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CYPROTERONE ACETATE is a brand name for Cyproterone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Management of patients with prostatic cancer (1) To suppress “flare” with initial LHRH analogue therapy (2) In long-term palliative treatment where LHRH analogues or surgery are contraindicated, not tolerated, or where oral therapy is preferred, and (3) In the treatment of hot flushes in patients under treatment with…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults The maximum daily dose is 300 mg. For long-term palliative treatment where LHRH analogues or surgery are contraindicated, not tolerated, or where oral therapy is preferred, the dosage is 200- 300 mg/day.
Dosage for suppression of "flare" with initial LHRH analogue therapy:
Initially 2 tablets of Cyproterone Tablets 50 mg twice daily (200 mg) alone for 5-7 days, followed by 2 tablets of Cyproterone Tablets 50 mg twice daily (200 mg) for 3-4 weeks together with the LHRH analogue therapy in the dosage recommended by the marketing authorisation holder (see SmPC of LHRH analogue).
For the above two indications the dosage should be divided into 2-3 doses per day and taken with some liquid after meals. For the treatment of hot flushes in patients under treatment with LHRH analogues or who have had orchidectomy a 50 mg starting dose, with upward titration if necessary, within the range 50-150 mg/day, is recommended.
For this indication the dosage should be divided into 1-3 doses per day and taken with some liquid after meals Additional information on special populations Paediatric population: Cyproterone Tablets is not recommended for use in male children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
Cyproterone Tablets must not be given before the conclusion of puberty since an unfavourable influence on longitudinal growth and the still unstabilised axes of endocrine function cannot be ruled out. Elderly There are no data suggesting the need for a dosage adjustment in elderly patients.
8). Renal impairment The use of Cyproterone Tablets in patients with renal impairment has not been investigated. 2). Method of administration For oral administration.
The most frequently observed adverse drug reactions (ADRs) in patients receiving cyproterone acetate are decreased libido, erectile dysfunction and reversible inhibition of spermatogenesis. The most serious ADRs in patients receiving cyproterone acetate are hepatic toxicity, benign and malignant liver tumours which may lead to intra-abdominal haemorrhage and thromboembolic events.
The following approximate incidences were estimated from published reports of a number of small clinical trials and spontaneous ADR reports: - very common: incidence ≥ 1:10 - common: incidence < 1:10 but ≥1:100 - uncommon: incidence < 1:100 but ≥1:1,000 - rare: incidence < 1:1,000 but ≥ 1:10,000 - very rare: incidence <1:10,000 - not known (cannot be estimated from available data) Neoplasms benign, malignant and unspecified (including cysts and polyps): Rare: Meningioma.
4). 4). 4).
Immune system disorders:
Rare: Hypersensitivity reactions Endocrine disorders: Not known: Suppression of adrenocortical function Metabolism and nutrition disorders: Common: Changes in bodyweight during long term treatment (chiefly weight gains in association with fluid retention).
4). 4).
Hepatobiliary disorders:
Common: Direct hepatic toxicity, including jaundice, hepatitis and hepatic failure has been observed in patients treated with Cyproterone acetate. At dosages of 100 mg and above, cases with fatal outcome have also been reported. Most reported fatal cases were in men with advanced carcinoma of the prostate.
Toxicity is dose related and develops, usually, several months after treatment has begun.
Skin and subcutaneous tissue disorders:
Meningiomas; The occurrence of (single and multiple) meningiomas has been reported in association with longer term use of cyproterone acetate primarily at doses of 25mg/day and above. 1). High cumulative doses can be reached with prolonged use (several years) or shorter duration with high daily doses.
Patients should be monitored for meningiomas in accordance with clinical practice. If a patient treated with Cyproterone acetate is diagnosed with meningioma, treatment with Cyproterone acetate and other cyproterone containing products must be permanently stopped (see section ‘Contraindications’).
