Safety of use of Protargol: shelf life before and after opening and storage conditions


Overdose

In case of overdose, which is associated with the accumulation of high concentrations of silver ions in the blood plasma, the skin may become discolored and slurred speech may occur. The accumulation of silver in the skin, mucous membranes, membranes and in the eyes, which is associated with long-term use of the drug, can cause allergies, a characteristic feature of which is the coloring of the skin in color from gray to dark blue, which is caused by the interaction of silver with various proteins and, as a result, , production of pigments. In addition, systemic symptoms may occur, such as hepatotoxicity, cardiomyopathy, amnesia, which are a consequence of the neurotoxicity process.

general information

Trade name: Protargol-ENT
International nonproprietary or generic name: silver proteinate

Dosage form: tablets for solution for topical use

Composition: Composition per tablet Active ingredient: silver proteinate (protargol) – 200.0 mg. Excipient: hydroxypropyl methylcellulose – 10.0 mg.

Description: round flat-cylindrical tablets from brown to dark brown or almost black with a bluish tint, uneven surface coloring, chamfered and scored.

Pharmacotherapeutic group: Antiseptic

ATX code: R01AX10

Pharmacological properties:

Pharmacodynamics When it enters the body, silver proteinate dissociates to form silver ions, which have an astringent, antiseptic and anti-inflammatory effect. Silver ions actively suppress the reproduction of infectious agents by binding their DNA. The mechanism of action is based on the fact that silver ions precipitate proteins on the damaged mucous membrane and form a protective film. At the same time, sensitivity decreases, blood vessels narrow (this leads to a decrease in swelling) and the inflammatory process is suppressed. Silver ions also inhibit the proliferation of various bacteria. Active against gram-positive and gram-negative bacteria: B.cereus, C.albicans, E.coli, P.aeruginosa. C.aureus, A.niger, S.abony, etc.

Pharmacokinetics: When applied topically, it is practically not absorbed.

Side effects: - allergic reactions: skin itching, irritation of the mucous membrane, urticaria; - burning sensation and numbness; - dry mouth; - redness of the eyes; - anaphylactic shock; - Quincke's edema; - atopic dermatitis. If any of the side effects indicated in the instructions worsen, the drug should be discontinued. If any of the side effects indicated in the instructions get worse or you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Symptoms: with the recommended method of use, an overdose is unlikely. Possible increased side effects. If a large amount of the drug is accidentally swallowed, irritation of the gastrointestinal tract may occur. With prolonged uncontrolled use of the drug, it is theoretically possible for a very rare disease to appear - argyrosis (gray or bluish discoloration of the skin and mucous membranes). If the recommended dosage regimen is followed, the risk of argyrosis is unlikely.

Treatment: in case of severe irritation, burning, itching of the eyes, skin, mucous membranes, rinse with plenty of water for 15 minutes. Treatment is symptomatic.

Interaction with other drugs Pharmacodynamic, pharmacokinetic interaction: not studied. Pharmaceutical interaction: salts of zinc, copper, lead, silver, mercury, iron, aluminum form insoluble precipitates with a solution of silver proteinate; silver proteinate solution is inactivated by alkaloid salts and organic bases (epinephrine). If you are using the above or other medications (including over-the-counter medications), consult your doctor before using Protargol - ENT.

Special instructions Nasal discharge may turn gray or blue. Read the instructions for use carefully before you start using the drug. Save the instructions, you may need them again. If you have any questions, consult your doctor. The medicine you are using is intended for you personally and should not be given to others as it may cause harm to them even if they have the same symptoms as you.

Effect of the drug on the ability to drive vehicles and machinery. The drug does not affect the ability to drive vehicles or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Conditions of release Dispensed without a prescription.

Shelf life: 2 years. Ready solution - 30 days. Do not use after the expiration date stated on the package.

Storage conditions In original packaging at a temperature not exceeding 25°C. Prepare the solution in a place protected from light at a temperature not exceeding 25°C. Keep out of the reach of children.

Owner of the registration certificate/Legal entity in whose name the registration certificate was issued OJSC Pharmstandard-Leksredstva 305022, Russia, Kursk, st. 2nd Aggregatnaya, 1a/18, (4712) 34-03-13, www.pharmstd.ru

Manufacturer/Organization accepting consumer complaints JSC Pharmstandard-Leksredstva 305022, Russia, Kursk, st. 2nd Aggregatnaya, 1a/18, tel./fax: (4712) 34-03-13.

