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خرید پکیج
تعداد ایتم قابل مشاهده باقیمانده : 4 مورد

Misoprostol: Drug information

Misoprostol: Drug information
(For additional information see "Misoprostol: Patient drug information")

For abbreviations and symbols that may be used in Lexicomp (show table)
ALERT: US Boxed Warning
Women of childbearing potential:

Misoprostol administration to women who are pregnant can cause birth defects, abortion, premature birth, or uterine rupture. Uterine rupture has been reported when misoprostol was administered in pregnant women to induce labor or to induce abortion. The risk of uterine rupture increases with advancing gestational ages and with prior uterine surgery, including cesarean delivery. Misoprostol should not be taken by pregnant women to reduce the risk of ulcers induced by NSAIDs.

Patients must be advised of the abortifacient property and warned not to give the drug to others.

Misoprostol 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 use of the NSAID, or is at high risk of developing gastric ulceration. In such patients, misoprostol may be prescribed if the patient has had a negative serum pregnancy test within 2 weeks prior to beginning therapy; is capable of complying with effective contraceptive measures; has received both oral and written warnings of the hazards of misoprostol, the risk of possible contraception failure, and the danger to other women of childbearing potential if the drug is taken by mistake; and will begin misoprostol only on the second or third day of the next normal menstrual period.

Brand Names: US
  • Cytotec
Brand Names: Canada
  • NOVO-Misoprostol [DSC];
  • PMS-Misoprostol [DSC]
Pharmacologic Category
  • Prostaglandin
Dosing: Adult

Early pregnancy loss (off-label use): Intravaginal (off-label route): Initial dose: 800 mcg in patients <13 weeks' gestation. May repeat with one dose if needed, ≥3 hours after the first dose and typically within 7 days if no response to the initial dose is observed. Consider using in combination with oral mifepristone when mifepristone is available (ACOG 2018; Schreiber 2018; Zhang 2005).

Incomplete abortion (treatment) (off-label use): Oral: 600 mcg as a single dose in patients <12 weeks' gestation (ACOG 2009b).

Labor induction or cervical ripening (off-label uses):

Intravaginal (off-label route): 25 mcg (one-fourth of 100 mcg tablet); may repeat at intervals no more frequent than every 3 to 6 hours; 50 mcg every 6 hours may be used in some cases (ACOG 2009a).

Oral: 25 mcg (one-fourth of 100 mcg tablet) every 2 hours (Tang 2013); 20 mcg doses every 2 hours have also been evaluated (Alfirevic 2014; Kundodyiwa 2009).

Note: The vaginal route may be more efficient; however, some adverse events may occur less frequently when misoprostol is administered orally for this indication (ACOG 2009a; Alfirevic 2014; Chen 2016; Kundodyiwa 2009). Sublingual and buccal routes should not be used for cervical ripening or induction of labor (ACOG 107 209).

Missed abortion (treatment) (off-label use):

Intravaginal (off-label route): 800 mcg; may repeat every 3 hours for 2 additional doses if needed in patients <12 weeks' gestation (ACOG 2009b).

Sublingual (off-label route): 600 mcg; may repeat every 3 hours for 2 additional doses if needed in patients <12 weeks' gestation (ACOG 2009b).

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.

Postpartum hemorrhage (off-label use):

Note: Misoprostol as adjunctive therapy with oxytocin has been used in high-risk patients; monotherapy is recommended in situations where oxytocin is not available (eg, resource-poor settings). The risk of adverse reactions may be associated with combination therapy, dose, and/or route of administration. Additional data may be necessary to further define the optimal dose and route of administration (Bolhmann 2014; FIGO 2012a; FIGO 2012b; FIGO [Morris 2017]; Gallos 2018; Koch 2019; Morfaw 2019; Muñoz 2019; Schaff 2005; SOGC [Leduc 2018]; Sweed 2018; Ugwu 2016).

Prevention:

Buccal/sublingual (off-label route): 200 to 400 mcg as a single dose administered immediately after delivery (as adjunctive therapy with oxytocin) (Bhullar 2004; Hamm 2005; Gallos 2018; Hernández-Castro 2016).

Oral: 600 mcg as a single dose administered immediately after delivery (FIGO 2012a; FIGO [Morris 2017]; Muñoz 2019).

