Betadine vaginal suppositories - instructions for use. Instructions for use of Betadine solution - composition, indications, side effects, analogues and price Betadine indications for use

Indications for use:
Betadine ointment:
Prevention of infection during skin trauma (minor abrasions and cuts, minor surgical interventions and minor burns);
treatment of infected trophic ulcers or bedsores;
treatment of bacterial, fungal and mixed skin infections.

Betadine solution:
For disinfection of hands, antiseptic treatment of the surgical field (skin or mucous membranes) before obstetric, gynecological, surgical operations and procedures; catheterization of the bladder, taking a biopsy, performing injections, punctures;
antiseptic treatment of burn surfaces and wounds;
as first aid when the skin or mucous membranes are contaminated with biological or other infected material;
surgical or hygienic hand disinfection.

Betadine suppositories:
Acute and chronic vaginal infections (vaginitis): mixed origin; nonspecific (bacterial vaginosis, etc.) and specific genesis (Trichomonas infection, genital herpes, etc.);
trichomoniasis (as part of combination therapy using systemic products);
treatment before or after interventions during transvaginal surgical operations, as well as during diagnostic and obstetric procedures;
vaginal infections of fungal etiology (including those caused by Candida albicans), which are provoked by treatment with steroid and antibacterial medications.

Pharmacological action:
Betadine is an antiseptic. Due to the inclusion of iodine, it has a wide spectrum of action against bacteria, protozoa, fungi and some viruses. It has a bactericidal effect with the gradual release of iodine from the product after contact with mucous membranes or skin. The mechanism of action is the interaction of iodine with oxidizable groups of amino acids, which are part of the structural proteins and enzymes of microorganisms, as a result of which they are subsequently destroyed or inactivated. The effect of the product begins in the first 15-30 seconds after application, and the complete death of most microbial cells (in vitro) is observed in less than 60 seconds. Due to interaction with cells, Betadine's iodine becomes discolored, so the weakening of the color of the product after contact with skin, affected surfaces or mucous membranes may be an indicator of its effectiveness.

Due to the polyvinylpyrrolidone polymer, the locally irritating effect of iodine, characteristic of alcohol solutions, is lost. Therefore, patients tolerate local effects of the product well. To date, no cases of resistance (including secondary resistance) of any microorganisms, fungi, viruses or protozoa to iodine have been detected, even in the case of long-term use, which is due to the peculiarities of the mechanism of action.

With long-term local use of Betadine, significant absorption of iodine is possible, especially when treating mucous membranes, burn surfaces, and extensive wound defects. Usually, with all this, an increase in the concentration of iodine in the blood is recorded, which returns to the original value after 1-2 weeks after subsequent use of Betadine. Since the molecular weight of povidone-iodine is in the range of 35,000–50,000 D, renal excretion and absorption of the active substance are delayed. Eliminated primarily by the kidneys. The half-life following vaginal administration is approximately 48 hours. Volume of distribution is approximately 38% of body weight. On average, the level of inorganic iodine in blood plasma is 0.01–0.5 μg/dl, total iodine is 3.8–6.0 μg/dl.

Betadine method of administration and dosage:
Betadine ointment
Used topically. In the treatment of infectious lesions: apply 1-2 times a day for 2 weeks.
For prevention in case of contamination: apply as long as necessary, 1 time every 3 days. Before application, the surface must be cleaned and dried. The ointment is applied in a thin layer. After this, an aseptic bandage can be applied to the skin.

Betadine solution
Betadine solution is used externally in undiluted or diluted form. You cannot use hot water to dilute the solution, but short-term heating to body temperature is allowed. Undiluted Betadine solution is used to treat the surgical field and hands before surgical interventions, injections or punctures, and bladder catheterization.

For hygienic disinfection of hand skin: 3 ml of undiluted Betadine solution 2 times, with each 3 ml portion of the product left on the skin for 30 seconds.
For surgical disinfection of hands: 5 ml of undiluted Betadine solution 2 times, with each 5 ml portion of the product left in contact with the skin for 5 minutes.
To disinfect the skin: after lubricating with an undiluted solution of Betadine, the product must dry for the full effect.

Solutions can be used 2-3 times a day.
For the same indications, Betadine solution is used after dilution with tap water. When treating burns and wounds, surgical interventions, Ringer's solution or isotonic (0.9%) sodium chloride solution is used for dilution. Betadine must be dissolved immediately before use.

The following dilutions are recommended:
for a wet compress – 100-200 ml of Betadine per 1 liter of solvent (1:5 – 1:10);
for sitz or local baths: 40 ml Betadine per 1 liter of solvent (1:25);
for a preoperative bath: 10 ml Betadine per 1 liter of solvent (1:100);
for a hygienic bath: 10 ml of Betadine per 10 liters of solvent (1:1000);
for douching, irrigation of the peritoneal area, urological irrigation, before the introduction of an intrauterine contraceptive - 4 ml of Betadine per 1 liter of solvent (1:25);
for irrigation after surgical or chronic wounds: 5-50 ml of Betadine per 100 ml of solvent (1:20; 1:2);
for irrigation of the oral cavity, traumatological or orthopedic irrigation: 10 ml of Betadine per 1 liter of solvent (1:100).

