Country: Singapura
Bahasa: Inggeris
Sumber: HSA (Health Sciences Authority)
CYPROTERONE ACETATE
BAYER (SOUTH EAST ASIA) PTE LTD
G03HA01
50 mg
TABLET
CYPROTERONE ACETATE 50 mg
ORAL
Prescription Only
DELPHARM LILLE S.A.S
ACTIVE
1990-06-13
Tablet ANDROCUR® 50 mg Important information, please read carefully ! COMPOSITION Each pack contains 50 round white tablets each with 50mg cyproterone acetate PHARMACODYNAMIC/PHARMACOKINETIC PROPERTIES PHARMACODYNAMIC PROPERTIES Androcur is an antiandrogenic hormone preparation. In the woman, androgen-dependent conditions such as pathological hair growth in hirsutism, androgenetic alopecia and increased sebaceous gland function in acne and seborrhea, are favorably influenced by competitive displacement of the androgens at the target organs. The reduction of the androgen concentration which results from the antigonadotropic property of cyproterone acetate has an additional therapeutic effect. These changes are reversible following discontinuation of the therapy. During the combined treatment with Diane-35, ovarian function is inhibited. In the man, under treatment with Androcur, sexual drive and potency are reduced and gonadal function is inhibited. These changes are reversible following discontinuation of the therapy. Cyproterone acetate inhibits competitively the effect of androgens at androgen-dependent target organs, e.g. it shields the prostate from the effect of androgens originating from the gonads and/or the adrenal cortex. Cyproterone acetate has a central inhibiting effect. The antigonadotropic effect leads to a reduction of testosterone synthesis in the testes and hence, to a reduction of the serum concentration of testosterone. The antigonadotropic effect of cyproterone acetate is also exerted when the substance is combined with LHRH agonists. The initial increase of testosterone provoked by this substance group is decreased by cyproterone acetate. An occasional tendency for the prolactin levels to increase slightly has been observed under higher doses of cyproterone acetate. PHARMACOKINETIC PROPERTIES Following oral administration, cyproterone acetate is completely absorbed over a wide dose range. The ingestion Baca dokumen lengkap
Androcur 50mg PI_CCDS 13_10 December 2018 1 NAME OF THE MEDICINAL PRODUCT Androcur Tablet 50mg QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50mg cyproterone acetate. For full list of excipients, see section ‘List of excipients’. PHARMACEUTICAL FORM Tablet. White to faintly yellowish tablets, scored on one side, with an embossed “BV” in a regular hexagon on the other side. The tablet can be divided into equal halves. THERAPEUTIC INDICATIONS INDICATIONS IN THE MAN • Reduction of drive in sexual deviations. • Antiandrogen treatment in inoperable carcinoma of the prostate. INDICATIONS IN THE WOMAN • Severe signs of androgenization, e.g. very severe hirsutism, severe androgenetic alopecia, often attended by severe forms of acne and/or seborrhoea. DOSAGE AND METHOD OF ADMINISTRATION METHOD OF ADMINISTRATION Oral use. The tablets are to be taken with some liquid after meals. DOSAGE IN THE MAN The maximum daily dose is 300mg. Reduction of drive in sexual deviations Generally, treatment is started with 1 Androcur 50mg tablet 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. Androcur 50mg PI_CCDS 13_10 December 2018 2 Antiandrogen treatment in inoperable carcinoma of the prostate To eliminate the effect of adrenocortical androgens after orchiectomy : 2 Androcur 50mg tablets once to twice daily (= 100 - 200 mg). Wit Baca dokumen lengkap