Mastodon

Protargol (Tablets, Solution, Powder) Instructions for Use

ATC Code

D08AL (Silver compounds)

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

Antiseptic

Pharmacological Action

When introduced into the body, silver proteinate dissociates to form silver ions, which exert an astringent, antiseptic, and anti-inflammatory effect.

Silver ions actively suppress the reproduction of infectious agents by binding their DNA.

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

Silver ions also suppress the reproduction of various bacteria.

It is active against Gram-positive and Gram-negative bacteria, including Bacillus cereus, Candida albicans, Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Aspergillus niger, Salmonella abony.

Indications

Use this medication exclusively for the symptomatic treatment of the following conditions affecting the upper respiratory tract.

  • Acute nasopharyngitis (runny nose)
  • Acute sinusitis

Apply the solution, tablets, or powder topically as directed to manage symptoms associated with these inflammatory and infectious processes.

ICD codes

ICD-10 code Indication
J00 Acute nasopharyngitis (common cold)
J01.9 Acute sinusitis, unspecified
ICD-11 code Indication
CA00 Acute nasopharyngitis
CA01 Acute rhinosinusitis

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer the medication three times daily. The specific dosage and preparation method are dependent on the pharmaceutical form and the patient’s age.

For tablets and powder, use topically according to an individualized scheme. For the solution, apply intranasally.

The therapeutic effect typically becomes apparent after 2-3 days of consistent use. Adhere strictly to the prescribed frequency and duration of treatment.

Adverse Reactions

Monitor for allergic reactions, which may include skin itching, urticaria, atopic dermatitis, angioedema, and in rare instances, anaphylactic shock.

Expect local reactions such as a sensation of burning, irritation, numbness of the nasal mucosa, and dry mouth. Other effects like eye redness have also been reported.

Discontinue use and seek medical advice if any adverse reactions are severe or persist. The risk of reactions may increase with excessive application.

Contraindications

Do not administer this drug under the following conditions.

  • Known hypersensitivity to silver proteinate or any component of the formulation.
  • Pregnancy and throughout the breastfeeding period.
  • Patients diagnosed with atrophic rhinitis.
  • Children under 3 years of age due to insufficient safety data and increased systemic absorption risk.

Drug Interactions

Avoid concurrent topical application with salts of zinc, copper, lead, mercury, iron, and aluminum, as they form insoluble precipitates with the silver proteinate solution, rendering both agents inactive.

This medication is also inactivated by salts of alkaloids and organic bases, such as epinephrine. Do not mix with these substances in a single preparation or administration.

Overdose

Symptoms of overdose are primarily an extension of adverse reactions and may include severe irritation, burning of the nasal mucosa, and intense skin itching.

Accidental ingestion can lead to gastrointestinal irritation. In case of overdose, immediately discontinue the medication and initiate symptomatic and supportive care.

Prevent overdose by strictly adhering to the recommended dosage regimen and frequency of application, particularly in pediatric and geriatric populations.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Recommended doses should not be exceeded, especially in children.

Contraindicated for use in children under 3 years of age.

Geriatric Use

Recommended doses should not be exceeded, especially in elderly patients.

Special Precautions

Nasal discharge may turn gray or blue.

Recommended doses should not be exceeded, especially in children and elderly patients.

With excessive use, side effects may increase in the form of irritation, burning of the nasal mucosa, skin itching. If accidentally ingested, gastrointestinal irritation is possible.

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Kirov Pharmaceutical Factory, JSC (Russia)

Manufactured By

Kirov Pharmaceutical Factory, JSC (Russia)

Dosage Form

Bottle OTC Icon Protargol Powder for solution for topical application 200 mg: bottle 1 pc. with solvent

Dosage Form, Packaging, and Composition

Powder for solution for topical application from yellow-brown to brown in color, light, amorphous, odorless; slightly hygroscopic; appearance changes under the influence of light.

1 fl.
Silver proteinate 200 mg

Solvent water for injections – 10 ml.

Dark glass bottles with a volume of 10 ml with a stopper or dropper stopper (1) complete with solvent (amp. 10 ml 1 pc.) and a cap with a pipette – cardboard packs (with or without an insert).
Dark glass bottles with a volume of 15 ml with a stopper or dropper stopper (1) complete with solvent (amp. 10 ml 1 pc.) and a cap with a pipette – cardboard packs (with or without an insert).
Dark glass bottles with a volume of 25 ml with a stopper or dropper stopper (1) complete with solvent (amp. 10 ml 1 pc.) and a cap with a pipette – cardboard packs (with or without an insert).

Marketing Authorization Holder

Coc Roche Pharm, LLC (Russia)

Manufactured By

Esco Pharm, LLC (Armenia)

Dosage Form

Bottle OTC Icon Protargol Solution for topical application 2%: dropper bottle 15 ml

Dosage Form, Packaging, and Composition

Solution for topical application in the form of a brown liquid.

100 ml
Silver proteinate 2 g

Excipients : purified water – up to 100 ml.

