DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Cytotec (Misoprostol) - Summary

 
 



WARNINGS

MISOPROSTOL ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE ABORTION, PREMATURE BIRTH, OR BIRTH DEFECTS. UTERINE RUPTURE HAS BEEN REPORTED WHEN MISOPROSTOL WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION BEYOND THE EIGHTH WEEK OF PREGNANCY. (See also PRECAUTIONS, and LABOR AND DELIVERY). MISOPROSTOL SHOULD NOT BE TAKEN BY PREGNANT WOMEN TO REDUCE THE RISK OF ULCERS INDUCED BY NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) (See CONTRAINDICATIONS, WARNINGS and PRECAUTIONS).

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 should the drug be taken by mistake.
  • will begin misoprostol only on the second or third day of the next normal menstrual period.
 

CYTOTEC SUMMARY

Misoprostol oral tablets contain either 100 mcg or 200 mcg of misoprostol, a synthetic prostaglandin E1 analog.

Misoprostol tablets are indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin) induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol should be taken for the duration of NSAID therapy. Misoprostol has been shown to reduce the risk of gastric ulcers in controlled studies of 3 month duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.
See all Cytotec indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Cytotec (Misoprostol)

Safety and efficacy of misoprostol versus oxytocin for the prevention of postpartum hemorrhage. [2014]
Postpartum hemorrhage (PPH) is the commonest cause of maternal death worldwide. Studies suggest that the use of misoprostol may be beneficial in clinical settings where oxytocin is unavailable... Results from this study indicate that it may be considered as an alternative for oxytocin in low resource clinical settings.

A trial comparing the use of rectal misoprostol plus perivascular vasopressin with perivascular vasopressin alone to decrease myometrial bleeding at the time of abdominal myomectomy. [2013]
OBJECTIVE: To compare the efficacy of rectal misoprostol plus perivascular vasopressin with perivascular vasopressin alone as hemostatic agents for the reduction of blood loss during myomectomies... CONCLUSION(S): We conclude that perivascular vasopressin plus misoprostol caused a significant reduction in blood loss compared with perivascular vasopressin alone.

Misoprostol vaginal insert and time to vaginal delivery: a randomized controlled trial. [2013]
vaginal delivery... CONCLUSION: Use of a 200-microgram misoprostol vaginal inset significantly

Cervical priming before diagnostic operative hysteroscopy in infertile women: a randomized, double-blind, controlled comparison of 2 vaginal misoprostol doses. [2013]
The aim of this study was to evaluate the efficacy of vaginal misoprostol for cervical priming at doses of 200 mcg and 400 mcg, 12 to 15 hours before diagnostic office hysteroscopy (OH) without anesthesia in patients with infertility. Sixty infertile patients requiring a diagnostic office hysteroscopy for investigation of infertility were included in the study...

Sublingual versus vaginal misoprostol for cervical ripening before hysteroscopy: a randomized clinical trial. [2013]
vaginal) for cervical ripening before hysteroscopy... CONCLUSION: Sublingual route of misoprostol could be considered as an effective

more studies >>

Clinical Trials Related to Cytotec (Misoprostol)

Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14-21 Weeks LMP) [Not yet recruiting]
The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double-blinded trial of 20 women comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.

Oral Titrated Misoprostol for Induction of Labour [Not yet recruiting]
The purpose of this study is to compare effectiveness and safety of an oral titrated solution of misoprostol with vaginal misoprostol for induction of labour with an alive fetus.

A Randomized Trial of Two Regimens of Misoprostol for Second Trimester Termination for Intrauterine Fetal Death [Recruiting]
Misoprostol (Cytotec®) is a synthetic prostaglandin E1 analog that has been marketed in the United States since 1988 as a gastric cytoprotective agent. Despite a focused campaign by the manufacturer to curtail its use in obstetric practice, misoprostol has, over the past several years, gained widespread acceptance to effect the medical termination of pregnancy in the second trimester, either alone or after pretreatment with mifepristone. The primary reasons for this prompt incorporation into standard practice include its low cost and the lack of stringent storage requirements.

Vaginal administration seems to be more efficacious than when given orally. The use of sublingual misoprostol for first trimester abortions has been extensively investigated as evidenced by the large number of publications comparing sublingual to other routes of misoprostol for first trimester pregnancy termination, on the assumption that the sublingual route would have a similar efficacy of the vaginal route. In addition, the sublingual route would combine an easier administration with the added advantage of no restriction of mobility after administration. There has been no previous report in the literature comparing the use of misoprostol given sublingually to that given vaginally for the second trimester termination following intrauterine fetal death. Our aim is to compare efficacy, safety and patient satisfaction with misoprostol given vaginally (the current standard) to that given sublingually.

Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (LMP)) [Recruiting]
The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double-blinded trial of 120 women in each country comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.

Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy [Not yet recruiting]
The purpose of this study is to determine whether using Misoprostol vaginally before an office endometrial biopsy is performed, will make it easier, more successful and less painful to do the procedure.

The investigators' hypothesis is that vaginal Misoprostol 12 hours prior to endometrial biopsy will increase the ease of performing office endometrial biopsy by reducing the need to use a tenaculum or a cervical dilator to achieve passage of a biopsy pipelle.

more trials >>

Reports of Suspected Cytotec (Misoprostol) Side Effects

OFF Label USE (11)Pyrexia (10)Drug Ineffective FOR Unapproved Indication (8)Bone Fissure (6)Chills (5)Maternal Exposure During Pregnancy (5)Maternal Exposure Timing Unspecified (5)Toxic Epidermal Necrolysis (4)Diarrhoea (4)Abdominal Pain (3)more >>


Page last updated: 2014-11-30

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014