Misoprostol Pfizer 200 mcg Tablets

MISOPROSTOL PFIZER is indicated for co-administration with non-steroidal anti-inflammatory drugs (NSAIDs) for the prevention of gastric and duodenal ulcers, haemorrhagic lesions and erosions induced by NSAIDs.

For the prevention of gastric ulcers, haemorrhagic lesions and erosions induced by NSAIDs: A minimum of 200 mcg (one tablet) with food, twice daily, together with the prescribed NSAID. Dosage may be increased to 200 mcg three times daily or to a maximum of 200 mcg four times daily, to correspond to the NSAID administration schedule or if indicated by the clinical condition of the patient.

For the prevention of duodenal ulcers induced by NSAIDs: 800 mcg (four tablets) daily, in divided doses, with food. Antacids containing aluminium may be given as needed for relief of pain.

To minimize the risk of diarrhoea, MISOPROSTOL PFIZER should be taken with food, and magnesium-containing antacids should be avoided. No dosage adjustment is recommended in older patients. Safety and effectiveness in children under the age of 18 years have not been established.

MISOPROSTOL PFIZER should not be administered to anyone with a known hypersensitivity to misoprostol or other prostaglandins. MISOPROSTOL PFIZER is contraindicated in patients who are pregnant or in whom pregnancy has not been excluded and in lactation (See Warnings and Special Precautions and Pregnancy and Lactation sections). Moderate to severely impaired renal function.

MISOPROSTOL PFIZER SHOULD NOT BE USED IN PREGNANT WOMEN AS TERATOGENICITY IN ANIMALS HAS BEEN DEMONSTRATED AND IT INDUCES UTERINE CONTRACTIONS AND THEREFORE HAS ABORTIFACIENT POTENTIAL. WOMEN OF CHILDBEARING POTENTIAL SHOULD NOT BE STARTED ON MISOPROSTOL PFIZER UNTIL PREGNANCY IS EXCLUDED AND SHOULD BE FULLY COUNSELLED ON THE IMPORTANCE OF ADEQUATE CONTRACEPTION WHILE UNDERGOING TREATMENT.

Symptomatic responses to MISOPROSTOL PFIZER do not preclude the presence of gastric malignancy. Patients with conditions that predispose to diarrhoea, such as inflammatory bowel disease, or those in whom dehydration would be dangerous, should be monitored carefully.

In animals, prostaglandins of the E type have the capacity to produce hypotension through peripheral vasodilation. The results of clinical trials indicate that MISOPROSTOL PFIZER does not produce hypotension at dosages of up to 800 mcg per day. However, MISOPROSTOL PFIZER should be used with caution in the presence of disease states where hypotension might precipitate severe complications, e.g. cerebral vascular disease or coronary artery disease. Gastro-intestinal bleeding, ulceration, and perforation have occurred in NSAID-treated patients receiving MISOPROSTOL PFIZER. Physicians and patients should remain alert for ulceration, even in the absence of gastro-intestinal symptoms.

Interaction studies with MISOPROSTOL PFIZER showed no clinically significant effect on the kinetics of ibuprofen, diclofenac, piroxicam or indomethacin. MISOPROSTOL PFIZER also did not exert any clinically significant effect on the steady-state blood level or anti-platelet effects of therapeutic doses of aspirin.

MISOPROSTOL PFIZER is contraindicated in women who are pregnant because it induces uterine contractions and is associated with abortion, premature birth and fetal death and birth defects. Misoprostol is rapidly metabolised in the mother to misoprostol acid, which is biologically active and excreted in the breast milk. MISOPROSTOL PFIZER should not be administered to breastfeeding mothers because the potential excretion of misoprostol acid could cause diarrhoea in nursing infants.

The effect of MISOPROSTOL PFIZER on the ability to drive or use machinery has not been systematically evaluated.

The following adverse events have been reported in association with MISOPROSTOL PFIZER therapy. In the table below all adverse reactions, which occurred at an incidence greater than placebo are listed by system organ class and frequency (very common (u2265 1/10), common (u2265 1/100<1/10), uncommon (u2265 1/1,000, <1/100) and rare (<1/1,000)).

System Organ Class Frequency Adverse Reaction Nervous System Disorders Common Dizziness, headache Gastrointestinal Disorders Very Common Diarrhoea* Common Abdominal pain*, constipation, dyspepsia, flatulence, nausea, vomiting Reproductive System and Breast Disorders Uncommon Vaginal haemorrhage(including postmenopausal bleeding, menstrual disorder, uterine cramping Rare Menorrhagia, dysmenorrhoea *The diarrhoea, abdominal pain are transient and mild in severity, self limiting and require discontinuation of MISOPROSTOL PFIZER in the minority of patients. Instances of profound diarrhoea leading to severe dehydration have been reported. Dose adjustment may also be helpful.

Post-marketing Experience Reactions from post-marketing experience include the following: Immune system : Anaphylactic reaction Skin and Subcutaneous tissue : Rash Pregnancy, puerperium and perinatal conditions : Abnormal uterine contractions, amniotic fluid embolism, foetal death, incomplete abortion, premature birth, retained placenta, uterine perforation, uterine rupture. Reproductive System and Breast Disorder : Uterine haemorrhage. Congenital Familial and Genetic Disorder : Birth defects. General Disorder and Administration Site Condition : Chills, pyrexia

Clinical signs that may indicate an overdose are sedation, tremor, convulsions, dyspnoea, abdominal pain, diarrhoea, fever, palpitations, hypotension and bradycardia. Symptoms should be treated with supportive therapy. Because MISOPROSTOL PFIZER is metabolised like a fatty acid, it is unlikely that dialysis would be appropriate treatment for overdosage.