Betadine suppositories
Before administration, the suppository is freed from the contour shell and slightly moistened. It is advisable to use sanitary pads during treatment. Insert 1 suppository deep into the vagina before bedtime. It can also be administered during menstruation. The dosage can be increased (2 suppositories every day), and the course of treatment can be continued if the product is incompletely effective. The course of treatment is approximately 7 days (depending on the desired effect).

Betadine contraindications:
Hyperthyroidism;
dysfunction or adenoma of the thyroid gland (endemic goiter, colloid nodular goiter or Hashimoto's thyroiditis);
the period before or after any procedures (for example, scintigraphy) with the administration of radioactive iodine;
Dühring's dermatitis herpetiformis;
period of pregnancy and lactation;
renal failure;
age up to 1 year;
individual hypersensitivity to iodine or other components of Betadine.

Betadine side effects:
Allergic reactions on the skin and mucous membranes are possible (hyperemia, itching, rash). Predisposed patients may develop iodine-induced hyperthyroidism. Rarely - acute generalized reactions with suffocation and/or hypotension (anaphylactic reactions). Possible dermatitis with the development of psoriasis-like elements. Application of the product to large areas of severe burns or wounds may provoke negative reactions from electrolyte metabolism (increased serum sodium levels), metabolic acidosis, changes in osmolarity, impaired renal function (including the possibility of acute renal failure).

Pregnancy:
It is recommended that Betadine be used during breastfeeding or pregnancy only if absolutely indicated and only in small doses. Absorbed iodine penetrates into breast milk and through the transplacental barrier. During lactation, the iodine content in breast milk is higher than the serum value, therefore, when using Betadine in pregnant women, breastfeeding is stopped. The use of povidone-iodine by pregnant and nursing mothers can provoke transient hyperthyroidism in the newborn (fetus). It is recommended to examine the baby for thyroid function.

Overdose:
Symptoms of acute iodine intoxication: increased salivation, metallic taste in the mouth, pain in the throat or mouth; heartburn, swelling and irritation of the eyes. Possible gastrointestinal disorders, skin reactions, anuria or deterioration in kidney function, laryngeal edema with signs of secondary asphyxia, circulatory failure, hypernatremia, metabolic acidosis, pulmonary edema.

Treatment: symptomatic or supportive measures under the control of thyroid and kidney function, electrolyte balance.
In case of intoxication with iodine accidentally taken orally, urgent gastric lavage (sodium thiosulfate 5% solution) and administration of food rich in protein and starch (for example, a solution of starch in milk) are necessary. If necessary, sodium thiosulfate solution (10 ml of 10%) is administered intravenously at intervals of 3 hours. During treatment, a thorough examination of the functions of the thyroid gland is indicated in order to timely diagnose hyperthyroidism, which can be caused by povidlon-iodine.

Use with other medications:
The combination of hydrogen peroxide and Betadine for treating wounds is not recommended, as this negatively affects the effectiveness of both antiseptics. You should also not use Betadine in combination with products that contain tauloridine, enzymes or silver. When mixed with mercury-containing products, alkaline mercury iodide is formed, so this combination is not allowed. The low effectiveness of the product can be compensated by increasing the dosage, since povidone-iodine reacts with organic unsaturated complexes and proteins. It is not recommended to prescribe Betadine to patients taking lithium-containing drugs. Prolonged use of the product on large areas of skin and mucous membranes should be avoided.

Release form:
Betadine ointment: 10% ointment in tubes of 20 g.
Betadine solution: solution for external use 10% in 30 bottles; 120; 1000 ml.
Betadine suppositories for vaginal use: 200 mg each, in a contour pack of 7; 14 suppositories.

Storage conditions:
Betadine ointment: at a temperature of 25°C in a dark place.
Betadine solution: at a temperature of 5 to 15°C in a dark, dry place.
Betadine suppositories: at a temperature of 5 to 15°C in a dark place.

Betadine composition:
Betadine ointment
Active substance: povidone-iodine 10% (which corresponds to active free iodine - 10 mg per 1 g).
Inactive substances: macrogol, sodium bicarbonate, purified water.

Betadine solution
Active substance (in 1 ml): povidone-iodine 100 mg (which corresponds to active free iodine - 10 mg in 1 ml).
Inactive substances: nonoxynol, glycerin, sodium hydroxide, citric disodium phosphate, anhydrous acid, purified water.

Betadine suppositories
Active substance: povidone-iodine 200 mg.
Inactive substances: macrogol 1000.

Additionally:
The effectiveness of the solution is indicated by the dark brown color after application: a decrease in brightness indicates a decrease in the antimicrobial activity of the product. When exposed to temperatures above 40°C or light, povidone-iodine is destroyed. Antimicrobial activity occurs at a pH of Betadine solution of 2-7. With the use of povidone-iodine, a decrease in the absorption of the iodine molecule by the thyroid gland may be observed - this affects the results of some additional studies (determination of protein-bound iodine, thyroid scintigraphy and other diagnostic methods using radioactive iodine). If the patient is scheduled for the above procedures, then the use of povidone-iodine is discontinued 1-4 weeks in advance. The oxidizing effect of Betadine causes corrosion of metals. Synthetic and plastic materials are not sensitive to povidone-iodine. Sometimes, upon contact with certain materials, the solution may change color, which usually recovers quickly. Povidone-iodine stains can be easily removed from textiles and other materials using warm soapy water. If stains are difficult to remove, they are treated with a solution of sodium thiosulfate or ammonia. It is not allowed to take Betadine solution orally.

