VIODIN (povidone-iodine) solution for skin 30 ml (with pipette cap)

Description

Who VIODIN is suitable for

A skin antiseptic based on povidone-iodine for situations when fast and reliable antiseptic treatment of the skin, mucous membranes, or wound surfaces is needed. Suitable for a home first-aid kit, medical office, and procedures where hand and skin hygiene is important.

When to choose VIODIN

The product is used for:

• antiseptic treatment of wounds and burns;
• hygienic and surgical hand disinfection;
• treatment of the skin and mucous membranes before procedures: injections, punctures, blood sampling, catheterization, etc.;
• first aid in case of accidental contamination of the skin with infected material.

What problem the product addresses

VIODIN works through povidone-iodine, which gradually releases iodine:

• Broad antimicrobial spectrum: acts against bacteria, viruses, fungi, and some protozoa.
• Fast effect: the main action occurs in the first seconds after application.
• Good tolerability: the PVP complex reduces the irritating effect typical of alcohol-based iodine solutions.
• Visual control: the brown color acts as an activity indicator: discoloration means reduced effectiveness.

Directions and special notes for use

• Use undiluted or diluted, depending on the purpose.
• For skin and hands before procedures, the undiluted solution is often used and left to dry.
• For wounds, burns, and certain procedures, dilutions are allowed — usually with saline or Ringer’s solution when wounds and burns are involved.
• Do not mix with hot water; only short-term warming to body temperature is allowed.
• When treating the skin, it is important not to leave puddles or excess solution under the body to avoid skin irritation.
• Long-term use or application to large areas requires caution, especially in thyroid diseases.

Compatibility and comprehensive care

• Do not combine simultaneously with certain antiseptics and products, in particular chlorhexidine, hydrogen peroxide, octenidine, etc., as they may reduce the effect or cause undesirable reactions.
• Do not combine with products containing mercury, silver, and certain other components that react with iodine.
• If there are thyroid problems or renal insufficiency, this is critically important to consider: there are contraindications.
• Stains are easily washed off with warm water and soap, including from fabrics.

Why choose VIODIN

• A powerful antiseptic with a broad spectrum of action.
• Suitable for hands, skin, wounds, and burns according to the relevant application regimen.
• Convenient for everyday use and medical procedures.
• Ukrainian manufacturer: PJSC FF “Viola”.

Composition:

active substance: povidone-iodine;

1 ml of the drug contains povidone-iodine 100 mg;

auxiliary substances: nonoxynol 9, glycerin, anhydrous citric acid, anhydrous sodium hydrogen phosphate, sodium hydroxide, purified water.

Medicinal form. Skin solution 100 mg/ml.

Main physicochemical properties: dark brown solution with the smell of iodine, does not contain suspended and precipitated particles.

Pharmacotherapeutic group. Antiseptic and disinfectants. Povidone-iodine.

ATX code D08A G02.

Pharmacological properties.

Pharmacodynamics.

Povidone-iodine is a complex of iodine and polyvinylpyrrolidone (PVP) polymer, which releases iodine for a certain time after it is applied to the skin. Elemental iodine has a strong bactericidal effect, has a wide spectrum of antimicrobial activity against bacteria, viruses, fungi and the simplest microorganisms.

Mechanism of action: free iodine has a rapid bactericidal effect, and the polymer is a depot for iodine.

Upon contact with the skin and mucous membranes, a significant amount of iodine is released from the polymer.

When forming a complex with PVP, iodine largely loses the local irritant effect inherent in alcohol solutions of iodine, so it is well tolerated by the skin, mucous membranes and affected surfaces.

Iodine reacts with oxidizing sulfide (SH–) and hydroxyl (OH–) groups of amino acids, which are part of enzymes and structural proteins of microorganisms, inactivating or destroying these proteins. Most microorganisms are destroyed in vitro in less than a minute, and the main destructive effect occurs in the first 15-30 seconds. At the same time, iodine is decolorized, in connection with which a change in the saturation of the brown color is an indicator of its effectiveness.

The active substance of VIODIN, a solution for the skin, has a wide antimicrobial spectrum of action: it acts on gram-positive and gram-negative bacteria (bactericidal), on viruses (virulicidal), on fungi (fungicidal) and fungal spores (sporicidal), as well as on some of the simplest microorganisms (antiprotozoan ).

Due to the mechanism of action, resistance to the drug, including secondary resistance with long-term use, is not expected.

The drug dissolves in water and is easily washed off with water.

Pharmacokinetics.

Long-term application of the drug to large wound surfaces or severe burns, as well as mucous membranes, can lead to the absorption of a significant amount of iodine. Usually, as a result of long-term use of the drug, the iodine content in the blood increases rapidly. The concentration returns to the initial level 7-14 days after the last use of the drug.

