BETADINE SOLUTION 10% 30ML

Active ingredient and dosage form

Solution for external and local use of 10%: 1 ml of solution contains 100 mg of povidone-iodine;
Excipients: glycerin, nonoxynol 9, anhydrous citric acid, disodium dihydrogen phosphate, 10% sodium hydroxide solution (m / o) for pH adjustment, purified water;
in PE dropper bottles of 30 and 120 ml; in a cardboard box 1 bottle or 1000 ml (without a cardboard box).

Ointment for external use of 10%: 1 g of ointment contains 100 mg of povidone-iodine;
Excipients: sodium bicarbonate, macrogol 400, macrogol 4000, macrogol 1000, purified water;
in aluminum tubes of 20 g each, in a carton pack of 1 tube.

Vaginal suppositories torpedo-shaped, dark brown.
1 suppository with 200 mg of povidone-iodine;
Excipients: macrogol 1000;
in a blister 7 pcs., in a carton of 1 or 2 blisters.

rr d / outward. and local approx. - П №015282/03, 18.11.03
ointment for external. approx. - P No. 012282/02, 11/18/03
supp. wag - P No. 015282/01, 18.11.03

Mechanism of action

Antiseptic and disinfectant drug. Released from the complex with polyvinylpyrrolidone upon contact with the skin and mucous membranes, Iodine forms the cells of the bacteria iodamines with proteins, coagulates them and causes the death of microorganisms. It has a bactericidal effect on gram-positive and gram-negative bacteria (with the exception of Mycobacterium tuberculosis).
Active against bacteria, fungi, viruses, protozoa.
Suppositories are made on a water-soluble basis and do not irritate.

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

Indications and usage

- treatment of the patient's skin before and after surgery (including injection, puncture, biopsy, blood sampling);
- treatment of wounds, burns, trophic ulcers, pressure sores, superinfection dermatitis;
- hygienic treatment of patients;
- acute and chronic vaginitis (mixed, non-specific infections);
- acute and chronic vaginitis (mixed, non-specific infections);
- bacterial vaginosis;
- candidiasis;
- trichomoniasis;
- genital herpes.

Contraindications

- hyperthyroidism;
- thyroid adenoma;
- Herpetiform dermatitis Duhring;
- simultaneous use of radioactive iodine;
- children's age up to 8 years;
- Hypersensitivity to iodine and other components of the drug.
Carefully the drug should be used during pregnancy and lactation (breastfeeding).

Dosage and administration

Solution Betadine can be used without dilution or as an aqueous solution at a dilution of 1:10 or 1: 100.
For skin disinfection in its healthy areas, the solution is used undiluted with an exposure time of 1-2 minutes.
When treating wounds, burns, bacterial and fungal skin lesions apply an aqueous solution of Betadine at a dilution of 1:10.
For hygienic treatment of the patient use an aqueous solution of Betadine at a dilution of 1: 100.

Ointment Apply a thin layer to the affected areas several times a day.

After preliminary hygienic processing suppositories injected deep into the vagina.
With acute vaginitis appoint 1 vaginal suppository 2 times / day for 7 days.
With subacute and chronic vaginitis appoint 1 suppository 1 time / day before bed for 14 days. If necessary, treatment can be extended.

Adverse reactions

Maybe: local manifestation of an allergic reaction to iodine (itching, hyperemia), which requires discontinuation of the drug.

Pregnancy and breastfeeding

Betadine is not recommended for use since 3 months of pregnancy and during lactation. If it is necessary to conduct therapy, the doctor decides on the prescription of the drug individually.
It is necessary to control the function of the thyroid gland in newborns and infants whose mothers used Betadine.

Special notes

Dilution of Betadine solution must be made immediately before use. The diluted solution can not be stored!
The solution of the drug should have a dark brown color. Discoloration of the solution indicates the destruction of the complex of polyvinylpyrrolidone iodine and a decrease in the effectiveness of the drug. Light and temperature above 40 ° C accelerate the decomposition of the active substance of the drug.
In case of violation of thyroid function, the drug can be used only under the supervision of a physician.
Color on the skin and tissues is easily washed off with water. After contact with the drug should avoid its contact with eyes.
During the use of suppositories, you can recommend the use of sanitary pads.
Use in pediatrics
It is possible to use girls aged 8 and over, being careful with the introduction of virgins.

Drug Interactions

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

Storage conditions

List B. The solution for external use should be stored in a dry, dark place, at a temperature not exceeding 25 ° C. Shelf life - 3 years.
The ointment should be stored at a temperature not exceeding 25 ° C and a relative humidity of not more than 75%. Shelf life - 3 years.
Vaginal suppositories should be stored in a dry, cool place. Shelf life - 2 years.

The drug is approved for use as a means of OTC.