duration of NSAID therapy. Treatment can be continued as required. Dosage should be individualised according to the clinical condition of each patient.Use in Women of Childbearing Potential,
Use in the Elderly: No dosage adjustment is recommended in older patients.
Use in Renal impairment: Dosage may need to be reduced in patients with renal failure.
Use in Hepatic impairment: Cytotec is metabolised by fatty acid oxidising systems present in organs throughout the body. Its metabolism and plasma levels are therefore unlikely to be affected markedly in patients with hepatic impairment.
Use in Children: Use of Cytotec in children under the age of 18 has not yet been evaluated in the treatment of peptic ulceration or NSAID-induced peptic ulcer disease.
Treatment of duodenal and gastric ulcer. Treatment and prevention NSAID induced ulcers lesions, erosions, while NSAID therapy continues. Use in conjunction with Mifepristone subject to the approval of a committee for the termination of pregnancy according to the Israeli penal law 1977. First-trimester pregnancy failure: Use is intended for emptying the uterus in states of first trimester pregnancy failure, including: presentation of a pregnancy sac in the uterus with no fetal echo, missed abortion (until week 11+6 and a fetus 40 mm in length) or incomplete abortion. The preparation is to be used after location of the sac in the uterus has been proved and the diagnosis of pregnancy failure is certain. The preparation can be used for this purpose in an ambulatory setting. The dosage and route of administration will be similar to the use of Cytotec in pregnancy termination after using Mifegyne. Informed consent and medicdbal surveillance are required. Softening and dilation of the cervix for performing intrauterine procedures, such as: curettage, hysteroscopy, IUD insertion and others, according to clinical judgment. The preparation can be used for this purpose in an ambulatory setting. The route of administration (vaginal, sublingual, buccal, oral or rectal) and the dosage are according to the decision of the attending doctor.
Pregnancy, women of child-bearing age, known allergy to prostaglandins.
Women of childbearing potential sould not be started on misoprostol until preganancy is excluded. Cytotec should not be used in pre-menopausal women unless the patient requires nonsteroidal antiinflammatory (NSAID) therapy and is at high risk of complications from NSAID-induced ulceration. In such patients it is advised that Cytotec should only be used if the patient:
Takes effective contraceptive measures, Has been advised of the risks of taking Cytotec if pregnant If pregnancy is suspected the product should be discontinued 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 them to diarrhea, such as inflammatory bowel disease- To minimize the risk of diarrhea, misoprostol should be taken with food, and magnesiumcontaining antacids should be avoided.
Patients in whom dehydration would be dangerous- These patients should be monitored carefully The results of clinical studies indicate that Cytotec does not produce hypotension at dosages effective in promoting the healing of gastric and duodenal ulcers. Nevertheless, Cytotec should be used with caution in the presence of disease states where hypotension might precipitate severe complications, e.g., cerebrovascular disease, coronary artery disease or severe peripheral vascular disease including hypertension. There is no evidence that Cytotec has adverse effects on glucose metabolism in human volunteers or patients with diabetes mellitus.
In clinical trials, over 15,000 patients and subjects received at least one dose of misoprostol. Adverse reactions involved primarily the gastrointestinal system. Adverse reactions with incidences > 1% included the following
Nervous System Disorders: dizziness, headache
Gastrointestinal Disorders: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, nausea, vomiting Diarrhea and abdominal pain were dose-related, usually developed early in the course of therapy, and were typically self-limiting. Rare instances of profound diarrhea leading to severe dehydration have been reported. The profile for adverse reactions with > 1% incidence was similar for subacute (four to twelve weeks duration) and long- term (up to one year) clinical trials.
The safety of long-term (greater than 12 weeks) administration of misoprostol has been demonstrated in several studies in which patients were treated continuously for up to one year. This includes no adverse or unusual change in the morphology of gastric mucosa, as determined by gastric biopsy.
Special Populations: Adverse reactions all occurring with incidences < 1% in women during clinical trials included the following:
Reproductive System and Breast Disorders: dysmenorrhea, intermenstrual bleeding menorrhagia, menstrual disorder, uterine cramping, vaginal hemorrhage (including postmenopausal bleeding) There were no significant differences in the safety profile of misoprostol in patients who were 65 years of age or older, compared with younger patients.
Other adverse events: Skin rashes have been reported.
Cytotec is predominantly metabolised via fatty acid oxidising systems and has shown no adverse effect on the hepatic microsomal mixed function oxidase (P450) enzyme system. In specific studies no clinically significant pharmacokinetic interaction has been demonstrated with antipyrine, diazepam and propranolol. In extensive clinical studies no drug interactions have been attributed to Cytotec. Additional evidence shows no clinically important pharmacokinetic or pharmacodynamic interaction with nonsteroidal anti-inflammatory drugs including aspirin, diclofenac, ibuprofen, piroxicam, naproxen, or indomethacin.
Pregnancy and Lactation
Women of childbearing potential: sould not be started on misoprostol until preganancy is excluded. Cytotec should not be used in pre-menopausal women unless the patient requires nonsteroidal antiinflammatory (NSAID) therapy and is at high risk of complications from NSAID-induced ulceration.
Use in pregnancy and lactation: Cytotec is contraindicated in pregnant women and in women planning a pregnancy or women in whom preganancy has not been excluded, as it increases uterine tone and contractions in pregnancy which may cause partial or complete expulsion of the products of conception.
Use in pregnancy: has been associated with birth defects. With the exception of cases when it is used in combined treatment with mifepristone for termination of pregnancy – subject to approval from an abortion committee. According to Penal law 1997. It is also contraindicated in patients with a known hypersensitivity to misoprostol or to any other component of the product, or to other prostaglandins.
Signs and Symptoms of Overdose: The toxic dose of misoprostol in humans has not been determined. Clinical signs that may indicate an overdose are sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea, fever, palpitations, hypotension, or bradycardia.
Treatment of Overdose: Because misoprostol is metabolized like a fatty acid, it is unlikely that dialysis would be appropriate treatment for overdose. In cases of overdose, standard supportive measures should be adopted as required.