When treating the skin before surgery, it is necessary to ensure that the solution does not flow under the patient’s body - otherwise skin irritation may occur. With prolonged (more than 2 weeks) use of the product over large areas (approximately 10% of the body surface), the development of hyperthyroidism cannot be ruled out, especially in elderly patients with latent thyroid dysfunction. In this category of patients, the use of the solution should be assessed from the point of view of comparing possible risks and expected benefits. When deciding to prescribe a product, it is necessary to monitor the functions of the thyroid gland for timely diagnosis of early signs of hyperthyroidism. Monitoring is carried out during the use of the product, as well as over a 3-month interval subsequently during subsequent use. Long-term use of Betadine may cause irritation and, in very rare cases, severe skin reactions. If symptoms of allergy or irritation appear, discontinue use of the product.

Patients with impaired thyroid function need to limit the surface to be treated or reduce the duration of contact of povidone-iodine with the skin (for solution or ointment). If signs of hyperthyroidism develop while using Betadine, a thyroid examination is necessary. In newborns, as well as young children, it is necessary to avoid the use of iodine in large dosages, since their skin has a high permeability threshold (a higher risk of hyperthyroidism or increased sensitivity to povidone-iodine). The drug is prescribed with caution to patients with insufficient renal function or taking lithium-containing drugs, especially if regular use of Betadine is necessary.

Attention!
Before using the medication "Betadine" You should consult your doctor.
The instructions are provided for informational purposes only. Betadine».

The drug Betadine is an effective remedy for eliminating pathogenic bacteria that cause the development of the inflammatory process. The disappearance of microbes leads to a decrease in the intensity of symptoms and an improvement in the patient’s well-being.

Release forms and composition

Dosage forms of the drug are represented by ointment, solution and suppositories. In all types of the drug, the active ingredient is povidone-iodine.

Ointment

The following are used as auxiliary components in the ointment:

macrogol 4000;
sodium bicarbonate;
macrogol 1000;
water;
macrogol 400.

The product is available in 20 g tubes. The medication is characterized by a faint odor of iodine and a brownish tint.

Solution

The solution is produced in containers of 30, 120 or 100 ml. The medicine does not contain precipitated elements. Excipients are:

glycerol;
water;
citric acid;
sodium hydroxide;
nonoxynol 9;
Disodium dihydrogen phosphate.

Candles

Vaginal suppositories contain the active element and the additional component macrogol 1000.

Pharmacological action

The medicine has a disinfectant effect. The main substance interacts with the mucous membranes and skin, resulting in the death of pathogenic microflora.

The drug is effective if the patient has gram-negative and gram-positive bacteria; is active against protozoa, viruses and fungi. The only microorganism that the medicine cannot cope with is Mycobacterium tuberculosis.

Suppositories restore the vaginal microflora, eliminating the symptoms of the disease: burning, itching, pain. In addition, suppositories do not irritate the mucous membrane of the organ, which reduces the risk of increased inflammation and adverse reactions.

With local treatment, the active component does not enter the systemic circulation.

What does it help with?

The use of the medication depends on the dosage form.

Indications for use are:

bedsores, burns;
diseases of viral origin, including those caused by herpes and human papillomavirus;
local therapy in the presence of infectious dermatitis, trophic ulcers, chickenpox;
preparation for diagnostic procedures in gynecology;
treatment of patients on the eve of surgery;
carrying out disinfection during preparation for childbirth;
infections of the skin, mucous membranes of the mouth and nasopharynx;
treatment during the use of probes, drainages, catheters;
preparation for infusion, biopsy, puncture and other manipulations;
treatment for damaged skin: ulcers, abrasions, cuts, wounds, acne.

Effective in the presence of the following diseases:

genital form of herpes;
chronic and acute inflammatory processes localized in the vagina;
infections of mixed and nonspecific nature;
fungal infections.

Contraindications

thyroid adenoma – a formation of a benign type, in which the patient loses body weight, experiences increased anxiety, and increases sweating;
hypersensitivity to the components of the product;
Dühring's disease - dermatitis of the herpetiform type, accompanied by rashes with itching and burning;
animal and insect bites;
hyperthyroidism is a dysfunction of the thyroid gland, leading to increased production of hormones.

In addition, it is prohibited to use the medicine while being used with radioactive iodine. It is not recommended to give the product to children under 1 year of age.

If the following points are present, the medication is prescribed with caution:

chronic skin inflammation;
disorders of the thyroid gland;
the need for regular use to treat damaged skin in patients suffering from chronic renal failure.

Directions for use and dosage regimen

Only the doctor selects the course of treatment. It is forbidden to use the medication yourself.

The ointment is used to treat the inflamed areas, applying the medicine in a thin layer. The procedure is carried out 2-3 times a day.

The concentration of the solution depends on the purpose for which the drug is used:

ulcers and acne are wiped with a swab soaked in 5 or 10% medicine;
treatment of wounds, burns and areas affected by microorganisms – 1:10;
use in gynecology - use undiluted drug;
washing of joint cavities and serous cavities – 1:10-1:100;
disinfection of healthy skin is carried out with an undiluted solution.

