Protargol
UkraineTable of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PROTAROL® (PROTARGOL)
Composition:
Active substance: silver proteinate;
1 vial contains 0.2 g of silver proteinate;
diluent in the kit — water for injections, 10 ml, or without diluent.
Pharmaceutical form. Powder for solution for intranasal use.
Main physicochemical properties: powder – yellowish-brown or brown light powder, hygroscopic, sensitive to light; diluent – clear, colorless liquid; reconstituted solution – brown liquid, opalescence may be present.
Pharmacotherapeutic group. Agents used in diseases of the nasal cavity. ATC code R01AX.
Pharmacological Properties.
Pharmacodynamics.
The medicinal product has astringent, antiseptic, and anti-inflammatory properties. Silver ions contained in the preparation exert a bactericidal and bacteriostatic effect on most gram-positive and gram-negative bacteria, such as Streptococcus pneumoniae, Staphylococcus aureus, Moraxella catarrhalis, and others, as well as on fungal flora. The mechanism of action of Protagol® is based on the formation of a protective film due to the precipitation of bacterial proteins by silver on the mucosa damaged by the infectious process, which in turn reduces the sensitivity of the mucous membranes to infectious agents, decreases the lumen of capillaries, and thereby inhibits inflammatory processes. In addition, Protagol® exerts a mild vasoconstrictive effect.
Pharmacokinetics.
When applied locally, Protagol® is poorly absorbed and therefore does not produce any systemic effects.
Clinical characteristics.
Indications.
As an astringent, antiseptic, anti-inflammatory and anti-edematous agent for the nasal mucosa.
Contraindications.
Hypersensitivity to the active substance.
Special precautions.
Avoid contact of the medication with the eyes.
Before use, apply a small amount of the medication to the skin in the area of the elbow bend to check for individual intolerance. If symptoms of individual intolerance occur (skin irritation, burning, itching), wash the application site thoroughly with large amounts of water. Discontinue use and consult a physician if necessary.
Follow the recommended dosage and method of administration. Silver-containing medications, when used excessively over a prolonged period, may cause argyria (pigmentation due to deposition of silver in tissues).
Interaction with other medicinal products and other forms of interaction.
Concomitant topical use with agents containing alkaloid salts and organic bases (e.g., adrenaline) is not recommended. Protargol® is pharmaceutically incompatible with zinc sulfate.
Special precautions for use.
Use during pregnancy or breastfeeding.
Prothargol® should not be used during pregnancy or breastfeeding, as there is insufficient data on the use of the medicinal product during these periods.
Ability to affect reaction speed when driving or operating machinery.
Not observed.
Method of Administration and Dosage
Intranasally as a 2% solution, which must be shaken before use.
Preparation of 2% Protargol® Solution Included with Solvent
Dissolve the contents of the vial in 10 mL of solvent (water for injections):
- Unscrew the cap from the vial containing the powder.
- Open the single-dose container with solvent (water for injections) by turning the upper part of the container counterclockwise.
- Completely pour the solvent into the vial with the powder.
- Screw the cap back onto the vial and shake until the drug is completely dissolved (8–10 minutes).
- Replace the cap with the dropper cap or nasal spray provided. The solution is now ready for use. After each use, cover the dropper or nasal spray with the protective cap.
Preparation of 2% Protargol® Solution Without Solvent, Included with Measuring Device (measuring tube or measuring cup)
Add freshly boiled and cooled to room temperature water to the vial with powder:
- Unscrew the cap from the vial containing the powder.
- Using the measuring device, measure 10 mL of freshly boiled and cooled to room temperature water (upper mark in the measuring tube or 10 mL in the measuring cup, depending on the kit) and add it to the vial with powder.
- Screw the cap back onto the vial and shake until the drug is completely dissolved (8–10 minutes).
- Replace the cap with the dropper cap or nasal spray provided. The solution is now ready for use. After each use, cover the dropper or nasal spray with the protective cap.
Vial with dropper cap
Before use, the dropper should be rinsed with warm water and inspected for damage. A damaged dropper must not be used.
After cleaning the nasal cavity, instill 1–3 drops of the 2% solution into each nostril 2–3 times daily for 5–10 days.
Vial with nasal spray
After cleaning the nasal cavity, insert the dispenser nozzle (nasal spray) into the nostril and press once. Administer the 2% solution as 1 spray into each nostril 2–3 times daily for 5–10 days.
Each actuation of the nasal spray delivers 0.12–0.13 mL (2–3 drops) of the solution, which constitutes a single dose.
Before first use, remove the protective cap and, by pressing the nasal spray periodically, ensure consistent spray performance. Avoid contact of the solution with clothing, as it may leave stains on fabric. During administration, the vial must be held in an upright position; do not tilt or tilt the head back.
Children
The medicinal product is recommended for children aged 3 years and older. The method of administration and dosage are the same as for adults.
Overdose
No cases of overdose with Protargol® have been reported.
However, prolonged uncontrolled use of the drug in large quantities may lead to its accumulation in the spleen, skin, and mucous membranes, resulting in gray-green or slate-colored pigmentation, especially in exposed areas of the body (argyria). UV radiation enhances pigmentation. The first signs of argyria during treatment with silver-containing drugs appear 2–4 years after the start of continuous, daily use: deposition of silver in connective tissue, capillary walls of various organs, including kidneys and bone marrow, is possible. Argyria may present with complaints of right upper quadrant pain, hepatomegaly, and reduced twilight vision.
Adverse reactions.
When used at recommended doses, Protargol® is generally well tolerated. Possible side effects include a burning sensation, itching, mild irritation of the mucous membrane at the site of application, and allergic reactions such as urticaria, anaphylactic shock, angioedema (Quincke's edema), and atopic dermatitis.
Prolonged use may cause argyria (see section "Overdose*").
Shelf life.
Powder for solution for intranasal use, 0.2 g — 3 years.
Solvent — Water for injections, 10 ml — 2 years.
Storage conditions.
Store in the original packaging, protected from light, at a temperature not exceeding 25 °C. Keep out of reach of children.
The prepared solution should be stored in a refrigerator for no more than 30 days (at a temperature of 2 to 8 °C).
Packaging.
0.2 g of powder in an amber glass vial, closed with a cap with a tamper-evident seal.
The vial with powder, a single-dose container with solvent (10 ml), and a dropper cap or nasal spray pump are packaged in a cardboard box.
The vial with powder, a measuring device (measuring tube or measuring glass), and a dropper cap or nasal spray pump are packaged in a cardboard box.
Classification by prescription requirement.
Over-the-counter (without prescription).
Manufacturer.
LLC "Istok-Plus".
Manufacturer's address and location of business activity.
4 Makarenko Street, Zaporizhzhia, 69032, Ukraine.