Drugs List

Therapeutic Indications

Uses

Depression - puerperal
Luteal support after oocyte retrieval during assisted reproduction
Premenstrual syndrome

Treatment of premenstrual syndrome, including premenstrual tension and depression
Treatment of puerperal depression
Luteal phase support as part of assisted reproductive technology (ART) treatment for women.

Administration

For rectal or vaginal insertion.

Rectal administration is advisable if barrier methods of contraception are used, in patients who have recently given birth, or if the patient suffers from vaginal infection or recurrent vaginal cystitis.

Use vaginally if patient has colitis or faecal incontinence.

Contraindications

Predisposition to thromboembolic disease
Suspected hormone dependent neoplasm
Undiagnosed irregular menstrual bleeding
Breastfeeding
Ectopic pregnancy
History during pregnancy of pemphigoid gestationis
History of cholestatic jaundice during pregnancy
History of hepatic neoplasm
History of pruritus during pregnancy
History of thromboembolic disorder
History of thrombophlebitis
Hormone dependent neoplasm
Missed abortion
Porphyria
Severe arterial disorder
Severe hepatic impairment
Thromboembolic disorder
Thrombophlebitis

Precautions and Warnings

Asthma
Cardiac impairment
Diabetes mellitus
Epileptic disorder
History of depression
Hypertension
Migraine
Mild hepatic impairment
Pregnancy
Renal impairment

Use rectally in patients with recurring cystitis
Use vaginally in patients with faecal incontinence
Not all available strengths are licensed for all indications
Use rectally during the puerperium
Use rectally in patients with vaginal infection
Use vaginally in patients with colitis
Female: Use rectally if barrier methods of contraception are used
Monitor blood glucose closely in patients with diabetes mellitus
Consider discontinuing if depression develops
Discontinue at first signs of thrombophlebitis or thromboembolism
Discontinue if cerebrovascular disorders occur
Discontinue if myocardial infarction occurs
Discontinue if retinal thrombosis occurs
Discontinue if thromboembolism occurs
Advise patient not to take St John's wort concurrently

Pregnancy and Lactation

Pregnancy

Use progesterone pessaries with caution in pregnancy.

Progesterone pessaries should only be used in the first trimester as indicated as part of assisted reproduction.

Progesterone is a naturally occurring hormone and is produced by the placenta during pregnancy. However, there is limited evidence on the affects of supplemental progesterone exposure during pregnancy.

Schaefer (2007) states that accidental high dose progesterone preparations used during pregnancy is not a valid reason for termination of the pregnancy. A detailed ultrasound examination could verify a normal development of the foetus.

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 14-17 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

Progesterone pessaries are contraindicated in breastfeeding.

Progesterone is a natural hormone and is present in breast milk in low levels. Therefore, progestogen is not expected to have adverse effects in a breastfed infant. However, the manufacturer advises against use in 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

Acne
Alopecia
Anaphylactoid reaction
Bloating
Breast tenderness
Changes in libido
Chloasma
Depression
Dizziness
Drowsiness
Fluid retention
Gastro-intestinal symptoms
Headache
Hirsutism
Insomnia
Irregular menstruation
Jaundice
Leakage of pessary base
Nausea
Premenstrual symptoms
Pruritus
Rash
Soreness, diarrhoea and flatulence may occur with rectal administration
Urticaria
Weight changes

Presentation

Pessaries containing progesterone

Drugs List

Therapeutic Indications

Uses

Depression - puerperal
Luteal support after oocyte retrieval during assisted reproduction
Premenstrual syndrome

Treatment of premenstrual syndrome, including premenstrual tension and depression
Treatment of puerperal depression
Luteal phase support as part of assisted reproductive technology (ART) treatment for women.

Dosage

Adults

Administration

For rectal or vaginal insertion.

Rectal administration is advisable if barrier methods of contraception are used, in patients who have recently given birth, or if the patient suffers from vaginal infection or recurrent vaginal cystitis.

Use vaginally if patient has colitis or faecal incontinence.

Contraindications

Predisposition to thromboembolic disease
Suspected hormone dependent neoplasm
Undiagnosed irregular menstrual bleeding
Breastfeeding
Ectopic pregnancy
History during pregnancy of pemphigoid gestationis
History of cholestatic jaundice during pregnancy
History of hepatic neoplasm
History of pruritus during pregnancy
History of thromboembolic disorder
History of thrombophlebitis
Hormone dependent neoplasm
Missed abortion
Porphyria
Severe arterial disorder
Severe hepatic impairment
Thromboembolic disorder
Thrombophlebitis

Precautions and Warnings

Asthma
Cardiac impairment
Diabetes mellitus
Epileptic disorder
History of depression
Hypertension
Migraine
Mild hepatic impairment
Pregnancy
Renal impairment

Use rectally in patients with recurring cystitis
Use vaginally in patients with faecal incontinence
Not all available strengths are licensed for all indications
Use rectally during the puerperium
Use rectally in patients with vaginal infection
Use vaginally in patients with colitis
Female: Use rectally if barrier methods of contraception are used
Monitor blood glucose closely in patients with diabetes mellitus
Consider discontinuing if depression develops
Discontinue at first signs of thrombophlebitis or thromboembolism
Discontinue if cerebrovascular disorders occur
Discontinue if myocardial infarction occurs
Discontinue if retinal thrombosis occurs
Discontinue if thromboembolism occurs
Advise patient not to take St John's wort concurrently

Pregnancy and Lactation

Pregnancy

Use progesterone pessaries with caution in pregnancy.

Progesterone pessaries should only be used in the first trimester as indicated as part of assisted reproduction.

Progesterone is a naturally occurring hormone and is produced by the placenta during pregnancy. However, there is limited evidence on the affects of supplemental progesterone exposure during pregnancy.

Schaefer (2007) states that accidental high dose progesterone preparations used during pregnancy is not a valid reason for termination of the pregnancy. A detailed ultrasound examination could verify a normal development of the foetus.

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 14-17 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

Progesterone pessaries are contraindicated in breastfeeding.

Progesterone is a natural hormone and is present in breast milk in low levels. Therefore, progestogen is not expected to have adverse effects in a breastfed infant. However, the manufacturer advises against use in 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

Acne
Alopecia
Anaphylactoid reaction
Bloating
Breast tenderness
Changes in libido
Chloasma
Depression
Dizziness
Drowsiness
Fluid retention
Gastro-intestinal symptoms
Headache
Hirsutism
Insomnia
Irregular menstruation
Jaundice
Leakage of pessary base
Nausea
Premenstrual symptoms
Pruritus
Rash
Soreness, diarrhoea and flatulence may occur with rectal administration
Urticaria
Weight changes

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: December 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.

Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press. Accessed on 22 December 2015].

Summary of Product Characteristics: Cyclogest 200mg. Actavis UK Ltd. Revised April 2015.
Summary of Product Characteristics: Cyclogest 400mg. Actavis UK Ltd. Revised November 2015.

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: 05 May 2015
Last accessed: 22 December 2015

The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.org
Last revised: 14 April 2010
Last accessed: 22 December 2015