Drugs List

Therapeutic Indications

Uses

Luteal support after oocyte retrieval during assisted reproduction

Administration

Progesterone is to be placed directly into the vagina by the applicator provided.

Contraindications

Children under 18 years
Patients over 65 years
Breast cancer
Breastfeeding
Ectopic pregnancy
Female genital cancer
History during pregnancy of pemphigoid gestationis
History of cholestatic jaundice during pregnancy
History of hepatic neoplasm
History of pruritus during pregnancy
History of venous thromboembolism
Missed abortion
Porphyria
Second trimester of pregnancy
Severe arterial disorder
Severe hepatic impairment
Third trimester of pregnancy
Thromboembolic disorder
Thrombophlebitis
Undiagnosed gynaecological haemorrhage

Precautions and Warnings

Disorders aggravated by fluid retention
Females over 35 years
Predisposition to thromboembolic disease
Tobacco smoking
Asthma
Atherosclerosis
Cardiac disorder
Diabetes mellitus
Epileptic disorder
Hepatic impairment
History of depression
Hypertension
Migraine
Renal impairment

May decrease glucose tolerance in patients with diabetes mellitus
Advise ability to drive/operate machinery may be affected by side effects
Monitor blood glucose closely in patients with diabetes mellitus
Monitor closely patient with depression
Monitor for signs of fluid retention
Monitor hepatic function
Advise patient to report sudden severe headache and visual disturbances
Avoid abrupt withdrawal
Discontinue at first signs of thrombophlebitis or thromboembolism
Discontinue if arterial thromboembolism develops
Discontinue if cerebrovascular disorders occur
Discontinue if depression worsens or recurs
Discontinue if myocardial infarction occurs
Discontinue if retinal thrombosis occurs
Discontinue if transient ischaemic events occur
Advise patient not to take St John's wort concurrently

Pregnancy and Lactation

Pregnancy

Progesterone is indicated for luteal support as part of an Assisted Reproductive Technology (ART) treatment program in infertile women.
There is limited and inconclusive data on the risk of congenital anomalies, including genital abnormalities in male or female infants, following intrauterine exposure during pregnancy. The rates of congenital anomalies, spontaneous abortion and ectopic pregnancies observed during the clinical trial were comparable with the event rate described in the general population, although the total exposure is too low to allow conclusions to be drawn.

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

Not indicated for use in breastfeeding women.

Progesterone is a natural hormone and is poorly bioavailable to the infant via milk. Therefore, progestogen is not expected to have adverse effects in a breastfed infant. However, no evidence is available to this effect and the preparation should be used with caution during breastfeeding.

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 distension
Abdominal pain
Breast pain
Breast swelling
Breast tenderness
Constipation
Diarrhoea
Dizziness
Fatigue
Genital mycosis
Genital pruritus
Headache
Hypersensitivity reactions
Insomnia
Nausea
Peripheral oedema
Rash
Urticaria
Uterine spasm
Vaginal discharge
Vaginal discomfort
Vaginal dryness
Vaginal haemorrhage
Vomiting
Vulvovaginal burning
Vulvovaginal disorders

Presentation

Vaginal tablets containing progesterone

Drugs List

Therapeutic Indications

Uses

Luteal support after oocyte retrieval during assisted reproduction

Dosage

Adults

Administration

Progesterone is to be placed directly into the vagina by the applicator provided.

Contraindications

Children under 18 years
Patients over 65 years
Breast cancer
Breastfeeding
Ectopic pregnancy
Female genital cancer
History during pregnancy of pemphigoid gestationis
History of cholestatic jaundice during pregnancy
History of hepatic neoplasm
History of pruritus during pregnancy
History of venous thromboembolism
Missed abortion
Porphyria
Second trimester of pregnancy
Severe arterial disorder
Severe hepatic impairment
Third trimester of pregnancy
Thromboembolic disorder
Thrombophlebitis
Undiagnosed gynaecological haemorrhage

Precautions and Warnings

Disorders aggravated by fluid retention
Females over 35 years
Predisposition to thromboembolic disease
Tobacco smoking
Asthma
Atherosclerosis
Cardiac disorder
Diabetes mellitus
Epileptic disorder
Hepatic impairment
History of depression
Hypertension
Migraine
Renal impairment

May decrease glucose tolerance in patients with diabetes mellitus
Advise ability to drive/operate machinery may be affected by side effects
Monitor blood glucose closely in patients with diabetes mellitus
Monitor closely patient with depression
Monitor for signs of fluid retention
Monitor hepatic function
Advise patient to report sudden severe headache and visual disturbances
Avoid abrupt withdrawal
Discontinue at first signs of thrombophlebitis or thromboembolism
Discontinue if arterial thromboembolism develops
Discontinue if cerebrovascular disorders occur
Discontinue if depression worsens or recurs
Discontinue if myocardial infarction occurs
Discontinue if retinal thrombosis occurs
Discontinue if transient ischaemic events occur
Advise patient not to take St John's wort concurrently

Pregnancy and Lactation

Pregnancy

Progesterone is indicated for luteal support as part of an Assisted Reproductive Technology (ART) treatment program in infertile women.
There is limited and inconclusive data on the risk of congenital anomalies, including genital abnormalities in male or female infants, following intrauterine exposure during pregnancy. The rates of congenital anomalies, spontaneous abortion and ectopic pregnancies observed during the clinical trial were comparable with the event rate described in the general population, although the total exposure is too low to allow conclusions to be drawn.

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

Not indicated for use in breastfeeding women.

Progesterone is a natural hormone and is poorly bioavailable to the infant via milk. Therefore, progestogen is not expected to have adverse effects in a breastfed infant. However, no evidence is available to this effect and the preparation should be used with caution during breastfeeding.

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 distension
Abdominal pain
Breast pain
Breast swelling
Breast tenderness
Constipation
Diarrhoea
Dizziness
Fatigue
Genital mycosis
Genital pruritus
Headache
Hypersensitivity reactions
Insomnia
Nausea
Peripheral oedema
Rash
Urticaria
Uterine spasm
Vaginal discharge
Vaginal discomfort
Vaginal dryness
Vaginal haemorrhage
Vomiting
Vulvovaginal burning
Vulvovaginal disorders

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: January 2015

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 23 January 2015.

Martindale: The Complete Drug Reference (online) London: Brayfield A (ed). Pharmaceutical Press Accessed on 23 January 2015.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

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
Progesterone Last revised: 6 December 2013
Last accessed: 23 January 2015