资料单张
ANDROCUR 100 mg TABLETS
SCHEDULING STATUS:
S4
PROPRIETARY NAME
(and dosage form):
ANDROCUR 100 mg TABLETS
Oral antiandrogen
COMPOSITION
1 Androcur 100 mg tablet contains
cyproterone
acetate (6-chloro-17-hydroxy-1alpha,2alpha-methylene-pregna-4,6-
diene-3,20-dione-acetate) 100 mg.
PHARMACOLOGICAL CLASSIFICATION
A. 21.12 Hormone inhibitors.
PHARMACOLOGICAL ACTION
Cyproterone acetate has an antiandrogenic, progestational and antigonadotropic effect.
Cyproterone acetate inhibits competitively the effect of androgens at their target organs. The following associated effects,
among others, have been described in men: inhibition of sexual drive, reduction of sebaceous gland activity, influence
on hair growth, prevention of androgenic growth impulses to the prostatic tissue.
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 LH-RH agonists.
The initial increase of testosterone provoked by this substance group is decreased by cyproterone acetate.
Prolactin levels may increase with higher doses of cyproterone acetate.
INDICATIONS
Inoperable carcinoma of the prostate.
CONTRA-INDICATIONS
Liver diseases, Dubin-Johnson syndrome, Rotor syndrome, previous or existing liver tumours (if these are not due to
metastases), wasting diseases (with the exception of inoperable carcinoma of the prostate), severe chronic depression,
existing thromboembolic processes.
In patients 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
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