Drugs List

Therapeutic Indications

Uses

Adjunct to oestrogen replacement therapy in peri and postmenopausal women
Amenorrhoea - secondary
Dysfunctional uterine bleeding
Endometriosis

Unlicensed Uses

Hot flushes associated with androgen deprivation in prostate cancer

Contraindications

Children under 18 years
Abnormal liver function test
Acute hepatic disorder
Breast cancer
Breastfeeding
Deep vein thrombosis
Female genital cancer
Galactosaemia
History of breast cancer
History of venous thromboembolism
Porphyria
Pregnancy
Pulmonary embolism
Recent arterial thromboembolic disorder
Thromboembolic disorder
Venous thromboembolism

Precautions and Warnings

Body mass index above 30kg per square metre
Family history of breast cancer
Family history of venous thromboembolism
History of recurrent spontaneous abortion
Predisposition to thromboembolic disease
Prolonged immobilisation
Recent surgery
Recent trauma
Risk factor for oestrogen-dependent neoplasm
Severe headache
Asthma
Cardiac impairment
Cholelithiasis
Diabetes mellitus
Epileptic disorder
Glucose-galactose malabsorption syndrome
Hepatic disorder
Hereditary fructose intolerance
History of acute visual disturbances
History of depression
History of thromboembolic disorder
Hypertension
Lactose intolerance
Migraine
Otosclerosis
Renal impairment
Systemic lupus erythematosus
Uterine fibroids

Assess family medical history prior to commencing treatment
Exclude breast cancer before treatment
Not all available brands are licensed for all indications
Contains lactose
Some formulations contain sucrose
Do breast & pelvic exam. before & during treatment if clinically indicated
Exclude pregnancy prior to initiation of treatment
Abnormal and/or irregular bleeding should be investigated
Monitor for signs and symptoms of glucose intolerance
Monitor patients with a history of treatment of mental depression
Advise patient that changes in their breasts should be reported to Dr/nurse
Advise patient to contact a doctor if symptoms of thromboembolism develop
May cause weight gain
Discontinue 4 - 6 weeks before major surgery
Discontinue at first signs of jaundice
Discontinue if first occurrence or worsening of migraine/severe headache
Discontinue if significant rise in blood pressure occurs
Discontinue if sudden pain in the chest occurs
Discontinue if venous thromboembolism develops
Discontinue in the event of a prolonged period of immobilisation
Pregnancy confirmed: Discontinue this medication
Advise patient not to take St John's wort concurrently
Delay in return to fertility can occur following treatment discontinuation
Male & female: Use in conjunction with barrier methods of contraception

Hormone replacement therapy (HRT) should only be considered for patients whose symptoms adversely affect quality of life. An annual careful appraisal of the risks and benefits should be undertaken. When carrying out initial medical examinations of patients, ensure that investigations (including appropriate imaging tools, e.g. mammography) are carried out in accordance with currently accepted screening practices.

For the treatment of menopausal symptoms the benefits of short-term HRT are considered to outweigh the risks in the majority of women. In all cases, it is good practice to use the lowest effective dose for the shortest possible time and to review the need to continue treatment at least annually. For postmenopausal women over 50 years who are at an increased risk of bone fracture, HRT should be used to prevent osteoporosis only in those who are intolerant of, or contraindicated for, other osteoporosis therapies.

Physical examination should be guided by this and a knowledge of the contraindications and precautions and warnings for use of the product. Investigations including mammography should be carried out in accordance with currently accepted screening practices, modified according to the clinical needs of the individual.

There is an increased risk of breast cancer in women currently or recently using Hormone Replacement Therapy (HRT). The risk of breast cancer increases with the duration of treatment and returns to normal after 5 years of stopping treatment.

Examinations to rule out endometrial abnormalities should be undertaken at regular intervals. Prolonged monotherapy with oestrogens increases the risk of endometrial hyperplasia and carcinoma in postmenopausal women unless supplemented by administration of a progestogen to protect the endometrium. Unless there is a previous diagnosis of endometriosis it is not recommended to add a progestogen in hysterectomised women.

Pregnancy and Lactation

Pregnancy

Medroxyprogesterone acetate is contraindicated during pregnancy.

The manufacturer states that the patient should be informed of the risks to the foetus if medroxyprogesterone acetate is used during pregnancy. Genital abnormalities have been associated in male and female foetuses from intrauterine exposure to progestational drugs in the first trimester of pregnancy.

Lactation

Medroxyprogesterone acetate is contraindicated during breastfeeding.

The manufacturer advises that medroxyprogesterone acetate should not be given sooner than six weeks post-partum when the infant's enzyme system is more developed. Medroxyprogesterone acetate and its metabolites are secreted in breast milk, no adverse effect have been shown in neonates and infants exposed.

Side Effects

Acne
Alopecia
Amenorrhoea
Anaphylactoid-like reaction
Anaphylaxis
Angioedema
Breast pain
Breast tenderness
Cervical discharge
Decreased glucose tolerance
Depression
Dizziness
Fatigue
Fluid retention
Galactorrhoea
Headache
Hirsutism
Indigestion
Insomnia
Irregular menstruation
Jaundice
Nausea
Nervousness
Oedema
Premenstrual symptoms
Pruritus
Rash
Somnolence
Temperature disturbances
Thromboembolism
Urticaria
Uterine cervical erosion
Vaginal bleeding
Weight changes

Presentation

Tablets containing low strength medroxyprogesterone acetate.