There is some evidence that the meningioma risk may decrease after treatment discontinuation of cyproterone. Thromboembolic events: the occurrence of thromboembolic events has been reported in patients using cyproterone acetate, although a causal relationship has not been established.
g. deep vein thrombosis, pulmonary embolism, myocardial infarction), with a history of cerebrovascular accidents or with advanced malignancies are at increased risk of further thromboembolic events and may be at risk of recurrence of the disease 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 individual case before Cyproterone acetate is prescribed Chronic depression: It has been found that some patients with severe chronic depression deteriorate whilst taking acetate therapy.
Such patients should be closely monitored for signs of deterioration and warned to contact their doctor immediately if their depression worsens. Liver disease: direct hepatic toxicity, including jaundice, hepatitis and hepatic failure, which has been fatal in some cases, has been reported in patients treated with dosages of cyproterone acetate of 100mg and above.
Cyproterone Tablets must not be used in patients with:
Meningioma or a history of meningioma. 1. Liver disease (including Dubin-Johnson syndrome and Rotor syndrome) Malignant tumours (except for carcinoma of prostate) Previous or existing liver tumours (only if these are not due to metastases from carcinoma of the prostate) Wasting diseases (with the exception of inoperable carcinoma of the prostate) Existing thrombosis or embolism
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Uncommon: Rash Not known: Reduction of sebum production leading to dryness of the skin and improvement of existing acne vulgaris has been reported as well as; transient patchy loss and reduced growth of body hair, increased growth of scalp hair, lightening of hair colour and female type of pubic hair growth.
Musculoskeletal and connective tissue disorders:
Not known: Osteoporosis (due to long-term androgen deprivation).
Reproductive system disorders:
Very common: Decreased libido, erectile dysfunction, reduced sexual drive and inhibition of gonadal function. These changes are reversible after discontinuation of therapy.
Inhibition of spermatogenesis:
Very common: Sperm count, and volume of ejaculate are reduced Infertility is usual, and there may be azoospermia after 8 weeks. There is usually slight atrophy of the seminiferous tubules. Follow-up examinations have shown these changes to be reversible, spermatogenesis usually reverting to its previous state about 3-5 months after stopping Cyproterone acetate, or in some users, up to 20 months.
That spermatogenesis can recover even after very long treatment is not yet known. There is evidence that abnormal sperms which might give rise to malformed embryos are produced during treatment with Cyproterone acetate.
Gynaecomastia:
Common: Gynaecomastia (sometimes combined with tenderness to touch of the mamillae) which usually regresses after withdrawal of the preparation Rare: Galactorrhoea and tender benign nodules. Symptoms mostly subside after discontinuation of treatment or reduction of dosage General disorders and administration site conditions: Common: Hot flushes, sweating, fatigue and lassitude.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
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Most reported fatal cases were in men with advanced prostatic cancer. Toxicity is dose related and develops usually several months after treatment has begun. Liver function tests should be performed pretreatment, regularly during treatment and whenever any symptoms or signs suggestive of hepatotoxicity occur.
g. metastatic disease, in which case cyproterone acetate should be continued only if the perceived benefit outweighs the risk. In very rare cases benign and malignant liver tumours, which may lead to life threatening intra-abdominal haemorrhage, have been observed after the use of cyproterone acetate.
If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur a liver tumour should be considered in the differential diagnosis.
Shortness of breath:
Shortness of breath may occur under high-dosed treatment with cyproterone acetate. This may be due to the stimulatory effect of progesterone and synthetic progestogens on breathing, which is accompanied by hypocapnia and compensatory alkalosis and which is not considered to require treatment.
Adrenocortical function:
During treatment, adrenocortical function should be monitored regularly during treatment as preclinical data suggest a possible suppression due to the corticoid-like effect of cyproterone acetate with high doses. 3) Diabetes mellitus: Strict medical supervision is necessary if the patient suffers from diabetes.
Cyproterone acetate can influence carbohydrate metabolism. Parameters of carbohydrate metabolism should be examined carefully in all disbetics before and regularly during treatment because the requirement for oral antidiabetics or insulin can change.
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