The use of suppositories depends on the form of the disease:

In the acute type, the medicine is used 2 times a day, 1 suppository. Duration of therapy is approximately 7 days.
For chronic and subacute disease, 1 suppository per day is prescribed. The duration of use of the medicine is 14 days.

Candles for thrush

To eliminate thrush, use according to the doctor’s recommendations. The suppository is inserted deep into the vagina, after moistening the preparation with water. After completing the procedure, you should use sanitary pads to prevent the medicine from leaking out.

How to dilute for gargling

For gargling, the product is diluted in a ratio of 1:10. Before starting treatment, you should consult a specialist.

Side effects and overdose

No cases of overdose have been reported, however, during topical use of the drug, side symptoms may appear:

Vaginal dysbiosis – occurs with long-term treatment with suppositories. In this case, itching occurs and discharge with an unpleasant odor occurs.
Thyrotoxicosis is a condition during which thyroid hormones are present in the body in increased quantities. Pathology more often appears in the presence of a hereditary predisposition. The patient's appetite changes, sleep is disturbed, constant weakness and anxiety arise.
An allergy to iodine, characterized by itching, skin rashes and redness.

The patient should stop treatment if these signs and conditions occur and then go to the hospital.

Drug interactions

The drug has the following features of interaction with other medications:

antiseptics containing mercury, alkalis and enzymes are not compatible with Betadine;
hydrogen peroxide reduces the therapeutic effect of the drug;
medications containing silver and taurolidine are not used together with Betadine.

Terms of sale and storage

All forms of the drug must be stored in places inaccessible to children. The medication should be protected from high temperature, exposure to sunlight and high humidity. It is forbidden to store the prepared solution.

The shelf life of all forms is no more than 5 years. To purchase the products you must obtain a prescription.

Features when using Betadine

The medicine has the following features:

A colored film may appear at the site of application of the medication, which remains until the active element is released. The film can be washed off with water.
The main component can influence the results of scintigraphy and urine analysis.
It is not recommended to regularly use the medication in patients who simultaneously use medications with lithium.
For the treatment of newborns, the drug is prescribed in extreme cases. In addition, before starting therapy, it is necessary to diagnose the thyroid gland.

During pregnancy and lactation

The drug is contraindicated during breastfeeding. After the first trimester of pregnancy, the medicine is also not recommended for use.

Betadine during menstruation

There is no need to stop therapy during menstruation.

Is it possible to have sex

The instructions do not prohibit intimacy during the period of use of the product. In addition, the use of suppositories after unprotected coitus reduces the risk of infections. However, for a similar effect to occur, the drug should be used within 2 hours after intimacy.

Alcohol compatibility

While taking the medication, you must refrain from drinking alcohol.

Effect on concentration

The product does not affect concentration.

Analogs

The following medications have similar effects:

Iodopirone is a medicine containing potassium iodide and povidone-iodine. The medication negatively affects the development of gram-negative and gram-positive bacteria, which leads to their death. The drug is effective against microorganisms resistant to other antibacterial agents.
Sodium iodide is a medicine with proteolytic and antiseptic effects. Has a positive effect on the functioning of the thyroid gland.
– an antiseptic that gets rid of yeast, streptococci, anthrax, and E. coli. However, Pseudomonas aeruginosa is resistant to the drug.
Instructions for medical use of the drug

BETADINE ®

Trade name

Betadine®

International nonproprietary name

Dosage form

Solution for external and local use 30 ml, 120 ml, 1000 ml

Compound

100 ml of solution contains

active substance- povidone-iodine 10 g (which corresponds to active iodine 0.9 - 1.2 g),

excipients: glycerin 85%, nonoxynol 9, anhydrous citric acid, disodium hydrogen phosphate anhydrate, sodium hydroxide (10% solution (w/v) to establish pH), purified water.

Description

The solution is dark brown in color, with the odor of iodine, and does not contain suspended or precipitated particles.

Pharmacotherapeutic group

Antiseptics and disinfectants. Iodine preparations. Povidone-Iodine

ATX code D08AG02

Pharmacological properties

Pharmacokinetics

In healthy people, the absorption of iodine when the drug is applied topically is negligible. The absorption of povidone and its excretion by the kidneys depends on the average molecular weight of the mixture. For substances with a molecular weight above 35,000-50,000, a delay in the body is possible. The fate of absorbed iodine or iodide in the body is basically similar to the fate of iodine administered by any other route.

In the body, iodine is converted into iodide, which is concentrated mainly in the thyroid gland. Iodide not captured by the thyroid gland is excreted by the kidneys. To a lesser extent, iodides are excreted in saliva and sweat. Iodides cross the placental barrier and are excreted into breast milk.

Iodine is excreted almost exclusively by the kidneys.

Pharmacodynamics

Povidone-iodine is a polymer complex of polyvinylpyrrolidone (povidone) with iodine. After application to the surface of the skin, iodine is released from this complex for some time. It has long been known that elemental iodine (I 2) is a highly effective microbicidal substance capable of in vitro quickly destroy bacteria, viruses, fungi and some protozoa using two mechanisms: free iodine quickly kills microorganisms, and the PVP-iodine complex is an iodine depot. Upon contact with the skin and mucous membranes, an increasing amount of iodine dissociates from the complex with the polymer.

