Medicinal Products

CYPROTERONE ACETATE SANDOZ 50 mg

Generic drug of Androcur
Therapeutic class: Oncology and hematology
active ingredients: Cyproterone acetate
laboratory: Sandoz

Tablet breackable
Box of 20
All forms

Indication

· Major feminine hirsutisms of non-tumoral origin (idiopathic, polycystic ovary syndrome), when they have a serious impact on psycho-emotional and social life.

· Anti-androgenic palliative treatment of prostate cancer.

Dosage ACETATE OF CYPROTERONE SANDOZ 50 mg Tablet scored Box of 20

In humans:

In prostate cancer: 200 to 300 mg, or 4 to 6 tablets a day without interruption.

In women:

Pregnant women should not take CYPROTERONE ACETATE SANDOZ 50 mg, scored tablet. It is recommended to check the absence of pregnancy before the start of treatment.

In women during periods of genital activity, ACETATE DE CYPROTERONE SANDOZ 50 mg, scored tablet must be combined with an estrogen.

Therapeutic patterns:

· 1st treatment regimen:

o from the 1st to the 10th day of the cycle: take 2 tablets of CYPROTERONE ACETATE SANDOZ 50 mg, scored tablet associated with 50 μg of ethinyl estradiol per day.

o from the 11th to the 21st day of the cycle: take 50 μg of ethinylestradiol per day.

o From the 22nd to the 28th day of the cycle: take no treatment for 7 days.

Then resume the treatment in the same sequence.

This treatment regimen is considered as the reference pattern.

This treatment is contraceptive in the first cycle of treatment.

In case of absence of uterine bleeding during the 7 days without treatment, the absence of pregnancy will have to be confirmed by an immunological test.

In case of forgetfulness, if the set time is exceeded by more than 12 hours, the contraceptive action of ACETATE DE CYPROTERONE SANDOZ 50 mg, scored tablet is no longer guaranteed. Continue treatment according to the prescribed treatment regimen but combine additional contraceptive measures (condom or other) until the end of the current cycle. At the end of the cycle, in case of absence of deprivation bleeding, confirm the absence of pregnancy before the resumption of treatment.

· 2nd treatment regimen:

It combines 1 tablet of CYPROTERONE ACETATE SANDOZ 50 mg, scored tablet per day at a lower dose of estrogen, for example a fixed combination of 35 μg of ethinyl estradiol and low dose cyproterone acetate. In the case of initial or relapsing oral contraceptive treatment, the treatment regimen will be as follows:

o from the 1st to the 20th day of the cycle: take 1 tablet per day of CYPROTERONE ACETATE SANDOZ 50 mg, scored tablet and 1 tablet of the fixed combination per day.

o 21st day of the cycle: take the last tablet of the fixed association.

o From the 22nd to the 28th day of the cycle: take no treatment for 7 days.

Then resume the treatment in the same sequence.

This regimen is contraceptive as of the 1st cycle of treatment.

· In case of contraindication to a synthetic estrogen, the following treatment regimen may be prescribed:

o from the 1st to the 20th day of the cycle: take 1 tablet of CYPROTERONE ACETATE SANDOZ 50 mg, scored tablet per day combined with a natural estrogen by oral or percutaneous route.

o From the 21st to the 28th day of the cycle: do not take any treatment for 8 days.

Then resume the treatment in the same sequence.

However in this case, it is necessary to take local contraceptive measures during the first two cycles of treatment, this scheme has not been demonstrated contraceptive before the 3rd cycle.

· After menopause: CYPROTERONE ACETATE SANDOZ 50 mg, scored tablet will be prescribed at a dose of 1/2 to 1 tablet per day, if possible in combination with estrogen replacement therapy.

Against indications

· Severe hepatic disorders, hepatic tumors (except metastases of prostate cancer), Dubin-Johnson syndrome, Rotor syndrome.

· Tuberculosis and Cachectic Diseases (excluding prostate cancer).

· Existence or history of thromboembolic events.

· Severe chronic depression.

· Sickle cell anemia.

· History of jaundice or pruritus persistent during pregnancy.

· History of herpes gestationis.

· Existence or history of meningiomas

Hypersensitivity to cyproterone acetate or any of the excipients.

Adverse effects Acetate Cyproterone Sandoz

The most serious adverse reactions associated with taking cyproterone acetate are hepatic toxicity, benign or malignant liver tumors that may lead to intra-abdominal hemorrhage and thromboembolic events (see Warnings and Precautions section). employment ).

In case of combination of cyproterone acetate with estrogen, also refer to the Undesirable effects section of the Summary of Product Characteristics of estrogen used.

Reproductive organs and breast disease

In humans:

· Inhibition of spermatogenesis usually reversible upon discontinuation of treatment (may result in temporary infertility).

Gynecomastia usually reversible upon discontinuation of treatment.

· Incapacity.

· Decreased libido.

In women:

· The progestational activity of cyproterone acetate may cause intercostal (spottings) or amenorrhea bleeding disorders.

· Inhibition of ovulation.

· Breast tension.

· Increase or decrease in libido.

Blood and lymphatic system disorders

In humans:

· Anemia.

Endocrine disorders

· Weight variation.

· As described with other antiandrogens, the use of cyproterone acetate in humans may induce bone loss which is a risk factor for possible osteoporosis. Very rare cases have been reported during long-term treatment with cyproterone acetate at an average dose of 100 mg daily. This effect was not observed during a short treatment.

Psychiatric disorders

· States of agitation, depressed mood.

Respiratory, thoracic and mediastinal disorders

· Dyspnea.

Vascular disorders

· Aggravation of venous insufficiency of the lower limbs.

· Thromboembolic events.

Nervous system disorders

· Migraines and headaches.

Hepatobiliary disorders

Jaundice, cytolytic hepatitis, fulminant hepatitis, liver failure.

· Benign liver tumors could be observed, even malignant liver tumors leading to isolated cases of abdominal hemorrhage.

General disorders and administration site conditions

· Fatigability, asthenia.

· Hot flashes and sweating (in men)

Skin and subcutaneous tissue disorders

· Rash.

Immune system disorders

· Hypersensitivity reaction.

Benign, malignant and unspecified tumors (incl cysts and polyps)

Cases of meningioma have been reported with prolonged use (several years) of cyproterone acetate at doses of 25 mg per day and above (see sections Contraindications and Warnings and Precautions for Use ).

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr

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