15 ml – high-density polyethylene dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

Moscow Pharmaceutical Factory CJS (Russia)

Dosage Form

Bottle OTC Icon Protargol Powder for solution for topical application 200 mg: bottle 1 pc. with solvent

Dosage Form, Packaging, and Composition

Powder for solution for topical application from yellow-brown to brown in color, odorless; slightly hygroscopic.

1 fl.
Silver proteinate 200 mg

Solvent: water for injections – 10 ml.

200 mg – bottles (1) complete with solvent (amp. 10 ml 1 pc.) and a cap with a pipette – cardboard packs.
200 mg – dropper bottles (1) complete with solvent (amp. 10 ml 1 pc.) and a cap with a pipette – cardboard packs.

Marketing Authorization Holder

Triangle, LLC (Russia)

Manufactured By

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Protargol Tablets for the preparation of a solution for topical application 200 mg: 1 pc. in a kit with or without a solvent

Dosage Form, Packaging, and Composition

Tablets for the preparation of a solution for topical application from dark brown to black in color, round, flat-cylindrical, with a bevel; metallic luster and uneven surface coloration are allowed.

1 tab.
Silver proteinate 200 mg

Excipients : hypromellose – 10 mg.

Solvent water for injections bufus, solvent for the preparation of dosage forms for injections – 10 ml (polymer ampoules).

Kit without solvent:
1 pc. – contour cell packaging (1), 1 dark glass bottle with a volume of 15 ml with a cap with a pipette or with an applicator – cardboard packs.

Kit with solvent
1 pc. – contour cell packaging (1) complete with solvent (amp. 10 ml 1 pc.), 1 dark glass bottle with a volume of 15 ml with a cap with a pipette or with an applicator – cardboard packs.

Marketing Authorization Holder

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

Dosage Form

Bottle OTC Icon Protargol Tablets for the preparation of a solution for topical application 200 mg: 1 pc. in a kit with a solvent

Dosage Form, Packaging, and Composition

Tablets for the preparation of a solution for topical application from dark brown to black with a bluish tint, with uneven surface coloration, round, flat-cylindrical.

1 tab.
Silver proteinate 200 mg

Excipients : povidone K17 – 20 mg.

Solvent: water for injections – 10 ml.

1 pc. – contour cell packaging (1) complete with solvent (amp. 10 ml 1 pc.) and a bottle with a dropper cap – cardboard packs.
1 pc. – contour cell packaging (1) – cardboard pack.

Marketing Authorization Holder

Pharmtekhnologiya LLC (Republic of Belarus)

Manufactured By

N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)

Dosage Form

Bottle OTC Icon Protargol Tablets for preparation of solution for topical application 200 mg: 1 pc. in a set with solvent and bottle with dropper cap

Dosage Form, Packaging, and Composition

Tablets for the preparation of a solution for topical application from dark brown to black with a bluish tint with uneven surface coloration, round, flat, with a score line.

1 tab.
Silver proteinate 200 mg

Solvent: water for injections – 10 ml.

1 pc. – contour cell packaging (1) complete with solvent (amp. 10 ml 1 pc.) and a bottle with a dropper cap – cardboard packs.

Marketing Authorization Holder

Pharmkhimkomplekt NPC, LLC (Russia)

Manufactured By

Technopark-Center LLC (Russia)

Or

Tver Pharmaceutical Factory, PJSC (Russia)

Dosage Form

Bottle OTC Icon Protargol Solution for topical application 2%: bottle or dropper bottle 10 ml or 100 ml

Dosage Form, Packaging, and Composition

Solution for topical application 10 ml
Silver proteinate* 0.2 g

* Silver proteinate (Protargol substance powder) – 0.2 g or Silver proteinate (Protargol substance-solution) – 0.2 g (calculated as dry Protargol).

Excipients : purified water – up to 10 ml.

100 ml – polymer dropper bottles (1) – cardboard packs.
10 ml – polymer dropper bottles (1) – cardboard packs.
10 ml – polymer bottles (1) with a dropper stopper or dispenser – cardboard packs.
100 ml – polymer bottles (1) with a dropper stopper or dispenser – cardboard packs.

Marketing Authorization Holder

Forp, JSC (Russia)

Manufactured By

PharmVILAR NPO, LLC (Russia)

Dosage Form

Bottle OTC Icon Protargol Tablets for the preparation of a solution for topical application 200 mg: 1 pc. with a bottle with a dropper cap, in a kit with or without a solvent

Dosage Form, Packaging, and Composition

Tablets for the preparation of a solution for topical application from dark brown to black with a bluish tint, with uneven surface coloration, round, flat, with a score line.

1 tab.
Silver proteinate 200 mg

Solvent: water for injections – 10 ml (ampoules).

1 pc. – contour cell packaging (1) complete with solvent (amp. 10 ml 1 pc.) and a dark glass bottle with a capacity of 15 ml (1) with a dropper cap – cardboard packs.
1 pc. – contour cell packaging (1) complete with a dark glass bottle with a capacity of 10 ml (1) with a dropper cap – cardboard packs.

Table of Contents

→ TABLE OF CONTENTS