Drugs List

Therapeutic Indications

Uses

Treatment of benign gastric or duodenal ulcer - NSAID associated
Ulcer prophylaxis during NSAID treatment

Unlicensed Uses

Abortion - induction of
Labour - induction of
Post partum haemorrhage

Contraindications

Children under 18 years
Females attempting to conceive
Pregnancy

Precautions and Warnings

Premenopausal females
Breastfeeding
Cerebrovascular disorder
Coronary arteriosclerosis
Dehydration
Hypertension
Inflammatory bowel disease
Severe peripheral vascular disease

Advise patient dizziness may affect ability to drive or operate machinery
Exclude pregnancy prior to initiation of treatment
Discontinue therapy if marked diarrhoea occurs
Female: Ensure adequate contraception during treatment

Gastrointestinal bleeding, ulceration and perforation may occur in NSAID treated patients receiving misoprostol. Where appropriate, endoscopy and biopsy should be carried out before use and at appropriate intervals to ensure that malignant disease is absent in the upper gastrointestinal tract.

Symptomatic responses to misoprostol do not preclude the presence of gastric malignancy.

Monitor patients carefully in whom dehydration would be dangerous.

Pregnancy and Lactation

Pregnancy

Contraindicated in pregnancy.

Misoprostol increases uterine tone and contractions during pregnancy which may cause partial or complete expulsion of the products of conception. Use in pregnancy has been associated with abortion, premature birth, foetal death and birth defects.

If pregnancy is suspected, discontinue treatment.

Women of child bearing potential should be advised to maintain adequate contraception throughout treatment.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use misoprostol with caution if breastfeeding.

The manufacturer suggests that misoprostol should not be administered to nursing mothers because the excretion of misoprostol could cause undesirable effects such as diarrhoea in nursing infants.

Small amounts of prostaglandin analogues appear normally in colostrum and milk. The amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants.

However if treatment is needed, Hale concludes that misoprostol could be taken immediately after a feed and the next feed be given four hours later, when milk levels are below 1 picogram/millilitre square. Infants should be monitored for signs of diarrhoea (Hale 2014).

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Amniotic fluid embolism
Anaphylactic reaction
Birth defects
Chills
Constipation
Diarrhoea
Dizziness
Dysmenorrhoea
Dyspepsia
Flatulence
Foetal death
Headache
Incomplete abortion
Intermenstrual bleeding
Menorrhagia
Menstrual discomfort
Nausea
Postmenopausal bleeding
Premature birth
Pyrexia
Rash
Retained placenta
Uterine contractions
Uterine cramps
Uterine haemorrhage
Uterine perforation
Uterine rupture
Vaginal bleeding
Vomiting

Presentation

Oral formulations of low strength misoprostol (200 micrograms)

Drugs List

Therapeutic Indications

Uses

Treatment of benign gastric or duodenal ulcer - NSAID associated
Ulcer prophylaxis during NSAID treatment

Unlicensed Uses

Abortion - induction of
Labour - induction of
Post partum haemorrhage

Dosage

Adults

Elderly

Contraindications

Children under 18 years
Females attempting to conceive
Pregnancy

Precautions and Warnings

Premenopausal females
Breastfeeding
Cerebrovascular disorder
Coronary arteriosclerosis
Dehydration
Hypertension
Inflammatory bowel disease
Severe peripheral vascular disease

Advise patient dizziness may affect ability to drive or operate machinery
Exclude pregnancy prior to initiation of treatment
Discontinue therapy if marked diarrhoea occurs
Female: Ensure adequate contraception during treatment

Gastrointestinal bleeding, ulceration and perforation may occur in NSAID treated patients receiving misoprostol. Where appropriate, endoscopy and biopsy should be carried out before use and at appropriate intervals to ensure that malignant disease is absent in the upper gastrointestinal tract.

Symptomatic responses to misoprostol do not preclude the presence of gastric malignancy.

Monitor patients carefully in whom dehydration would be dangerous.

Pregnancy and Lactation

Pregnancy

Contraindicated in pregnancy.

Misoprostol increases uterine tone and contractions during pregnancy which may cause partial or complete expulsion of the products of conception. Use in pregnancy has been associated with abortion, premature birth, foetal death and birth defects.

If pregnancy is suspected, discontinue treatment.

Women of child bearing potential should be advised to maintain adequate contraception throughout treatment.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use misoprostol with caution if breastfeeding.

The manufacturer suggests that misoprostol should not be administered to nursing mothers because the excretion of misoprostol could cause undesirable effects such as diarrhoea in nursing infants.

Small amounts of prostaglandin analogues appear normally in colostrum and milk. The amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants.

However if treatment is needed, Hale concludes that misoprostol could be taken immediately after a feed and the next feed be given four hours later, when milk levels are below 1 picogram/millilitre square. Infants should be monitored for signs of diarrhoea (Hale 2014).

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Amniotic fluid embolism
Anaphylactic reaction
Birth defects
Chills
Constipation
Diarrhoea
Dizziness
Dysmenorrhoea
Dyspepsia
Flatulence
Foetal death
Headache
Incomplete abortion
Intermenstrual bleeding
Menorrhagia
Menstrual discomfort
Nausea
Postmenopausal bleeding
Premature birth
Pyrexia
Rash
Retained placenta
Uterine contractions
Uterine cramps
Uterine haemorrhage
Uterine perforation
Uterine rupture
Vaginal bleeding
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: May 2015.

Reference Sources

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press. Accessed on 14 May 2015.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Summary of Product Characteristics: Cytotec 200mcg Tablets. Pfizer Limited. Revised March 2014.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Misoprostol Last revised: 6 March 2014
Last accessed: 14 May 2015