Instructions Betadine ointment 10% tube 20 g
Composition
active ingredient: povidone-iodine;
1 g of ointment contains 100 mg of povidone-iodine;
excipients: macrogol 400, macrogol 4000, macrogol 1000, macrogol 1500, sodium bicarbonate, purified water.
Dosage form
Ointment.
Main physicochemical properties: homogeneous brown ointment with a faint odor of iodine.
Pharmacotherapeutic group
Antiseptics and disinfectants. 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 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, significant amounts of iodine are released from the polymer.
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 ingredient of Betadine ointment 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 simpler microorganisms (protozoal).
Due to the mechanism of action, resistance to the drug, including secondary resistance, is not expected with long-term use.
The drug dissolves 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 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.
Pharmacokinetics
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 absorption of povidone-iodine or iodide is the same as that of regular iodine from other sources.
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 through 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 infections of bedsores and trophic ulcers.
Contraindication
Hypersensitivity to iodine or suspected hypersensitivity to iodine or to other components of the drug; patients with thyroid dysfunction (nodular colloid goiter, endemic goiter and Hashimoto's thyroiditis); patients with hyperthyroidism or other acute thyroid disorders; before and after treatment and scintigraphy with radioactive iodine in patients with thyroid carcinoma; dermatitis herpetiformis of Duhring; renal failure.
Interaction with other medicinal products and other types of 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 Betadine 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, therefore their combined use is not recommended.
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 site of application of the drug.
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 povidone-iodine, 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 thyroid therapy.
Thyroid scintigraphy should be performed after discontinuation of long-term therapy for 1-2 weeks to obtain reliable results.
Application features
The drug is intended for topical use only.
Prolonged use may cause irritation and sometimes severe skin reactions. If signs of irritation or hypersensitivity appear, application should be discontinued.
The use of PVIodine 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.
It is necessary to take a break from using PVIod for at least 1-4 weeks.
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 time and area of skin treated with the ointment.
Even after treatment is completed, it is necessary to monitor for the appearance of early symptoms of hyperthyroidism and monitor thyroid function.
With prolonged use on large areas of skin (e.g. extensive 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. an area exceeding 10% of the body surface); and a treatment duration exceeding 14 days is 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.
Particular attention should be paid to patients with pre-existing renal failure when using the ointment regularly.
Regular use of the ointment should be avoided in patients receiving lithium medications.
The oxidizing effect of PVI can cause corrosion of metals, while plastic and synthetic materials are usually not sensitive to PVI. In isolated cases, discoloration may occur, which is usually reversible. PVI 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 oxidative action 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).
Do not heat before use. Keep out of reach of children.
Ability to influence reaction speed when driving vehicles or other mechanisms
Betadine ointment does not affect the reaction speed when driving or working with other mechanisms.
Use during pregnancy or breastfeeding
Povidone-iodine should be used only in cases strictly prescribed by a doctor, but in the smallest doses. Iodine crosses the placental barrier and can penetrate into breast milk, so there may be a risk of hypersensitivity of the fetus or newborns 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 the function of the thyroid gland in children.
The drug is contraindicated for use after the 2nd month of pregnancy and during breastfeeding. Breastfeeding should be discontinued during treatment.
Method of administration and doses
The drug should be applied topically.
For the treatment of infections: apply 1 or 2 times a day. Duration of treatment - no more than 14 days.
For the prevention of infections: apply 1 or 2 times a week as needed. The affected skin should be cleaned and dried. Apply a thin layer of ointment to the affected skin surface. A bandage may be applied to the treated skin.
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 because 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, a burning sensation 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.
Treatment: symptomatic and supportive therapy should be administered with special attention to electrolyte balance, renal function and thyroid function.
Adverse reactions
Immune system disorders: hypersensitivity, anaphylactic reactions.
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.
Expiration date
3 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
Packaging
20 g of 10% ointment in a tube, 1 tube in a cardboard box.
Vacation category
Without a prescription.
Producer
CJSC Pharmaceutical Plant EGIS.
Location of the manufacturer and its business address
9900, Kermend, Matyas Kirai Street 65, Hungary.
