Misoprostol

NSAID use, prophylaxis of Gastric ulcer, Postpartum Hemorrhage + 8 more

Treatment

5 FDA approvals

10 Active Studies for Misoprostol

What is Misoprostol

Misoprostol

The Generic name of this drug

Treatment Summary

Misoprostol is a drug that works by activating prostaglandin receptors in the stomach and uterus. It is used to reduce the risk of ulcers caused by non-steroidal anti-inflammatory drugs, to manage miscarriages, to prevent postpartum bleeding, and for first trimester abortions. Misoprostol was approved by the FDA in 1988.

Cytotec

is the brand name

image of different drug pills on a surface

Misoprostol Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Cytotec

Misoprostol

1986

109

Approved as Treatment by the FDA

Misoprostol, also known as Cytotec, is approved by the FDA for 5 uses which include Gastric Ulcer and Stomach Ulcer .

Gastric Ulcer

Stomach Ulcer

Medically induced abortion

Used to treat Medically induced abortion in combination with Mifepristone

NSAID use

prophylaxis of Gastric ulcer

Effectiveness

How Misoprostol Affects Patients

Misoprostol is a drug that is used to reduce the risk of stomach ulcers caused by taking NSAIDs. It can also be used to treat miscarriages or abortions. Depending on how it is taken, the drug starts working between 8-100 minutes and lasts for about 2-4 hours.

How Misoprostol works in the body

Misoprostol is a drug similar to prostaglandin that works to reduce the amount of acid in the stomach and increase protective secretions like mucus. It also acts on the lining of the uterus to increase contractions, loosen the cervix, and break down collagen.

When to interrupt dosage

The amount of Misoprostol is contingent upon the diagnosed condition, including Incomplete Abortion, prophylaxis of Gastric ulcer and Missed Abortion. The dose may differ, in line with the procedure of administration (e.g. Tablet - Oral or Oral) featured in the table underneath.

Condition

Dosage

Administration

Postpartum Hemorrhage

0.2 mg, , 0.1 mg

Oral, , Tablet, delayed release - Oral, Tablet, delayed release, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Buccal; Oral, Kit; Tablet - Buccal; Oral, Kit; Tablet

prophylaxis of Gastric ulcer

0.2 mg, , 0.1 mg

Oral, , Tablet, delayed release - Oral, Tablet, delayed release, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Buccal; Oral, Kit; Tablet - Buccal; Oral, Kit; Tablet

Abortion, Incomplete

0.2 mg, , 0.1 mg

Oral, , Tablet, delayed release - Oral, Tablet, delayed release, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Buccal; Oral, Kit; Tablet - Buccal; Oral, Kit; Tablet

Labour

0.2 mg, , 0.1 mg

Oral, , Tablet, delayed release - Oral, Tablet, delayed release, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Buccal; Oral, Kit; Tablet - Buccal; Oral, Kit; Tablet

Postpartum Hemorrhage

0.2 mg, , 0.1 mg

Oral, , Tablet, delayed release - Oral, Tablet, delayed release, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Buccal; Oral, Kit; Tablet - Buccal; Oral, Kit; Tablet

NSAID use

0.2 mg, , 0.1 mg

Oral, , Tablet, delayed release - Oral, Tablet, delayed release, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Buccal; Oral, Kit; Tablet - Buccal; Oral, Kit; Tablet

Cervix Uteri

0.2 mg, , 0.1 mg

Oral, , Tablet, delayed release - Oral, Tablet, delayed release, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Buccal; Oral, Kit; Tablet - Buccal; Oral, Kit; Tablet

Stomach Ulcer

0.2 mg, , 0.1 mg

Oral, , Tablet, delayed release - Oral, Tablet, delayed release, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Buccal; Oral, Kit; Tablet - Buccal; Oral, Kit; Tablet

Medically induced abortion

0.2 mg, , 0.1 mg

Oral, , Tablet, delayed release - Oral, Tablet, delayed release, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Buccal; Oral, Kit; Tablet - Buccal; Oral, Kit; Tablet

Induction of Labour

0.2 mg, , 0.1 mg

Oral, , Tablet, delayed release - Oral, Tablet, delayed release, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Buccal; Oral, Kit; Tablet - Buccal; Oral, Kit; Tablet

Abortion, Spontaneous

0.2 mg, , 0.1 mg

Oral, , Tablet, delayed release - Oral, Tablet, delayed release, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Buccal; Oral, Kit; Tablet - Buccal; Oral, Kit; Tablet

Warnings

Misoprostol has one contraindication. It should not be employed when dealing with the conditions detailed in the following table.

Misoprostol Contraindications

Condition

Risk Level

Notes

Pulse Frequency

Do Not Combine

There are 2 known major drug interactions with Misoprostol.

Common Misoprostol Drug Interactions

Drug Name

Risk Level

Description

Carbetocin

Major

The risk or severity of adverse effects can be increased when Misoprostol is combined with Carbetocin.

