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CYPROSTAT 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 Cyprostat 50 mg twice daily (200 mg) alone for 5 - 7 days, followed by 2 tablets of Cyprostat 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:
Cyprostat 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. Cyprostat 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 Cyprostat 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 Cyprostat are decreased libido, erectile dysfunction and reversible inhibition of spermatogenesis. The most serious ADRs in patients receiving Cyprostat 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 (incl 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).
Psychiatric disorders Common:
Depressive moods and restlessness (temporary). 4). 4).
Hepato-biliary disorders Common:
Direct hepatic toxicity, including jaundice, hepatitis and hepatic failure has been observed in patients treated with Cyprostat. 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.
Liver:
Direct hepatic toxicity, including jaundice, hepatitis and hepatic failure, has been observed in patients treated with Cyprostat. At dosages of 100 mg and above cases with fatal outcome have also been reported. 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 pre-treatment, regularly during treatment and whenever any symptoms or signs suggestive of hepatotoxicity occur.
g. metastatic disease, in which case Cyprostat 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 Cyprostat.
If severe upper abdominal complaints, liver enlargement or signs of intra- abdominal haemorrhage occur, a liver tumour should be considered in the differential diagnosis.
Thromboembolic events:
The occurrence of thromboembolic events has been reported in patients using Cyprostat, 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 Cyprostat.
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 Cyprostat is prescribed.
Meningiomas:
The occurrence of meningiomas (single and multiple) has been reported in association with use of cyproterone acetate primarily at doses of 25 mg and above. 1). High cumulative doses can be reached with prolonged use (several years) or shorter duration with high daily doses.
Cyprostat must not be used in patients with:
Meningioma or a history of meningioma. 1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Toxicity is dose related and develops, usually, several months after treatment has begun.
Skin and subcutaneous tissue disorders 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 Cyprostat, 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 Cyprostat.
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.
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Patients should be monitored for meningiomas in accordance with clinical practice. If a patient treated with Cyprostat is diagnosed with meningioma, treatment with Cyprostat 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.
Chronic depression:
It has been found that some patients with severe chronic depression deteriorate whilst taking Cyprostat therapy. Such patients should be closely monitored for signs of deterioration and warned to contact their doctor immediately if their depression worsens.
Shortness of breath:
Shortness of breath may occur under high-dosed treatment with Cyprostat. 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.
3).
Diabetes mellitus:
Strict medical supervision is necessary if the patient suffers from diabetes as Cyprostat can influence carbohydrate metabolism. Parameters of carbohydrate metabolism should be examined carefully in all diabetics before and regularly during treatment because the requirement for oral antidiabetics or insulin can change.
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