There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Pediatric Indications and Dosage-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
<!--Off-Label Use and Dosage (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Contraindications-->
|contraindications=* Condition1
<!--Warnings-->
|warnings=* Description
====Precautions====
* Description
<!--Adverse Reactions-->
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Drug Interactions-->
|drugInteractions=* Drug
:* Description
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
<!--Administration and Monitoring-->
|administration=* Oral
* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
* Description
<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
<!--Overdosage-->
|overdose====Acute Overdose===
====Signs and Symptoms====
* Description
====Management====
* Description
===Chronic Overdose===
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
<!--Pharmacology-->
<!--Drug box 2-->
|drugBox=<!--Mechanism of Action-->
|mechAction=*
==Overview==
<!--Structure-->
'''Misoprostol''' is a [[Medication|drug]] that is [[Food and Drug Administration|FDA]]-approved in the [[United States]] for the prevention of [[non-steroidal anti-inflammatory drug|NSAID]]-induced [[peptic ulcer|gastric ulcer]]s. It is also used (and approved in other countries) to [[Induction (birth)|induce labor]] and as an [[abortifacient]]. It was invented and marketed by G.D. Searle & Company (now [[Pfizer]]) under the trade name '''Cytotec''', but other brand-name and [[generic drug|generic]] formulations are now available as well.
|structure=*
Chemically, misoprostol is a synthetic [[prostaglandin]] E<sub>1</sub> (PGE<sub>1</sub>) analogue.
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
==Indicated (in the United States) use==
<!--Pharmacodynamics-->
Misoprostol stimulates increased secretion of the protective [[mucus]] that lines the [[gastrointestinal tract]] and increases mucosal blood flow, thereby increasing mucosal integrity. It is sometimes co-prescribed with [[non-steroidal anti-inflammatory drug]]s to prevent their common adverse effect of [[gastric ulcer]]ation (e.g. with [[Diclofenac]] in [[Arthrotec]]).
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
==Off label (in the United States) uses==
<!--Pharmacokinetics-->
===Obstetric and gynecological===
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
====Labor Induction====
Misoprostol is commonly prescribed off-label to cause birth [[Induction (birth)|induction]] by [[childbirth|uterine contractions]] and the ripening (effacement or thinning) of the [[cervix]]. Misoprostol is highly effective and much less expensive than [[pitocin]] and [[dinoprostone]], the [[Approved drug|FDA-approved drugs]] for medically necessary labor induction. Trial meta-analysis by the [[Cochrane Collaboration]] demonstrates no difference in efficacy or side effects between inductions undertaken with dinoprostone or misoprostol (when used at the correct dosage).
Concern has been expressed about the overuse or misuse of misoprostol for labor induction. High doses can cause [[uterus|uterine]] rupture (especially in women who have previously had a caesarean section), [[fetus|fetal]] death and severe fetal brain damage, according to a ''CBS Evening News'' story by correspondent Sharyn Alfonsi.<ref>{{cite web |author=Alfonsi, Sharyn]] |month=November 30, |year=2004 |title=Labor Induction Drug Under Fire| work=CBS Evening News|url=http://www.cbsnews.com/stories/2004/11/30/eveningnews/main658388.shtml|accessdate=2006-08-22}}</ref> All induction agents cause uterine contractions – this can affect the blood supply to the fetus, especially if contractions become very frequent. Induction agents therefore need to be used with great care and with close fetal monitoring. One of the problems with induction using prostaglandins (either cervidil or misoprostol) is that once given, the process is difficult to reverse. In contrast, Pitocin (oxytocin, a hormone that also causes contractions) has a half-life of about 10 minutes and is administered via intravenous drip, which can be stopped immediately in the event of adverse reaction, according to a ''Salon.com'' webzine article by [[midwife]] Ina May Gaskin.<ref>{{cite web |author=Ina May Gaskin |title=Cytotec: Dangerous Experiment or Panacea |publisher=''Salon.com'' |date=July 11, 2000|accessdate=2006-09-08|url=http://archive.salon.com/health/feature/2000/07/11/cytotec/index.html}}</ref> A [[clinical trial]] is currently underway to establish a controlled delivery method for misoprostol.<ref>{{cite web|title=Clinical Trial Description at clinicaltrials.gov|work=Information on Clinical Trials and Human Research Studies|publisher=NIH|date=August, 2006|url=http://clinicaltrials.gov/ct/show/NCT00308711?order=5|accessdate=2006-08-29}}</ref>
