Prostolor^® (Tablets) Instructions for Use

ATC Code

R01AX10 (Other drugs)

Active Substance

Silver proteinate (Grouping name)

Clinical-Pharmacological Group

A drug with antimicrobial and anti-inflammatory action for topical use in ENT practice

Pharmacotherapeutic Group

Drugs for the treatment of nasal diseases; decongestants and other preparations for topical use; other drugs for the treatment of nasal diseases

Pharmacological Action

A product based on silver (Silver proteinate contains 7.5-8.5% silver). It has an astringent, antiseptic, and anti-inflammatory effect.

It dissociates to form silver ions, which bind to bacterial DNA and prevent their reproduction on mucous membranes under conditions of topical application.

The mechanism of action of silver proteinate is based on the fact that silver ions precipitate proteins and form a protective film on the damaged mucous membrane, which helps to reduce the sensitivity of nerve endings and constrict blood vessels (this leads to a reduction in swelling), which in turn causes the inhibition of inflammatory reactions.

Silver ions also suppress the reproduction of various bacteria.

It is active against gram-positive and gram-negative microorganisms: B. cereus, C. albicans, E. coli, P. aeruginosa, S. aureus, A. niger, S. Abony, and others.

Indications

Use for the symptomatic treatment of the following conditions:

• Acute nasopharyngitis
• Acute sinusitis
• Acute rhinitis

ICD codes

Dosage Regimen

Apply topically three times per day.

Follow an individualized dosing scheme based on the patient’s age and the specific pharmaceutical form being used.

Adhere strictly to the age-specific recommendations provided for the product.

Adverse Reactions

Possible local reactions include mild irritation of the mucous membrane, a sensation of burning, or itching at the application site.

May cause allergic reactions ranging from skin manifestations like urticaria and atopic dermatitis to severe systemic reactions such as angioedema or anaphylactic shock.

Contraindications

• Hypersensitivity to silver proteinate or any other component of the formulation.
• Pregnancy and breastfeeding.
• Diagnosis of atrophic rhinitis.
• Use in children under 6 months of age.

Strictly observe all age restrictions specified for the specific medicinal product containing silver proteinate.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children under 6 months of age.

When using various medicinal products containing Silver proteinate, age restrictions for use in children over 6 months of age must be strictly observed.

Special Precautions

Nasal discharge may turn gray or blue.

Drug Interactions

Do not co-administer with solutions containing salts of zinc, copper, lead, mercury, iron, or aluminum, as these form insoluble precipitates with silver proteinate.

Silver proteinate is inactivated by salts of alkaloids and by epinephrine; avoid concurrent application.

Overdose

Excessive topical application may lead to intensified local adverse effects, such as severe mucosal irritation.

In case of accidental ingestion, silver ions can cause argyria, a permanent blue-gray discoloration of the skin and mucous membranes.

Symptomatic and supportive care is recommended; there is no specific antidote.

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.