Description
Latin name
ANDROCUR
Form release Tablets
packaging 60 pcs
Indications of
Common inoperable or metastatic prostate cancer if testosterone is to be suppressed: antiandrogen therapy of inoperable prostate cancer
reduction in the severity of hyperandrogenism observed at the beginning of therapy with GnRH
patients with treatment of congestive gland patients or patients having undergone an orchiectomy.
Contraindications
hypersensitivity to cyproterone or other components of the drug
liver disease (including Dubin-Johnson syndrome, Rotor syndrome)
liver tumors in history or currently (with the exception of prostate cancer metastases in liver srd) (with the exception of cachexia in prostate cancer)
severe chronic depression
thrombosis and thromboembolism currently
the presence of meningiomas currently or in the history of
children and adolescents under 18 years of age.
Caution: in the presence of a history of thrombosis and thromboembolism in patients with inoperable prostate cancer, severe diabetes mellitus with angiopathy, sickle cell anemia, Androkur ® is prescribed only after assessing the individual benefit-risk ratio in each case.
Use during pregnancy and lactation
Contraindicated in pregnancy and during breastfeeding.
Composition
1 tablet contains:
Active ingredients: cyproterone acetate, micro 20 – 100 mg
Excipients: lactose monohydrate – 193 mg, corn starch – 100 mg, povidone 25 000 – 4 mg, magnesium stearate – 3 mg.
Dosage and administration
Antiandrogen therapy for inoperable prostate cancer: 200 300 mg / day (1 tablet 2-3 times a day, for a long time).
When improving or achieving remission, treatment should not be interrupted or dosage should be reduced.
To reduce the initial increase in androgen levels during therapy with GnRH agonists: First, 200 mg per day (1 tablet 2 times a day) as monotherapy for 5 7 days, then 200 mg per day for 3-4 weeks in combination with a GnRH agonist in the dosage recommended by the manufacturer.
For the treatment of hot flashes during therapy with GnRH analogues or after orchiectomy: 50 100 mg / day (0.5 1.5 tablets per day), if necessary, followed by a dose increase to 300 mg per day (1 tablet 3 times a day).
Side effects
From the hematopoietic system: frequency unknown – anemia.
On the part of the immune system: rarely – hypersensitivity reactions.
Mental disorders: often – depression, depressed mood, feeling of anxiety (temporarily).
From the vessels: the frequency is unknown – thrombosis and thromboembolism.
Drug Interaction
The antigonadotropic action of cyproterone acetate is enhanced by its combined use with gonadotropin releasing hormone agonists.
Under the action of cyproterone acetate, the initial increase in testosterone production caused by gonadotropin releasing hormone agonists is reduced.
Overdose
Ciproteron is a virtually non-toxic agent.
Acute intoxication should not be expected with unintentional single doses exceeding the therapeutic dose many times over.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Expiration
5 years.
Deystvuyuschee
substance cyproterone
Dosage form
dosage form
tablets
Bayer Pharma AG, Germany
