Soe
04.11.2020

Betadine: instructions for use. Instructions for use of Betadine solution - composition, indications, side effects, analogues and price Betadine solution how to dilute

Release form: Soft dosage forms. Ointment.



General characteristics. Compound:

Solution for local and external use 1 ml
Active substance: povidone-iodine 100 mg
excipients: glycerin; nonoxynol 9; anhydrous citric acid; disodium dihydrogen phosphate; 10% sodium hydroxide solution (w/v) to establish pH; purified water

in PE dropper bottles of 30 and 120 ml; in a cardboard box 1 bottle or 1000 ml (without cardboard box).

Ointment for external use 1 g
povidone-iodine 100 mg
excipients: sodium bicarbonate; macrogol 400; macrogol 4000; macrogol 1000; purified water in aluminum tubes of 20 g; in a cardboard pack 1 tube.

Pharmacological properties:

The pharmacological group of the drug is antimicrobial and antiseptic agents. The active substance is a complex compound of iodine with polyvinylpyrrolidone. Upon contact with the epithelium, the active iodine ion is released from the complex and interacts with the amino acid groups of cellular proteins of microorganisms, leading to the formation of iodamines. Thanks to the mechanism of action, the likelihood of developing resistance to it with long-term use is excluded.

The drug has a pronounced bactericidal effect. Shows antifungal, antiviral, antiprotozoal activity. Gram-negative and gram-positive bacteria are sensitive to the drug. Not sensitive - pathogen (Mycobacterium tuberculosis).
The effect of the drug is longer compared to inorganic iodine preparations. It continues until the painted layer completely disappears from the application surface. The intensity of coloring is an indicator of the effectiveness of the drug. The local irritant effect is weak.

Indications for use:

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

Betadine solution:
. For hand disinfection, antiseptic (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.

Important! Get to know the treatment

Directions for use 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).

Features of application:

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 lactating mothers can provoke transient in the newborn (fetus). It is recommended to examine the baby for thyroid function.

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 with the development of psoriasis-like elements. Application of the product to large areas for severe burns or wounds may provoke negative reactions from electrolyte metabolism (increased serum sodium levels), changes in osmolarity, and impaired renal function (including the possibility of).

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 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.

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;
. During pregnancy and breastfeeding;
. renal failure;
. age up to 1 year;
. individual hypersensitivity to iodine or other components of Betadine.

Overdose:

Treatment: symptomatic or supportive measures under the control of thyroid and kidney function, electrolyte balance.
In case of intoxication with iodine accidentally taken orally, an urgent (sodium thiosulfate 5% solution) prescription of food rich in protein and starch (for example, a solution of starch in milk) is 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.

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.

Vacation conditions:

On prescription

Package:

Betadine ointment: 10% ointment in tubes of 20 g.
Betadine solution: solution for external use 10% in 30 bottles; 120; 1000 ml.


Betadine (povidone-iodine) is an antiseptic drug for use in gynecological practice. Today, not a single home first aid kit is complete without an antiseptic - a means for disinfecting the skin and treating the wound surface. Iodine solution has long been considered one of the classic antiseptics. Betadine from the Hungarian pharmaceutical company EGIS Pharmaceuticals, having absorbed all the benefits of iodine, thanks to a more advanced formula, does not irritate the mucous membranes, which allows it to be used in gynecology as a vaginal antiseptic. Since the inclusion of the first antiseptic in the arsenal of doctors in the mid-19th century, the range of representatives of this pharmacological group has increased significantly, making it more difficult for the consumer to choose. Requirements for a truly effective antiseptic include:

Ability to be active against a wide range of pathogens;

Lack of microbial tolerance;

An impressive list of indications for use;

Favorable safety profile, no systemic effects;

Performance.

