INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VITAPROST (VITAPROST)

Composition:

Active substance:

1 suppository contains lyophilized from aqueous solution of extract of bovine prostate gland obtained by extraction, calculated as peptides not less than 0.0024 g;

Excipients: glycine, polysorbate 80, pumpkin seed oil, hard fat.

Pharmaceutical form. Rectal suppositories.

Main physicochemical properties: suppositories from light yellow with a greenish tint to green with a yellowish tint in color.

Pharmacotherapeutic group. Medicinal products used in urology. ATC code G04BX.

Pharmacological Properties

Pharmacodynamics

The drug is used for the treatment of prostate gland disorders. The extract of bull prostate gland contained in the suppositories exerts organotropic action on the prostate gland (prostatoprotective effect), exerts anti-inflammatory action by reducing edema and leukocyte infiltration of the gland, improves microcirculation and platelet-vascular hemostasis, and positively affects the functional activity of spermatozoa. It stimulates the activity of the humoral immunity and certain factors of the body's resistance, and influences the tone of urinary bladder muscles, including the detrusor tone.

Pharmacokinetics

The components of the drug are effectively absorbed from the rectum. The extract of bull prostate gland is broken down by cellular proteases into amino acids and does not accumulate. The extract of bull prostate gland and its metabolites are excreted in urine.

Clinical characteristics.

Indications.

Chronic prostatitis;
prevention and treatment of complications following surgery on the prostate gland.

Contraindications.

Hypersensitivity to the components of the drug, particularly to proteins of cattle.

Interaction with other medicinal products and other forms of interaction.

Drug interaction with VITAPROST has not been studied.

Special precautions for use.

Use with caution in patients with atherosclerosis and increased risk of thromboembolism. When administering high doses of the drug for prolonged periods, blood coagulation time should be monitored. During treatment with the drug, it is recommended to perform clinical tests assessing the activity of the prostate gland (prostate-specific antigen). The drug is practically free of sodium and potassium.

After using suppositories, hands should be thoroughly washed.

Use during pregnancy or breastfeeding.
The drug is not intended for use in women.

Ability to affect reaction rate when driving or operating machinery.
No data available.

Method of Administration and Dosage

Remove the suppository from its packaging and insert deeply into the rectum.

Administer 1 suppository 1–2 times daily (in the morning and evening) for 5–10 days.

The duration of treatment is determined by the nature and severity of the disease, the therapeutic response achieved, and the type of therapy (monotherapy or combination treatment). If necessary, the course may be repeated after 1–6 months.

Children. Do not use in children.

Overdose

Cases of overdose with suppositories containing bull prostate extract have not been reported.

When high doses of the drug are used (over 400 mg daily for a prolonged period), the following may occur: dyspeptic disorders, fatigue, general weakness, headache, creatinuria, increased creatine kinase activity, elevated cholesterol and triglyceride levels, decreased serum concentrations of thyroxine and triiodothyronine, and increased urinary excretion of estrogens and androgens. There is no specific antidote. Treatment is symptomatic.

Side effects.

Allergic reactions: itching, skin hyperemia, skin rashes;

changes at the application site: burning sensation.

Shelf life. 2 years.

Storage conditions. Store in the original packaging to protect from light at a temperature not exceeding 25 ºС. Keep out of reach of children.

Packaging. 5 suppositories in a blisters pack. 2 blisters packs in a cardboard box.

Prescription status. Over-the-counter.

Manufacturer. LLC "FZ "STADA", Ukraine.

Manufacturer's address.
Ukraine, 09100, Kyiv region, city Bila Tserkva, Kyivska str., 37.