Firma Chun Cheong
Concise Prescribing Info
Cyproterone acetate
Women: Moderately severe to severe signs of androgenization (eg, hirsutism, androgenic alopecia, acne &/or seborrhea). Men: Reduction of drive in sexual deviations. Inoperable prostatic carcinoma.
Dosage/Direction for Use
Women Commence treatment on the 1st day of the cycle. Women w/ amenorrhoea or very irregular menstrual bleeding can start immediately. Women should receive a progestogen-oestrogen containing prep. Hirsutism secondary to female androgenization Initially 1 tab (50 mg) daily for 10 days mthly, may be reduced once a satisfactory response has been attained. Maintenance therapy: 10 mg daily for 10 days mthly. Other severe signs of androgenization 2 tab daily from 1st to 10th day of the cycle. Postmenopausal or hysterectomised women ½-1 tab once daily for 21 days, followed by a 7-day tab-free interval. May be administered alone. Men Max daily dose: 300 mg. Reduction of drive in sexual deviations Initially 1 tab bd, if necessary may be increased to 2 tab bd-tds for a short period of time. When establishing maintenance dose or discontinuing the prep, reduce daily dose by 1 or ½ tab at intervals of several wk. To reduce initial increase of male sex hormones in treatment w/ LH-RH agonists Initially 100 mg (2 tab) bd alone for 5-7 days, then 100 mg (2 tab) bd for 3-4 wk together w/ an LH-RH agonist. In long-term palliative treatment of advanced prostate cancer w/o orchiectomy 100 mg (2 tab) bd-tds. To treat hot flushes in patients under treatment w/ LH-RH analogues or who have had orchiectomy 50 mg (1 tab) once daily-tds, titrated to 100 mg (2 tab) tds if necessary.
Should be taken with food.
Hypersensitivity. Liver diseases; Dubin-Johnson syndrome, Rotor syndrome; previous or existing liver tumours; presence or history of meningioma; wasting diseases; severe chronic depression; previous or existing thromboembolic processes; severe diabetes w/ vascular changes; sickle-cell anaemia. Should not be given before the conclusion of puberty. Women: History of jaundice or persistent pruritus during a previous pregnancy. History of herpes of pregnancy. Pregnancy & lactation. Men w/ inoperable prostatic carcinoma: Previous or existing liver tumours (only if these are not due to metastases from prostatic carcinoma); wasting diseases (except inoperable prostatic carcinoma).
Special Precautions
Regularly monitor liver & adrenocortical function & RBC count during treatment. W/draw treatment if hepatotoxicity is confirmed. Include liver tumour in differential diagnostic considerations in case of severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage. Risk of meningioma at doses ≥25 mg; shortness of breath w/ high-dose treatment; thromboembolic events; anaemia. DM patients. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May impair ability to concentrate. Women: Perform thorough general medical & gynaecological exam prior to treatment. Serious organic causes of androgenization eg, Cushing's syndrome, ovarian tumours, adrenal carcinoma & androgenital syndrome should be excluded. Perform gynaecological exam in case of persistent or recurrent bleeding at irregular intervals, to exclude organic diseases. Pregnancy must be excluded prior to treatment initiation. Men: Long-term androgen deprivation may lead to osteoporosis. Sexual drive-reducing effect of Androcur can be diminished under the influence of alcohol. Inoperable prostate carcinoma patients w/ history of thromboembolic processes or sickle-cell anaemia or severe diabetes w/ vascular changes. Spermatogenesis has taken 3-20 mth to return to normal after discontinuing therapy.
Adverse Reactions
Tiredness, wt increase; diminished libido. Headache, depressive moods; thrombotic phenomena; nausea & other GI complaints; mastodynia, irregular menstrual cycles, spotting; erectile dysfunction, reversible inhibition of spermatogenesis.
Drug Interactions
Requirement for oral antidiabetics or insulin can change. Increased levels w/ strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clotrimazole, ritonavir). Reduced levels w/ CYP3A4 inducers (eg, rifampicin, phenytoin, St. John's wort-containing products). Increased risk of myopathy or rhabdomyolysis due to HMG-CoA inhibitors when co-administered w/ high doses of cyproterone acetate. Potential interaction w/ substrates of CYP2C8, CYP2C9, 2C19, 3A4 or 2D6.
MIMS Class
Cancer Hormone Therapy / Other Drugs Affecting Hormonal Regulation
ATC Classification
G03HA01 - cyproterone ; Belongs to the class of antiandrogen preparations.
Androcur tab 50 mg
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