Betadine has all of the above advantages. It contains povidone-iodine, which is bound to a carrier - polyvinylpyrrolidone. Polyvinylpyrrolidone is a synthetic polymer that is devoid of toxic properties and does not exhibit antigenic activity, which is capable of reversibly binding other substances. With iodine, it forms a hydrophilic complex in the ratio of its own molecules to iodine 19 to 1. Upon contact with the skin and mucous membranes, the complex of iodine with polyvinylpyrrolidone disintegrates, and the former begins to have a pronounced disinfecting effect against gram-positive and gram-negative aerobes and anaerobes, viruses, protozoa, fungi . Such a wide therapeutic range allows Betadine to be in demand in various fields of medicine, including gynecology, surgery, traumatology, dermatology, and burn medicine. The mechanism of action of povidone-iodine is the inactivation and destruction of amino acids of bacterial enzymes and structure-forming proteins, which leads to the death of infectious agents.

It is very important that to date, not a single case of the development of microbial resistance to povidone-iodine has been registered in medicine, which significantly expands the range of its use. A common pathogen such as Staphylococcus aureus (including its methicillin-resistant strains) is sensitive to Betadine. To date, impressive clinical experience has been accumulated in the use of Betadine. It is known that it remains stable and does not reduce its effectiveness in the presence of blood, purulent exudate, or vaginal secretions. The speed of onset of the antibacterial effect of the drug is also worthy of mention - only 15-45 seconds. Indications for the use of Betadine include vaginal infections, cuts, burns, pyoderma, trophic ulcers, bedsores with microbial contamination. The drug in the form of vaginal suppositories can be used for acute and chronic vulvovaginitis caused by Trichomonas and Candida (especially after the use of systemic antibacterial drugs and corticosteroids). The hydrophilic base of the suppositories eliminates irritating effects on the skin and mucous membranes. Betadine has a favorable safety profile and is well tolerated by patients. Today, this drug is the “gold standard” for the treatment of a number of vaginal infections, including vulvovaginal candidiasis, nonspecific and viral vaginitis, trichomonas colpitis, and bacterial vaginosis. Betadine, as already noted, is not absorbed into the systemic bloodstream (when used in recommended doses for a period of time prescribed by the doctor), therefore the side effects it causes are exclusively local in nature - itching, hyperemia, allergic reactions. Betadine is contraindicated starting from the third month of pregnancy and throughout the entire period of breastfeeding. When using vaginal suppositories, the use of pads is allowed.

Pharmacology

Antiseptic and disinfectant preparation. Blocks amino groups of cellular proteins. Has a wide spectrum of antimicrobial action. Active against bacteria (including Escherichia coli, Staphylococcus aureus), fungi, viruses, protozoa.

Released from the complex with polyvinylpyrrolidone upon contact with the skin and mucous membranes, iodine forms iodamines with bacterial cell proteins, coagulates them and causes the death of microorganisms.

It has a rapid bactericidal effect on gram-positive and gram-negative bacteria (with the exception of Mycobacterium tuberculosis).

Pharmacokinetics

When applied topically, there is almost no absorption of iodine from the mucous membrane.

Release form

Vaginal suppositories are torpedo-shaped, homogeneous, dark brown in color.

1 sup.
povidone-iodine200 mg

Excipients: macrogol 1000.

7 pcs. - blisters (1) - cardboard packs.
7 pcs. - blisters (2) - cardboard packs.

Dosage

For acute vaginitis, 1 suppository is prescribed 1-2 times a day for 7 days.

For chronic and subacute vaginitis - 1 suppository 1 time per day before bedtime for 14 days, if necessary - for a longer period.

Overdose

Acute iodine intoxication is characterized by the following symptoms: metallic taste in the mouth, increased salivation, burning sensation or pain in the mouth or throat; irritation and swelling of 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 carried out with special attention to electrolyte balance, renal and thyroid function.

Interaction

Betadine is incompatible with other disinfectants and antiseptics, especially those containing alkalis, enzymes and mercury.

The combined use of povidone iodine and hydrogen peroxide, as well as enzyme preparations containing silver and tauloridine, for the treatment of wounds, as well as antiseptic drugs, leads to a mutual decrease in effectiveness.

In the presence of blood, the bactericidal effect may decrease, but by increasing the concentration of the solution, the bactericidal activity may be increased.

Side effects

Local reactions: rarely - itching, hyperemia, hypersensitivity reactions.

