Misotec®
Misoprostol
Tablet
Nonsteroidal anti-inflammatory drug-induced gastric ulcers, prevention: To reduce the risk of nonsteroidal anti-inflammatory drug-induced gastric ulcers in patients at high risk of complications.
Termination of intrauterine pregnancy: Medical termination of intrauterine pregnancy through 70 days gestation in combination with mifepristone
Mechanism of Action:
Misoprostol is a synthetic prostaglandin E analog that replaces the protective prostaglandins consumed with prostaglandin-inhibiting therapies (eg, NSAIDs); has been shown to induce uterine contractions
Method of Administration:
Nonsteroidal anti-inflammatory drug-induced gastric ulcers, prevention: Oral: 200 mcg 4 times daily; if not tolerated, may decrease dose to 100 mcg 4 times daily.
Termination of intrauterine pregnancy, combination therapy: Monotherapy may be used when mifepristone is not available, however misoprostol monotherapy is less effective
Notes
Hypersensitivity to misoprostol, other prostaglandins, or any component of the formulation; pregnancy
Interactions:
Antacids: May enhance the adverse/toxic effect of MiSOPROStol. More specifically, concomitant use with magnesium-containing antacids may increase the risk of diarrhea. Management: Avoid concomitant use of misoprostol and magnesium-containing antacids. In patients requiring antacid therapy, employ magnesiumfree preparations. Monitor for increased adverse effects (e.g., diarrhea, dehydration). Risk X: Avoid combination
Carbetocin: MiSOPROStol may enhance the adverse/toxic effect of Carbetocin. Specifically, Carbetocin oxytocic effects may be enhanced. Risk X: Avoid combination
Oxytocin: MiSOPROStol may enhance the adverse/toxic effect of Oxytocin. Specifically, oxytocic effects may be enhanced. Management: The manufacturer of misoprostol recommends avoiding concomitant use with oxytocin. Misoprostol may augment effects of oxytocin, particularly when given within 4 hours of oxytocin initiation. Risk D: Consider therapy modification
Phenylbutazone: May enhance the neurotoxic effect of MiSOPROStol. Specifically, the combination may result in headache, dizziness, and transient diplopia. Risk C: Monitor therapy
Pregnancy and Lactation:
Misoprostol should not be taken by pregnant patients to reduce the risk of ulcers induced by nonsteroidal anti-inflammatory drug; use is contraindicated during pregnancy.
Adverse events have not been reported in breastfeeding infants. It is recommended that caution might be used if administered to a breastfeeding woman.
Warning and Precaution:
- Cardiovascular disease: Use with caution in patients with cardiovascular disease.
- Renal impairment: Use with caution in patients with renal impairment; dosage adjustment may be needed.
Adverse Reactions:
>10%: Gastrointestinal: Diarrhea, abdominal pain
Storage:
Store below 30ºC and protect from light and moisture.