Drugs List

Therapeutic Indications

Uses

Adjunct to oestrogen replacement therapy in postmenopausal women

Adjunctive use in combination with oestrogen for hormone replacement therapy in post-menopausal women with an intact uterus.

Contraindications

Breast cancer
Cerebrovascular haemorrhage
Female genital cancer
Porphyria
Pregnancy
Severe hepatic impairment
Thromboembolic disorder
Thrombophlebitis
Undiagnosed gynaecological haemorrhage

Precautions and Warnings

Disorders aggravated by fluid retention
Predisposition to thromboembolic disease
Asthma
Breastfeeding
Cardiac impairment
Diabetes mellitus
Epileptic disorder
History of depression
Hypertension
Migraine
Moderate hepatic impairment
Renal impairment

May decrease glucose tolerance in patients with diabetes mellitus
Advise patient ability to drive or operate machinery may be impaired
Must be prescribed with oestrogen - consider oestrogen product information
Contains soya or soya derivative
Exclude pregnancy prior to initiation of treatment
Monitor blood glucose closely in patients with diabetes mellitus
Monitor hepatic function in patients with hepatic impairment
Advise patient to seek advice at first indications of pregnancy
Discontinue at first signs of thrombophlebitis or thromboembolism
Discontinue if first occurrence or worsening of visual disturbances
Advise patient not to take St John's wort concurrently
Female: Not for contraception.Use non-hormonal contraception, if required

This product is intended for use in combination with an oestrogen product. The prescribing information for the oestrogen product should be consulted for additional precautions and warnings.

Assessment of each woman before taking hormone replacement therapy (and at regular intervals thereafter) should include a personal and family medical history. Physical examination should be guided by this and a knowledge of the contraindications and precautions and warnings for use of the product. Clinical examination of the breasts and pelvic examination should be performed where clinically indicated rather than as a routine procedure. Patients should be encouraged to report any changes in their breasts to their doctor or nurse. Investigations including mammography should be carried out in accordance with currently accepted screening practices, modified according to the clinical needs of the individual.

Discontinue treatment and initiate appropriate diagnostic and therapeutic measure in the event of any deterioration in vision, proptosis, migraine, diplopia, papilloedema or retinal vascular lesions.

Pregnancy and Lactation

Pregnancy

Contraindicated during pregnancy.

Exclude pregnancy prior to initiating therapy with progesterone.

Discontinue immediately if pregnancy occurs during treatment.

Development alterations in the psychosexual performance of boys have been attributed to exposure to estradiol and progestogen in the womb. Males who have been exposed to estradiol and progestogen have demonstrated a trend to have less heterosexual characteristics and fewer masculine interests than males which have not been exposed to these hormones prenatally.

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

Not indicated for use in breastfeeding women.

Progesterone is secreted in breast milk.

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
Breakthrough bleeding
Breast discomfort
Changes in libido
Chloasma
Deep vein thrombosis (DVT)
Depression
Dizziness
Fluid retention
Gastro-intestinal disturbances
Hirsutism
Insomnia
Jaundice
Menstrual disturbances
Premenstrual symptoms
Pulmonary embolism
Pyrexia
Rash
Somnolence
Thromboembolism
Urticaria
Weight changes

Presentation

Capsules containing progesterone.

Drugs List

Therapeutic Indications

Uses

Adjunct to oestrogen replacement therapy in postmenopausal women

Adjunctive use in combination with oestrogen for hormone replacement therapy in post-menopausal women with an intact uterus.

Dosage

All doses should be taken in the evening before retiring for the night.

Adults

Elderly

Contraindications

Breast cancer
Cerebrovascular haemorrhage
Female genital cancer
Porphyria
Pregnancy
Severe hepatic impairment
Thromboembolic disorder
Thrombophlebitis
Undiagnosed gynaecological haemorrhage

Precautions and Warnings

Disorders aggravated by fluid retention
Predisposition to thromboembolic disease
Asthma
Breastfeeding
Cardiac impairment
Diabetes mellitus
Epileptic disorder
History of depression
Hypertension
Migraine
Moderate hepatic impairment
Renal impairment

May decrease glucose tolerance in patients with diabetes mellitus
Advise patient ability to drive or operate machinery may be impaired
Must be prescribed with oestrogen - consider oestrogen product information
Contains soya or soya derivative
Exclude pregnancy prior to initiation of treatment
Monitor blood glucose closely in patients with diabetes mellitus
Monitor hepatic function in patients with hepatic impairment
Advise patient to seek advice at first indications of pregnancy
Discontinue at first signs of thrombophlebitis or thromboembolism
Discontinue if first occurrence or worsening of visual disturbances
Advise patient not to take St John's wort concurrently
Female: Not for contraception.Use non-hormonal contraception, if required

This product is intended for use in combination with an oestrogen product. The prescribing information for the oestrogen product should be consulted for additional precautions and warnings.

Assessment of each woman before taking hormone replacement therapy (and at regular intervals thereafter) should include a personal and family medical history. Physical examination should be guided by this and a knowledge of the contraindications and precautions and warnings for use of the product. Clinical examination of the breasts and pelvic examination should be performed where clinically indicated rather than as a routine procedure. Patients should be encouraged to report any changes in their breasts to their doctor or nurse. Investigations including mammography should be carried out in accordance with currently accepted screening practices, modified according to the clinical needs of the individual.

Discontinue treatment and initiate appropriate diagnostic and therapeutic measure in the event of any deterioration in vision, proptosis, migraine, diplopia, papilloedema or retinal vascular lesions.

Pregnancy and Lactation

Pregnancy

Contraindicated during pregnancy.

Exclude pregnancy prior to initiating therapy with progesterone.

Discontinue immediately if pregnancy occurs during treatment.

Development alterations in the psychosexual performance of boys have been attributed to exposure to estradiol and progestogen in the womb. Males who have been exposed to estradiol and progestogen have demonstrated a trend to have less heterosexual characteristics and fewer masculine interests than males which have not been exposed to these hormones prenatally.

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

Not indicated for use in breastfeeding women.

Progesterone is secreted in breast milk.

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

Effects on Ability to Drive and Operate Machinery

Caution is advised when driving or operating machinery as progesterone capsules may cause dizziness and / or drowsiness. These effects can be reduced by taking the capsules immediately before retiring for the night.

Counselling

Advise women that these tablets should only be taken as part of a hormone replacement therapy regime that includes an oestrogen.

Advise patients to take at night, to reduce the risk of drowsiness.

Advise patients to take progesterone capsules on an empty stomach

Side Effects

Acne
Alopecia
Breakthrough bleeding
Breast discomfort
Changes in libido
Chloasma
Deep vein thrombosis (DVT)
Depression
Dizziness
Fluid retention
Gastro-intestinal disturbances
Hirsutism
Insomnia
Jaundice
Menstrual disturbances
Premenstrual symptoms
Pulmonary embolism
Pyrexia
Rash
Somnolence
Thromboembolism
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 (https://www.toxbase.org/).

Further Information

Last Full Review Date: February 2013

Reference Sources

British National Formulary, 64th Edition (2012) Pharmaceutical Press, London.

Summary of product characteristics: Utrogestan 100 mg capsules. Marlborough Pharmaceuticals Ltd. Revised July 2014.
Summary of product characteristics: Utrogestan 200 mg capsules. Marlborough Pharmaceuticals Ltd. Revised February 2006.