In rare cases, the use of the drug can cause hypersensitivity reactions, for example, contact dermatitis with the formation of psoriasis-like red small bullous elements. If such phenomena occur, use of the drug should be discontinued.

Long-term use of povidone iodine may result in the absorption of significant amounts of iodine. The development of iodine-induced hyperthyroidism has been described in some cases, mainly in patients with pre-existing thyroid disease.

Indications

  • acute or chronic vaginitis (mixed, nonspecific infection);
  • bacterial vaginosis (caused by Gardnerella vaginalis);
  • candidiasis;
  • Trichomonas vaginalis infection;
  • vaginal infections after antibiotic or steroid therapy;
  • prophylaxis before surgical or diagnostic interventions in the vagina.

Contraindications

  • dysfunction of the thyroid gland (nodular colloid goiter, endemic goiter and Hashimoto's thyroiditis, hyperthyroidism);
  • thyroid adenoma;
  • Dühring's dermatitis herpetiformis;
  • simultaneous use of radioactive iodine;
  • children under 8 years of age (see section "Special instructions");
  • hypersensitivity to iodine and other components of the drug.

The drug should be used with caution during pregnancy and lactation (breastfeeding).

Features of application

Use during pregnancy and breastfeeding

Use for renal impairment

Use in children

Contraindication: children under 8 years of age.

special instructions

Due to the oxidizing properties of povidone-iodine, trace amounts may cause false-positive results in some types of tests to detect occult blood in the stool and blood or glucose in the urine.

During use of povidone-iodine, iodine uptake by the thyroid gland may be decreased, which may affect the results of some diagnostic tests (eg, thyroid scintigraphy, protein-bound iodine, radioiodine measurements), and may also interact with iodine supplements used. for the treatment of thyroid diseases. To obtain undistorted results of thyroid scintigraphy after long-term therapy with povidone-iodine, it is recommended to maintain a sufficiently long period of time without this drug.

If the function of the thyroid gland is impaired, the drug can be used only as directed by a doctor. If symptoms of hyperthyroidism occur during treatment, thyroid function should be checked. It is necessary to monitor thyroid function in newborns and breastfed infants whose mothers used Betadine.

Caution should be exercised when using the drug regularly in patients with previously diagnosed renal failure.

Regular use of Betadine vaginal suppositories should be avoided in patients receiving lithium preparations.

Coloring on leather and fabrics is easily washed off with water. After contact with the drug, avoid contact with the eyes.

Suppositories have a spermicidal effect, and therefore their use is not recommended for people planning pregnancy.

The use of povidone-iodine is permitted from the neonatal period, but taking into account the form of release - vaginal suppositories - the drug is not recommended for use in girls under 8 years of age; in the future, caution should be exercised when administered to virgins.

Impact on the ability to drive vehicles and operate machinery

Correct use of the drug does not affect the ability to drive vehicles or operate machinery.

P N015282/01

Tradename: Betadine ®

INN or group name: povidone-iodine

Dosage form:

vaginal suppositories

Compound:

active ingredient: 200 mg of povidone-iodine (corresponds to 18 - 24 mg of active iodine) in each vaginal suppository. Excipients: macrogol 1000-2800 mg.

Description: Torpedo-shaped homogeneous suppositories of dark brown color.

Pharmacotherapeutic group:

antiseptic

ATX Code: G01AX11

PHARMACOLOGICAL PROPERTIES
Pharmacodynamics
It has an antiseptic, disinfectant, antifungal and antiprotozoal effect. Blocks amino groups of cellular proteins. Has a wide spectrum of antimicrobial action. Active against bacteria (including Escherichia coli, Staphylococcus aureus), fungi, viruses, protozoa. Released from the complex with polyvinylpyrrolidone upon contact with the skin and mucous membranes, iodine forms iodamines with bacterial cell proteins, coagulates them and causes the death of microorganisms. It has a rapid bactericidal effect on gram-positive and gram-negative bacteria (with the exception of M. tuberculosis).
Pharmacokinetics:
When applied topically, there is almost no reabsorption of iodine from the mucous membrane.

