Prostacor^® (Solution, Lyophilisate) Instructions for Use

ATC Code

G04CX (Other preparations for the treatment of benign prostatic hyperplasia)

Active Substance

Prostate extract (Grouping name)

Clinical-Pharmacological Group

Drug of animal origin used for prostate diseases

Pharmacotherapeutic Group

Remedy for chronic prostatitis

Pharmacological Action

A drug of animal origin. It has an organotropic effect on the prostate gland.

It reduces the degree of edema and leukocyte infiltration of the prostate gland, normalizes the secretory function of epithelial cells, increases the number of lecithin grains in the secretion of acini, and stimulates the muscle tone of the urinary bladder.

It reduces thrombus formation, has antiplatelet activity, and prevents the development of thrombosis in the venules of the prostate gland.

It normalizes the parameters of the prostate gland and ejaculate.

Pharmacokinetics

As a peptide substance, it is broken down by cellular proteases into amino acids.

It does not have a cumulative effect.

Indications

• Chronic prostatitis for the reduction of edema, leukocyte infiltration, and normalization of secretory function.
• Benign prostatic hyperplasia to alleviate symptoms and improve parameters of the prostate gland.
• Pre-operative and post-operative conditions for prostate gland surgery to support recovery and manage post-procedural states.

ICD codes

Dosage Regimen

Administer the solution via intramuscular injection at a dose of 5-10 mg once daily for a duration of 5 to 10 days.

If required, a repeat course may be administered after an interval of 1 to 6 months based on clinical assessment.

For the lyophilisate form, use in adult men only via oral, intramuscular, or rectal routes.

The specific dose and administration schedule must be individually determined by the physician according to the indication and selected dosage form.

Adverse Reactions

Allergic reactions may occur, though they are reported very rarely.

These can manifest as urticaria (hives). Monitor the patient for any signs of hypersensitivity during treatment.

Contraindications

• Hypersensitivity to the active substance (prostate extract) or any component of the drug formulation.
• Use in patients under 18 years of age due to a lack of safety and efficacy data in this population.

Use in Pregnancy and Lactation

Not applicable.

Pediatric Use

Contraindicated for use under the age of 18 years.

Special Precautions

Before starting treatment for chronic prostatitis and, if necessary, during treatment, it is recommended to perform an analysis of the prostate secretion.

During the use of the drug for the treatment of benign prostatic hyperplasia, standard monitoring of this disease should be regularly performed.

Before starting treatment, it is necessary to ensure that the pathology is benign.

Drug Interactions

The drug is compatible with antibacterial agents commonly prescribed for the treatment of prostatitis.

No other clinically significant drug interactions have been reported. Always inform the physician of all concomitant medications.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°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.