Proctoprost^® (Suppositories) Instructions for Use

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

ATC Code

G04BX (Other drugs for the treatment of urological diseases)

Active Substance

Prostate extract (Grouping name)

Dosage Form

Proctoprost®

Rectal suppositories 10 mg: 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Rectal suppositories of a torpedo-like shape, from white to white with a yellowish or grayish-brownish tint; the appearance of a white coating on the surface of the suppository and the presence of an air rod and a funnel-shaped depression on the cut are allowed.

Excipients: hard fat (Witepsol W35) – to obtain a suppository weighing 1.25 g.

5 pcs. – contour cell packs (1) – cardboard boxes.
5 pcs. – contour cell packs (2) – cardboard boxes.

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 bladder.

It reduces thrombus formation, has antiplatelet activity, and prevents the development of venule thrombosis in 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; benign prostatic hyperplasia; conditions before and after surgical interventions on the prostate gland.

ICD codes

Dosage Regimen

Use rectally in adult men only.

Administer one 10 mg suppository twice daily.

Insert the suppository deeply into the rectum after bowel evacuation.

Perform a thorough hand hygiene before and after the procedure.

The standard treatment course is 10 days.

Repeat courses are possible as prescribed by a physician.

For chronic prostatitis, initiate treatment after prostate secretion analysis.

For benign prostatic hyperplasia, confirm benign pathology before starting therapy.

Perform standard monitoring for prostatic hyperplasia during treatment.

Use pre- and post-operatively on physician’s recommendation.

Discontinue use and consult a physician if allergic reactions such as urticaria occur.

Adverse Reactions

Allergic reactions very rarely – urticaria.

Contraindications

Hypersensitivity to the active substance; age under 18 years.

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

Compatible with antibacterial drugs used to treat prostatitis.

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

Over-the-Counter

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.