Adenoprosin

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

Composition:

Active substance: adenoprosin;

1 suppository contains 150 mg of adenoprosin;

Excipient: hard fat.

Pharmaceutical form. Rectal suppositories.

Main physicochemical properties: cylindrical-conical shaped suppositories, yellow to brown in colour, with a glossy and/or matte surface. Slight colour inhomogeneity in the form of darker specks is acceptable. On cross-section, the presence of an air-filled porous core and a cup-shaped depression is permissible.

Pharmacotherapeutic group.

Medicinal products for the treatment of diseases of the genitourinary system and sex hormones. Medicinal products for the treatment of urological diseases. Other medicinal products for the treatment of urological diseases.

ATC code G04BX.

Pharmacological properties.

Pharmacodynamics.

The active substance contained in the medicinal product, adenoprosin, is a biomass rich in lipoproteids obtained from larvae of the insect species Lymantriadispar, exerting antioxidant, vasoprotective, anti-inflammatory, and immunomodulatory effects.

Biologically active components of the drug reduce the formation of phospholipase A2 and the release of arachidonic acid, thereby decreasing the synthesis of prostaglandins and leukotrienes (inhibiting 5-lipoxygenase). The drug reduces vascular permeability and decreases prostate edema. Adenoprosin exerts beneficial effects in benign prostatic hyperplasia (BPH), including cases where symptoms of chronic prostatitis predominate. The drug also regulates tone and peristalsis in the lower urinary tract segments, facilitating urination and reducing urinary frequency, especially at night. Through pathogenetic and nonspecific mechanisms, Adenoprosin improves urodynamic parameters and the overall condition of patients with BPH and chronic prostatitis.

The antioxidant effect of adenoprosin is manifested by inhibition of lipid peroxidation due to water-soluble antioxidant compounds present in the drug.

Pharmacokinetics.

The effect of adenoprosin results from the combined action of biologically active components of the biomass obtained from Lymantriadispar larvae; therefore, pharmacokinetic studies are currently not feasible.

Clinical characteristics.

Indications.

• Benign prostatic hyperplasia (Grade I–II), with or without chronic prostatitis;
• Chronic prostatitis, as part of combined therapy with anti-inflammatory and antibacterial agents.

Contraindications.

• Hypersensitivity to any component of the drug.
• Acute urinary retention.
• Prostate cancer.

Interaction with other medicinal products and other forms of interaction.

To date, there have been no reported cases of clinically significant drug interactions between adenoprosin and other medicinal products.

Instructions for use.

The medication should be administered after defecation or an enema. After administration, the patient is recommended to remain in a lying position for 30–40 minutes.

Use during pregnancy or breastfeeding.

The medication is not used for the treatment of women.

Ability to affect reaction rate when driving or operating machinery.

Does not affect.

Method of Administration and Dosage.

Rectally, 1 suppository once daily (preferably at night, at the same time each day). The drug should be administered after defecation or enema. After administration, the patient is advised to remain lying down for 30–40 minutes.

The duration of treatment ranges from 1 to 3 months, depending on the severity of inflammatory processes in the prostate and the intensity of symptoms of benign prostatic hyperplasia, as well as their combination. If necessary, the treatment course may be repeated.

Children.

There is no data on the use of the drug in pediatric practice; therefore, Adenoprosin is not prescribed to children (under 18 years of age).

Overdose.

There have been no reports of overdose cases to date.

Side effects.

Gastrointestinal disorders: diarrhea or frequent bowel movements.

Shelf life. 2 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in the original packaging. Do not freeze.

Keep out of reach of children.

Packaging.

5 suppositories per blister; 2 blisters per cardboard box.

Prescription status. Prescription only.

Marketing Authorization Holder.

″Biotehnos″ S.A.

Address of the Marketing Authorization Holder.

3-5 Gorunului Street, Otopeni-Ilfov, 075100, Romania.

Manufacturer.

LLC «Farmaprim».

Manufacturer's address and place of business.

5 Crinilor Street, village Porumbeni, Criuleni district, MD-4829, Republic of Moldova.