Instructions Povidone-iodine Vayum cutaneous solution 100 mg/ml bottle 100 ml
Composition
active ingredient: povidone-iodine;
100 ml of solution contain 10.0 g of povidone-iodine;
Excipients: glycerin, purified water.
Dosage form
The solution is topical.
Main physicochemical properties: brown solution with a characteristic odor of iodine.
Pharmacotherapeutic group
Antiseptics and disinfectants. Povidone-iodine.
ATX code D08A G02.
Pharmacological properties
Pharmacodynamics
Povidone-iodine is a complex of iodine and polyvinylpyrrolidone polymer, which releases iodine over a period of time after application to the skin. Elemental iodine has a strong bactericidal effect, has a wide spectrum of antimicrobial activity against bacteria, viruses, fungi and protozoa.
Mechanism of action: free iodine exhibits a rapid bactericidal effect, and the polymer is a depot for iodine.
Upon contact with skin and mucous membranes, a significant amount of iodine is released from the polymer.
When complexed with polyvinylpyrrolidone (PVP), iodine largely loses the local irritant effect inherent in alcoholic iodine solutions, and is therefore well tolerated by the skin, mucous membranes, and affected surfaces.
Iodine reacts with oxidative sulfide (SH) and hydroxyl (OH) groups of amino acids that are part of enzymes and structural proteins of microorganisms, inactivating or destroying these proteins. Most microorganisms are destroyed by in vitro action in less than a minute, and the main destructive effect occurs in the first 15–30 seconds. In this case, iodine is discolored, and therefore a change in the saturation of the brown color is an indicator of its effectiveness.
The active substance of the drug has a broad antimicrobial spectrum of action, namely: 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 protozoan microorganisms (protozoal).
Due to the mechanism of action, resistance to the drug, including secondary resistance with long-term use, is not expected.
The medicine dissolves in water and is easily washed off with water.
Pharmacokinetics
Prolonged 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. As a rule, 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 application.
In patients with normal thyroid function, increasing iodine stores does not cause clinically significant changes in thyroid hormonal status.
The absorption and renal excretion of povidone-iodine depends on its molecular weight, and since it varies between 35,000 and 50,000, retention of the substance is possible.
The volume of distribution corresponds to approximately 38% of body weight, the biological half-life after vaginal administration is about 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 mcg of iodine per 1 g of creatinine).
Indication
For hygienic and surgical hand disinfection and antiseptic treatment of skin and mucous membranes, e.g. before surgical operations, gynecological and obstetric procedures, bladder catheterization, biopsy, injections, punctures, blood sampling, as well as in case of accidental contamination of the skin with infected material (as a first-line measure). For antiseptic treatment of wounds and burns.
Contraindication
Hypersensitivity to iodine or suspected hypersensitivity to other components of the drug; dermatitis herpetiformis; thyroid dysfunction (nodular colloid goiter, endemic goiter and Hashimoto's thyroiditis); period before and after treatment and scintigraphy with radioactive iodine in patients with thyroid carcinoma; renal failure.
The drug is contraindicated for use after the 2nd month of pregnancy and during breastfeeding.
Interaction with other medicinal products and other types of interactions
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 be reduced - this may interfere with the results of some diagnostic tests (e.g. thyroid scintigraphy, determination of protein-bound iodine, measurement of radioactive iodine). Interaction with iodine used for thyroid therapy is also possible.
The use of povidone-iodine simultaneously with or immediately after the use of antiseptics containing octenidine may lead to the appearance of dark necrosis at the site of application of the drug.
The drug can react with proteins and unsaturated organic complexes, so the decrease in the effect of povidone-iodine can be compensated by increasing its dose.
Simultaneous topical application of povidone-iodine and benzoin tincture results in a decrease in pH, which may cause a burning sensation, especially if the wound is bandaged.
Concomitant use of povidone-iodine and lithium preparations may cause a synergistic hypothyroid effect.
Application features
The use of povidone-iodine may reduce the uptake of iodine by the thyroid gland, which may affect the results of some examinations and procedures (thyroid scintigraphy, determination of protein-bound iodine, diagnostic procedures using radioactive iodine), and therefore the treatment of thyroid disease with iodine preparations may not be possible. After stopping treatment with povidone-iodine, a break of at least 1-4 weeks is required.
The drug should not be used in patients before or after treatment of thyroid cancer with radioactive iodine or radioactive iodine scintigraphy.
Significant amounts of iodine can cause hyperthyroidism in patients with thyroid dysfunction (e.g., nodular colloid goiter, endemic goiter). Therefore, they should limit the use of the drug in terms of time and surface area treated. Even after the end of treatment, it is necessary to monitor the appearance of early symptoms of hyperthyroidism and monitor thyroid function.
The oxidizing effect of povidone-iodine may cause false-positive results in diagnostic tests (e.g. 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 generally insensitive to povidone-iodine. In isolated cases, a discoloration of povidone-iodine may occur, which is usually reversible.
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.
