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Drug overview for MISOPROSTOL (misoprostol):
Generic name: MISOPROSTOL (MYE-soe-PROS-tol)
Drug class: Abortifacients
Therapeutic class: Gastrointestinal Therapy Agents
Misoprostol, a synthetic analog of prostaglandin E1 (alprostadil), is a gastric antisecretory agent with protective effects on the gastroduodenal mucosa; the drug also increases the amplitude and frequency of uterine contractions and stimulates uterine bleeding and total or partial expulsion of uterine contents in pregnant women.
Misoprostol is used for reducing the risk of nonsteroidal anti-inflammatory agent (NSAIA)-induced gastric ulcer in patients at high risk of developing complications from these ulcers and in patients at high risk of developing gastric ulceration. Misoprostol has been used for the short-term treatment of active duodenal ulcer+ and for the short-term treatment of active, benign gastric ulcer+. Misoprostol also has been used as maintenance therapy following healing of gastric ulcer to reduce ulcer recurrence+.
Misoprostol is used as an adjunct to mifepristone for the medical termination of intrauterine pregnancy (i.e., medical abortion). The drug has been used for induction of labor+ and for treatment of serious postpartum hemorrhage+ in the presence of uterine atony. For information on the use of misoprostol in fixed combination with diclofenac, a NSAIA, see Diclofenac 28:08.04.92.
Generic name: MISOPROSTOL (MYE-soe-PROS-tol)
Drug class: Abortifacients
Therapeutic class: Gastrointestinal Therapy Agents
Misoprostol, a synthetic analog of prostaglandin E1 (alprostadil), is a gastric antisecretory agent with protective effects on the gastroduodenal mucosa; the drug also increases the amplitude and frequency of uterine contractions and stimulates uterine bleeding and total or partial expulsion of uterine contents in pregnant women.
Misoprostol is used for reducing the risk of nonsteroidal anti-inflammatory agent (NSAIA)-induced gastric ulcer in patients at high risk of developing complications from these ulcers and in patients at high risk of developing gastric ulceration. Misoprostol has been used for the short-term treatment of active duodenal ulcer+ and for the short-term treatment of active, benign gastric ulcer+. Misoprostol also has been used as maintenance therapy following healing of gastric ulcer to reduce ulcer recurrence+.
Misoprostol is used as an adjunct to mifepristone for the medical termination of intrauterine pregnancy (i.e., medical abortion). The drug has been used for induction of labor+ and for treatment of serious postpartum hemorrhage+ in the presence of uterine atony. For information on the use of misoprostol in fixed combination with diclofenac, a NSAIA, see Diclofenac 28:08.04.92.
DRUG IMAGES
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The following indications for MISOPROSTOL (misoprostol) have been approved by the FDA:
Indications:
Prevention of NSAID-induced gastric ulcer
Professional Synonyms:
NSAID-induced gastric ulcer prophylaxis
Indications:
Prevention of NSAID-induced gastric ulcer
Professional Synonyms:
NSAID-induced gastric ulcer prophylaxis
The following dosing information is available for MISOPROSTOL (misoprostol):
Routine reduction of misoprostol dosage in patients with renal impairment or in geriatric patients does not appear to be necessary; however, if patients are unable to tolerate the usual adult dosage, dosage can be reduced.
Misoprostol usually is administered orally. When used to reduce the risk of nonsteroidal anti-inflammatory agent (NSAIA)-induced gastric ulcers, the incidence of misoprostol-induced diarrhea may be minimized by administering the drug in divided doses after meals and at bedtime and by avoiding concomitant administration with a magnesium-containing or other laxative antacid. When used in conjunction with mifepristone for the medical termination of pregnancy, misoprostol is administered intrabuccally 24-48 hours following mifepristone administration; patients should be instructed to place 2 misoprostol tablets in each side of the mouth between the cheek and gums for 30 minutes, then swallow any remnants with water or another liquid.
Misoprostol should be administered in an appropriate setting for the patient, taking into account that expulsion of uterine contents could begin within 2 hours of misoprostol administration. Misoprostol also has been administered intravaginally+ using tablets formulated for oral administration.