INDICATIONS
Acute or chronic vaginitis (mixed, nonspecific infection), bacterial vaginosis (caused by Gardnerella vaginalis), candidiasis, Trichomonas vaginalis infection. Vaginal infections following antibiotic or steroid therapy. Prevention before surgical or diagnostic interventions in the vagina.

CONTRAINDICATIONS
Hypersensitivity to iodine and other components of the drug; dysfunction of the thyroid gland (nodular colloid goiter, endemic goiter and Hashimoto's thyroiditis, hyperthyroidism) (see section "Special instructions"); thyroid adenoma; Dühring's dermatitis herpetiformis; simultaneous use of radioactive iodine; children under 8 years of age (see section “Special instructions”).

Carefully: pregnancy and lactation period.

Pregnancy and lactation period
The use of Betadine is not recommended from the 3rd month of pregnancy and during lactation. If necessary, in these cases, treatment is possible under individual medical supervision.

METHOD OF APPLICATION AND DOSES
For insertion into the vagina. It is recommended to moisten the suppository with water and insert it deep into the vagina in the evening before bed.
Insert 1 suppository deep into the vagina: for acute vaginitis 1-2 times a day for 7 days, for chronic and subacute vaginitis - 1 time a day before bed for 14 days (possibly longer).
It is also recommended to use sanitary pads during the course of treatment. You should not stop using suppositories during menstruation.

SIDE EFFECTS
Hypersensitivity reactions to the drug, hyperemia, itching.
In rare cases, it can cause hypersensitivity reactions, such as contact dermatitis with the formation of psoriasis-like red small bullous lesions. If such phenomena occur, use of the drug should be discontinued.
Long-term use of povidone iodine may result in the absorption of significant amounts of iodine. The development of iodine-induced hyperthyroidism has been described in some cases, mainly in patients with pre-existing thyroid disease.

OVERDOSE
Acute iodine intoxication is characterized by the following symptoms: metallic taste in the mouth, increased salivation, burning sensation or pain in the mouth or throat; irritation and swelling of 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 carried out with special attention to electrolyte balance, renal and thyroid function.

INTERACTIONS WITH OTHER MEDICINES
Incompatible with other disinfectants and antiseptics, especially those containing alkalis, enzymes and mercury.
The combined use of povidone iodine and hydrogen peroxide, as well as enzyme preparations containing silver and tauloridine, for the treatment of wounds, as well as antiseptic drugs, leads to a mutual decrease in effectiveness.
In the presence of blood, the bactericidal effect may decrease, but by increasing the concentration of the solution, the bactericidal activity may be increased.

SPECIAL INSTRUCTIONS
Due to the oxidizing properties of povidone-iodine, trace amounts may cause false-positive results in some types of tests to detect occult blood in the stool and blood or glucose in the urine.
During use of povidone-iodine, iodine uptake by the thyroid gland may be decreased, which may affect the results of some diagnostic tests (eg, thyroid scintigraphy, protein-bound iodine, radioiodine measurements), and may also interact with iodine supplements used. for the treatment of thyroid diseases. To obtain undistorted results of thyroid scintigraphy after long-term therapy with povidone-iodine, it is recommended to maintain a sufficiently long period of time without this drug.
If the function of the thyroid gland is impaired, the drug can be used only as directed by a doctor. If symptoms of hyperthyroidism occur during treatment, thyroid function should be checked. It is necessary to monitor thyroid function in newborns and breastfed infants whose mothers used Betadine.
Caution should be exercised when using the drug regularly in patients with previously diagnosed renal failure. Regular use of Betadine vaginal suppositories should be avoided in patients receiving lithium preparations.
The use of povidone-iodine is permitted from the neonatal period, but taking into account the form of release - vaginal suppositories, the drug is not recommended for use before 8 years of age and caution should be exercised when administered to virgins.
Coloring on leather and fabrics is easily washed off with water. After contact with the drug, avoid contact with the eyes.
Suppositories have a spermicidal effect, and therefore their use is not recommended for people planning pregnancy.
During the use of suppositories, the use of sanitary pads can be recommended.

