Androfarm (cyproterone) tablets 50 mg. №20

Androfarm (cyproterone) tablets 50 mg. №20

$56.00

Manufacturer: Ukraine

Androfarm is a hormonal drug with antiandrogenic action.

For men

  • For palliative therapy of metastatic or locally advanced inoperable prostate cancer:
    • if treatment with luteinizing hormone-releasing hormone (LHR) analogs or surgery proves insufficient, oral therapy is contraindicated or preferred;
    • to prevent the occurrence of adverse secondary effects and complications that may be caused by an increase in serum testosterone levels at the beginning of treatment with LHR agonists;
    • for the treatment of hot flashes that occur during treatment with LHRH agonists or after orchiectomy.
  • Decreased sexual desire with hypersexuality and sexual deviations.
Category:

Description

Ingredients

active ingredient: cyproterone;

1 tablet contains cyproterone acetate in terms of 100% substance 50 mg;

excipients: corn starch, lactose monohydrate, anhydrous colloidal silicon dioxide, povidone, magnesium stearate.

Dosage form

Pills.

Basic physical and chemical properties : tablets of a round shape with a flat surface with a notch and a chamfer, white or almost white. Marbling is allowed on the surface of the tablets.

Pharmacotherapeutic group

Hormones of the gonads and drugs used in the pathology of the genital area. Antiandrogens. Code ATX G03H A01.

Pharmacodynamics

Androfarm is a hormonal drug with antiandrogenic action.

Cyproterone acetate competitively inhibits the effect of androgens on androgen-dependent target organs, for example, protects the prostate gland from the effects of androgens produced in the gonads and / or adrenal cortex.

Cyproterone acetate has a central inhibitory effect. The antigonadotropic effect leads to a decrease in the synthesis of testosterone in the testicles and, as a result, a decrease in the concentration of this hormone in the serum.

In men, when using the drug Androfarm, libido and potency decrease, and the function of the sex glands is also inhibited. After discontinuation of the drug, these phenomena disappear.

The antigonadotropic effect of cyproterone acetate also appears when it is used in combination with gonadotropin-releasing hormone (GnRH) agonists. The increase in testosterone levels caused by them at the beginning of therapy is reduced due to cyproterone acetate.

When using high doses of cyproterone acetate, a slight increase in prolactin levels was sometimes observed.

Data from standard preclinical studies of the toxicity of cyproterone acetate with repeated use do not indicate the existence of any specific risk to the human body.

In the course of embryotoxicity studies, no effects were found that indicate a teratogenic effect of Androfarm during organogenesis before the development of the external genitalia.

However, high doses of cyproterone acetate during the hormone-sensitive phase of genital differentiation in male fetuses can lead to feminization. Observations of newborn boys exposed to cyproterone acetate in utero did not reveal any signs of feminization in them.

Treatment with Androfarm does not cause damage to spermatozoa, which could cause birth defects or reduced fertility in offspring, which has been proven during studies on male rats.

Today, clinical experience and the results of epidemiological studies do not suggest an increase in the incidence of liver tumors in humans. The results of studies of the carcinogenicity of cyproterone acetate conducted on rodents do not indicate the existence of any specific carcinogenic effect. However, it should be noted that sex steroids can promote the growth of already existing hormone-dependent tissues and tumors.

During experimental studies of cyproterone acetate at high doses, it demonstrated a corticoid effect on the adrenal glands in rats and dogs, which indicates the possibility of similar effects in humans when taking high doses of the drug (300 mg / day).

Indications

For men

  • For palliative therapy of metastatic or locally advanced inoperable prostate cancer:
    • if treatment with luteinizing hormone-releasing hormone (LHR) analogs or surgery proves insufficient, oral therapy is contraindicated or preferred;
    • to prevent the occurrence of adverse secondary effects and complications that may be caused by an increase in serum testosterone levels at the beginning of treatment with LHR agonists;
    • for the treatment of hot flashes that occur during treatment with LHRH agonists or after orchiectomy.
  • Decreased sexual desire with hypersexuality and sexual deviations.

Contraindications

For men (to reduce sexual desire with pathological abnormalities in the genital area):

  • hypersensitivity to any of the components of the drug;
  • liver disease;
  • Dubin-Johnson syndrome, Rotor syndrome;
  • liver tumors at present or in history;
  • meningioma at present or in history;
  • established malignant diseases or suspicion of their presence;
  • severe chronic depression;
  • thromboembolic conditions at present or in history;
  • severe forms of diabetes with vascular complications;
  • sickle cell anemia;
  • adolescents before puberty and children.

For men (for the treatment of inoperable prostate cancer):

  • hypersensitivity to any of the components of the drug;
  • liver disease;
  • Dubin-Johnson syndrome, Rotor syndrome;
  • liver tumors at present or in history (only in the case when the tumor is not caused by metastases of prostate cancer);
  • meningioma at present or in history;
  • established malignant diseases or suspicion of their presence (except for tumors in advanced prostate cancer);
  • severe chronic depression;
  • existing thromboembolic conditions;
  • severe forms of diabetes with vascular complications;
  • sickle cell anemia;
  • adolescents before puberty and children.

Dosage and administration

Apply inside. Tablets should be taken after meals with a small amount of liquid. The maximum daily dosage is 300 mg.

To reduce sexual desire with hypersexuality and sexual deviations.

Tablets should be taken after meals with a small amount of liquid.

The duration of treatment is determined individually. Sometimes the therapeutic effect may appear after a few weeks, and sometimes the success of the treatment can be observed only after a few months. The initial dose is usually 50 mg 2 times a day. If necessary, the dose can be increased to 100 mg twice a day (200 mg) or for a short period of time up to 100 mg 3 times a day (300 mg). After achieving a satisfactory result of treatment, the therapeutic effect should be maintained with a minimum dose. In most cases, 25 mg twice a day (50 mg per day) is sufficient. Prescribe a maintenance dose or discontinue the drug should be gradual. To do this, the daily dose should be reduced at intervals of several weeks by 50 mg, and preferably by 25 mg.

For the treatment of inoperable prostate cancer.

  • Palliative therapy of metastatic or locally advanced inoperable prostate cancer without orchiectomy or treatment with LHR agonists : take 100 mg of the drug 2-3 times a day (daily dose – 200-300 mg). Tablets should be taken after meals with a small amount of liquid. With the improvement of the condition or remission of the disease, you should not reduce the prescribed dose of the drug or interrupt treatment.
  • Initially, to prevent the occurrence of adverse secondary effects and complications that may be caused by an increase in serum testosterone levels at the beginning of treatment with LHRH agonists: first, monotherapy with Androfarm: 100 mg 2 times a day (200 mg) for 5-7 days. After that, for 3-4 weeks, apply Androfarm 100 mg twice a day (200 mg) in combination with an LHR agonist at the recommended dose.

When treating with LHR agonists, these instructions for use of the respective drug should be followed.

  • For relief of hot flushes in patients during treatment with LHRH agonists or after orchiectomy: Androfarm 50–150 mg daily, increased if necessary to 100 mg 3 times daily (300 mg).

Elderly patients

There are no data indicating the need for dose adjustment for elderly patients.

Patients with liver failure

The use of Androfarm is contraindicated in patients with liver disease (until liver function parameters return to normal).

Patients with renal insufficiency

There are no data indicating the need for dose adjustment for patients with renal insufficiency.

Related products