Treatment:

Oral: 600 to 1,000 mcg as a single dose (ACOG 2017).

Rectal (off-label route): 600 to 1,000 mcg as a single dose (ACOG 2017).

Sublingual (off-label route): 800 mcg as a single dose. Use caution if a prophylactic dose was already given, especially if adverse events were observed (FIGO 2012b; FIGO [Morris 2017]; Muñoz 2019). Dosage ranges of 600 to 1,000 mcg as a single dose have been noted (ACOG 2017), however, a lower 400 mcg dose has also been recommended (SOGC [Leduc 2018]).

Termination of intrauterine pregnancy, combination therapy: Refer to Mifepristone monograph.

Termination of intrauterine pregnancy, monotherapy (off-label use): Note: Monotherapy may be used when mifepristone is not available, however misoprostol monotherapy is less effective (ACOG 2020; FIGO [Morris 2017]; WHO 2018). Vaginal administration should be avoided in patients with bleeding or signs of infection (FIGO [Morris 2017]).

Patients <13 weeks' gestation: 800 mcg sublingually every 3 hours for 2 to 3 doses. Alternately, may be administered vaginally or buccally every 3 to 12 hours for 2 to 3 doses (FIGO [Morris 2017]; WHO 2018).

Patients 13 to 24 weeks' gestation: 400 mcg vaginally, sublingually, or buccally every 3 hours. May give an additional dose if placenta is not expelled 30 minutes after fetal expulsion (FIGO [Morris 2017]).

Patients 25 to 26 weeks’ gestation: 200 mcg vaginally, sublingually, or buccally every 4 hours. May give an additional dose if placenta is not expelled 30 minutes after fetal expulsion (FIGO [Morris 2017]).

Patients 27 to 28 weeks’ gestation: 200 mcg vaginally, sublingually, or buccally every 4 hours. May give an additional dose if placenta is not expelled 30 minutes after fetal expulsion. Data is insufficient to recommend use in patients with a prior cesarean delivery or transmural uterine scar (FIGO [Morris 2017]).

Patients >28 weeks’ gestation: 100 mcg vaginally, sublingually, or buccally every 6 hours. May give an additional dose if placenta is not expelled 30 minutes after fetal expulsion. Data is insufficient to recommend use in patients with a prior cesarean delivery or transmural uterine scar (FIGO [Morris 2017]).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Renal Impairment: Adult

Dose adjustment is not routinely needed; however, the dose may be reduced if the recommended dose is not tolerated. It is not known if misoprostol is removed by dialysis.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Geriatric

Nonsteroidal anti-inflammatory-induced gastric ulcers, prevention: Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Cytotec: 100 mcg, 200 mcg [DSC]

Cytotec: 200 mcg [scored]

Generic: 100 mcg, 200 mcg

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Generic: 100 mcg, 200 mcg

Administration: Adult

Nonsteroidal anti-inflammatory drug-induced gastric ulcers, prevention: Administer with food and avoid magnesium-containing antacids (minimizes diarrhea); last dose of the day should be taken at bedtime. Therapy should continue through the duration of NSAID therapy.

Termination of intrauterine pregnancy, combination therapy: Refer to Mifepristone monograph.

Labor induction or cervical ripening (off-label uses): Because the recommended doses require breaking of the commercially available tablets, some reports recommend weighing the tablet fragments (for oral or vaginal use) or preparing a solution (for oral use) to ensure accurate dosing (Alfirevic 2014; Williams 2002).

Misoprostol is available as an oral tablet. Administration of the tablet via the buccal, sublingual, vaginal, and rectal routes has been evaluated. Each route provides different pharmacokinetic and adverse event profiles which may benefit specific indications (Tang 2007).

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 3]).

Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage. NIOSH recommends single gloving for administration of intact tablets or capsules (NIOSH 2016). Assess risk to determine appropriate containment strategy (USP-NF 2017).

Use: Labeled Indications

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 (Mifeprex prescribing information April 2019).