Misoprostol should be administered in an appropriate setting for the patient, taking into account that expulsion of uterine contents could begin within 2 hours of misoprostol administration. Misoprostol also has been administered intravaginally+ using tablets formulated for oral administration.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| MISOPROSTOL 200 MCG TABLET | Maintenance | Adults take 1 tablet (200 mcg) by oral route 4 times per day after meals and at bedtime |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| MISOPROSTOL 200 MCG TABLET | Maintenance | Adults take 1 tablet (200 mcg) by oral route 4 times per day after meals andat bedtime |
The following drug interaction information is available for MISOPROSTOL (misoprostol):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for MISOPROSTOL (misoprostol):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Pregnancy |
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Inflammatory bowel disease |
| Uterine rupture in pregnancy |
There are 3 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Dehydration |
| Previous cesarean section |
| Uterine scar present |
The following adverse reaction information is available for MISOPROSTOL (misoprostol):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 15 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Abnormal hepatic function tests |
| Rare/Very Rare |
|---|
|
Acute myocardial infarction Anaphylaxis Anemia Bronchospastic pulmonary disease Cardiac arrhythmia CNS toxicity Gout Hearing loss Purpura Seizure disorder Tachycardia Thrombocytopenic disorder Thromboembolic disorder Uterine rupture in pregnancy |
There are 52 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abdominal pain with cramps Diarrhea |
Constipation Dyspepsia Flatulence Headache disorder Nausea Vomiting |
| Rare/Very Rare |
|---|
|
Abnormal vaginal bleeding Acute cognitive impairment Agitation Alopecia Arthralgia Back pain Chest pain Chills Conjunctivitis Cramps Depression Dizziness Drowsy Dysgeusia Dysmenorrhea Dysphagia Dyspnea Dysuria Earache Edema Epistaxis Erectile dysfunction Fatigue Fever General weakness Gingivitis Hematuria Hyperhidrosis Hypertension Hypotension Mastalgia Menstrual disorder Myalgia Pallor Phlebitis Polyuria Skin inflammation Skin rash Symptoms of anxiety Syncope Tinnitus Upper respiratory infection Uterine cramps Visual changes |
The following precautions are available for MISOPROSTOL (misoprostol):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Misoprostol exhibits abortifacient activity and therefore can cause serious fetal harm when administered to pregnant women. A boxed warning about this risk is included in the prescribing information for the drug. Misoprostol should not be used in pregnant women for reducing the risk of NSAIA-induced gastric ulcers.
The drug also should not be used for reducing the risk of NSAIA-induced gastric ulcers in women of childbearing potential unless the woman is at high risk of developing gastric ulcers or of complications resulting from NSAIA-induced gastric ulcers; such women should not receive misoprostol until pregnancy is excluded and other necessary precautions are ensured. Misoprostol has been reported to produce uterine contractions and to stimulate uterine bleeding and total or partial expulsion of the products of conception in pregnant women. Spontaneous abortions induced by the drug may be incomplete, may require hospitalization and/or surgery, and can result in dangerous uterine bleeding, premature birth, or birth defects.
Intravaginal use of misoprostol may result in hyperstimulation of the uterus, which may progress to uterine tetany with marked impairment of uteroplacental blood flow, uterine rupture (requiring surgical repair, hysterectomy, and/or salpingo-oophorectomy), or amniotic fluid embolism. Pelvic pain, retained placenta, severe genital bleeding, shock, fetal bradycardia, and fetal and maternal death have been reported. Use of intravaginal misoprostol dosages exceeding 25 mcg may be associated with an increased risk of uterine tachysystole, uterine rupture, meconium passage, meconium staining of amniotic fluid, and cesarean delivery resulting from uterine hyperstimulation.
The risk of uterine rupture increases with advancing gestational age, prior uterine surgery (including cesarean delivery), and grand multiparity; the American College of Obstetricians and Gynecologists (ACOG) states that intravaginal use of misoprostol for cervical ripening or labor induction is not recommended in patients with a previous cesarean delivery or prior major uterine surgery. Serious, sometimes fatal, bacterial (e.g., Clostridium sordellii) infection and sepsis or prolonged heavy vaginal bleeding have been reported following spontaneous, surgical, and medical abortions, including in patients receiving mifepristone and misoprostol for termination of pregnancy; a causal relationship to the regimen has not been established. Congenital abnormalities, sometimes associated with fetal death, have been reported subsequent to the unsuccessful use of misoprostol as an abortifacient.