The antiseptic drug betadine effectively eliminates bacterial tissue damage. The medication is for external and local use. Following the instructions will lead to maximum effectiveness when using the medicine.

Indications

Main indications for the use of betadine:

  • trophic ulcers;
  • bedsores;
  • diabetic foot;
  • household wounds and burns;
  • treatment of wounds and burns in combustiology, traumatology, surgery;
  • treatment of fungal, bacterial, viral skin infections;
  • antiseptics of ulcers and microdamages of the skin;
  • in dermatology - prevention of the development of superinfections (including treatment of infectious dermatitis);
  • disinfection of the oral cavity for stomatitis and other oral infections, as well as during dental operations;
  • treatment of areas of mucous tissue and skin in preparation for invasive and surgical interventions (during operations, examinations);
  • disinfection of the skin around probes, catheters, drainage systems;
  • in gynecology - treatment of mucous membranes during minor operations (coagulation of polyp and erosion, insertion of an IUD, abortion);
  • in venereology - mycoses, trichomoniasis (antiseptic treatment);
  • in obstetrics - disinfection of the birth canal.

Directions for use and doses

When used in drainage systems:

  • A 10% solution of Betadine® is prepared immediately before use;
  • dilution proportions of the solution 10-100 times;
  • Remains of unused solution cannot be stored.

Preoperative treatment:

  • moisten the skin with water;
  • apply a 10% solution;
  • stand for 3 to 5 minutes;
  • Consumption of Betadine® is approximately 1 ml per area of ​​55-70 sq. cm;
  • then rinse the solution with sterile water;
  • reapply betadine and leave until completely dry.

When disinfecting burns, wounds and mucous membranes:

  • It is recommended to use a 10% betadine solution;
  • a sterile swab moistened with a solution is carefully applied to the affected areas;
  • tampon application time is 1-2 seconds.

When treating mucous membranes and affected areas of the skin:

  • use a wet compress or tampons for lubrication;
  • the product is applied to clean cotton cloth, bandages or gauze;
  • Betadine® is not diluted (used undiluted).

Disinfection of hands of surgeons (doctors and staff):

  • a 7.5% solution is used;
  • moisten the skin generously with water;
  • apply Betadine® in an amount of ~5 ml;
  • rub thoroughly until foaming;
  • wash off the foam with water;
  • repeat application of betadine;
  • Leave the product on the skin of your hands until completely dry.

Contraindications

This drug has serious contraindications due to the presence of iodine in Betadine®:

  • simultaneous use of radioactive iodine;
  • thyroid adenoma;
  • hyperthyroidism (increased thyroid function);
  • hypersensitivity to iodine and iodine-containing medications.

Other contraindications:

  • Dühring's dermatitis herpetiformis at any age;
  • individual intolerance to individual components in betadine;
  • renal failure (especially chronic);
  • lactation, pregnancy 2 and 3 trimesters;
  • Betadine is strictly not recommended for use in newborns and premature infants.

Special Notes:

  • Do not heat betadine before use;
  • if there is an urgent need to use Betadine® despite contraindications, the issue is resolved individually under the strict supervision of a competent physician;
  • In any case, betadine should not be used for bites of wild and domestic animals, as well as insects;
  • do not leave excess solution under bedridden patients;
  • protect your eyes from contact with Betadine® solution;
  • Do not combine with antiseptics and disinfectants containing mercury, enzymes, oxidizing agents and alkaline salts.

Pregnancy and lactation

Betadine is not recommended starting from the 2nd trimester of pregnancy, as well as during lactation. If there is an urgent need for the drug, its use should be agreed with the doctor individually.

Overdose

The question of overdose relates to the question of contraindications. That is, it is necessary to monitor the body’s reaction when using betadine for:

  • chronic renal failure;
  • dysfunction of the thyroid gland;
  • unspecified individual intolerance.

Side effects

Sometimes betadine causes side effects such as:

  • hyperemia (increased thyroid function);
  • itching, burning in the mouth and other mucous membranes;
  • pain, swelling of the skin at the application sites;
  • on large areas of wounds and burns, with frequent use of Betadine®, systemic absorption of iodine is possible.

