Extaprost^® (Suppositories) Instructions for Use

Marketing Authorization Holder

Salvus, LLC (Russia)

Manufactured By

Rubicon, LLC (Republic of Belarus)

ATC Code

G04BX (Other drugs for the treatment of urological diseases)

Active Substance

Prostate extract (Grouping name)

Dosage Form

Extaprost®

Rectal suppositories 10 mg: 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Rectal suppositories from white to white with a yellowish or grayish-brownish tint, torpedo-shaped; the presence of an air core and a funnel-shaped depression on the cut is allowed.

Excipients: solid fat – up to 1.25 g.

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

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, 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 Extaprost^® suppositories rectally in adult men only.

For chronic prostatitis, administer one 50 mg suppository twice daily.

For benign prostatic hyperplasia, administer one 50 mg suppository twice daily.

For pre- and post-operative conditions, administer one 50 mg suppository twice daily. Begin the course 5-7 days before surgery and continue for 10-15 days postoperatively.

The standard treatment course is 10-15 days.

Repeat courses may be administered as prescribed by a physician, typically after a 1-1.5 month interval.

Prior to administration, ensure the suppository is firm. If softened, chill it in the refrigerator while in the foil.

Perform rectal administration after natural bowel emptying or a cleansing enema.

Thoroughly wash hands before and after the procedure.

Remove the suppository from its contour packaging immediately before use.

Assume a comfortable position, such as lying on your side with the lower leg straightened and the upper leg bent toward the stomach.

Gently insert the suppository, narrow end first, completely into the rectum.

Remain lying down for 20-30 minutes after insertion.

Discontinue use and consult a physician if severe local irritation or allergic reactions 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 18 years of age.

Special Precautions

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

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.