Free iodine reacts with oxidizable groups of SH- or OH- amino acid units of enzymes and structural proteins of microorganisms, inactivating and destroying these enzymes and proteins. In conditions in vitro most vegetative microorganisms are destroyed in 15-30 seconds. In this case, the iodine becomes discolored, and therefore the intensity of the brown color serves as an indicator of the effectiveness of the drug. After bleaching, the product can be reapplied. There have been no reports of development of resistance.

Indications for use
Directions for use and doses

Betadine solution is intended for local external use.

Betadine solution can be used undiluted or after dilution with water as a 10% (1:10) or 1% (1:100) solution, depending on the area to be disinfected.

The drug should be left on the skin for 1-2 minutes before injection, blood draw, biopsy, blood transfusion, infusion therapy, or before any other surgical procedures on intact skin.

For aseptic treatment of wounds, burns, for disinfection of mucous membranes, and for bacterial and fungal skin infections, use a 10% solution (dissolving Betadine with water in a ratio of 1:10).

For preoperative disinfectant baths, a 1% solution of Betadine (1:100) is used. The entire surface of the body should be evenly treated with a 1% Betadine solution and after a 2-minute exposure, rinse the solution with warm water. Betadine solution should be diluted immediately before use. The prepared solution cannot be stored.

Betadine solution can be easily removed with warm water. Difficult to remove stains should be treated with sodium thiosulfate solution.

When preoperatively disinfecting the skin, care must be taken to ensure that excess solution does not accumulate under the patient. Prolonged contact with the solution may cause skin irritation and, in rare cases, severe skin reactions. Accumulation of solution under the patient can cause a chemical burn.

Side effects

Rarely (≥1/10,000 -<1/1,000)

Increased sensitivity

Contact dermatitis (with symptoms such as erythema, small blisters on the skin, itching)

Very rarely

Anaphylactic reaction

Hyperthyroidism (sometimes accompanied by symptoms such as tachycardia and restlessness). In patients with a history of thyroid disease after use of povidone-iodine in significant quantities (for example, after long-term use of povidone-iodine solution for the treatment of wounds and burns on a large surface of the skin)

Angioedema

Frequency unknown (cannot be determined from available data):

Hypothyroidism (after using large amounts of povidone-iodine or after long-term use)

Electrolyte imbalance (possibly after use of povidone-iodine in significant quantities (for example, in the treatment of burns))

Metabolic acidosis**

Acute renal failure**

Change in blood osmolarity**

Chemical burn of the skin due to the accumulation of excess solution under the patient during preparation for surgery

** may develop after the use of povidone-iodine in significant quantities (for example, in the treatment of burns)

Contraindications

Hypersensitivity to the active substance or other excipients

Hyperthyroidism

Other acute thyroid diseases

Dühring's dermatitis herpetiformis

Condition before and after the use of radioactive iodine in the treatment of the thyroid gland.

Drug interactions

The povidone-iodine complex is effective in the pH range 2.0 - 7.0. It is likely that the drug may react with proteins and other unsaturated organic complexes, which will lead to a deterioration in its effectiveness.

The combined use of Betadine and enzyme preparations for wound treatment leads to a mutual decrease in effectiveness. Medicines containing mercury, silver, hydrogen peroxide, and taurolidine may interact with povidone-iodine and should not be used at the same time.

Using povidone-iodine at the same time or immediately after using antiseptics containing octenidine on the same or adjacent areas of the skin may result in the formation of dark spots on the treated surface.

The oxidative effect of povidone-iodine can lead to false-positive results in various diagnostic tests (eg, hemoglobin and glucose measurements in feces and urine using toluidine and guaiac gums).

Absorption of iodine from povidone-iodine solution may alter the results of thyroid function tests.

The use of PVP-iodine may reduce the uptake of iodine by the thyroid gland, which may affect the results of some tests and procedures (thyroid scintigraphy, determination of protein-bound iodine, diagnostic procedures using radioactive iodine), and therefore planning the treatment of thyroid diseases with iodine preparations may become impossible. After stopping the use of PVP-iodine, a certain period of time should be maintained until the next scintigraphy is performed.

Special instructions

During preoperative preparation of the patient, it is necessary to ensure that excess solution does not accumulate under the patient. Prolonged contact with the solution may cause skin irritation and, in rare cases, severe skin reactions. Accumulation of solution under the patient can cause a chemical burn. In case of skin irritation, contact dermatitis or increased sensitivity, the drug should be discontinued.

The drug should not be heated before use.

Patients with goiter, thyroid nodules, and other non-acute thyroid diseases have an increased risk of developing hyperthyroidism when given large amounts of iodine. In this group of patients, in the absence of clear indications, the use of povidone-iodine solution for a long time and on large surfaces of the skin is unacceptable. Such patients should be monitored to identify early signs of hyperthyroidism and, if necessary, monitor thyroid function, even after discontinuation of the drug.

Betadine should not be used before or after radioiodine scintigraphy or radioiodine treatment for thyroid carcinoma.

The dark red color of the solution indicates its effectiveness. Discoloration of the solution indicates a deterioration in its antimicrobial properties. Degradation of the solution occurs in light and at temperatures above 40 o C. Avoid contact of the drug with the eyes.