Oxytocin

Major

The risk or severity of adverse effects can be increased when Misoprostol is combined with Oxytocin.

Misoprostol Toxicity & Overdose Risk

The lowest toxic dose of misoprostol in rats has been found to be 81mg/kg and 27mg/kg in mice. Signs of an overdose may include drowsiness, trembling, seizures, difficulty breathing, abdominal pain, diarrhea, fever, heart palpitations, low blood pressure, and slow heart rate. Hemodialysis is not likely to help in overdosing on misoprostol but activated charcoal may help reduce absorption. Treatment for an overdose may include removing any undissolved tablets from the mouth or vagina, giving intravenous fluids, taking acetaminophen, diazepam, haloperidol,

image of a doctor in a lab doing drug, clinical research

Misoprostol Novel Uses: Which Conditions Have a Clinical Trial Featuring Misoprostol?

Three ongoing studies are investigating Misoprostol's potential for Medically induced abortion, Gastric ulcer prophylaxis and NSAID use.

Condition

Clinical Trials

Trial Phases

Induction of Labour

1 Actively Recruiting

Phase 4

Cervix Uteri

0 Actively Recruiting

Postpartum Hemorrhage

0 Actively Recruiting

Abortion, Incomplete

0 Actively Recruiting

prophylaxis of Gastric ulcer

0 Actively Recruiting

Labour

2 Actively Recruiting

Phase 4, Phase 3

Medically induced abortion

0 Actively Recruiting

Abortion, Spontaneous

0 Actively Recruiting

Stomach Ulcer

2 Actively Recruiting

Phase 4, Not Applicable

Postpartum Hemorrhage

5 Actively Recruiting

Phase 2, Not Applicable

NSAID use

0 Actively Recruiting

Misoprostol Reviews: What are patients saying about Misoprostol?

5

Patient Review

10/23/2022

Misoprostol for Abortion

After taking the first set of pills, I took four more 24 hours later. Almost immediately, I started feeling intense cramping which was only alleviated somewhat by sitting on the toilet. In addition to this, I passed large clots and experienced heavy bleeding. Despite all of this, I can say that the pain is manageable now and the bleeding has slowed down significantly.

5

Patient Review

11/12/2022

Misoprostol for Abortion

Though I can't speak for everyone, this treatment wasn't as bad as some of the reviews made it out to be. For me, there was constant cramping, but heating pad and baths helped a lot. I was even able to eat during the treatment!

5

Patient Review

10/31/2022

Misoprostol for Abortion

I took the medication as directed and experienced mild cramping around 1pm. I began bleeding shortly thereafter and passed a number of clots. Overall, it wasn't as bad as I had anticipated based on other reviews I had read.

3.7

Patient Review

11/13/2022

Misoprostol for Abortion

The effects were great for the first few hours, then I started to feel really bad. I was in a lot of pain and crying for many hours into the next day.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about misoprostol

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Clinical Trials for Misoprostol

Image of Sentara Norfolk General Hospital in Norfolk, United States.

Lactated Ringer's + Dextrose for Induction of Labour

18+
Female
Norfolk, VA

The goal of this clinical trial is to determine which of two types of standard intravenous (IV) fluids (a combination of 5% dextrose and Lactated Ringers solution and Lactated Ringers solution alone) has a better influence on labor when inducing labor in pregnant women. The main questions it aims to answer are: 1. Does the use of 5% dextrose and Lactated Ringers lead to a shorter labor than the use of just Lactated Ringers? 2. Does the use of 5% dextrose and Lactated Ringers increase the risk of neonatal hypoglycemia when compared to Lactated Ringers? Participants in this trial will be randomly assigned to one of two groups: a group that receives a solution of 5% dextrose and Lactated Ringers, and a group that receives Lactated Ringers alone. Researchers will compare the outcomes of the two groups to see which IV fluid is more effective.

Phase 4
Recruiting

Sentara Norfolk General Hospital

Image of Brigham and Women's Hospital in Boston, United States.

Low Thermal Plasma for Marginal Ulcers

18+
All Sexes
Boston, MA

The objective of the study is to investigate the treatment of marginal ulcers with Low Thermal plasma in an endoscopic setting. By a treatment of the ulcerated areas with argon plasma with low power settings (\~ 1 W) we hypothesize that the size of the ulcers will shrink, and the healing is accelerated compared to standard of care alone. Patients will benefit from this minimally invasive approach compared to a much more invasive surgical approach that comes with higher risks and hospital stay length time. From a societal and scientific perspective, this study aims to extend the well-documented clinical benefits of plasma technology - from external wound healing to internal ulcer treatment - within an endoscopic framework. The success of this study could pave the way for broader applications of LTP in the treatment of other endoscopically accessible conditions such as peptic ulcers, duodenal ulcers and esophageal ulcers. This advancement has the potential not only to improve patient outcomes through less invasive methods, but also to position LTP as a cornerstone in the future of gastroenterological wound management strategies.

