Pharmacological properties
PVPiodine 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 bactericidal effect, has a broad spectrum of antimicrobial activity against bacteria, viruses, fungi and protozoa.
Mechanism of action: free iodine has 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.
Iodine reacts with the oxidative-sulfide (SH) and hydroxyl (OH) parts 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 1 min, and the main destructive effect occurs in the first 15-30 s. 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 Ranostop has a wide antimicrobial spectrum of action, namely - it acts on gram-positive and gram-negative bacteria (bactericidal), on viruses (virulicidal), on fungi (fungicidal) and fungal spores (sporocidal), as well as on some simple microorganisms (antiprotozoal). Due to the mechanism of action, resistance to the drug, including secondary resistance with prolonged use, is not expected.
The drug is soluble in water and is easily washed off with water.
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 prolonged 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 stores does not cause clinically significant changes in thyroid hormonal status.
The absorption of PVPiodine or iodide is the same as that of regular iodine from other sources.
The volume of distribution corresponds to ≈38% of body weight, T ½ after vaginal administration is ≈2 days. The normal total iodine level in blood plasma is ≈3.8-6 μg/dl, and the level of inorganic iodine 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 (normal - 100-300 mcg of iodine per 1 g of creatinine).
Indication
Prevention of infections in minor cuts and abrasions, minor burns and minor surgical procedures. Treatment of fungal and bacterial skin infections, as well as infected bedsores and trophic ulcers.
Application
Drug for topical use. For the treatment of infection: apply 1-2 times a day. Duration of treatment ≤14 days.
For prevention of infection: apply 1-2 times a week, as needed. Clean and dry the affected skin, then apply a thin layer of ointment to the damaged skin surface. You can apply a bandage to the treated skin.
Contraindication
Hypersensitivity to iodine or any other component of the drug, hyperthyroidism, adenoma or dysfunction of the thyroid gland (nodular colloid goiter, endemic goiter and Hashimoto's thyroiditis), dermatitis herpetiformis of Duhring, the period before and after radioactive iodine therapy, renal failure.
Side effects
Investigations: changes in plasma 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.
Endocrine system: hyperthyroidism. Prolonged use of povidone-iodine may lead to absorption of large amounts of iodine.
In some cases, iodine-induced hyperthyroidism resulting from prolonged use of the drug has been described, mainly in patients with existing thyroid disease.
In some cases, generalized acute reactions with a decrease in blood pressure and/or difficulty breathing (anaphylactic reactions) are possible.
Special instructions
The drug is intended for topical use only.
Prolonged use may cause irritation and sometimes severe reactions. If signs of irritation or hypersensitivity appear, application of the drug should be discontinued.
The use of Ranostop may reduce the absorption of iodine by the thyroid gland, which may affect the results of some examinations and procedures (thyroid scintigraphy, determination of protein-binding iodine, diagnostic procedures using radioactive iodine), and therefore planning treatment for thyroid diseases with iodine preparations may be impossible. It is necessary to take a break from the use of Ranostop for at least 1-4 weeks.
With prolonged use on large areas of skin (e.g. large burns or wounds), a significant amount of iodine may be absorbed, which may lead to hyperthyroidism in susceptible patients. A large area of skin (i.e. 10% of the body surface area) and a treatment duration of 14 days are considered long-term treatment.
Iodine absorption is individual for each patient, so there are no exact recommendations. Thyroid function tests, as well as doctor's recommendations, are crucial in this case.
If symptoms of hyperthyroidism occur during treatment, thyroid function should be checked.
Regular use of the ointment should be avoided in patients receiving lithium preparations.
The oxidizing effect of Ranostop can cause corrosion of metals, while plastic and synthetic materials are usually not sensitive to povidone-iodine. In some cases, discoloration is possible, usually reversible. Ranostop is easily removed from textiles and other materials with warm soapy water. Stains that are difficult to remove should be treated with ammonia solution or sodium thiosulfate.
The oxidizing effect of povidone-iodine may lead to false-positive results of diagnostic tests (e.g. toluidine and guaiac tests for hemoglobin and glucose in feces and urine).
Pregnancy and breastfeeding. Do not use the drug in the 2nd and 3rd trimesters of pregnancy and during breastfeeding.
Ability to influence the speed of reaction when driving vehicles or working with mechanisms. The drug does not affect the ability to drive vehicles and perform other activities that require increased concentration of attention and speed of psychomotor reactions.
Children. Do not use the ointment to treat children under 1 year of age.
Interactions
The povidone-iodine complex is active against microorganisms at pH 2-7.
Proteins and other organic compounds reduce its activity.
The simultaneous use of Ranostop and enzyme ointments for wound treatment reduces the effectiveness of both drugs. Drugs containing mercury, silver, hydrogen peroxide or taurolidine may interact with the povidone-iodine complex, and therefore their combined use is not recommended.
WARNING!
Due to its oxidizing properties, povidone-iodine may affect the results of some diagnostic tests, such as the detection of occult blood in stool or urine, or glucose in urine.
When using PVIod, iodine uptake by the thyroid gland may be reduced, which may affect the results of some diagnostic tests (e.g. thyroid scintigraphy, protein-bound iodine determination, radioactive iodine measurement) or may interfere with iodine used for therapy of thyroid disease.
Thyroid scintigraphy should be performed after discontinuation of long-term therapy for 1-2 weeks to obtain reliable results.
Overdose
Acute iodine intoxication is characterized by the following symptoms: metallic taste in the mouth, increased salivation, a feeling of heartburn or pain in the mouth and throat; irritation and swelling of the mucous membrane of the eyes; skin reactions; disorders of the gastrointestinal tract; impaired renal function and anuria; circulatory failure; laryngeal edema with secondary asphyxia, pulmonary edema, metabolic acidosis, hypernatremia.
Treatment: symptomatic and supportive therapy, accompanied by special attention to electrolyte balance, renal function and thyroid gland.
Storage conditions
At a temperature not exceeding 25 °C.