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
The manufacturers of misoprostol have never sought to license misoprostol for labor induction. Recently, however, generic forms of misoprostol have become available, and it is now licensed for labor induction in Egypt and Brazil, and a licensed induction product is expected in the UK in 2008.<ref>{{cite web|title=Misoprostol.org website|author=Misoprostol.org|url=http://http://www.misoprostol.org/File/availability.php.html|acccessdate=2006-12-06}}</ref> <ref>{{cite web|title=Labour Induction website|author=Alliance Pharmaceuticals|url=http://www.labourinduction.co.uk/defaultflash.asp?page=1.html|acccessdate=2006-12-06}}</ref>
<!--Clinical Studies-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
The American College of Obstetricians and Gynecologists advocates misoprostol for labor inductions, and it is on the WHO essential drug list for labour induction.<ref>{{cite web|title=WHO Essential drug list 2005 section 22.1 website|author=WHO|url=http://whqlibdoc.who.int/hq/2005/a87017_eng.pdf|acccessdate=2006-12-06}}</ref> Other agencies await more evidence as to its safety, including obstetric organizations in Britain, Canada and Scandinavia, according to a ''Midwifery Today'' magazine article by [[neonatologist]] Marsden Wagner.<ref>{{cite journal | author=Marsden Wagner | title=Cytotec Induction and Off-Label Use | journal=Midwifery Today | issue=Issue 67 | year=2003 | month=Fall | year=2003 | url=http://www.midwiferytoday.com/articles/cytotec.asp}}</ref>
<!--How Supplied-->
|howSupplied=*
====Abortion====
<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
'''Misoprostol''' is one of the drugs used for [[medical abortion]]s. In many countries it is used in conjunction with [[mifepristone]] (RU-486). After mifepristone is taken orally, misoprostol is taken 24–72 hours later causing the expulsion of the fetus and associated matter in approximately 92% of the cases. No large studies have established a protocol for the use of misoprostol alone,<ref>{{cite web|title=Annotated Bibliography on Misoprostol Alone for Early Abortion|publisher=Gynuity Health Projects|url=http://www.rhtp.org/news/publications/documents/Miso%20for%20Pregnancy%20Termination.Bibliography.pdf|formate=PDF|accessdate=2006-08-22}}</ref> and the range of efficacy is 65%–93% depending on sample size, gestational age, and other test variables;<ref>{{cite web|title=Medication Abortion: Misoprostol Alone|publisher=Ibis|accessdate=2006-09-08|url=http://www.medicationabortion.com/misoprostol/index.html}}</ref> Misoprostol alone may be more effective in earlier gestation.<ref>{{cite web|title=Instructions for Use: Abortion Induction with Misoprostol in Pregnancies up to 9 Weeks LMP|publisher=Gynuity Health Projects|format=PDF|year=2003|url=http://www.rhtp.org/news/publications/documents/Miso%20for%20Pregnancy%20Termination.IFU.English.pdf#search=%22%20site%3Awww.rhtp.org%20misoprostol%20abortion%20success%20rate%22|accessdate=2006-08-24}}</ref> The side effects associated with the misoprostol-only regimen are generally much more severe than those associated with the combined regimens. Misoprostol is used for [[self-induced abortion]]s in Brazil, where black market prices exceed US $100 per dose. Illegal medically-unsupervised misoprostol abortions in Brazil are associated with a lower complication rate than other forms of illegal self-induced abortion, but are still associated with a higher complication rate than legal, medically supervised surgical and chemical abortions. Failed misoprostol abortions are associated with birth defects in some cases. <ref>{{cite journal|author=Corta, SH et al|title=Misoprostol and illegal abortion in Rio de Janeiro, Brazil|journal=Lancet|year=1993|volume=15|issue=341|page=1258-61|id=PMID 8098402}}</ref> <ref>{{cite journal|author=Coelho, HL et al|title=Misoprostol: the experience of women in Fortaleza, Brazil|journal=Contraception|year=1994|volume=49|issue=2|page=101-10|id=PMID 8143449}}</ref><ref>{{cite journal|author=Barbosa, RM|title=The Brazilian Experience with Cytotec|journal=Stud Fam Plann|year=1993|volume=24|issue=4|pages=236-40|id=PMID 8212093}}</ref> <ref>{{cite journal|author=Rocha, J et al|title=Brazil investigates drug's possible link with birth defects|journal=BMJ|year=1994|volume=309|issue=6957|page=757-8|id=PMID 7950553}}</ref> <ref>{{cite journal|author=Gonzalez, CH et al|title=Limb deficiency with or without Mobius sequence in seven Brazilian children associated with misoprostol use in the first trimester of pregnancy|journal=Am J Med Genet|year=1993|volume=47|issue=1|page=59-64|id=PMID 8368254}}</ref> Poor immigrant populations in New York have also been observed to use self-administered misoprostol to induce abortions, as this method is much cheaper than a surgical abortion (about $2 per dose).<ref>John Leland: "Abortion Might Outgrow Its Need for Roe v. Wade", ''The New York Times'', October 2, 2005</ref>