Some data indicate that use of misoprostol during the first trimester of pregnancy has been associated with skull defects, cranial nerve palsies, facial malformations, and limb defects; however, the precise mechanism(s) for these teratogenic effects has not been fully elucidated. Effects of misoprostol on later growth, development, and functional maturation of the child whose mother received the drug for cervical ripening or labor induction have not been established. The effects of misoprostol on the need for forceps delivery or other intervention are not known.
Currently, it is recommended that misoprostol be used for reducing the risk of NSAIA-induced gastric ulcers in women of childbearing potential only if they are at high risk of complications resulting from NSAIA-induced gastric ulceration or are at high risk of developing gastric ulceration. Such therapy should be initiated in such women only after determining that they are reliable and able to comply with effective contraceptive measures and ensuring that they have received both oral and written warnings concerning the hazards associated with misoprostol therapy, the risk of possible contraceptive failure, and the danger to other women of childbearing potential should the drug be taken by them. In addition, a reliable, blood pregnancy test must be performed within 2 weeks prior to beginning misoprostol therapy and the drug should not be provided to the patient until the pregnancy test is reported as negative, initiating therapy on the second or third day of the next normal menstrual cycle.
If misoprostol is inadvertently administered during pregnancy or if the patient becomes pregnant while receiving the drug for reducing the risk of NSAIA-induced gastric ulcer, misoprostol should be discontinued and the patient informed of the potential hazard to the fetus. Reproduction studies in rats and rabbits using oral misoprostol dosages up to 10 and 1 mg/kg (625 and 63 times the usual human dosage), respectively, have not revealed evidence of fetotoxicity or teratogenicity. However, increased fetal resorption occurred in rabbits, suggesting possible embryotoxicity.
The drug also should not be used for reducing the risk of NSAIA-induced gastric ulcers in women of childbearing potential unless the woman is at high risk of developing gastric ulcers or of complications resulting from NSAIA-induced gastric ulcers; such women should not receive misoprostol until pregnancy is excluded and other necessary precautions are ensured. Misoprostol has been reported to produce uterine contractions and to stimulate uterine bleeding and total or partial expulsion of the products of conception in pregnant women. Spontaneous abortions induced by the drug may be incomplete, may require hospitalization and/or surgery, and can result in dangerous uterine bleeding, premature birth, or birth defects.
Intravaginal use of misoprostol may result in hyperstimulation of the uterus, which may progress to uterine tetany with marked impairment of uteroplacental blood flow, uterine rupture (requiring surgical repair, hysterectomy, and/or salpingo-oophorectomy), or amniotic fluid embolism. Pelvic pain, retained placenta, severe genital bleeding, shock, fetal bradycardia, and fetal and maternal death have been reported. Use of intravaginal misoprostol dosages exceeding 25 mcg may be associated with an increased risk of uterine tachysystole, uterine rupture, meconium passage, meconium staining of amniotic fluid, and cesarean delivery resulting from uterine hyperstimulation.
The risk of uterine rupture increases with advancing gestational age, prior uterine surgery (including cesarean delivery), and grand multiparity; the American College of Obstetricians and Gynecologists (ACOG) states that intravaginal use of misoprostol for cervical ripening or labor induction is not recommended in patients with a previous cesarean delivery or prior major uterine surgery. Serious, sometimes fatal, bacterial (e.g., Clostridium sordellii) infection and sepsis or prolonged heavy vaginal bleeding have been reported following spontaneous, surgical, and medical abortions, including in patients receiving mifepristone and misoprostol for termination of pregnancy; a causal relationship to the regimen has not been established. Congenital abnormalities, sometimes associated with fetal death, have been reported subsequent to the unsuccessful use of misoprostol as an abortifacient.
Some data indicate that use of misoprostol during the first trimester of pregnancy has been associated with skull defects, cranial nerve palsies, facial malformations, and limb defects; however, the precise mechanism(s) for these teratogenic effects has not been fully elucidated. Effects of misoprostol on later growth, development, and functional maturation of the child whose mother received the drug for cervical ripening or labor induction have not been established. The effects of misoprostol on the need for forceps delivery or other intervention are not known.