Use in pediatrics

Infants and children under 6 months of age are at increased risk of developing hypothyroidism when given large amounts of iodine. Since children of this age have increased sensitivity to iodine and increased skin permeability, the use of iodine PVP in children of this age group should be minimal. If necessary, thyroid function should be monitored (levels of T4 hormones and thyroid stimulating hormone /TSH). Any possible oral exposure of povidone-iodine to children should be strictly avoided.

Pregnancy and lactation

The use of the drug during pregnancy, as well as during breastfeeding, is possible only according to strict indications, and it is necessary to use an absolutely minimal amount of the drug. In these cases, the drug can only be used for a short time.

Since iodine crosses the placental barrier and is excreted into breast milk, as well as due to the increased sensitivity of the fetus and newborn to iodine, povidone-iodine should not be used in significant quantities during pregnancy and breastfeeding. In addition, iodine is concentrated in breast milk, exceeding plasma levels. In the fetus and newborn, povidone-iodine can cause transient hypothyroidism with an increase in thyroid-stimulating hormone (TSH) levels. It may be necessary to carefully monitor the child's thyroid function.

Any possible oral exposure of povidone-iodine to children should be strictly avoided.

Features of the effect of the drug on the ability to drive vehicles and operate machinery

Betadine does not affect or has a negligible effect on the ability to drive vehicles and work with moving machinery.

Overdose

Symptoms: abdominal symptoms, anuria, circulatory failure, pulmonary edema, metabolic disorders.

Treatment: symptomatic and supportive therapy.

Release form and packaging

30, 120 and 1000 ml of solution are placed in green polyethylene bottles with a PE dropper and a screw-on PP cap with first opening control. Labels are attached to the bottles. Bottles of 30, 120 ml, together with instructions for medical use in the state and Russian languages, are placed in a cardboard pack. 1000 ml bottles are not placed in a cardboard pack; together with instructions for use in the state and Russian languages, they are placed in a group package.

Compound
Description of the dosage form
Ointment: homogeneous, brown in color, with a faint odor of iodine.
Pharmacological action
Pharmacological action- antiseptic.
Pharmacodynamics
Antiseptic and disinfectant. Released from the complex with PVP, upon contact with the skin and mucous membranes, iodine forms iodamines with bacterial proteins, coagulates them and causes the death of microorganisms. Has a rapid bactericidal effect on gram-positive and gram-negative bacteria (except M. tuberculosis). Effective against fungi, viruses, protozoa.
Pharmacokinetics
When applied topically, there is almost no absorption of iodine.
Indications of the drug Betadine ®
bacterial and fungal skin infections;

trophic ulcers;

bedsores;

infectious dermatitis;

Contraindications
hypersensitivity to iodine and other components of the drug;

dysfunction of the thyroid gland (hyperthyroidism) (see “Special instructions”);

thyroid adenoma;

Dühring's dermatitis herpetiformis;

simultaneous use of radioactive iodine;

premature and newborn babies (see “Special instructions”).

With caution: pregnancy and lactation, chronic renal failure.

Side effects
With frequent use over a large area of the wound surface and mucous membranes, systemic absorption of iodine may occur, which may affect tests of the functional activity of the thyroid gland.

Hypersensitivity reactions to the drug - an allergic reaction (hyperemia, burning, itching, swelling, pain) is possible, which requires discontinuation of the drug.
Interaction
Incompatible with other disinfectants and antiseptics, especially those containing alkalis, enzymes and mercury.

In the presence of blood, the bactericidal effect may decrease, however, with increasing concentrations of the drug, the bactericidal activity may be increased.
Directions for use and doses
Externally. The ointment is applied in a thin layer to the affected surface 2-3 times a day; can be used under an occlusive dressing.
Special instructions
In case of dysfunction of the thyroid gland, the use of the drug is possible only under the strict supervision of a doctor.

