Androcur Dosage/Direction for Use

Androcur tablets should be taken with some liquid after a meal.
WOMEN: Pregnant women must not take Androcur. Therefore, pregnancy must be excluded before the start of therapy.
In women of childbearing potential, the treatment is commenced on the 1st day of the cycle (= 1st day of bleeding). Only women with amenorrhoea or menstrual bleeding at very irregular intervals can start treatment immediately. In this case the first day of treatment is to be regarded as the 1st day of the cycle and the following recommendations then observed as normal.
For hirsutism secondary to female androgenization; the usual starting dose should be 1 tablet of Androcur 50 mg taken daily for 10 days per month (from the 1st to the 10th day of the cycle). Once a satisfactory response has been attained it is usually possible to reduce the dose further. Doses as low as 10 mg a day for 10 days per month have been shown to be adequate for maintenance therapy in this condition.
For other severe signs of androgenization; 2 tablets of Androcur 50 mg are to be taken daily from the 1st to the 10th day of the cycle (= for 10 days).
In addition, these women should receive a progestogen-oestrogen containing preparation, to provide the necessary contraceptive protection and to stabilise the cycle. An appropriate combined oral contraceptive preparation should be commenced on day 1 of the cycle as directed.
Women receiving the cyclical combined therapy should keep to a particular time of the day for tablet-taking. If more than 12 hours elapse from this time, contraceptive protection in this cycle may be reduced. Attention is drawn to the special notes (especially on contraceptive reliability and to the missed tablet recommendations) in the product information for the combined oral contraceptive preparation being taken in conjunction with Androcur. If bleeding fails to occur after this cycle, pregnancy must be excluded before tablet-taking is resumed.
Missed Androcur tablets may diminish the therapeutic efficacy and may lead to intermenstrual bleeding. The missed Androcur tablet should be disregarded (no double dose should be taken to make up for the missed tablet) and tablet taking resumed at the regular time together with the combined oral contraceptive preparation.
A withdrawal bleeding usually occurs during the tablet free interval or whilst taking the 7-day placebo tablets. 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. If no bleeding occurs during the tablet free or 7 day placebo tablet interval, the possibility of pregnancy must be excluded before restarting tablet taking.
Following clinical improvement, the daily dose of Androcur 50 mg may be reduced to 1 or 1/2 tablet during the 10 days on which it is given in each treatment cycle. The dose regimen for the combined oral contraceptive preparation remains unchanged. Re-evaluate the treatment with Androcur 50 mg at the start of the menopause. Long-term use (years) of Androcur 50 mg should be avoided (see Meningioma under Precautions).
In postmenopausal or hysterectomised patients Androcur may be administered alone. According to the severity of the complaints, the average dose should be 1/2 to 1 tablet Androcur 50mg once daily for 21 days, followed by a 7-day tablet-free interval.
The length of treatment depends on the severity of the pathological signs of androgenization and response to treatment. Treatment is usually carried out over several months initially. Acne and seborrhoea usually respond sooner than hirsutism or alopecia. Hirsutism and alopecia are likely to recur when treatment is stopped.
MEN: The maximum daily dose is 300 mg.
Reduction of drive in sexual deviations: The individual dose will be determined by the response. Generally, treatment is started with one 50 mg tablet twice daily. It may be necessary to increase the dose to two 50 mg tablets twice daily, or even two 50 mg tablets three times daily for a short period of time. The duration of cyproterone acetate treatment should be defined on an individual basis. When a satisfactory result has been achieved, the therapeutic effect should be maintained with the lowest possible dose. When changing the dose or when discontinuing cyproterone acetate, this should be done gradually.
To this end, the daily dose should be reduced by 1 tablet, or better 1/2 tablet, at intervals of several weeks.
To stabilise the therapeutic effect it is necessary to take Androcur over a protracted period of time, if possible with the simultaneous use of psychotherapeutic measures.
Inoperable prostatic carcinoma: To reduce the initial increase of male sex hormones ('flare') in treatment with LH-RH agonists: Initially 100 mg (2 tablets Androcur 50 mg) twice daily alone for 5-7 days, then 100 mg (2 tablets Androcur 50 mg) twice daily for 3-4 weeks together with an LH-RH agonist in the dosage recommended by the manufacturer.
In long term palliative treatment of advanced prostate cancer in patients who have not had an orchiectomy: 100 mg (2 tablets Androcur 50 mg) two to three times daily. Treatment should not be interrupted nor the dosage reduced after improvement or remissions have occurred.
To treat hot flushes in patients under treatment with LH-RH analogues or who have had orchiectomy: 50 mg once to three times daily with upward titration to 100 mg three times daily if necessary.
Paediatric use: Androcur is not recommended for use in female patients before conclusion of puberty. There are no data suggesting the need for dosage adjustment in female patients who have completed puberty.
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 unfavourable influence on longitudinal growth and the still unstabilised axes of endrocine function cannot be ruled out.
Use in the elderly: There are no data suggesting the need for dosage adjustment in elderly patients.
Patients with hepatic impairment: The use of Androcur is contraindicated in patients with liver diseases.
Patients with renal impairment: There are no data suggesting the need for dosage adjustment in patients with renal impairment.