CYTOTEC

Posology Adults Healing of duodenal ulcer, gastric ulcer and NSAID-induced peptic ulcer: 800 micrograms daily 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. Prophylaxis of NSAID-induced peptic ulcer: 200 micrograms twice daily, three times daily or four times daily.

Treatment can be continued as required. Dosage should be individualised according to the clinical condition of each patient.

Renal impairment:

Available evidence indicates that no adjustment of dosage is necessary in patients with renal impairment.

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. Elderly The usual dosage may be used.

Paediatric population Use of Cytotec in children has not yet been evaluated in the treatment of peptic ulceration or NSAID- induced peptic ulcer disease.

01%) Not Known Immune System Disorder Not Known Anaphylactic reaction Nervous System Disorders Common Dizziness, headache Gastrointestinal Disorders Very common Common Diarrhoea* Abdominal pain*, constipation, dyspepsia, flatulence, nausea, vomiting Skin and Subcutaneous Tissue Disorders Very Common Rash Pregnancy, puerperium, and perinatal conditions Rare Not Known Uterine rupture** Amniotic fluid embolism, abnormal uterine contractions, foetal death, incomplete abortion, premature birth, retained placenta, uterine perforation Reproductive System and Breast Disorders Uncommon Vaginal haemorrhage (including postmenopausal bleeding), intermenstrual bleeding, menstrual Rare Not Known disorder, uterine cramping Menorrhagia, dysmenorrhoea Uterine haemorrhage Congenital, Familial and Genetic Disorders Common Foetal malformations General Disorders and Administration Site Conditions Not Known Uncommon Chills Pyrexia * Diarrhoea and abdominal pain were dose-related, usually developed early in the course of therapy, and were typically self-limiting.

Rare instances of profound diarrhoea leading to severe dehydration has been reported. **Uterine rupture has been uncommonly reported after prostaglandin intake during the second or third trimester of pregnancy. Uterine ruptures occurred particularly in multiparous women or in women with a caesarean section scar.

Diarrhoea can be minimised by using single doses not exceeding 200 micrograms with food and by avoiding the use of predominantly magnesium containing antacids when an antacid is required. The pattern of adverse events associated with Cytotec is similar when an NSAID is given concomitantly.

Clinical trials:

In clinical trials, over 15,000 patients and subjects received at least one dose of misoprostol. Adverse reactions involved primarily the gastrointestinal system. Diarrhoea and abdominal pain were dose-related, usually developed early in the course of therapy, and were typically self-limiting.

In women of childbearing potential Cytotec must not be started on misoprostol until pregnancy is excluded, and should be fully counselled on the importance of adequate contraception while undergoing treatment. 8). 3) 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, and, where appropriate, endoscopy and biopsy should be carried out before use to ensure that malignant disease is absent in the upper gastrointestinal tract.

These investigations and any others considered necessary by the clinician should be repeated at appropriate intervals for follow-up purposes. Symptomatic responses to misoprostol do not preclude the presence of gastric malignancy. Misoprostol should be used with caution in patients with conditions that predispose them to diarrhoea, such as inflammatory bowel disease.

5). Misoprostol should be used with caution in 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.

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.

Excipient information Cytotec contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.

8). Use in pregnancy has been associated with birth defects. • In patients with a known hypersensitivity to misoprostol or to any other component of the product, or to other prostaglandins.