Androkur tablets 50 mg, 50 pcs. (cyproterone)

packaging 50 pcs

Indications

Common inoperable or metastatic prostate cancer when testosterone suppression is necessary: ​​antiandrogen therapy for inoperable prostate cancer

reduction in the severity of hyperandrogenism, observed at the beginning of gonadotropin hormone releasing hormone (GnRH)

agonist therapy, relief of hot flashes in patients with prostate cancer receiving GnRH agonist therapy or in patients who underwent

orchiectomy with increased sexual desire during sexual deviations.

Contraindications

hypersensitivity to cyproterone or other components of the drug

liver disease (including Dubin-Johnson syndrome, Rotor syndrome)

liver tumor history or currently (with the exception of metastases of prostate cancer 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: if patients with an inoperable prostate cancer have thrombosis and thromboembolism in their history, severe form of diabetes mellitus with angiopathy, sickle cell anemia Androkur® is prescribed only after assessing the individual ratio of benefit and risk in each case.

Use during pregnancy and lactation

Contraindicated in pregnancy and during breastfeeding.

Composition

1 tablet contains:

Active ingredients: cyproterone acetate, micro 20 - 50 mg

Excipients: lactose monohydrate - 110.5 mg, corn starch - 59.5 mg, polyvidone 25 000 - 2.5 mg, silicon dioxide anhydrous colloidal - 2 mg, magnesium stearate - 0.5 mg.

Dosage and administration

Antiandrogen therapy for inoperable prostate cancer: 200–300 mg / day (2 tablets 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 treatment with GnRH agonists: Initially, 200 mg per day (2 tablets 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 (1-3 tablets per day), if necessary, followed by a dose increase to 300 mg per day (2 tablets 3 times a day )

With increased sexual desire for sexual disorders. As a rule, treatment begins with 1 tablet of Androkur® 50 mg 2 times a day. If necessary, the dose can be increased to 200-300 mg per day (2 tablets 2-3 times a day) for a short period. When a satisfactory result is achieved, try to reduce the dose to the minimum effective. In most cases, it is enough to take 50 mg / day (1/2 tablet 2 times a day). When selecting a maintenance dose or discontinuing therapy, the dose should be reduced gradually. For this purpose, the daily dose is recommended to be reduced by 1 tablet, or better by 0.5 tablets, with an interval of several weeks. To achieve a sustainable therapeutic effect, Androkur® should be taken for a long time, if possible with simultaneous psychotherapy.

Side effects of

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.

Overdose

Acute toxicity studies of Androkur have shown that cyproterone acetate can be attributed to very low toxicity.

The chance of developing intoxication should not be expected with the accidental intake of several Androkur tablets.

Storage conditions

No specific storage conditions.

Expiration

5 years.

Active ingredient

zip oteron



pharmacy terms and conditions

prescription

dosage form

dosage form

tablets

Bayer Pharma AG, Germany



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