Cytotec

/ Pfizer

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.

In women of childbearing potential who are not using effective contraception.
-In women who are pregnant, or in whom pregnancy has not been excluded, or who are planning a pregnancy as misoprostol 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 1977.
-In patients with a known hypersensitivity to misoprostol or to any other component of the product, or to other 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.

Very common: Diarrhea, rash.
Common: Dizziness, headache, abdominal pain, constipation, , dyspepsia, flatulence, nausea, vomiting, foetal malformations.
See prescribing information for full details.

In extensive clinical studies no drug interactions have been attributed to Cytotec.
See prescribing information for full details.

Women of childbearing potential:  Women of childbearing potential must be informed about the risk of teratogenicity prior to treatment. Treatment must not be initiated until pregnancy is excluded, and women should be fully counselled on the importance of adequate contraception while undergoing treatment. If pregnancy is suspected, treatment must be immediately discontinued
Pregnancy: Misoprostol induces uterine contractions and is associated with abortion, premature birth, foetal death and foetal malformations.
Approximately a 3-fold increased risk of malformations was reported in pregnancies exposed to misoprostol during the first trimester, compared to a control group incidence of 2%. In particular, prenatal exposure to misoprostol has been associated with Moebius syndrome (congenital facial paralysis leading to hypomimia, troubles of suckling and deglutition and eye movements, with or without limb defects); amniotic band syndrome (limb deformities/ amputations, especially clubfoot, acheiria, olygodactyly, cleft palate inter alia) and central nervous system anomalies (cerebral and cranial anomalies as anencephaly, hydrocephaly, cerebellar hypoplasia, neural tube defects). Other defects including arthrogryposis have been observed.
Consequently:
– Women should be informed of the risk of teratogenicity.
– Should the patient wish to continue with her pregnancy after exposure of misoprostol in utero, a careful ultrasound scan monitoring of the pregnancy, with special attention to the limbs and head must be carried out.
The risk of uterine rupture increases with advancing gestational age and with prior uterine surgery, including Caesarean delivery. Grand multiparity also appears to be a risk factor for uterine rupture.
Lactation: Misoprostol is rapidly metabolised in the mother to misoprostol acid, which is biologically active and is excreted in breast milk. Misoprostol should not be administered to nursing mothers because the excretion of misoprostol acid could cause undesirable effects such as diarrhoea in nursing infants.

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.

Cytotec can cause dizziness. Patients should be cautioned about operating machinery and driving.
contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.