<!--Precautions with Alcohol-->
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Misoprostol is sometimes used to treat early fetal death in the absence of spontaneous [[miscarriage]], but further research is needed to establish a a safe, effective protocol. <ref>{{cite journal|author=Neilson JP et al|title=Medical treatment for early fetal death (less than 24 weeks)|journal=Cochrane Database Syst Rev|year=2006|volume=19|issue=3|id=PMID 16855990}}</ref> It can also be used to dilate the cervix in preparation for a surgical abortion. Misoprostol is also used to prevent and treat post-partum hemorrhage, but it has more side effects and is less effective than oxytocin for this purpose. <ref>{{cite web|author=J Villar MD et al|title=Systematic Review of Randomized Controlled Trials of Misoprostol to Prevent Postpartum Hemorrhage|publisher=Obstetrics & Gynecology|year=2002|accessdate=2006-09-21|url=http://www.greenjournal.org/cgi/content/abstract/100/6/1301}}</ref>
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
===Erectile dysfunction===
<!--Look-Alike Drug Names-->
A 1998 study found misoprostol to be helpful as a supplement to a vacuum pump (VED) in the treatment of [[erectile dysfunction]], but not effective by itself.<ref>{{cite journal | author=Ekmekçioğlu, Demirci, Yilmaz & Tatli|title=Intraurethral misoprostol: a different agent in the treatment of erectile dysfunction|journal=Sexual Dysfunction|year=1998|volume=1|pages=161 |id={{doi|10.1046/j.1460-2679.1998.00030.x}} | url=http://www.blackwell-synergy.com/doi/full/10.1046/j.1460-2679.1998.00030.x}}</ref> The paper concluded "The intraurethral application of misoprostol significantly improves the quality of VED-induced erections. This agent seems to be a cheap intraurethral adjunct to VED with mild to moderate local side-effects".
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
==Side effects and contraindications==
<!--Drug Shortage Status-->
The most commonly reported [[adverse effect]] of taking a misoprostol 200 µg tablet by mouth four times a day to reduce the risk of NSAID-induced gastric ulcers is [[diarrhea]]. In clinical trials, an average 13% of patients reported diarrhea, which was dose-related and usually developed early in the course of therapy (after 13 days) and was usually self-limiting (often resolving within 8 days), but sometimes (in 2% of patients) required discontinuation of misoprostol.<!--
|drugShortage=
--><ref name="Cytotec USPI">{{cite web |author=Pfizer |month=September |year=2006 |title=Cytotec US Prescribing Information |url=http://www.pfizer.com/pfizer/download/uspi_cytotec.pdf |accessdate=2007-03-15}}</ref>
}}
{{PillImage
|fileName=No image.jpg
}}
{{LabelImage
|fileName={{PAGENAME}}11.png
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{{LabelImage
|fileName={{PAGENAME}}11.png
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<!--Pill Image-->
The next most commonly reported adverse effects of taking a misoprostol 200 µg tablet by mouth four times a day to reduce the risk of NSAID-induced gastric ulcers are: [[abdominal pain]], [[nausea]], [[flatulence]], [[headache]], [[dyspepsia]], [[vomiting]], and [[constipation]], but none of these adverse effects occurred significantly more often than when taking [[placebo]]s.<!--
--><ref name="Cytotec USPI"/>
Misoprostol should not be taken by pregnant women to reduce the risk of NSAID-induced gastric ulcers because it increases uterine tone and contractions in pregnancy which may cause partial or complete abortions, and because its use in pregnancy has been associated with birth defects.<!--
--><ref name="Cytotec USPI"/><!--
--><ref name="Cytotec UK SPC">{{cite web |author=Pharmacia |month=July |year=2004 |title=Cytotec UK SPC (Summary of Product Characteristics) |url=http://emc.medicines.org.uk/emc/assets/c/html/displaydoc.asp?documentid=9352 |accessdate=2007-03-15}}</ref>
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Black Box Warning
ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Overview
Misoprostol is a {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition1
Dosing Information
Dosage
Condition2
Dosing Information
Dosage
Condition3
Dosing Information
Dosage
Condition4
Dosing Information
Dosage
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Misoprostol in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Misoprostol in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Misoprostol in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Misoprostol in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Misoprostol in pediatric patients.
Contraindications
Condition1
Warnings
ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Misoprostol in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Misoprostol in the drug label.