Significant side effects that make themselves felt are a signal to stop using betadine. Contact your doctor to agree on further treatment or adjust it.

Composition and pharmacokinetics

Release form:

  • cardboard pack 1;
  • dropper bottle 30 ml;
  • container material - polyethylene;
  • concentration of solution for local and external use - 10%;
  • transparent solution of dark brown color.

Betadine® contains the following components (based on 100 ml of the drug):

  • 10 g - active substance Povidone-iodine (povindone-iodine);
  • 0.015 g - disodium hydrogen phosphate;
  • 0.071 g - anhydrous citric acid;
  • 0.25 g - nonoxyl 9;
  • 1 g - glycerol;
  • sodium hydroxide solution (w/o) to establish the pH level;
  • the rest of the volume is purified water.

Mechanism of action:

  • iodine is released from the complex with PVP;
  • comes into contact with tissues of mucous membranes or skin;
  • forms iodamines (when combined with bacterial proteins) and coagulates them;
  • microorganisms die;
  • iodine absorption does not occur with topical application of betadine.

Other

Other information about Betadine®:

  • dispensed in pharmacies without a prescription; :)
  • EAN code: 5995327165387;
  • Certificate No. P N015282/03, 2008-09-18 from EGIS Pharmaceuticals PLC (Budapest, Hungary);
  • manufactured under license from MUNDIPHARMA A.O. (Basel, Switzerland);
  • shelf life 3 years;
  • see the manufacturing date on the packaging;
  • do not use after the expiration date;
  • store in places out of reach of children, away from light;
  • storage temperature from +10 to +25 °C.
Egis JSC pharmaceutical plant Egis Pharmaceutical plant JSC Egis Pharmaceutical plant JSC

Country of origin

Hungary

Product group

Antibacterial drugs

Antiseptic for external and local use

Release forms

  • 30 ml - polyethylene dropper bottle (1) - cardboard packs. 120 ml - polyethylene dropper bottle (1) - cardboard packs. 1 l - polyethylene dropper bottle. tube 20g pack 14 suppository pack 7 suppository bottle 120ml bottle 30ml

Description of the dosage form

  • Ointment for external use 10% brown in color, with a faint odor of iodine. Solution for local and external use 10% Solution for local and external use 10% is dark brown in color and does not contain suspended or settled particles. Vaginal suppositories Vaginal suppositories are torpedo-shaped, homogeneous, dark brown in color.

pharmachologic effect

It has an antiseptic, disinfectant, antifungal and antiprotozoal effect. Blocks amino groups of cellular proteins. Has a wide spectrum of antimicrobial action. Active against bacteria (including Escherichia coli, Staphylococcus aureus), fungi, viruses, protozoa. Released from the complex with polyvinylpyrrolidone upon contact with the skin and mucous membranes, iodine forms iodamines with bacterial cell proteins, coagulates them and causes the death of microorganisms. It has a rapid bactericidal effect on gram-positive and gram-negative bacteria (with the exception of M. tuberculosis).

Pharmacokinetics

When applied topically, there is almost no reabsorption of iodine from the mucous membrane

Special conditions

Due to the oxidizing properties of povidone-iodine, trace amounts may cause false-positive results in some types of tests to detect occult blood in the stool and blood or glucose in the urine. During use of povidone-iodine, iodine uptake by the thyroid gland may be decreased, which may affect the results of some diagnostic tests (eg, thyroid scintigraphy, protein-bound iodine, radioiodine measurements), and may also interact with iodine supplements used. for the treatment of thyroid diseases. To obtain undistorted results of thyroid scintigraphy after long-term therapy with povidone-iodine, it is recommended to maintain a sufficiently long period of time without this drug. If the function of the thyroid gland is impaired, the drug can be used only as directed by a doctor. If symptoms of hyperthyroidism occur during treatment, thyroid function should be checked. It is necessary to monitor thyroid function in newborns and breastfed infants whose mothers used Betadine. Caution should be exercised when using the drug regularly in patients with previously diagnosed renal failure. Regular use of Betadine vaginal suppositories should be avoided in patients receiving lithium preparations. The use of povidone-iodine is permitted from the neonatal period, but taking into account the form of release - vaginal suppositories, the drug is not recommended for use before 8 years of age and caution should be exercised when administered to virgins. Coloring on leather and fabrics is easily washed off with water. After contact with the drug, avoid contact with the eyes. Suppositories have a spermicidal effect, and therefore their use is not recommended for people planning pregnancy. During the use of suppositories, the use of sanitary pads can be recommended.