Note!

Description of the drug Protargol drops. nasal/ear solution 2% fl. 10ml on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.

Rules for storing medicine

Storing medicine is a complex thing, which is carried out by specialists with pharmaceutical education. The antiseptic contains 8% of the chemical compound Ag2O, as well as ingredients that take part in protein hydrolysis.

The preparation of the composition is based on the ability of protein structures to penetrate into the solution through diffusion. In the room where the medicine is stored, temperature and humidity are maintained according to established standards.

The room where the drug is located can be equipped with air conditioning; second doors with bars are installed in it. The medicine should be stored on a rack, in a cabinet or on a special tray. The premises must be wet cleaned daily.

There should be a thermometer or hygrometer in the room where Protargol is located. Their testimony is recorded in a log kept for 12 months.

It is necessary to identify cabinets and shelves, racks that are used to store the drug.

On each shelf there is a special card in which Protargol is written under the corresponding serial number. It indicates the form of release of the medicine, the dose of the substance, the series of the drug, the expiration date, and the name of the manufacturer of the medicine.

Sometimes a drug is assigned a code.

Protargol, which has expired, is stored in a special room (in the quarantine zone). The equipped room must have a smooth floor covering. Storing medical products on the floor without a pallet is not permitted.

Conditions for storing the drug in pharmacies and clinics

The medical institution applies special rules for the maintenance of medications. An anti-inflammatory agent that has an antiseptic effect on the patient’s body, destroys the DNA of dangerous bacteria.

A high concentration of the drug affects healthy cells throughout the body.

In the clinic, the medicine is stored in dark glass containers.

A small container fits in the refrigerator. After opening the bottle, health workers determine the expiration date of the medicinal substance. The drug is protected from the ingress of unknown substances and excess moisture, exposure to bright light.

If the medicine has been left overnight in a lighted room, it must be disposed of.

In clinical practice, silver preparations are stored according to special instructions from the Ministry of Health, since silver ions react with enzymes in human cells. Radicals appear that destroy genetic material.

Silver restores the regeneration process in the wound. The wide spectrum of antibacterial action of the drug is manifested only if it has been stored correctly.

The medication is stored with extreme caution in a hospital or clinic. The classic product containing silver has clusters and nanoparticles; their large or medium size reduces the stability of the solution, which has a short shelf life.

The medicine must be kept in a dark place, since silver ions are quickly reduced when exposed to light. Storage conditions affect the toxicity of the drug.

How to properly store at home

Colloidal metallic silver in the finished solution produces a practically harmless drug if it is stored in accordance with the instructions.

At home, the unopened bottle is stored in a special wall cabinet, in a cool, dark place.

Proper storage determines the active bactericidal effect of the drug, for example, on the intestinal microflora (dysbacteriosis does not occur, pathogenic microorganisms die). The drug does not accumulate in the patient's body. The medication is removed through the kidneys after 7 days.

Proper storage of Protargol allows you to use the medicine at home if:

  • infected wound;
  • abscess;
  • boil;
  • abrasions;
  • bruise;
  • burn;
  • stomatitis;
  • conjunctivitis;
  • HIV infections;
  • flu;
  • ARVI.

Protargol, as a colloidal silver preparation, requires proper storage, and when the prescribed conditions change, it changes its properties, which can cause unwanted side effects, central nervous system depression, and disruption of the digestive system.

How to store Protargol after opening

After opening the bottle, Protargol must be stored for 30 days in a dark place, at a temperature not exceeding +25˚С. At the pharmacy, the pharmacist will give accurate information about the timing and methods of storing the opened package.

Some doctors advise keeping the bottle of the drug in a cool place. In a pharmacy, all freezers must comply with the conditions of Art. General Pharmacopoeia Monograph 1.1.0010.15 “Content of Medicines”.

The relative humidity for an open bottle should not exceed 60% and correspond to climatic conditions. If the medication is placed in a household refrigerator, it is necessary to install 2 temperature measuring devices. A household refrigerator must be equipped with a temperature recorder that records readings 2 times a day.

