Instructions Betavid cutaneous solution 100 mg/ml bottle 30 ml
Composition
active ingredient: povidone-iodine;
1 ml of the drug contains povidone-iodine 100 mg;
excipients: nonoxynol 9, glycerin, citric acid anhydrous, sodium hydrogen phosphate anhydrous, sodium hydroxide, purified water.
Dosage form
Transdermal solution 100 mg/ml.
Main physicochemical properties: dark brown solution with an iodine odor, free from suspended and precipitated particles.
Pharmacotherapeutic group
Antiseptics and disinfectants. Povidone-iodine.
ATX code D08A G02.
Pharmacological properties
Pharmacodynamics.
Povidone-iodine is a complex of iodine and the polymer polyvinylpyrrolidone (PVP), which releases iodine over a period of time after application to the skin. Elemental iodine has a strong bactericidal effect, has a broad 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 forming a complex with PVP, iodine largely loses the local irritant effect inherent in alcoholic solutions of iodine, therefore 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 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 ingredient of the drug BETAVID, a cutaneous solution, has a broad 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 protozoan microorganisms (antiprotozoal).
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.
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. 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 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 35,000-50,000, 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 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 (normal: 100-300 mcg of iodine per 1 g of creatinine).
Indication
Hand disinfection and antiseptic treatment of mucous membranes, for example before surgical operations, gynecological and obstetric procedures, bladder catheterization, biopsy, injections, punctures, blood sampling, as well as as first aid for accidental contamination of the skin with infected material.
Antiseptic treatment of wounds and burns.
Hygienic and surgical hand disinfection.
Contraindication
Hypersensitivity to iodine or suspected hypersensitivity to other components of the drug.
Thyroid dysfunction (nodular colloid goiter, endemic goiter and Hashimoto's thyroiditis).
Hyperthyroidism or other acute thyroid disorders.
The drug is contraindicated before and after treatment and radioactive iodine scintigraphy in patients with thyroid carcinoma.
During's dermatitis herpetiformis.
Kidney failure.
Interaction with other medicinal products and other types of interactions
Povidone-iodine complex is active against microorganisms at pH 2-7. Having oxidizing properties, povidone-iodine may affect the results of some diagnostic tests, such as the detection of occult blood in feces or urine or glucose in urine. When using povidone-iodine, iodine uptake by the thyroid gland may decrease, which may affect the results of some diagnostic tests (e.g., thyroid scintigraphy, determination of protein-bound iodine, measurement of radioactive iodine). Povidone-iodine may also interfere with iodine used for thyroid therapy. Drugs containing mercury, silver, hydrogen peroxide or taurolidine may interact with povidone-iodine complex, therefore their combined use is not recommended. The drug may react with proteins and unsaturated organic complexes, therefore the effect of povidone-iodine may be compensated by increasing its dose.
The use of povidone-iodine simultaneously with or immediately after use with antiseptics containing octenidine may lead to the appearance of dark necrosis at the application sites.
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 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 planning the treatment of thyroid disease with iodine preparations may be impossible. 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).
Even after treatment is completed, it is necessary to monitor for the appearance of early symptoms of hyperthyroidism and monitor thyroid function.
The oxidizing effect of povidone-iodine may lead to 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 may cause corrosion of metals, while plastic and synthetic materials are generally not sensitive to povidone-iodine. In isolated cases, discoloration 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 ammonia solution or sodium thiosulfate.
The solution is not intended for internal use.
During preoperative skin disinfection, care should be taken to ensure that no solution remains under the patient (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 use in significant quantities on 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 expected benefit and possible risk. Such patients should be monitored for early signs of hyperthyroidism and appropriate thyroid function testing should be performed, even after discontinuation of the drug (up to 3 months).
In the case of oropharyngeal use, pneumonitis may occur.
Discoloration of the solution indicates a decrease in the effectiveness of the drug. Light and temperatures above 40 ° C accelerate the decomposition of the active substance of the drug. The solution is intended for external use only.
Use during pregnancy or breastfeeding
Povidone-iodine should be used only when strictly prescribed by a doctor, but in the lowest possible doses. Iodine crosses the placental barrier and can enter breast milk, so there may be a risk of hypersensitivity of the fetus or newborn to iodine. The level of povidone-iodine is higher in breast milk than in blood serum. Therefore, the drug may cause hyperthyroidism or increased levels of thyroid hormone in the fetus or newborn. There is a need to check thyroid function in children.
The drug is contraindicated for use after the 2nd month of pregnancy and during breastfeeding. Breastfeeding should be discontinued during treatment.
Ability to influence reaction speed when driving vehicles or other mechanisms
Unknown.
Method of administration and doses
The drug is intended for external use in dissolved and undiluted form. The drug should not be mixed with hot water. Only short-term heating to body temperature is permissible.
The undiluted solution of BETAVID 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 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:
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, intrauterine device insertion, perineal irrigation, urological irrigation - 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 surgeries - 1:10: 10 ml/100 ml.
The solution should be diluted immediately before use.
Children.
Povidone-iodine can be used in newborns and children under 1 year of age only under strict indications.
High doses of iodine should be avoided in neonates and young children, as their skin is more permeable and they are more likely to be hypersensitive to iodine, which increases the risk of developing hyperthyroidism. Povidone-iodine should be used in small doses in such patients. If necessary, monitor thyroid function in children.
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;
irritation and swelling in the eyes;
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 may cause 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 accidental oral administration of the drug, 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
Immune system disorders: hypersensitivity, anaphylactic reactions.
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, exfoliative dermatitis, dry skin, chemical and thermal skin burns.
Endocrine system: hyperthyroidism (sometimes with symptoms such as tachycardia or anxiety); hypothyroidism.
Metabolism and nutrition disorders: electrolyte imbalance, metabolic acidosis.
Prolonged use of povidone-iodine may result in the absorption of large amounts of iodine.
In some cases, iodine-induced hyperthyroidism resulting from long-term 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.
Investigations: changes in serum electrolyte levels (hypernatremia) and osmolarity, metabolic acidosis.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
30 ml in a bottle, 1 bottle, sealed with a pipette cap, in a pack;
100 ml in a bottle, 1 bottle, sealed with a nozzle and cap, in a pack;
1000 ml in a bottle sealed with a cap or dropper and cap.
Vacation category
Without a prescription.
Producer
PrJSC FF "Viola".
Location of the manufacturer and address of its place of business.
Ukraine, 69063, Zaporizhia, 75 Academician Amosov St.
