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Presentation

Tablets containing 50mg of cyproterone acetate.

Drugs List

  • ANDROCUR 50mg tablets
  • CYPROSTAT 50mg tablets
  • cyproterone 50mg tablets
  • Therapeutic Indications

    Uses

    Management of patients with prostatic cancer:
    - Suppress "flare" with initial LHRH analogue therapy.
    - Long-term palliative treatment where LHRH analogues or surgery are contraindicated, not tolerated, or
    where oral therapy is preferred.
    - Treatment of hot flushes in patients under treatment with LHRH analogues or who have had
    orchidectomy.

    Control of libido in severe hypersexuality and/or sexual deviation in the adult male.

    Not all available brands are licensed for all indications.

    Unlicensed Uses

    Gonadotrophin-independent precocious puberty

    Dosage

    Adults

    The maximum daily dose in management of prostatic cancer is 300mg.

    Suppression of flare with initial LHRH analogue therapy
    Initially 100mg twice daily alone for 5 to 7 days, followed by 100mg twice daily for 3 to 4 weeks together with the LHRH analogue therapy. The manufacturer states dosage should be in 2 to 3 divided doses and taken with liquid and meals.

    Long-term palliative treatment where LHRH analogues or surgery are contraindicated or not tolerated
    200mg to 300mg daily in 2 to 3 divided doses and taken with liquid after meals.

    Treatment of hot flushes with LHRH analogues or after orchidectomy:
    Initially 50mg daily, titrate upwards if necessary to a dose range of 50mg to 150mg daily in 1 to 3 divided doses with liquid after meals.

    Hypersexuality or sexual deviation in males:
    One 50mg tablet to be taken twice daily with liquid after morning and evening meals. Once a satisfactory result is achieved, the lowest possible dose should be used to maintain the therapeutic effect. When establishing the maintenance dose or discontinuing treatment, dose reduction should be gradual.

    Elderly

    See Adult dose

    Children

    Gonadotrophin-independent precocious puberty (unlicensed)
    Initial dose: 25mg twice a day. Adjust dose according to response.

    Patients with Renal Impairment

    The Renal Drug Handbook suggests no dose reduction is necessary in all grades of renal impairment.

    Patients with Hepatic Impairment

    Contraindicated.

    Administration

    For oral administration with liquid after food.

    Contraindications

    All indications
    Hepatic disease including Dubin-Johnson syndrome/Rotor syndrome.
    Thromboembolic disorders
    Galactosaemia
    Wasting disease (except prostate cancer)
    Malignant neoplasm (except prostate cancer)
    Meningioma or a history of meningioma
    Liver tumour or a history of liver tumour

    Male hypersexuality / sexual deviation
    History of thromboembolic disorders
    Severe diabetes with vascular changes
    Sickle cell anaemia
    Severe chronic depression

    Precautions and Warnings

    Not licensed for use in children.

    Direct hepatic toxicity, including jaundice, hepatitis and hepatic failure has been reported in patients treated with 200mg to 300mg cyproterone acetate daily. Most cases are in men with prostatic cancer. Hepatic toxicity is dose related and develops, usually, several months after treatment has begun. Liver function should be monitored and test should be performed before starting and during treatment and whenever any symptoms or signs suggestive of hepatotoxicity occur. If hepatotoxicity is confirmed, cyproterone acetate should normally be withdrawn, unless it can be explained by another cause.

    Patients with a history of thrombosis (e.g. deep vein thrombosis, pulmonary embolism, myocardial infarction), advanced malignancies or a history of cerebrovascular accidents may be at risk of recurrence of the disease or further thromboembolic events during cyproterone acetate therapy. In patients with a history of thromboembolic processes or suffering from sickle-cell anaemia or severe diabetes with vascular changes, the risk: benefit ratio must be considered carefully in each case before cyproterone acetate therapy is initiated.

    Benign and malignant liver changes have been reported. Liver tumours may lead to life-threatening intra-abdominal haemorrhage. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a liver tumour should be considered in the differential diagnosis.

    Meningiomas have been reported after long term use at doses of 25mg/day and above. Treatment must be stopped if the patient is diagnosed with meningioma.

    A spermatogram should be recorded before starting treatment in patients of procreative age, as a guard against attribution of pre-existing infertility to cyproterone acetate at a later stage. The sperm count and the volume of ejaculate are reduced, infertility is usual, and there may be azoospermia after 8 weeks. Note that spermatogenesis is slow, and cyproterone should therefore not be regarded as a male contraceptive. There is evidence that abnormal spermatozoa are produced during treatment with cyproterone, which might give rise to malformed embryos.

    Adrenocortical function should be supervised during treatment, since suppression has been observed due to the corticoid-like effects of cyproterone at high doses.

    Blood-counts before and at regular intervals during treatment are advisable. Anaemia has occurred during long-term treatment.

    Diabetic patients should have parameters of carbohydrate metabolism examined carefully before and regularly during treatment. Dose requirements for oral antidiabetics or insulin can change.

    Shortness of breath may occur during treatment with cyproterone, which may be accompanied by hypocapnia and compensatory alkalosis.

    It has been found that some patients with severe chronic depression deteriorate whilst taking cyproterone. Patients should be closely monitored. Advise them to contact their doctor deterioration is noticed.

    Contains lactose and is therefore unsuitable for patients with glucose-galactose malabsorption or lactose intolerance.

    St John's wort is an inducer of CYP3A4 and may reduce the levels of cyproterone acetate. Advise patients to avoid taking St John's wort products during treatment.

    In the treatment of hypersexuality
    Doctors are advised to ensure that the fully informed consent of the patient to treatment with cyproterone acetate is witnessed and verified.

    Alcohol may reduce the effect of cyproterone to the extent that it is of no value in the control of libido/sexual deviation in chronic alcoholics.

    Pregnancy and Lactation

    Pregnancy

    Not indicated for use in women.

    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 women.

    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

    Fatigue and lassitude are common. Advise patients that the ability to drive or operate machinery may be affected by side effects.

    Counselling

    Advise patient not to drive or operate machinery if affected by side effects such as lassitude or fatigue.

    Advise patient to avoid St John's wort.

    Advise patient to contact their doctor if depression worsens.

    Side Effects

    Fatigue
    Lassitude
    Breathlessness
    Weight changes
    Changes in hair pattern
    Changes in scalp or body hair
    Discolouration of hair
    Female type hair growth
    Gynaecomastia
    Galactorrhoea
    Breast nodules (benign)
    Teratospermia
    Spermatogenesis suppression
    Reduction in sperm count and volume
    Atrophy of seminiferous tubules
    Reduced libido
    Infertility
    Hepatotoxicity
    Jaundice
    Hepatitis
    Hepatic failure
    Benign and malignant liver changes
    Osteoporosis
    Thromboembolism
    Hypersensitivity reactions
    Rash
    Sebum production decreased
    Depression
    Worsening depression
    Adrenal suppression
    Changes in glucose metabolism
    Hypocapnia
    Alkalosis
    Azoospermia
    Dry skin
    Restlessness
    Anaemia
    Erectile dysfunction
    Hot flushes
    Sweating
    Meningioma

    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 ).

    Shelf Life and Storage

    No special requirements.

    Further Information

    Last Full Review Date: April 2010

    Reference Sources

    Martindale: The Complete Drug Reference, 36th edition (2009) ed. Sweetman, S. Pharmaceutical Press, London.

    Summary of Product Characteristics: Cyprostat 50mg. Bayer plc. Revised January 2011

    Summary of Product Characteristics: Androcur. Bayer plc. Revised January 2011

    The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 August 2017

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