Use: Off-Label: Adult

Cervical ripening and labor induction; Early pregnancy loss; Incomplete or missed abortion (treatment); Postpartum hemorrhage (prevention/treatment); Termination of intrauterine pregnancy (monotherapy)

Medication Safety Issues
Sound-alike/look-alike issues:

Cytotec may be confused with Cytoxan

MiSOPROStol may be confused with metoprolol, miFEPRIStone

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Gastrointestinal: Diarrhea, abdominal pain

1% to 10%:

Central nervous system: Headache

Gastrointestinal: Constipation, dyspepsia, flatulence, nausea, vomiting

<1%, postmarketing, and/or case reports: Abnormal hepatobiliary function, alopecia, anaphylaxis, anemia, anxiety, arterial thrombosis, arthralgia, back pain, bronchitis, bronchospasm, cardiac arrhythmia, cerebrovascular accident, change in appetite, chest pain, chills, confusion, conjunctivitis, deafness, depression, dermatitis, diaphoresis, dizziness, drowsiness, dysgeusia, dysphagia, dyspnea, dysuria, edema, epistaxis, fatigue, fever, gastroesophageal reflux disease, gastrointestinal hemorrhage, GI inflammation, gingivitis, glycosuria, gout, gynecological disease (cramps, dysmenorrhea, hypermenorrhea, spotting, postmenopausal vaginal bleeding, and other menstrual disorders), hematuria, hypertension, hypotension, impotence, increased amylase, increased blood urea nitrogen, increased cardiac enzymes, increased erythrocyte sedimentation rate, increased serum alkaline phosphatase, increased thirst, loss of libido, mastalgia, muscle cramps, myalgia, myocardial infarction, neuropathy, otalgia, pallor, phlebitis, pneumonia, polyuria, psychoneurosis, pulmonary embolism, purpura, rigors, skin rash, stiffness, syncope, thrombocytopenia, tinnitus, upper respiratory tract infection, urinary tract infection, uterine rupture, visual disturbance, weakness, weight changes

Contraindications

Hypersensitivity to misoprostol, other prostaglandins, or any component of the formulation; pregnancy

When used for termination of intrauterine pregnancy (additional contraindications): Refer to Mifepristone monograph.

Warnings/Precautions

Concerns related to adverse effects:

• Abortifacient: Patients must be advised of the abortifacient property and warned not to give the drug to others.

Disease-related concerns:

• 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.

Other warnings/precautions:

• Appropriate use: Termination of pregnancy: Misoprostol is approved for use with mifepristone for termination of pregnancy. Refer to mifepristone warnings, precautions, and contraindications for appropriate use of misoprostol for this indication.

• Appropriate use: Gastric ulcers: For use only in patients at high risk of complications from gastric ulcers (eg, elderly patients, patients with concomitant diseases) or patients at high risk for developing gastric ulcers (eg, those with a history of ulcers) taking nonsteroidal anti-inflammatory drug (NSAIDs) (including aspirin). Misoprostol must be taken during the duration of NSAID therapy. It is not effective in preventing duodenal ulcers in patients taking NSAIDs.

Metabolism/Transport Effects

None known.

Drug 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 magnesium-free 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

Food Interactions

Misoprostol peak serum concentrations may be decreased if taken with food (not clinically significant).

Reproductive Considerations

Misoprostol should not be used for reducing the risk of nonsteroidal anti-inflammatory drug (NSAID)-induced ulcers in patients of childbearing potential unless the patient is at high risk of complications from gastric ulcers associated with use of the NSAIDs, or is at high risk of developing gastric ulceration. When needed, misoprostol may be prescribed if the patient has had a negative serum pregnancy test within 2 weeks prior to beginning therapy; is capable of complying with effective contraceptive measures; has received both oral and written warnings of the hazards of misoprostol, the risk of possible contraception failure, and the danger to other patients of childbearing potential if the drug is taken by mistake; and will begin misoprostol only on the second or third day of the next normal menstrual period. Patients must be advised of the abortifacient property and warned not to give the drug to others.

Pregnancy Considerations

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.

Misoprostol administration to pregnant patients may cause birth defects, abortion, or premature birth. Congenital anomalies following first trimester exposure include skull defects, cranial nerve palsies, facial malformations, and limb defects. Misoprostol may produce uterine contractions leading to fetal death, uterine perforation, or abortion. Patients must be advised of the abortifacient property. Uterine tachysystole may occur and progress to uterine tetany; uteroplacental blood flow may be impaired and uterine rupture or amniotic fluid embolism leading to adverse fetal heart changes may occur.