Compound

  • 200 mg povidone iodine (corresponds to 18 - 24 mg active iodine) in each vaginal suppository. Excipients: macrogol 1000 2800 mg 200 mg povidone-iodine (corresponding to 18 - 24 mg active iodine) in each vaginal suppository. Excipients: macrogol 1000-2800 mg. 1 g of ointment contains 100 mg of the active ingredient - povidone iodine, as well as excipients: sodium bicarbonate, macrogol 400, macrogol 4000, macrogol 1000, macrogol 1500, purified water. 1 ml of solution contains 0.1 g of the active substance povidone iodine, and also excipients: glycerin, nonoxynol 9, citric acid, anhydrous, disodium hydrogen phosphate, sodium hydroxide 10% solution (w/o) to establish pH, ​​purified water. 1 ml of solution contains 0.1 g of the active substance povidone iodine, as well as excipients : glycerin, nonoxynol 9, citric acid, anhydrous, disodium hydrogen phosphate, sodium hydroxide 10% solution (w/o) to establish pH, ​​purified water. povidone-iodine 100 mg Excipients: glycerol, nonoxynol 9, citric acid (anhydrous), disodium hydrogen phosphate, sodium hydroxide solution 10% (to maintain pH level), purified water.

Betadine indications for use

  • Treatment and prevention of wound infections in surgery, traumatology, combustiology, dentistry Treatment of bacterial, fungal and viral skin infections, prevention of superinfection in dermatological practice Treatment of bedsores, trophic ulcers, diabetic foot Disinfection of the skin and mucous membranes of patients in preparation for surgical interventions, invasive studies (puncture , biopsies, injections, etc.) Disinfection of the skin around drainages, catheters, probes Disinfection of the oral cavity during dental operations Disinfection of the birth canal; when performing “minor” gynecological operations (artificial termination of pregnancy, insertion of an intrauterine device (IUD), coagulation of erosion and polyp, etc.)

Betadine contraindications

  • - hyperthyroidism; - thyroid adenoma; - Dühring's dermatitis herpetiformis; - simultaneous use of radioactive iodine; - children under 8 years of age; - hypersensitivity to iodine and other components of the drug. The drug should be used with caution from the 3rd month of pregnancy and during lactation (breastfeeding). If necessary, in these cases, treatment is possible under individual medical supervision.

Betadine dosage

  • 10% 10% 200 mg 200 mg

Betadine side effects

  • Hypersensitivity reactions to the drug, hyperemia, itching. In rare cases, it can cause hypersensitivity reactions, such as contact dermatitis with the formation of psoriasis-like red small bullous lesions. If such phenomena occur, use of the drug should be discontinued. Long-term use of povidone iodine may result in the absorption of significant amounts of iodine. The development of iodine-induced hyperthyroidism has been described in some cases, mainly in patients with pre-existing thyroid disease.

Drug interactions

Incompatible with other disinfectants and antiseptics, especially those containing alkalis, enzymes and mercury. The combined use of povidone iodine and hydrogen peroxide, as well as enzyme preparations containing silver and tauloridine, for the treatment of wounds, as well as antiseptic drugs, leads to a mutual decrease in effectiveness. In the presence of blood, the bactericidal effect may decrease, but by increasing the concentration of the solution, the bactericidal activity may be increased.

Overdose

Data on overdose of Betadine® are not provided.

Storage conditions

  • store in a dry place
  • keep away from children
  • store in a place protected from light
Information provided
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