Presentation and Status in Health Basket
50 X 50 mg
Reduction of drive in sexual deviations in men: Generally, treatment is started with 1 tablet Androcur 50 mg twice daily. It may be necessary to increase the dose to 2 tablets twice daily, or even 2 tablets three times daily for a short period of time. When a satisfactory result has been achieved, one should try to maintain the therapeutic effect with the lowest possible dose. Quite often 1/2 tablet twice daily is sufficient. When establishing the maintenance dose or when discontinuing the preparation, one should not reduce the dosage abruptly, but gradually. To this end, the daily dose should be reduced by 1 tablet, or better 1/2 tablet, at intervals of several weeks. To stabilize the therapeutic effect it is necessary to take Androcur over a protracted period of time, if possible with the simultaneous use of psychotherapeutic measures.
Antiandrogen treatment: in inoperable carcinoma of the prostate 2 tablets Androcur 50 mg twice to three times daily (= 200 – 300 mg). Treatment should not be interrupted nor the dosage reduced after improvement or remissions have occurred. To reduce the initial increase of male sex hormones in combination therapy with GnRH agonists Initially 2 tablets Androcur 50 mg twice daily (= 200 mg) alone for 5 – 7 days, followed by 2 tablets Androcur 50 mg twice daily (= 200 mg) for 3 – 4 weeks together with a GnRH agonist in the dosage recommended by the marketing authorization holder. To treat hot flushes in patients under combination therapy with GnRH analogs or who have had orchiectomy. 1-3 tablets Androcur 50 mg per day (50-150 mg) with upward titration up to 2 tablets three times daily (300 mg) if necessary.
Additional information on special populations
Children and adolescents: Androcur 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. Androcur must not be given before the conclusion of puberty since an unfavorable influence on longitudinal growth and the still unstabilized axes of endocrine function cannot be ruled out.
Geriatric patients: There are no data suggesting the need for a dosage adjustment in elderly patients.
Patients with hepatic impairment: The use of Androcur is contraindicated in patients with liver diseases (i.e. as long as liver function values have not returned to normal).
Patients with renal impairment: There are no data suggesting the need for a dosage adjustment in patients with renal impairment.
Antiandrogen therapy in men: Sexual disorders, inoperable prostatic carcinoma.
Reduction of drive in sexual deviations in men: Liver diseases, Dubin-Johnson syndrome, Rotor syndrome, Previous or existing liver tumors, Presence or history of meningioma, Wasting diseases, Severe chronic depression, Previous or existing thromboembolic processes, Severe diabetes with vascular changes, Sickle-cell anaemia, Hypersensitivity to the active substance or to any of the excipients.
Antiandrogen treatment in inoperable carcinoma of the prostate: Liver diseases, Dubin-Johnson syndrome, Rotor syndrome, Previous or existing liver tumors (only if these are not due to metastases from carcinoma of the prostate), Presence or history of meningioma, Wasting diseases (with the exception of inoperable carcinoma of the prostate), Severe chronic depression, Existing thromboembolic processes, Hypersensitivity to the active substance or to any of the excipients.
Liver: Direct hepatic toxicity, including jaundice, hepatitis and hepatic failure, , has been observed in patients treated with Androcur. At dosages of 100 mg and above also cases with fatal outcome have 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. Liver function tests should be performed pre-treatment, at regular intervals during treatment and whenever any symptoms or signs suggestive of hepatotoxicity occur. If hepatotoxicity is confirmed, Androcur should be withdrawn, unless the hepatotoxicity can be explained by another cause, e.g. metastatic disease, in which case Androcur should be continued only if the perceived benefit outweighs the risk. In very rare cases benign and malignant liver tumors, which may leadto life-threatening intraabdominal hemorrhage, have been observed after the use of Androcur. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal hemorrhage occur, a liver tumor should be included in the differential-diagnostic considerations.
Meningioma: The occurrence of meningiomas (single and multiple) has been reported in association with longterm use (years) of cyproterone acetate at doses of 25 mg/day and above. If a patient treated with Androcur is diagnosed with meningioma, treatment with Androcur must be stopped.
Thromboembolic events: The occurrence of thromboembolic events has been reported in patients using Androcur, although a causal relationship has not been established. Patients with previous arterial or venous thrombotic/ thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or with a history of cerebrovascular accidents or with advanced malignancies are at increased risk of further thromboembolic events. In patients with inoperable carcinoma of the prostate, presenting with a history of thromboembolic processes or suffering from sickle-cell anemia or from severe diabetes with vascular changes, a careful risk:benefit evaluation must be carried out in each individual case before Androcur is prescribed.
Anemia: Anemia has been reported during treatment with Androcur. Therefore, the red-blood cell count should be checked regularly during treatment.
Diabetes mellitus: Strict medical supervison is necessary if the patient suffers from diabetes, because the requirement for oral antidiabetics or insulin can change during Androcur treatment.
Shortness of breath: A sensation of shortness of breath may occur under high-dosed treatment with Androcur. The differential diagnosis in such cases must include the stimulating effect on breathing known for progesterone and synthetic progestogens which is accompanied by hypocapnia and compensated respiratory alkalosis and which is not considered to require treatment.
Adrenocortical function: During treatment, adrenocortical function should be checked regularly, as preclinical data suggest a possible suppression due to the corticoid-like effect of Androcur with high doses.
Other conditions: In the indication “reduction of drive in sexual deviations”, the drive-reducing effect of Androcur can be diminished under the influence of alcohol. Androcur 50 contains 110.5 mg lactose monohydrate per tablet. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Decreased libido, erectile dysfunction and reversible inhibition of spermatogenesis, weight changes, depressed mood, restlessness, shortness of breath, hepatic toxicity, gynaecomastia, fatigue, hot flushes, sweating.
For full details see prescribing information.
Although clinical interaction studies have not been performed, since this drug is metabolized by CYP3A4, it is expected that ketoconazole, itraconazole, clotrimazole, ritonavir and other strong inhibitors of CYP3A4 inhibit the metabolism of cyproterone acetate. On the other hand, inducers of CYP3A4 such as e.g. rifampicin, phenytoin and products containing St. John´s wort may reduce the levels of cyproterone acetate. Based on in vitro inhibition studies, an inhibition of the cytochrome P450 enzymes CYP2C8, 2C9, 2C19, 3A4, and 2D6 is possible at high therapeutic cyproterone acetate doses of 3 times 100 mg per day. The risk of statin-associated myopathy or rhabdomyolysis may be increased when those HMGCoA inhibitors (statins), which are primarily metabolized by CYP 3A4, are coadministered with high therapeutic cyproterone acetate doses since they share the same metabolic pathway.
Pregnancy and Lactation
Treatment with Androcur 50 (for use in men) is not indicated in women.
Acute toxicity studies following single administration showed that cyproterone acetate, the active ingredient of Androcur, can be classified as practically non-toxic. Nor is any risk of acute intoxication to be expected after a single inadvertent intake of a multiple of the dose required for therapy.