In patients with normal thyroid function, increasing iodine reserves does not cause clinically significant changes in thyroid hormone status.

Absorption and renal excretion of povidone-iodine depends on its molecular weight, and since it ranges from 35,000 to 50,000, retention of the substance is possible.

The volume of distribution corresponds to approximately 38% of body weight, the period of biological half-life after vaginal application is approximately 2 days. The normal total plasma iodine level is approximately 3.8-6 μg/dL, and the inorganic iodine level is 0.01-0.5 μg/dL.

The drug is excreted from the body mainly by the kidneys with a clearance of 15 to 60 ml/min depending on the level of iodine in the blood plasma and creatinine clearance (normally: 100-300 μg of iodine per 1 g of creatinine).

Clinical characteristics.

Indication.

Disinfection of hands and antiseptic treatment of mucous membranes, for example, before surgical operations, gynecological and obstetric procedures, bladder catheterization, biopsy, injections, punctures, blood sampling, and as first aid for accidental skin contamination with infected material.

Antiseptic treatment of wounds and burns.

Hygienic and surgical hand disinfection.

Contraindication.

Hypersensitivity to iodine or suspicion of it or hypersensitivity to other components of the drug.

Dysfunction of the thyroid gland (nodular colloid goiter, endemic goiter and Hashimoto’s thyroiditis).

The drug is contraindicated before treatment and after treatment and scintigraphy with radioactive iodine in patients with carcinoma of the thyroid gland.

During’s dermatitis herpetiformis.

Kidney failure.

Interaction with other medicinal products and other types of interactions.

The povidone-iodine complex is active against microorganisms at pH 2-7. Due to its oxidizing properties, povidone-iodine may interfere with the results of some diagnostic tests, such as the detection of occult blood in the stool or urine or glucose in the urine. When using povidone-iodine, the uptake of iodine by the thyroid gland may decrease, which may affect the results of some diagnostic tests (eg, thyroid scintigraphy, determination of protein-bound iodine, radioactive iodine measurement). Also, povidone-iodine can interact with iodine, which is used for thyroid therapy. Preparations containing mercury, silver, hydrogen peroxide or taurolidine can interact with the povidone-iodine complex, so their simultaneous use is not recommended. The drug can react with proteins and unsaturated organic complexes, so the effect of povidone-iodine can be compensated by increasing its dose.

The use of povidone-iodine simultaneously or immediately after use with antiseptics that contain octenidine can lead to the appearance of dark necrosis in the places where the drug is applied.

Povidone-iodine should not be used simultaneously with disinfectants containing chlorhexidine, hydrogen peroxide, taurolidine, silver sulfadiazine, mercury and alkalis, due to a possible partial decrease in the activity of the drug.

Simultaneous local application of povidone-iodine and benzoin tincture leads to a decrease in pH, which can cause a burning sensation, especially if the wound is bandaged.

Simultaneous use of povidone-iodine and lithium preparations can cause a synergistic hypothyroid effect.

Features of application.

The use of povidone-iodine can reduce the absorption of iodine by the thyroid gland, which can affect the results of some examinations and procedures (thyroid scintigraphy, determination of protein-bound iodine, diagnostic procedures with the use of radioactive iodine), in connection with which planning the treatment of thyroid disease iodine preparations may not be possible. After stopping treatment with povidone-iodine, it is necessary to take a break of at least 1-4 weeks.

The oxidizing effect of povidone-iodine can lead to false-positive results of diagnostic tests (for example, toluidine and guaiac tests for hemoglobin and glucose in feces and urine).

The oxidizing action of povidone-iodine can cause corrosion of metals, while plastic and synthetic materials are usually not sensitive to povidone-iodine. In some cases, a change in color can be observed, which usually recovers.

Povidone-iodine is easily removed from textiles and other materials with warm soapy water. Stains that are difficult to remove should be treated with a solution of ammonia or sodium thiosulfate.

The solution is not intended for internal use.

During preoperative disinfection of the skin, care should be taken to ensure that no residues of the solution remain under the patient (due to the possibility of skin irritation).

Since it is impossible to exclude the development of hyperthyroidism, long-term (more than 14 days) use of povidone-iodine or its use in significant quantities on large surfaces (more than 10% of the body surface) in patients (especially the elderly) with latent disorders of the thyroid gland function is permissible only after careful evaluation of the expected benefit and possible risk. The condition of such patients should be monitored for early signs of hyperthyroidism and proper examination of thyroid gland function, even after discontinuation of the drug (up to 3 months).

Discoloration of the solution indicates a decrease in the effectiveness of the medicinal product. Light and temperature above 40 oC accelerate the decay of the active substance of the medicinal product. The solution is intended for external use only.