The contents of an opened bottle of Protargol may change color due to non-compliance with the rules for storing the medication. The drug is considered spoiled and must be destroyed.

Precautions should be taken to prevent dust from contaminating the contents of the vial. The spoiled drug must be disposed of; in the pharmacy it will be placed in a special bag marked “Class G waste”.

Shelf life of Protargol

The shelf life of Protargol is 24 months, but an open bottle should not be kept in the refrigerator for more than 30 days. Spray for children is used as a treatment for ENT diseases.

The shelf life of Protargol in aerosol form is 2-3 months. The drug is stored for 30 days. Sialor 2% solution can be stored in the cold.

If, a few days after opening the bottle while taking the medicine, the patient develops symptoms of individual intolerance to the drug, it is necessary to stop taking it and consult a doctor.

Sialor for runny nose drops is prepared immediately before use and used in accordance with the instructions. The solution is stored in the refrigerator.

Silver proteinate has a shelf life of 1 month after opening the bottle if it is used for the treatment of ENT diseases. This medicine is difficult to obtain, because it has a limited release in the pharmacy and a short shelf life of an already opened package of medicine. The composition of the contents of the vial changes quickly, in just 2 weeks. In dry form, the tablets are stored for a long time.

The colloidal composition of Protargol contains silver oxide; under the influence of sunlight, a change in the products of protein hydrolysis is observed, and the drug turns into metallic silver. Therefore, 30 days is the maximum “life” of the drug.

Additional factors affecting product quality

Before starting medication treatment, you must familiarize yourself with the rules for storing the medication.

When using a popular and effective remedy, you need to remember the following facts:

  1. The drug is released in dark glass containers. If the pharmacist offers the medicine in a different package, it is better to refuse the purchase and purchase the medicine at another pharmacy.
  2. Protargol, presented on the medical market in the form of a powdery substance, is stored no longer than the liquid form of the drug. The powder must be placed in a dry and cool room. If the contents of the bag become wet, it is discarded.
  3. If you prepare the liquid composition yourself, you must carefully study all the details of the process. You should prepare glassware in advance (boil a plate and spoon). Water is heated in a porcelain teapot.
  4. Sialor is packaged in bottles made of dark material with well-closing lids. The products are placed on the bottom shelf of the refrigerator. Before use, the contents of the bottle should be shaken slightly.

You should not self-medicate, because Protargol can cause severe poisoning. An inaccurate dose of the drug taken by the patient will cause an increase in the symptoms of the pathological process, which will lead to dangerous consequences.

What determines the shelf life?

You can store a product manufactured on an industrial scale for much longer than in a pharmacy. This is achieved by the presence in the drug of substances that slow down oxidation processes.

To establish the time of permissible use of the solution, compliance with aseptic conditions during its manufacture is important. The drug prepared using different technologies has differences in storage modes . This time for solutions made at home increases to 30 days due to storage at a temperature of 2 to 8 degrees.

When making your own solution, you must use a sterile bottle and water for injection from the preparation kit. Otherwise, the equipment must be subjected to heat treatment and boiled water must be prepared.

Shelf life of the solution

Protargol has a short shelf life, therefore it is classified as an extemporaneous drug. These dosage forms are prepared as needed by pharmacies with a manufacturing department. Factory analogues of the drug have already appeared.

The patient is asked to prepare the product himself from the active substance and water for injection included in the kit. There are pharmaceutical companies that produce the drug in liquid form on an industrial scale. Various forms of release of the drug have features in storage modes .

In a closed package

  • The product prepared in a pharmacy can be stored for no more than 30 days.
  • Pharmaceutical companies produce Protargol with a period of use of two years. This long shelf life is due to the presence in the formulation of a number of auxiliary ingredients that ensure the stability of the drug.
  • Medicine prepared from Protargol tablets or powder at home can be used for one month.

After opening

Opening the primary packaging causes a violation of the sterility of the substance, the occurrence of oxidation processes of the ingredients, and the gradual destruction of the active substance. This results in a change in storage time. After opening the bottle for the first time, the medicine can be used for 15 days.

A drug prepared by the patient independently, taking into account the specifics of the formulation and storage conditions, is acceptable for use for 30 days.

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