| TAH Drug Code | OAND |
|---|---|
| Indications | Antiandrogen with progestogenic activity |
| Dosing | Dosage in females [For severe signs of androgenisation]100 mg are to be taken with some liquid after a meal from the 5th to the14th day of the cycle (i.e. for ten days). Every 28 days (the usual duration of a menstrual cycle), the above dosage regimen is to be followed. Seven inactive tablets are taken once daily after 21 days, during which time a withdrawal bleeding occurs. Exactly 4 weeks after the first course of treatment was started, i.e. on the same day of the week, the next cyclical course of combined treatment is started, regardless of whether bleeding has stopped or not. Following clinical improvement, the daily dose of Androcur 50 mg during the 10 days of the combined treatment with a combined oral contraceptive can be reduced to one or half a tablet of Androcur 50 mg. Dosage in males [Reduction of drive in sexual deviations] 50 mg twice daily initially; may be increased to 100 mg 2-3 time daily. Quite often 25 mg twice daily (50 mg daily) is sufficient. When establishing the maintenance dose or when discontinuing the preparation, dosage should not be reduced abruptly, but gradually. [Antiandrogen treatment in inoperable carcinoma of the prostate] 100 mg 2-3 times daily (= 200-300 mg/day)- To reduce the initial increase of male sex hormones in treatment with GnRH agonists: 100 mg twice daily alone for 5-7 days, followed by 100 mg twice daily for 3-4 weeks together with a GnRH agonist in the dosage recommended by the manufacturer.- To treat hot flushes in patients under treatment with GnRH analogues or who have had orchidectomy: 50-150 mg daily; may be increased to 300 mg/day as needed. |
| Hepatic Impairment | Dose adjustment required |
| Renal Impairment | Dose adjustment not necessary |
| Contraindications | Hypersensitivity to cyproterone or any component of the formulation; liver disease or hepatic dysfunction; Dubin-Johnson syndrome; Rotor syndrome; previous or existing liver tumors (if not due to metastases from prostate cancer); presence or history of meningioma; wasting diseases (except inoperable prostate cancer); severe chronic depression; existing thromboembolic processes |
| Adverse Effects | Decreased libido, erectile dysfunction, inhibition of ovulation, reversible inhibition of spermatogenesis, weight increase/decrease, mood depression, restlessness, breast tenderness, gynecomastia, fatigue, hot flushes, sweating. |
| Pregnancy | Unknown |
| Lactation | Unknown |
| More Info | UpToDate |