Uterine rupture has been reported when misoprostol was administered in pregnant patients to induce labor or to induce abortion. The risk of uterine rupture increases with advancing gestational age, grand multiparity, and with prior uterine surgery, including cesarean delivery. Uterine activity and fetal status should be monitored in a hospital setting. Misoprostol should not be used in situations where uterotonic drugs are otherwise contraindicated or inappropriate.

Misoprostol is FDA approved for the medical termination of pregnancy of ≤70 days in conjunction with mifepristone (refer to the Mifepristone monograph for details). It is also may be used as monotherapy when mifepristone is not available (ACOG 2020; FIGO [Morris 2017]; WHO 2018). Medical termination of pregnancy is not recommended for patients with chronic adrenal failure, porphyrias, coagulopathy or concurrent anticoagulant therapy, intrauterine device in place, ectopic pregnancy or concurrent long-term corticosteroid therapy (ACOG 2020).

Because misoprostol may induce or augment uterine contractions, it has been used off label as a cervical-ripening agent for induction of labor. Misoprostol should not be used for this purpose during the third trimester in conditions where a spontaneous labor and vaginal delivery would be contraindicated, including patients who have had a prior cesarean delivery or major uterine surgery (because the risk of uterine rupture is increased) (ACOG 2009a; ACOG 205 2019).

Misoprostol is used off-label for the treatment of incomplete abortion (defined as the passage of some but not all products of conception in a patient with an open cervix) or missed abortion (defined as embryonic or anembryonic demise in a patient with a closed cervix that does not increase in size) in patients <12 weeks' gestation. Patients with suspected ectopic pregnancy or hemodynamic instability should not be treated with misoprostol and therapy has not been evaluated in patients with a septic abortion (ACOG 2009b). Misoprostol is also used off-label for the treatment of early pregnancy loss (<13 weeks of gestation), defined as a nonviable, intrauterine pregnancy with either an empty gestational sac or a gestational sac containing an embryo or fetus without fetal heart activity. Use may be considered in patients who do not want to undergo surgical evacuation and who do not show signs of an infection, hemorrhage, severe anemia, or bleeding disorders (ACOG 2018).

Misoprostol is effective for the management of postpartum hemorrhage. Misoprostol as adjunctive therapy with oxytocin has been used off-label in high-risk patients; monotherapy is recommended in situations where oxytocin is not available (eg, resource-poor settings). The risk of adverse reactions may be associated with combination therapy (ACOG 2017; FIGO 2012a; FIGO 2012b; FIGO [Morris 2017]; Gallos 2018; Koch 2019; Morfaw 2019; SOGC [Leduc 2018]; Sweed 2018). Various routes of administration have been used for postpartum hemorrhage. Sublingual administration has the most rapid onset, the oral route produces the most pronounced initial increase in tonus, and rectal and vaginal routes exhibit longer durations of action as compared to oral and sublingual routes (SOGC [Leduc 2018]). Chills, fever, and/or shivering are commonly associated with use of sublingual misoprostol when used for postpartum hemorrhage; incidence of adverse reactions may be dose related (FIGO 2012b). Buccal administration may be associated with lower plasma concentrations and a decreased risk of adverse reactions compared to sublingual administration (Schaff 2005).

Breast-Feeding Considerations

Misoprostol acid (the active metabolite of misoprostol) is present in breast milk.

Peak milk concentrations of misoprostol acid occur within 1 hour after an oral maternal dose and generally decline over 5 hours (Abdel-Aleem 2003; Vogel 2004). The authors of one study suggest taking the maternal dose immediately after a feed; the next feed would be acceptable in 3 to 4 hours (Vogel 2004).

Adverse events have not been reported in breastfeeding infants (FIGO 2012a; FIGO 2012b). The manufacturer recommends that caution be used if administered to a breastfeeding woman.

Dietary Considerations

When used for the prevention of NSAID-induced ulcers, take with food.