Name:
Betadine
Pharmacological action:
Betadine is an antiseptic. Due to the inclusion of iodine, it has a wide spectrum of action against bacteria, protozoa, fungi and some viruses. It has a bactericidal effect with the gradual release of iodine from the drug after contact with mucous membranes or skin. The mechanism of action is the interaction of iodine with oxidizable groups of amino acids, which are part of the structural proteins and enzymes of microorganisms, as a result of which the latter are destroyed or inactivated. The effect of the drug begins in the first 15-30 seconds after application, and the complete death of most microbial cells (in vitro) is observed in less than 60 seconds. Due to interaction with cells, Betadine's iodine becomes discolored, so the weakening of the color of the drug after contact with the skin, affected surface or mucous membranes may be an indicator of its effectiveness.
Due to the polyvinylpyrrolidone polymer, the locally irritating effect of iodine, characteristic of alcohol solutions, is lost. Therefore, patients tolerate the local effects of the drug well. To date, no cases of resistance (including secondary resistance) of any microorganisms, fungi, viruses or protozoa to iodine have been detected, even in the case of long-term use, which is due to the peculiarities of the mechanism of action.
With prolonged local use of Betadine, significant absorption of iodine is possible, especially when treating mucous membranes, burn surfaces, and extensive wound defects. Usually, an increase in the concentration of iodine in the blood is recorded, which returns to the original value 1-2 weeks after the last use of Betadine. Since the molecular weight of povidone-iodine is in the range of 35,000–50,000 D, renal excretion and absorption of the active substance are delayed. Eliminated primarily by the kidneys. The half-life after vaginal administration is approximately 48 hours. Volume of distribution is approximately 38% of body weight. On average, the level of inorganic iodine in blood plasma is 0.01–0.5 μg/dl, total iodine is 3.8–6.0 μg/dl.
Indications for use:
Betadine ointment:
Prevention of infection during skin trauma (minor abrasions and cuts, minor surgical interventions and minor burns),
Treatment of infected trophic ulcers or bedsores,
Treatment of bacterial, fungal and mixed skin infections.
Betadine solution:
For disinfection of hands, antiseptic treatment of the surgical field (skin or mucous membranes) before obstetric, gynecological, surgical operations and procedures, catheterization of the bladder, taking a biopsy, performing injections, punctures,
Antiseptic treatment of burn surfaces and wounds,
As first aid when skin or mucous membranes become contaminated with biological or other infectious material,
Surgical or hygienic hand disinfection.
Betadine suppositories:
Acute and chronic infections of the vagina (vaginitis): mixed origin, nonspecific (bacterial vaginosis, etc.) and specific origin (Trichomonas infection, genital herpes, etc.),
Trichomoniasis (as part of combination therapy using systemic drugs),
Treatment before or after interventions during transvaginal surgeries, as well as during diagnostic and obstetric procedures,
Vaginal infections of fungal etiology (including those caused by Candida albicans), which are provoked by treatment with steroid and antibacterial medications.
Method of application:
Betadine ointment
Used topically. In the treatment of infectious lesions: apply 1-2 times a day for 2 weeks.
For prevention in case of contamination: apply as long as necessary, 1 time every 3 days. Before application, the surface must be cleaned and dried. The ointment is applied in a thin layer. After this, an aseptic bandage can be applied to the skin.
Betadine solution
Betadine solution is used externally in undiluted or diluted form. You cannot use hot water to dilute the solution, but short-term heating to body temperature is allowed. Undiluted Betadine solution is used to treat the surgical field and hands before surgical interventions, injections or punctures, and bladder catheterization.
For hygienic disinfection of hand skin: 3 ml of undiluted Betadine solution 2 times, with each 3 ml portion of the drug left on the skin for 30 seconds.
For surgical disinfection of hands: 5 ml of undiluted Betadine solution 2 times, with each 5 ml portion of the drug left to contact the skin for 5 minutes.
To disinfect the skin: after lubricating with an undiluted solution of Betadine, the drug must dry for the full effect.
Solutions can be used 2-3 times a day.
For the same indications, Betadine solution is used after dilution with tap water. When treating burns and wounds, surgical interventions, Ringer's solution or isotonic (0.9%) sodium chloride solution is used for dilution. Betadine must be dissolved immediately before use.
For a wet compress – 100-200 ml of Betadine per 1 liter of solvent (1:5 – 1:10),
For sitz or local baths: 40 ml Betadine per 1 liter of solvent (1:25),
For a preoperative bath: 10 ml Betadine per 1 liter of solvent (1:100),
For a hygienic bath: 10 ml of Betadine per 10 liters of solvent (1:1000),
For douching, irrigation of the peritoneal area, urological irrigation, before insertion of an intrauterine contraceptive - 4 ml of Betadine per 1 liter of solvent (1:25),
For irrigation of postoperative or chronic wounds: 5-50 ml of Betadine per 100 ml of solvent (1:20, 1:2),
For irrigation of the oral cavity, traumatological or orthopedic irrigation: 10 ml of Betadine per 1 liter of solvent (1:100).
Betadine suppositories
Before administration, the suppository is freed from the contour shell and slightly moistened. It is advisable to use sanitary pads during treatment. Insert 1 suppository deep into the vagina before bedtime. It can also be administered during menstruation. The dosage can be increased (2 suppositories per day), and the course of treatment can be continued if the drug is incompletely effective. The average course of treatment is 7 days (depending on the desired effect).
Adverse events:
Allergic reactions on the skin and mucous membranes (redness, itching, rash) are possible. Predisposed patients may develop iodine-induced hyperthyroidism. Rarely - acute generalized reactions with suffocation and/or hypotension (anaphylactic reactions). Possible dermatitis with the development of psoriasis-like elements. Application of the drug to large areas for severe burns or wounds may provoke negative reactions from electrolyte metabolism (increased serum sodium levels), metabolic acidosis, changes in osmolarity, impaired renal function (including the possibility of acute renal failure).