During preoperative skin disinfection, care should be taken to ensure that there are no solution residues under the patient's body (due to the possibility of skin irritation).
Since the development of hyperthyroidism cannot be excluded, long-term (more than 14 days) use of povidone-iodine or its application in significant quantities to large surfaces (more than 10% of the body surface) in patients (especially the elderly) with latent thyroid dysfunction should be considered only after careful assessment of the ratio of expected benefits and possible risks. Such patients should be monitored for early signs of hyperthyroidism and appropriate examination of thyroid function, even after discontinuation of the drug (for a period of up to 3 months).
In newborns and children under 1 year of age, povidone-iodine should be used only under strict indications. If necessary, thyroid function should be monitored.
Light and temperatures above 40 °C accelerate the breakdown of the active ingredient of the drug.
In the case of oropharyngeal use, pneumonitis may occur.
The solution is intended for external use only.
Use during pregnancy or breastfeeding
Povidone-iodine is not teratogenic. The drug is contraindicated for use after the 2nd month of pregnancy and during breastfeeding. Iodine crosses the placental barrier and can enter breast milk. The level of the drug in breast milk exceeds the level in blood plasma. There is a risk of transient hypothyroidism of the newborn in case of ingestion into the gastrointestinal tract of the child. Breastfeeding should be discontinued during treatment.
The ability to influence the speed of reactions when driving vehicles or other mechanisms
Unknown.
Method of administration and doses
The medicinal product is intended for external use in diluted and undiluted form.
Do not mix the drug with hot water. Only brief heating to body temperature is permissible.
Dosage.
The undiluted solution is used to treat the patient's 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 hand disinfection
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 application.
According to the above indications, the solution can be used after dilution with tap water. During operations, as well as for 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 the drug / volume of dilution solution |
| Wet compress | 1:5 – 1:10 | 200 ml – 100 ml / 1 l |
| Sitz baths | 1:25 | 40 ml / 1 l |
| Preoperative bath | 1:100 | 10 ml / 1 l |
| Hygienic bath | 1:1000 | 10 ml / 10 l |
| Insertion of an intrauterine device (IUD) Perineal irrigation 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 oral surgery | 1:10 | 10 ml / 100 ml |
The solution should be diluted immediately before use.
Children.
In newborns and children under 1 year of age, povidone-iodine should be used only under strict indications. If necessary, thyroid function should be monitored.
Overdose
The following symptoms are characteristic of acute iodine intoxication:
– metallic taste in the mouth, increased salivation, heartburn or pain in the mouth or throat;
– eye irritation and swelling;
– skin reactions;
– gastrointestinal disorders and diarrhea;
– renal dysfunction and anuria;
– circulatory failure;
– laryngeal edema with secondary asphyxia, pulmonary edema, metabolic acidosis, hypernatremia. Long-term treatment of burn wounds with significant amounts of povidone-iodine can provoke electrolyte imbalance or serum osmolarity with impaired renal function or metabolic acidosis.
Treatment: Symptomatic and supportive therapy should be administered with special attention to electrolyte balance, renal function, and thyroid function.
In case of intoxication caused by oral administration, immediate administration of food containing starch or protein (such as starch solution in water or milk), gastric lavage with 5% sodium thiosulfate solution, and if necessary, intravenous administration of 10 ml of 10% sodium thiosulfate solution at 3-hour intervals is indicated. Monitoring of thyroid function is indicated for early detection of iodine-induced hyperthyroidism.
Adverse reactions
Investigations: changes in serum electrolyte levels (hypernatremia) and osmolarity, metabolic acidosis.
Renal and urinary disorders: renal dysfunction, acute renal failure.
Skin and subcutaneous tissue disorders: local skin hypersensitivity reactions such as contact dermatitis with the formation of psoriasis-like red small bullous lesions; allergic reactions including itching, redness, rash, angioedema. Chemical skin burns. If these signs occur, the drug should be discontinued.
Endocrine system: hyperthyroidism, hypothyroidism. Prolonged use of povidone-iodine may lead to absorption of large amounts of iodine.
In some cases, iodine-induced hyperthyroidism has been described, resulting from prolonged use of the drug, mainly in patients with pre-existing thyroid disease.
In some cases, generalized acute reactions with a decrease in blood pressure and/or difficulty breathing (anaphylactic reactions) are possible.
Expiration date
3 years.
Do not use the medicine after the expiry date stated on the packaging.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
30 ml, 50 ml, 100 ml in a bottle, 50 ml in a bottle with a sprayer; 1 bottle in a pack.
500 ml in a bottle.
Vacation category
Without a prescription.
Producer
LLC "ELADUM PHARMA".
ELADUM PHARMA SRL.
Address
MD-3715, Str. Centenarului, No. 2/s, Cojusna village, Streseni district, Republic of Moldova.
MD-3715, Centenarului street, no. 2/c, Cojusna village, Straseni district, Republic of Moldova.
Applicant
LLC "VAYUM-PHARM".
Applicant's location
Ukraine, 04060, Kyiv, Yu. Glushka St., building 7A, apt. 1.