Monitoring Parameters

Early pregnancy loss: Evaluate Rh status; ultrasound or serial serum β-hCG (if ultrasound not available) 1 to 2 weeks after dosing; patient reported symptoms (ACOG 2018).

Incomplete or missed abortion: Physical exam and patient reported symptoms 1 to 2 weeks after dosing (ACOG 2009b).

Prevention of nonsteroidal anti-inflammatory drug-induced gastric ulcers: Pregnancy test prior to therapy in patients who may become pregnant; adequate diagnostic measures in all cases of undiagnosed abnormal vaginal bleeding.

Termination of intrauterine pregnancy: Refer to Mifepristone monograph.

Mechanism of Action

Misoprostol is a synthetic prostaglandin E1 analog that replaces the protective prostaglandins consumed with prostaglandin-inhibiting therapies (eg, NSAIDs); has been shown to induce uterine contractions

Pharmacodynamics and Pharmacokinetics

Onset of action: Inhibition of gastric acid secretion: 30 minutes

Duration of action: Inhibition of gastric acid secretion: 3 hours

Absorption: Rapid and extensive; extensive; food decreases absorption of misoprostol acid

Protein binding: Misoprostol acid: <90%

Metabolism: Hepatic; rapid de-esterification to misoprostol acid (active)

Half-life elimination: Misoprostol acid: 20 to 40 minutes

Time to peak, serum: Misoprostol acid: Fasting: 12 ± 3 minutes

Excretion: Urine (80%)

Pharmacodynamics and Pharmacokinetics: Additional Considerations

Renal function impairment: Cmax, AUC, and t½ are almost doubled, but no clear correlation between degree of impairment and AUC is shown.

Geriatric: AUC is increased in patients >64 years of age.

Pricing: US

Tablets (Cytotec Oral)

100 mcg (per each): $4.56

200 mcg (per each): $6.65

Tablets (miSOPROStol Oral)

100 mcg (per each): $0.82 - $0.98

200 mcg (per each): $1.09 - $1.43

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Aboprost (IN);
  • Alsoben (KR, VN);
  • Asotec (BD);
  • Cyprostil (PT);
  • Cyprostol (AT);
  • Cyrux (CR, DO, GT, HN, MX, NI, PA, SV);
  • Cytil (CO);
  • Cytolog (IN);
  • Cytotec (AE, AU, BB, BE, BF, BG, BH, BJ, BR, CH, CI, CN, CR, CY, DE, DK, EC, ES, FI, FR, GB, GH, GM, GN, GR, HK, HN, IE, IL, IQ, IR, IS, IT, JO, JP, KE, KR, KW, LB, LR, LU, LY, MA, ML, MR, MT, MU, MW, MX, MY, NE, NG, NI, NL, NO, NZ, OM, PA, PE, PL, PT, QA, RU, SA, SC, SD, SE, SG, SI, SL, SN, SV, SY, TH, TN, TR, TW, UG, VE, YE, ZA, ZM, ZW);
  • Dazitum (PT);
  • Gastrul (ID);
  • Gymiso (AU, FR);
  • Herwont (IN);
  • Isovent (BD);
  • Mipros (ID);
  • Mirolut (RU, UA);
  • Misel (KR, SG);
  • Miso-Fem (ET);
  • Misoclear (BD, TZ);
  • Misodel (AT, AU, CH, DE, DK, ES, FI, HU, IL, IS, LB, LT, LV, MT, NL, NO, PL, PT, RO, SE, SG, SK);
  • Misodex (IT);
  • Misofar (ES);
  • MisoOne (BG);
  • Misoone (ES, LV);
  • Misopa (BD);
  • Misoprost (EG, IN);
  • Misoprost-200 (ZW);
  • Misotac (EG);
  • Misotrol (CL);
  • Mispregnol (CZ, HR, SK);
  • Misprolen (PE);
  • Misprosmek (PE);
  • Mysodelle (BE, EE, GB);
  • Myspess (CR, DO, GT, HN, NI, PA, SV);
  • Mystol (PE);
  • Noprostol (ID);
  • Prosomed (ID);
  • Taneciprol (MX);
  • Topogyne (BE, EE, GB, RO);
  • U-Miso (TW);
  • Vagiprost (EG)


For country abbreviations used in Lexicomp (show table)

REFERENCES

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