Contraindications:
Hyperthyroidism,
Thyroid dysfunction or adenoma (endemic goiter, colloid nodular goiter or Hashimoto's thyroiditis),
The period before or after any procedures (for example, scintigraphy) with the administration of radioactive iodine,
Dühring's dermatitis herpetiformis,
The period of pregnancy and lactation,
Kidney failure
Age up to 1 year,
Individual hypersensitivity to iodine or other components of Betadine.
During pregnancy:
It is recommended that Betadine be used during breastfeeding or pregnancy only if absolutely indicated and only in small doses. Absorbed iodine penetrates into breast milk and through the transplacental barrier. During lactation, the iodine content in breast milk is higher than the serum value, therefore, when using Betadine in pregnant women, breastfeeding is stopped. The use of povidone-iodine by pregnant and nursing mothers can provoke transient hyperthyroidism in the newborn (fetus). It is recommended to examine the child for thyroid function.
Interaction with other drugs:
The combination of hydrogen peroxide and Betadine for treating wounds is not recommended, as this negatively affects the effectiveness of both antiseptics. You also cannot use a combination of Betadine with drugs that contain tauloridine, enzymes or silver. When mixed with mercury-containing preparations, alkaline mercury iodide is formed, so this combination is not allowed. The low effectiveness of the drug can be compensated by increasing the dosage, since povidone-iodine reacts with organic unsaturated complexes and proteins. It is not recommended to prescribe Betadine to patients taking lithium-containing drugs. Prolonged use of the drug over large areas of skin and mucous membranes should be avoided.
Overdose:
Symptoms of acute iodine intoxication: increased salivation, metallic taste in the mouth, pain in the throat or mouth, heartburn, swelling and irritation of the eyes. Possible gastrointestinal disorders, skin reactions, anuria or deterioration in kidney function, laryngeal edema with signs of secondary asphyxia, circulatory failure, hypernatremia, metabolic acidosis, pulmonary edema.
Treatment: symptomatic or supportive measures under the control of thyroid and kidney function, electrolyte balance.
In case of intoxication with iodine accidentally taken orally, urgent gastric lavage (sodium thiosulfate 5% solution) and administration of food rich in protein and starch (for example, a solution of starch in milk) are necessary. If necessary, sodium thiosulfate solution (10 ml of 10%) is administered intravenously at intervals of 3 hours. During treatment, a thorough examination of the functions of the thyroid gland is indicated in order to timely diagnose hyperthyroidism, which can be caused by povidlon-iodine.
Release form of the drug:
Betadine ointment: 10% ointment in 20 g tubes.
Betadine solution: solution for external use 10% in bottles of 30, 120, 1000 ml.
Betadine suppositories for vaginal use: 200 mg each, in blister packs 7, 14 suppositories.
Storage conditions:
Betadine ointment: at a temperature of 25°C in a dark place.
Betadine solution: at a temperature of 5 to 15°C in a dark, dry place.
Betadine suppositories: at a temperature of 5 to 15°C in a dark place.
Compound:
Betadine ointment
Active substance: povidone-iodine 10% (which corresponds to active free iodine - 10 mg per 1 g).
Inactive substances: macrogol, sodium bicarbonate, purified water.
Betadine solution
Active substance (in 1 ml): povidone-iodine 100 mg (which corresponds to active free iodine - 10 mg in 1 ml).
Inactive substances: nonoxynol, glycerin, sodium hydroxide, citric disodium phosphate, anhydrous acid, purified water.
Betadine suppositories
Active substance: povidone-iodine 200 mg.
Inactive substances: macrogol 1000.
Additionally:
The effectiveness of the solution is indicated by the dark brown color after application: a decrease in brightness indicates a decrease in the antimicrobial activity of the product. When exposed to temperatures above 40°C or light, povidone-iodine is destroyed. Antimicrobial activity occurs at a pH of Betadine solution of 2-7. With the use of povidone-iodine, a decrease in the absorption of iodine molecules by the thyroid gland may be observed - this affects the results of some additional studies (determination of protein-bound iodine, thyroid scintigraphy and other diagnostic methods using radioactive iodine). If the patient is scheduled for the above procedures, then the use of povidone-iodine is discontinued 1-4 weeks in advance. The oxidizing effect of Betadine causes corrosion of metals. Synthetic and plastic materials are not sensitive to povidone-iodine. Sometimes, upon contact with certain materials, the solution may change color, which usually recovers quickly. Povidone-iodine stains can be easily removed from textiles and other materials using warm soapy water. If stains are difficult to remove, they are treated with a solution of sodium thiosulfate or ammonia. It is not allowed to take Betadine solution orally.
When treating the skin before surgery, it is necessary to ensure that the solution does not flow under the patient’s body - otherwise skin irritation may occur. With prolonged (more than 2 weeks) use of the drug over large areas (approximately 10% of the body surface), the development of hyperthyroidism cannot be ruled out, especially in elderly patients with latent thyroid dysfunction. In this category of patients, the use of the solution should be assessed from the point of view of comparing possible risks and expected benefits. When deciding to prescribe the drug, it is necessary to monitor the functions of the thyroid gland for timely diagnosis of early signs of hyperthyroidism. Monitoring is carried out during the use of the product, as well as during a 3-month interval after the last use. Long-term use of Betadine may cause irritation and, in very rare cases, severe skin reactions. If symptoms of allergy or irritation appear, stop using the drug.
Patients with impaired thyroid function need to limit the surface to be treated or reduce the duration of contact of povidone-iodine with the skin (for solution or ointment). If signs of hyperthyroidism develop while using Betadine, a thyroid examination is necessary. In newborns, as well as young children, it is necessary to avoid the use of iodine in large dosages, since their skin has a high permeability threshold (higher risk of hyperthyroidism or increased sensitivity to povidone-iodine). The drug should be prescribed with caution to patients with insufficient renal function or taking lithium-containing drugs, especially if regular use of Betadine is necessary.
Drugs with similar effects:
Kerasal Vokadine (solution) Wokadine Wokadine (ointment) Wokadine (vaginal pessaries) Anti-angin

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