Currently, it is recommended that misoprostol be used for reducing the risk of NSAIA-induced gastric ulcers in women of childbearing potential only if they are at high risk of complications resulting from NSAIA-induced gastric ulceration or are at high risk of developing gastric ulceration. Such therapy should be initiated in such women only after determining that they are reliable and able to comply with effective contraceptive measures and ensuring that they have received both oral and written warnings concerning the hazards associated with misoprostol therapy, the risk of possible contraceptive failure, and the danger to other women of childbearing potential should the drug be taken by them. In addition, a reliable, blood pregnancy test must be performed within 2 weeks prior to beginning misoprostol therapy and the drug should not be provided to the patient until the pregnancy test is reported as negative, initiating therapy on the second or third day of the next normal menstrual cycle.
If misoprostol is inadvertently administered during pregnancy or if the patient becomes pregnant while receiving the drug for reducing the risk of NSAIA-induced gastric ulcer, misoprostol should be discontinued and the patient informed of the potential hazard to the fetus. Reproduction studies in rats and rabbits using oral misoprostol dosages up to 10 and 1 mg/kg (625 and 63 times the usual human dosage), respectively, have not revealed evidence of fetotoxicity or teratogenicity. However, increased fetal resorption occurred in rabbits, suggesting possible embryotoxicity.
It is not known whether misoprostol and/or misoprostol acid cross the placenta. The drug is metabolized rapidly to the free acid following oral administration, which is biologically active and distributed into breast milk. There are no published reports of adverse effects associated with misoprostol in breast-fed infants. Caution is advised if the drug is used during breast-feeding.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for MISOPROSTOL (misoprostol):
WARNING: Do not take this medication if you think that you may be pregnant. It may cause a pregnancy to end, premature birth, or birth defects. In rare cases, serious complications (such as uterine rupture) have occurred when misoprostol was used to start labor or end a pregnancy.
These complications have resulted in harm to the unborn baby and mother. The risk for uterine rupture increases as your pregnancy advances and if you had prior uterine surgery (including Cesarean delivery) or if you had five or more previous pregnancies. Avoid pregnancy while taking misoprostol and for at least one month or one completed menstrual cycle after you have stopped treatment.
If you become pregnant while taking misoprostol, contact your doctor right away. If you are pregnant, do not take this medication to reduce the risk of stomach ulcers due to aspirin or other related drugs (non-steroidal anti-inflammatory drugs-NSAIDs such as ibuprofen). Also, if you are of childbearing age, do not use this drug to reduce the risk of ulcers from NSAIDs unless you are at high risk of having an ulcer or ulcer complications.
Female patients must meet the following four requirements in order to use this drug: 1) test negative for pregnancy within two weeks before starting treatment; 2) use effective birth control to prevent pregnancy; 3) receive oral and written warnings on the dangers of using misoprostol while of childbearing age and the risks of possible birth control failure; 4) start taking misoprostol only on the second or third day of the next normal menstrual period. This medication must not be shared with others.
WARNING: Do not take this medication if you think that you may be pregnant. It may cause a pregnancy to end, premature birth, or birth defects. In rare cases, serious complications (such as uterine rupture) have occurred when misoprostol was used to start labor or end a pregnancy.
These complications have resulted in harm to the unborn baby and mother. The risk for uterine rupture increases as your pregnancy advances and if you had prior uterine surgery (including Cesarean delivery) or if you had five or more previous pregnancies. Avoid pregnancy while taking misoprostol and for at least one month or one completed menstrual cycle after you have stopped treatment.
If you become pregnant while taking misoprostol, contact your doctor right away. If you are pregnant, do not take this medication to reduce the risk of stomach ulcers due to aspirin or other related drugs (non-steroidal anti-inflammatory drugs-NSAIDs such as ibuprofen). Also, if you are of childbearing age, do not use this drug to reduce the risk of ulcers from NSAIDs unless you are at high risk of having an ulcer or ulcer complications.
Female patients must meet the following four requirements in order to use this drug: 1) test negative for pregnancy within two weeks before starting treatment; 2) use effective birth control to prevent pregnancy; 3) receive oral and written warnings on the dangers of using misoprostol while of childbearing age and the risks of possible birth control failure; 4) start taking misoprostol only on the second or third day of the next normal menstrual period. This medication must not be shared with others.
The following icd codes are available for MISOPROSTOL (misoprostol)'s list of indications:
| Prevention of NSAId-induced gastric ulcer | |
| Z79.1 | Long term (current) use of non-steroidal anti-inflammatories (NSAId) |
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