Recruiting
Has No Placebo

Brigham and Women's Hospital

Christopher C. Thompson, MD, MSc

Image of Vanderbilt University Medical Center in Nashville, United States.

Risk Prediction Model for Postpartum Hemorrhage

Any Age
Female
Nashville, TN

This research project aims to enhance the safety of childbirth by using advanced computer models to predict the risk of postpartum hemorrhage (PPH). PPH is a significant concern for mothers during and after delivery. Current risk assessment tools are basic and do not adapt to changing conditions. This study will investigate whether a new and recently validated model for predicting PPH, combined with a provider-facing Best Practice Advisory (BPA) regarding currently recommended strategies triggered by an increased predicted risk, can improve perinatal outcomes. This study will compare the current category based risk assessment tool with a new, enhanced prediction model which calculates risk based on 21 factors, automatically updates as new information becomes available during labor and, if elevated, provides a provider-facing Best Practice Advisory (BPA) recommending consideration of strategies that are institutionally agreed to represent high-quality practice. Investigators hypothesize that the enhanced care approach will result in improved perinatal outcomes. The goal of the study is to improve the wellbeing of mothers during childbirth by harnessing the power of modern technology and data analysis.

Recruiting
Has No Placebo

Vanderbilt University Medical Center

Holly Ende, MD

Have you considered Misoprostol clinical trials?

We made a collection of clinical trials featuring Misoprostol, we think they might fit your search criteria.
Go to Trials
Image of Icahn School of Medicine at Mount SInai in New York, United States.

Ephedrine for Childbirth

18 - 55
Female
New York, NY

Labor analgesia is an important component of the care of laboring patients. A known side effect of combined spinal and epidural anesthesia (a type of labor analgesia) is an increased incidence of category II fetal heart rate tracing (defined below) and low blood pressure. The study team aims to study if a prophylactic dose of ephedrine will decrease the occurrence of this type of tracing after combined spinal epidural (CSE) anesthesia placement. Ephedrine is not currently routinely used as prevention for category II tracings or low blood pressure. The use of Ephedrine in this study is investigational (this is the first time that the drug has been studied for its effect on these conditions). Fetal heart rate (FHR) tracings are classified into three categories. In clinical practice, FHR tracing categories are used as a guide to obstetric management and suggest the following approach: * Category I tracing is "reactive" and reassuring → may continue labor * Category II tracing is neither category I nor category III. For obvious reasons, category II is the broadest and largest category, consisting of various FHR tracing patterns that do not fit into either category I or category III. * Category III tracing is non-reassuring → expedited vaginal or cesarean delivery recommended. A Category II tracing is not diagnostic. Most pregnancies have at least one Category II tracing. There is not always an identifiable reason for a Category II tracing. Ephedrine is a medication that causes an increase in heart rate and blood pressure while also causing some degree of relaxation of the uterus therefore improving uterine blood flow. It has been used in the obstetric population for over 50 years without issues. The dose that the research team will administer, 7.5 mg, is below the dose the research team will often administer to treat hypotension (low blood pressure).

Phase 4
Recruiting

Icahn School of Medicine at Mount SInai (+1 Sites)

James Leader

Image of University of Chicago in Chicago, United States.

Deuterated Oxytocin for Postpartum Hemorrhage

18 - 50
Female
Chicago, IL

Oxytocin is the first-line drug to promote contraction of the uterus and prevent atony immediately after delivery. Nonetheless, unpredictable uterine atony refractory to oxytocin affects roughly 250,000 parturients annually in the U.S. and rates are increasing. This two-part study will measure the action of oxytocin at cesarean delivery. The first part will measure the pharmacokinetics of a single intravenous (IV) dose of deuterium-labeled oxytocin. The second part will measure the pharmacodynamics of all plasma oxytocin to see how concentrations correspond to the contractile effect on the uterus. After delivery of the fetus, study subjects will receive a bolus of IV deuterated oxytocin followed by an unlabeled oxytocin infusion. Venous blood samples drawn at multiple time points (within 1 hour after delivery) will be analyzed for plasma concentrations of labeled and unlabeled (endogenous + exogenous infused) oxytocin over time. Plasma concentrations will be compared with 0-10 uterine tone scores measuring uterine contraction strength, to describe the concentration-effect relationship. The goal of this study is to define both the pharmacokinetics and pharmacodynamics of oxytocin in parturients to help identify the cause(s) of failed first-line oxytocin therapy.

Phase 2
Recruiting

University of Chicago (+1 Sites)

Naida M Cole, MD

Have you considered Misoprostol clinical trials?

We made a collection of clinical trials featuring Misoprostol, we think they might fit your search criteria.
Go to Trials