Usual Adult Dose for Duodenal Ulcer

200 mcg orally 4 times a day after meals and at bedtime

• Maintenance dose: 100 to 200 mcg orally 4 times a day

Comment: Treatment should be taken for the duration of non-steroidal anti-inflammatory drug (NSAID) therapy.

Use: Reducing the risk of NSAID-induced gastric ulcers in patients at high risk of complications from gastric ulcers (e.g., patients who are elderly, with concomitant debilitating disease) or at high risk of developing gastric ulceration (e.g., history of gastric ulcer)

Usual Adult Dose for Gastric Ulcer

200 mcg orally 4 times a day after meals and at bedtime

• Maintenance dose: 100 to 200 mcg orally 4 times a day

Comment: Treatment should be taken for the duration of non-steroidal anti-inflammatory drug (NSAID) therapy.

Use: Reducing the risk of NSAID-induced gastric ulcers in patients at high risk of complications from gastric ulcers (e.g., patients who are elderly, with concomitant debilitating disease) or at high risk of developing gastric ulceration (e.g., history of gastric ulcer)

Usual Adult Dose for NSAID-Induced Ulcer Prophylaxis

200 mcg orally 4 times a day after meals and at bedtime

• Maintenance dose: 100 to 200 mcg orally 4 times a day

Comment: Treatment should be taken for the duration of non-steroidal anti-inflammatory drug (NSAID) therapy.

Use: Reducing the risk of NSAID-induced gastric ulcers in patients at high risk of complications from gastric ulcers (e.g., patients who are elderly, with concomitant debilitating disease) or at high risk of developing gastric ulceration (e.g., history of gastric ulcer)

Usual Adult Dose for Cervical Ripening

American College of Obstetricians and Gynecologists (ACOG) Recommendations:
25 mcg vaginally every 3 to 6 hours

• Some patients may require doses of 50 mcg every 6 hours

Comments:

• The manufacturer states that use outside of the approved indication should be reserved for hospital use only.
• Some experts state that this drug is a more efficient method of labor (compared to oxytocin) in patients before 28 weeks' gestation.
• Higher doses may be associated with a higher risk of adverse events (e.g., uterine tachysystole with fetal heart rate decelerations).
• Use should be avoided during the third trimester or in patients with a history of cesarean delivery or major uterine surgery.

Use: Cervical ripening and labor induction in women with premature rupture of membranes

Usual Adult Dose for Labor Induction

American College of Obstetricians and Gynecologists (ACOG) Recommendations:
25 mcg vaginally every 3 to 6 hours

• Some patients may require doses of 50 mcg every 6 hours

Comments:

• The manufacturer states that use outside of the approved indication should be reserved for hospital use only.
• Some experts state that this drug is a more efficient method of labor (compared to oxytocin) in patients before 28 weeks' gestation.
• Higher doses may be associated with a higher risk of adverse events (e.g., uterine tachysystole with fetal heart rate decelerations).
• Use should be avoided during the third trimester or in patients with a history of cesarean delivery or major uterine surgery.

Use: Cervical ripening and labor induction in women with premature rupture of membranes

Usual Adult Dose for Postpartum Bleeding

ACOG Recommendations:
800 to 1000 mcg rectally once

Use: Management of postpartum hemorrhage

International Federation of Gynecology Obstetrics (FIGO) Recommendations:
600 mcg orally OR 800 mcg sublingually once immediately after delivery

Comments:

• The manufacturer states that use outside of the approved indication should be reserved for hospital use only.
• Prior to administration of treatment, abdominal palpitation is recommended to confirm that there are no additional babies in utero.
• The dose is not based upon the patient's weight.
• The addition of this drug to oxytocin was not shown to provide additional benefit, but may increase the risk of adverse events.

Use: Prevention of postpartum hemorrhage in settings where oxytocin is not available

Usual Adult Dose for Abortion

ACOG Recommendations:
First Trimester of Pregnancy:

• Early Pregnancy Loss: 800 mcg intravaginally once; a second dose may be given if there is no response to the first dose no sooner than 3 hours after the first dose, and usually within 7 days
• Incomplete Abortion: 600 mcg orally once
• Missed Abortion: 800 mcg intravaginally OR 600 mcg sublingually once; the dose may be repeated every 3 hours for 2 additional doses

Comments:

• Pain medications should be provided.
• Patients that are Rh(D) negative and unsensitized: Rh(D)-immune globulin should be given within 72 hours of administration of the initial dose.
• Follow-up treatment should be made within 7 to 14 days to ensure complete expulsion has occurred.
• If treatment fails, patients may opt for expectant management or suction curettage.

Use: Treatment of early pregnancy loss, incomplete abortion, or missed abortion

Renal Dose Adjustments

Dosage adjustment(s) may be required; however, no specific guidelines have been suggested. Caution recommended.

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNINGS:

• Administration to women who are pregnant can cause birth defects, abortion, premature birth, or uterine rupture.
• Uterine rupture has been reported when this drug was administered in pregnant women to induce labor or to induce abortion. The risk of uterine rupture increased with advancing gestational ages and with prior uterine surgery, including cesarean delivery.
• This drug should not be taken by pregnant women to reduce the risk of ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs).
• Patients must be advised of the abortifacient property and warned not to give the drug to others.
• This drug should not be used for reducing the risk of NSAID-induced ulcers in women of childbearing potential unless the patient is at high risk of complications from gastric ulcers associated with the use of the NSAID, or is at high risk of developing gastric ulceration. In such patients, this drug may be prescribed IF the patient:
• Has a negative serum pregnancy test within 2 weeks prior to starting treatment.
• Is capable of complying with effective contraceptive measures.
• Has received BOTH oral and written warnings of the hazards of this drug, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake.
• Will begin treatment only on the second or third day of the next normal menstrual period.

Safety and efficacy have not been established in patients younger than 18 years; this drug is not recommended for use in these patients.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Doses should be taken with food, with the last dose taken before bedtime.
• When this drug is used for medical termination of pregnancy, intrauterine devices in situ should be removed before use.

Storage requirements:

• Protect from moisture; store below 30C.

General:

• Treatment has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs.
• Meconium passage, meconium staining of amniotic fluid, cesarean delivery, maternal shock, maternal death, fetal bradycardia, and fetal death have occurred after the use of tablet formulations for labor and delivery.
• Controlled studies over 3 months have shown a reduction in the risk of gastric ulcers; however, this drug did not have an effect on NSAID-associated gastrointestinal pain/discomfort compared to placebo.
• New pregnancies can occur between expulsion and menses resumption; contraception should be resumed immediately.

Monitoring:

• Genitourinary: Vaginal bleeding
• Metabolic: Signs/symptoms of dehydration
• Other: Incomplete abortion, retained placenta

Patient advice:

• Patients should not give this drug to anyone else.
• Patients undergoing medical termination of pregnancy should avoid traveling far from the prescribing center until complete expulsion is documented.
• Patients should seek immediate medical treatment if signs/symptoms of infection or excessive vaginal bleeding occur during use.
• Patients of childbearing potential should be told to use effective contraception during treatment. Patients should discontinue treatment and should speak to a healthcare provider immediately if pregnancy occurs.
• Patients should be instructed to read the included leaflet each time the prescription is filled.