Instructions Protargol powder for solution for intranasal use bottle 0.2 g with nasal spray No. 1
Composition
active ingredient: silver proteinate;
1 bottle contains 0.2 g of silver proteinate;
solvent included in the kit - water for injection, 10 ml.
Dosage form
Powder for intranasal solution.
The main physical and chemical properties: powder – yellow-brown or brown light powder, hygroscopic, sensitive to light; solvent - transparent, colorless liquid; the reconstituted solution is a brown liquid, opalescence is allowed.
Pharmacotherapeutic group
Means used for diseases of the nasal cavity. ATX code R01AX.
Pharmacological properties
Pharmacodynamics
The drug has astringent, antiseptic and anti-inflammatory properties. Silver ions, which are part of the drug, have 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 basis of the action of Protargol® is the formation of a protective film due to the deposition of silver on bacterial proteins on the mucous membrane damaged by the infectious process, which, in turn, helps to reduce the sensitivity of the mucous membranes to infectious agents, reduces the lumen of capillaries, thereby inhibiting inflammatory processes. In addition, Protargol® has a mild vasoconstrictor effect.
Pharmacokinetics
When applied topically, Protargol® is poorly absorbed, therefore it does not have a general systemic effect.
Indication
As an astringent, antiseptic, anti-inflammatory and decongestant for the nasal mucosa.
Contraindication
Increased individual sensitivity to the active substance.
Special safety precautions
Do not allow the drug to get into the eyes.
Before use, apply a small amount of the drug to the skin in the elbow bend to detect individual intolerance. If symptoms of individual intolerance occur (irritation, burning, itching of the skin), rinse the application site with plenty of water. Discontinue use and consult a doctor if necessary.
Follow the recommended doses and method of administration. Silver preparations, if used excessively over a long period of time, can cause argyria (pigmentation caused by silver deposition in tissues).
Interaction with other medicinal products and other types of interactions
Simultaneous topical application of products containing alkaloid salts and organic bases (adrenaline) is not recommended. Protargol® is pharmaceutically incompatible with zinc sulfate.
Ability to influence reaction speed when driving vehicles or other mechanisms
Not detected.
Use during pregnancy or breastfeeding
Protargol® should not be used during pregnancy or breastfeeding, as there is insufficient data on the use of the drug during these periods.
Method of administration and doses
Intranasally in the form of a 2% solution, which must be shaken before use.
Method of preparing 2% Protargol® solution
Dissolve the contents of the vial in 10 ml of solvent (water for injections):
Unscrew the cap on the powder vial. Open the single-dose container with the solvent (water for injections) by turning the top of the container counterclockwise. Pour the solvent completely into the powder vial. Screw the cap on 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 ready for use. After each use of the drug, close the dropper or nasal spray with the protective cap.
Bottle with dropper cap
Before use, the dropper should be rinsed with warm water and checked for damage. A damaged dropper should not be used.
After cleaning the nasal cavity, instill 1–3 drops of a 2% solution into each nasal passage 2–3 times a day for 5–10 days.
Nasal spray bottle
After cleaning the nasal cavity, the nozzle of the dispenser (nasal spray) should be inserted into the nasal passage and pressed once. A 2% solution of the drug should be applied 1 spray into each nasal passage 2–3 times a day for 5–10 days.
With each press, the nasal spray sprays 0.12–0.13 ml (2–3 drops) of the drug, which is a single dose.
Before the first use, remove the protective cap and, by periodically pressing the nasal spray, ensure a stable spray. Avoid contact of the drug with clothing, as the solution may leave stains on the fabric. During use, the bottle should be in an upright position, so you should not tilt or throw your head back.
Children
The medicine is recommended for children aged 3 and over. The method of administration and dosage are the same as for adults.
Overdose
However, with prolonged uncontrolled use of the drug in large quantities, the latter may accumulate in the spleen, skin, mucous membranes, which gives them a gray-green or aspid color, especially on exposed areas of the body (argyria). UV rays increase pigmentation. The first signs of argyria in treatment with silver preparations appear 2–4 years after the start of constant daily use of the drug: silver may be deposited in the connective tissue, capillary walls of various organs, including the kidneys, bone marrow. Argyria is accompanied by complaints of pain in the right hypochondrium, liver enlargement, and decreased visual acuity at dusk.
Adverse reactions
When the recommended doses are observed, Protargol® is usually well tolerated. A burning sensation, itching, mild irritation of the mucous membrane at the site of exposure and allergic reactions in the form of urticaria, anaphylactic shock, Quincke's edema, atopic dermatitis are possible.
Prolonged use may cause argyria (see section "Overdose").
Expiration date
2 years.
Storage conditions
Store in the original packaging to protect from light at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Store the prepared solution in the refrigerator for no more than 30 days (at a temperature of 2 to 8 °C).
Packaging
0.2 g of powder in an orange glass bottle, closed with a tamper-evident cap. A bottle with powder and a dropper cap or nasal spray in a cardboard box.
Vacation category
Without a prescription.
Producer
OOO "Istok-Plus".
Location of the manufacturer and its business address
Ukraine, 69032, Zaporizhia, Makarenka St., 4.
