CHLOROTRIANISENE

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT CHLORTRIANISENE

Composition:

Active ingredient: 1 tablet contains 12 mg of chlorotrianisene;

Excipients: potato starch, talc, refined sugar, calcium stearate.

Medicinal form. Tablets.

Main physicochemical properties: white or almost white tablets, flat cylindrical, with beveled edges.

Pharmacotherapeutic group. Antineoplastic agents. ATC code L01X.

Pharmacological Properties.

Pharmacodynamics.

Chlortrianisene is an anticancer agent and a synthetic analogue of estrogens.

It inhibits tumor cell proliferation at all stages of prostate cancer. It reduces sex hormone production. Compared to other synthetic estrogenic drugs, its action is longer-lasting.

It has low efficacy in estrogen-resistant tumor forms.

It has minimal feminizing properties (ability to cause female secondary sexual characteristics in men, such as breast enlargement and fat deposition on the thighs).

It increases blood coagulation, decreases cholesterol concentration, and increases triglyceride concentration in the blood. It promotes the shift of intravascular fluid into the extracellular space, leading to edema formation. It exhibits fewer central effects compared to drugs containing estrone or estradiol.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Prostate cancer.

Breast cancer in the development of endocrine resistance to antiestrogens and aromatase inhibitors (only in patients with hysterectomy and in late menopause).

Contraindications.

Hypersensitivity to the components of the drug; acute and chronic liver diseases, genital bleeding of undetermined origin, history of thromboembolic disorders.

Interaction with other medicinal products and other types of interactions.

Chlortrianisene reduces the effectiveness of warfarin, insulin, thyroid hormones, phenytoin, carbamazepine, phenobarbital, rifampicin when used concomitantly; increases the effectiveness of tricyclic antidepressants.

Should not be used simultaneously with tamoxifen.

Special precautions for use.

In breast cancer treatment, the medicinal product should be prescribed only to patients in late menopause and with the uterus removed (due to the possible risk of endometrial mucosa hyperplasia).

The drug should be administered with caution in patients with diabetes mellitus, epilepsy, as well as cardiac and renal disorders.

At the beginning of treatment, nausea, loss of appetite, vomiting, diarrhea, breast swelling and tenderness may occur; these symptoms usually resolve spontaneously.

When taking chlortrianisene, prolonged exposure to sunlight should be avoided, as the drug increases skin photosensitivity.

If a patient has known intolerance to certain sugars, medical advice should be sought before taking this medicinal product.

Use during pregnancy or breastfeeding.

The medicinal product must not be used during pregnancy or breastfeeding.

If it is necessary to use the drug, breastfeeding should be discontinued.

Ability to influence reaction rate when driving or operating machinery.

Data are lacking.

Dosage and Administration.

For adults only. Take orally during meals.

Prostate cancer. Administer 1 tablet (12 mg) 2–3 times daily. In cases of metastases, additionally prescribe prednisolone.

Breast cancer. Administer 1 tablet (12 mg) 4 times daily; daily dose – 4 tablets (48 mg).

Maximum doses for adults: single dose – 1 tablet (12 mg), daily dose – 4 tablets (48 mg).

The drug is intended for long-term use. The duration of treatment is determined individually by the physician.

Children. Information regarding use in children is not available.

Overdose.

Symptoms: nausea, vomiting.

Treatment: symptomatic. There is no specific antidote.

Side effects.

Gastrointestinal tract: nausea, loss of appetite, vomiting, diarrhea.

Reproductive system: breast swelling and pain, gynecomastia in males, uterine bleeding in females.

Cardiovascular system and blood: signs of circulatory insufficiency, thromboembolic complications, edema, arterial hypertension, increased blood coagulation and viscosity, increased bleeding tendency.

Other: allergic reactions, disturbances in mineral metabolism.

Shelf life. 5 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. Tablets, 100 pcs in a container in a box; 100 pcs (10×10) in blisters in a box.

Release category. Prescription only.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's address and place of business.

22, Shevchenka Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.