ANDROCUR

Androcur Information

Androcur is an anti-androgenic hormone preparation. It inhibits the influence of androgens which are also produced - to a slight extent- in the female organism, and also exerts a progestational and anti-gonadotrophic effect. 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. In men under the treatment with Androcur, sexual drive and potency are reduced and gonadal function is inhibited. These changes are reversible following discontinuation of the therapy. It is used for anti-androgen treatment in inoperable carcinoma of the prostate. In women, hirsuitism is reduced, but also androgen-dependent Alopecia and elevated sebaceous gland function are reduced. During treatment, ovarian function is reduced. It is used for severe signs of androgenization, e.g. very severe hirsutism in the female, severe Androgenetic Alopecia, often attended by severe forms of acne and/or seborrhoea.

Androcur Warnings

The drive-reducing effect of ANDROCUR can be diminished under the disinhibitory influence of alcohol. ANDROCUR should not be given before the conclusion of puberty because of an unfavourable influence on longitudinal growth and the still non-stabilized axes of endocrine function cannot be ruled out. During treatment, liver function, adrenocortical function and the red blood-cell count should be checked regularly. Direct hepatic toxicity, including jaundice, hepatitis and hepatic failure, which has been fatal in some cases, has been reported in patients treated with 200 - 300mg cyproterone acetate. Most reported cases are in men with prostatic cancer. In isolated cases benign and malignant liver changes have been reported. Strict medical supervision is necessary if the patient suffers from diabetes. A sensation of shortness of breath may occur in individual cases 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. The therapy of sexual deviations with ANDROCUR is usually ineffective in chronic alcoholism. Before the start of therapy, a thorough general medical and gynaecological examination (including the breasts and a cytological smear of the cervix) should be carried out in women. Pregnancy must be excluded in women of childbearing age. If, during the combined treatment, persistent or recurrent bleeding occurs at irregular intervals, a gynecological examination must be carried out to exclude organic disease. With regard to the necessary additional use of Diane-35, attention is drawn to all the data contained in the product information for this preparation.

On the whole the available toxicological findings do not raise any objection to the use of ANDROCUR in humans if used in accordance with the directions for the given indications and at the recommended dosages. Pregnancy and lactation : The administration of ANDROCUR during pregnancy and lactation is contraindicated. About 0.2% of the dose is excreted with the breast milk. Drug interactions : The requirement for oral antidiabetics or insulin can change. Contraindications: In patients with inoperable prostatic carcinoma presenting with a history of thromboembolic processes or suffering from sickle-cell anaemia or from severe diabetes with vascular changes, the risk:benefit ratio must be considered carefully in each individual case before ANDROCUR is prescribed.

Androcur Side Effects

Over the course of several weeks, ANDROCUR inhibits spermatogenesis as a result of the anti-androgenic and anti-gonadotropic actions. Spermatogenesis recovers gradually within a few months of discontinuing the therapy. In male patients, ANDROCUR occasionally leads to gynaecomastia (sometimes combined with tenderness to touch of the mamillae) which usually regresses after withdrawal of the preparation. In women, ovulation is inhibited under the combined treatment, so that a state of infertility exists. A feeling of tension in the breasts may occur. Tiredness and diminished vitality and occasionally temporary inner restlessness or depressive moods can occur. Changes in body weight are possible.

Androcur Overdose

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.

Androcur Usage Guidelines

Dosage in men: Antiandrogen treatment in inoperable carcinoma of the prostate To eliminate the effect of adrenocortical androgens after orchiectomy: 2 tablets once or twice daily (= 100-200mg). Without orchiectomy: 2 tablets twice to three times daily (= 200-300mg). The tablets are to be taken with some liquid after meals. Treatment should not be interrupted nor the dosage reduced after improvement or remissions have occurred. To eliminate the effect of adrenocortical androgens in treatment with LH-RH agonists: Continuation of the antiandrogen therapy with 2 tablets ANDROCUR once to twice daily. 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.

Dosage in women : Pregnant women must not take ANDROCUR. Therefore pregnancy must be excluded before the start of therapy. In women of childbearing age, the treatment is commenced on the 1st day of the cycle. Only women with amenorrhea can start the 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. Two tablets of ANDROCUR are to be taken daily with some liquid after a meal from the 1st to the 10th day of the cycle .In addition, these women receive a progestogen-oestrogen preparation, e.g. from the 1st to the 21st day of the cycle, to provide the necessary contraceptive protection and to stabilise the cycle. Store below 25°C.

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