Use during pregnancy or breastfeeding.

Povidone-iodine does not have a teratogenic effect. The drug is contraindicated for use after the 2nd month of pregnancy and during breastfeeding. Iodine penetrates the placental barrier and can enter breast milk. Breastfeeding should be stopped during the treatment period.

The ability to influence the speed of reaction when driving vehicles or other mechanisms.

Unknown

Method of application and dosage.

The drug is intended for external use in diluted and undiluted form. Do not mix the drug with hot water. Allow only short-term heating to body temperature.

Dosage

The undiluted solution of VIODIN is used to treat hands and skin before surgery, bladder catheterization, injections, and punctures.

The solution can be used 2-3 times a day.

Hygienic hand disinfection: 2 times 3 ml of undiluted solution, each dose of 3 ml remains on the skin for 30 seconds.

Surgical disinfection of hands: 2 times 5 ml of undiluted solution, each dose of 5 ml remains on the skin for 5 minutes.

To disinfect the skin, the undiluted solution is left to dry after its application.

According to the above indications, the solution can be used after dilution with tap water. During operations, as well as during antiseptic treatment of wounds and burns, 0.9% sodium chloride solution or Ringer’s solution should be used for dilution.

The following dilutions are recommended:

Indication	Dilution	Volume of drug/volume of solvent
Wet compress	1:5-1:10	200 ml–100 ml/1 l
Immersion and sitz baths	1:25	40 ml/1 l
Preoperative bath	1:100	10 ml/1 l
Hygienic bath	1:1000	10 ml/10 l
Vaginal douching Introduction intrauterine spiral Irrigation of the perineum Irrigation in urology	1:25	4 ml/100 ml
Irrigation of chronic and postoperative wounds	1:2-1:20	50 ml–5 ml/100 ml
Irrigation in orthopedics and traumatology Irrigation during operations in the oral cavity	1:10	10 ml/100 ml

The solution should be diluted immediately before use.

Children.

Newborns and children under 1 year of age should use povidone-iodine only for vital indications. It is necessary to monitor the function of the thyroid gland.

Overdose.

The following symptoms characterize acute iodine intoxication:

– metallic taste in the mouth, increased salivation, burning sensation or pain in the mouth or throat;

– irritation and swelling in the eyes;

– skin reactions;

– gastrointestinal disorders and diarrhea;

– impaired kidney function and anuria;

– lack of blood circulation;

– swelling of the larynx with secondary asphyxia, pulmonary edema, metabolic acidosis, hypernatremia.

Long-term treatment of burn wounds with significant amounts of povidone-iodine can provoke a violation of the electrolyte balance or osmolality of the blood serum with impaired kidney function or metabolic acidosis.

Treatment: Symptomatic and supportive therapy should be given with special attention to electrolyte balance, renal and thyroid function.

In case of intoxication caused by the accidental use of the medicinal product internally, the immediate introduction of food products containing starch or protein (such as a solution of starch in water or milk), gastric lavage with a 5% solution of sodium thiosulfate, and, if necessary, intravenous administration of 10 ml 10 % sodium thiosulfate solution at 3-hour intervals. Monitoring of thyroid function is indicated for early detection of iodine-induced hyperthyroidism.

Adverse reactions.

Research: changes in the level of blood serum electrolytes (hypernatremia) and osmolality, metabolic acidosis.

On the part of the kidneys and urinary system: impaired kidney function, acute renal failure.

From the side of the skin and subcutaneous tissues: local skin reactions of hypersensitivity, such as contact dermatitis with psoriasis-like red small bullous formations; allergic reactions, including itching, redness, rash, angioedema.

If these symptoms appear, you should stop using the medicine.

From the endocrine system: hyperthyroidism, hypothyroidism. Long-term use of povidone-iodine can lead to the absorption of large amounts of iodine.

In some cases, iodine-induced hyperthyroidism was observed, which occurred as a result of long-term use of the drug, mainly in patients with thyroid disease.

In some cases, generalized acute reactions with a decrease in blood pressure and/or difficulty breathing (anaphylactic reactions) are possible.

Expiration date. 2 years.

Storage conditions.

Store in the original packaging at a temperature not higher than 25 °C.

Keep out of the reach of children.

Packaging.

30 ml in a bottle, 1 bottle closed with a dropper cap, in a pack;

100 ml in a bottle, 1 bottle, closed with a nozzle and a lid, in a pack;

1000 ml each in a bottle closed with a lid.

Leave category. Without a prescription.

Producer.

PrJSC FF “Viola”.

The location of the manufacturer and the address of the place of its activity.

Ukraine, 69063, m. Zaporozhye, Akademika Amosova, 75.