Drugs List

Therapeutic Indications

Uses

Adjunct to oestrogen replacement therapy in peri and postmenopausal women
Amenorrhoea - secondary
Dysfunctional uterine bleeding
Endometriosis

Unlicensed Uses

Hot flushes associated with androgen deprivation in prostate cancer

Dosage

Adults

Contraindications

Children under 18 years
Abnormal liver function test
Acute hepatic disorder
Breast cancer
Breastfeeding
Deep vein thrombosis
Female genital cancer
Galactosaemia
History of breast cancer
History of venous thromboembolism
Porphyria
Pregnancy
Pulmonary embolism
Recent arterial thromboembolic disorder
Thromboembolic disorder
Venous thromboembolism

Precautions and Warnings

Body mass index above 30kg per square metre
Family history of breast cancer
Family history of venous thromboembolism
History of recurrent spontaneous abortion
Predisposition to thromboembolic disease
Prolonged immobilisation
Recent surgery
Recent trauma
Risk factor for oestrogen-dependent neoplasm
Severe headache
Asthma
Cardiac impairment
Cholelithiasis
Diabetes mellitus
Epileptic disorder
Glucose-galactose malabsorption syndrome
Hepatic disorder
Hereditary fructose intolerance
History of acute visual disturbances
History of depression
History of thromboembolic disorder
Hypertension
Lactose intolerance
Migraine
Otosclerosis
Renal impairment
Systemic lupus erythematosus
Uterine fibroids

Assess family medical history prior to commencing treatment
Exclude breast cancer before treatment
Not all available brands are licensed for all indications
Contains lactose
Some formulations contain sucrose
Do breast & pelvic exam. before & during treatment if clinically indicated
Exclude pregnancy prior to initiation of treatment
Abnormal and/or irregular bleeding should be investigated
Monitor for signs and symptoms of glucose intolerance
Monitor patients with a history of treatment of mental depression
Advise patient that changes in their breasts should be reported to Dr/nurse
Advise patient to contact a doctor if symptoms of thromboembolism develop
May cause weight gain
Discontinue 4 - 6 weeks before major surgery
Discontinue at first signs of jaundice
Discontinue if first occurrence or worsening of migraine/severe headache
Discontinue if significant rise in blood pressure occurs
Discontinue if sudden pain in the chest occurs
Discontinue if venous thromboembolism develops
Discontinue in the event of a prolonged period of immobilisation
Pregnancy confirmed: Discontinue this medication
Advise patient not to take St John's wort concurrently
Delay in return to fertility can occur following treatment discontinuation
Male & female: Use in conjunction with barrier methods of contraception

Hormone replacement therapy (HRT) should only be considered for patients whose symptoms adversely affect quality of life. An annual careful appraisal of the risks and benefits should be undertaken. When carrying out initial medical examinations of patients, ensure that investigations (including appropriate imaging tools, e.g. mammography) are carried out in accordance with currently accepted screening practices.

For the treatment of menopausal symptoms the benefits of short-term HRT are considered to outweigh the risks in the majority of women. In all cases, it is good practice to use the lowest effective dose for the shortest possible time and to review the need to continue treatment at least annually. For postmenopausal women over 50 years who are at an increased risk of bone fracture, HRT should be used to prevent osteoporosis only in those who are intolerant of, or contraindicated for, other osteoporosis therapies.

Physical examination should be guided by this and a knowledge of the contraindications and precautions and warnings for use of the product. Investigations including mammography should be carried out in accordance with currently accepted screening practices, modified according to the clinical needs of the individual.

There is an increased risk of breast cancer in women currently or recently using Hormone Replacement Therapy (HRT). The risk of breast cancer increases with the duration of treatment and returns to normal after 5 years of stopping treatment.

Examinations to rule out endometrial abnormalities should be undertaken at regular intervals. Prolonged monotherapy with oestrogens increases the risk of endometrial hyperplasia and carcinoma in postmenopausal women unless supplemented by administration of a progestogen to protect the endometrium. Unless there is a previous diagnosis of endometriosis it is not recommended to add a progestogen in hysterectomised women.

Pregnancy and Lactation

Pregnancy

Medroxyprogesterone acetate is contraindicated during pregnancy.

The manufacturer states that the patient should be informed of the risks to the foetus if medroxyprogesterone acetate is used during pregnancy. Genital abnormalities have been associated in male and female foetuses from intrauterine exposure to progestational drugs in the first trimester of pregnancy.

Lactation

Medroxyprogesterone acetate is contraindicated during breastfeeding.

The manufacturer advises that medroxyprogesterone acetate should not be given sooner than six weeks post-partum when the infant's enzyme system is more developed. Medroxyprogesterone acetate and its metabolites are secreted in breast milk, no adverse effect have been shown in neonates and infants exposed.

Side Effects

Acne
Alopecia
Amenorrhoea
Anaphylactoid-like reaction
Anaphylaxis
Angioedema
Breast pain
Breast tenderness
Cervical discharge
Decreased glucose tolerance
Depression
Dizziness
Fatigue
Fluid retention
Galactorrhoea
Headache
Hirsutism
Indigestion
Insomnia
Irregular menstruation
Jaundice
Nausea
Nervousness
Oedema
Premenstrual symptoms
Pruritus
Rash
Somnolence
Temperature disturbances
Thromboembolism
Urticaria
Uterine cervical erosion
Vaginal bleeding
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: October 2019

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Summary of product characteristics: Climanor Tablet. Resource Medical UK Ltd. Revised April 2009.

Summary of product characteristics: Provera Tablets 2.5mg, Provera tablets 5mg, Provera tablets 10mg. Pfizer Limited. Revised February 2020.

NAPOS. The drug database for acute porphyria.
Available at: https://www.drugs-porphyria.org/
Medroxyprogesterone Last revised: 10 August 2012
Last accessed: 14 August 2019

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 August 2019