Concise Prescribing Info
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Gastric and duodenal ulcers; NSAID-associated ulceration 800 mcg/day in 2-4 divided doses for at least 4 wk, may continue up to 8 wk if needed. Prophylaxis of NSAID-induced ulcers 200 mcg 2-4 times/day, may reduce dose to 100 mcg 4 times/day. Termination of pregnancy (49 days or less duration) 400 mcg as a single dose, given 36-48 hr after mifepristone. Vag Labour induction 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 delivery system.
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.
Drug Interactions
Mg-containing antacids may aggravate misoprostol-induced diarrhoea.
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 © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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