Cyproterone-Teva (Tablets) Instructions for Use

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Teva Czech Industries, s.r.o. (Czech Republic)

ATC Code

G03HA01 (Cyproterone)

Active Substance

Cyproterone (Rec.INN registered by WHO)

Dosage Form

Cyproterone-Teva

Tablets 50 mg: 50 pcs.

Dosage Form, Packaging, and Composition

Tablets from white to light yellow in color, flat, round, with beveled edges, with a score on one side and the inscription “CYPROT 50” on the other.

Excipients: potato starch, lactose monohydrate, crospovidone, sodium lauryl sulfate, hydroxypropylcellulose, talc, magnesium stearate, colloidal silicon dioxide.

10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blister (5) – cardboard pack.

Clinical-Pharmacological Group

Antiandrogenic drug

Pharmacotherapeutic Group

Antiandrogen

Pharmacological Action

Synthetic antiandrogen. It is similar in chemical structure to natural androgens and has the ability to competitively bind to tissue receptors of these hormones in target organs. It reduces or eliminates the effects of androgens, including those associated with excessive production of male sex hormones.

It has gestagenic activity and antigonadotropic properties.

Pharmacokinetics

After oral administration, it is slowly absorbed from the gastrointestinal tract. C_max in plasma is reached after 3-4 hours. The terminal T_1/2 is about 38 hours.

Cyproterone is metabolized in the liver. The main metabolite, 15β-hydroxycyproterone, has antiandrogenic activity.

About 35% of the dose is excreted in the urine in the form of free and conjugated metabolites. The remainder is excreted in the feces.

Indications

For men: correction of pathological deviations in the sphere of sexual behavior (if it is necessary to reduce sexual activity), metastatic or inoperable prostate cancer (without and after orchiectomy, as well as in combination with GnRH agonists).

For women: moderate androgenic alopecia; moderate hirsutism; severe and moderate acne and/or seborrhea; contraception (as part of combined preparations).

ICD codes

Dosage Regimen

Determine the dosage individually based on the specific indication, disease severity, and patient response.

For prostate cancer, administer 200-300 mg daily, divided into 2-3 doses. Initiate therapy with a lower dose, then titrate based on tolerance and clinical effect.

For the reduction of sexual drive in men, prescribe 50 mg twice daily. Adjust the dose downward to a maintenance level of 25-50 mg daily as clinically appropriate.

For androgenic conditions in women (such as severe acne, hirsutism, alopecia), take one 50 mg tablet daily from day 1 to day 10 of the menstrual cycle. For contraception, use only as a component of a combined oral contraceptive regimen.

Take tablets with a small amount of water after a meal to improve gastrointestinal tolerance.

Do not exceed the maximum daily dose of 300 mg. Regularly reassess the need for continued therapy and adjust the dose to the lowest effective level.

Perform regular monitoring of liver function, adrenal cortex activity, and hematological parameters throughout the treatment course.

Adverse Reactions

From the endocrine system, changes in body weight are possible. In men – suppression of spermatogenesis, gynecomastia are possible; in women – a feeling of tension in the chest; in children, when used in high doses, a negative effect on the hypothalamus is possible, leading to suppression of the adrenal cortex.

From the central nervous system, anxiety, depression, fatigue, and impaired concentration may occur.

From the digestive system, in some cases when used in high doses – impaired liver function.

From the respiratory system, with rapid administration, cough and shortness of breath are possible.

Contraindications

Liver diseases, hereditary benign hyperbilirubinemias (Dubin-Johnson and Rotor syndromes); cachexia (except for patients with prostate carcinoma); severe chronic depression; thromboembolic processes or their history; severe diabetes mellitus complicated by angiopathy; sickle cell anemia; adolescence until the completion of puberty; pregnancy, idiopathic jaundice of pregnancy or severe pruritus and herpes of pregnancy in history, lactation period.

Use in Pregnancy and Lactation

Cyproterone is contraindicated for use during pregnancy and lactation.

In women, pregnancy should be excluded before starting therapy.

Use in Hepatic Impairment

Contraindicated in liver diseases.

Pediatric Use

Contraindicated in adolescence until the completion of puberty.

In children receiving high doses of cyproterone, during high-intensity stress, replacement therapy with corticosteroids may be required due to the presence of latent adrenal insufficiency.

Special Precautions

Use with caution in patients at risk of developing depressive conditions.

During treatment, careful monitoring of liver function, adrenal cortex function, peripheral blood picture, and blood glucose levels is necessary.

In patients with diabetes mellitus, dose adjustment of insulin or other hypoglycemic drugs may be required.

In women, pregnancy should be excluded before starting therapy.

In children receiving high doses of cyproterone, during high-intensity stress, replacement therapy with corticosteroids may be required due to the presence of latent adrenal insufficiency.

Effect on the ability to drive vehicles and machinery

During treatment, one should refrain from potentially hazardous activities that require concentration and increased speed of psychomotor reactions.

Drug Interactions

With simultaneous use, a change in the clinical efficacy of oral hypoglycemic drugs and insulin is possible.

With simultaneous use, the effectiveness of cyproterone is reduced.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.