Full Generic Medicine Info
Dosage/Direction for Use

NSAID-associated ulceration
Adult: 800 mcg daily in 2-4 divided doses for at least 4 wk even if symptoms are relieved sooner, may continue up to 8 wk if needed. Further courses may be given if the ulcer relapses.

Gastric and duodenal ulcers
Adult: 800 mcg daily in 2-4 divided doses for at least 4 wk even if symptoms are relieved sooner, may continue up to 8 wk if needed. Further courses may be given if the ulcer relapses.

Prophylaxis of NSAID-induced ulcers
Adult: 200 mcg 2-4 times daily; if not tolerated, may reduce dose to 100 mcg 4 times daily.

Termination of pregnancy (49 days or less duration)
Adult: 400 mcg as a single dose, given 36-48 hr after mifepristone.

Labour induction
Adult: As a 200 mcg controlled release vag insert releasing approx 7 mcg/hr over 24 hr: In women w/ unfavourable cervix (from 36 wk gestation): Max: 1 vag insert. Remove on the following conditions: Onset of active labour, prolonged or excessive uterine contractions, evidence of foetal compromise, 24 hr have elapsed since insertion. Do not replace if the insert falls out.
Should be taken with food.
Pregnancy, including those not confirmed by ultrasound or biological tests, ectopic pregnancy, contraindication for mifepristone, pregnancy beyond 49 days of amenorrhoea. When labour has started; suspicion or evidence of foetal compromise prior to induction or uterine scar; uterine abnormality; placenta praevia or unexplained vag bleeding after 24 wk gestation; foetal malpresentation; signs/symptoms of chorioamnionitis (unless prior treatment has been instituted); before 36 wk gestation. Concurrent use of oxytoxic drugs or other labour induction agents.
Special Precautions
Patients w/ conditions that predispose to diarrhoea (e.g. inflammatory bowel disease); CV disease; disease states where hypotension may precipitate severe complications (e.g. cerebrovascular disease, coronary artery disease or severe peripheral vascular disease including HTN). Patients in whom dehydration would be dangerous. Renal impairment. Lactation. Monitoring Parameters Conduct pregnancy test in women of reproductive potential prior to therapy. Monitor uterine activity and foetal condition when used for labour induction.
Adverse Reactions
Diarrhoea, dyspepsia, flatulence, abdominal pain, nausea, vomiting, rashes, dizziness, headache, increased uterine contractility, abnormal vag bleeding. Rarely, hypotension.
Potentially Fatal: Toxic shock and septic shock following infections.
Symptoms: Convulsions, sedation, tremor, dyspnoea, diarrhoea, abdominal pain, fever, palpitations, hypotension, bradycardia. Management: Supportive treatment.
Drug Interactions
Mg-containing antacids may aggravate misoprostol-induced diarrhoea.
Potentially Fatal: Increased uterotonic effects w/ oxytoxic drugs or other labour induction agents.
Misoprostol is a synthetic prostaglandin E1 analogue. It protects the GI mucosa by inhibiting basal, stimulated and nocturnal acid secretion and by reducing the volume of gastric secretions and increasing bicarbonate and mucus secretion. It also induces contractions of smooth muscle fibres of the myometrium and relaxation of the cervix uteri.
Absorption: Rapidly and almost completely absorbed from the GI tract. Time to peak plasma concentration: Approx 15-30 min.
Distribution: Enters breast milk. Plasma protein binding: <90% (misoprostol acid).
Metabolism: Rapidly metabolised to misoprostol acid (active form) and further metabolised via oxidation in several body organs.
Excretion: Mainly via urine (80%). Elimination half-life: 20-40 min.
Oral: Store at or below 25°C. Vaginal: Store at or below 25°C.
CIMS Class
Antacids, Antireflux Agents & Antiulcerants / Drugs Acting on the Uterus
ATC Classification
G02AD06 - misoprostol ; Belongs to the class of prostaglandins. Used as an oxytocic.
A02BB01 - misoprostol ; Belongs to the class of prostaglandins. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Disclaimer: This information is independently developed by CIMS based on misoprostol from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 CIMS. All rights reserved. Powered by CIMSAsia.com
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