BETADIN (Solution)
Active material: Povidone-iodine
When ATH: D08AG02
CCF: Antiseptic for external and local application
ICD-10 codes (testimony): I83.2, L89, T30, T79.3, Z51.4
When CSF: 23.03.05
Manufacturer: EGIS PHARMACEUTICALS Plc (Hungary)
Pharmaceutical form, composition and packaging
◊ Solution for local and external use 10% dark brown, does not contain suspended or besieged particles.
| 1 ml | |
| povidone iodine- | 100 mg |
Excipients: glycerol, nonoxynol 9, lemon acid (Anhydrous), disodium hydrogen phosphate, sodium hydroxide p-r 10% (to maintain pH), Purified water.
30 ml – dropper bottle plastic (1) – packs cardboard.
120 ml – dropper bottle plastic (1) – packs cardboard.
1 l – dropper bottle plastic.
Pharmacological action
Antiseptic preparations. When released from the complex with polyvinylpyrrolidone in contact with skin and mucous membranes, Iodine forms a protein bacterial cells yodaminy, coagulates and causes the death of microorganisms. It provides rapid bactericidal activity against gram-positive and gram-negative bacteria (except M. tuberculosis). Effective against fungi, Virus, protozoa.
Pharmacokinetics
Absorption
The local application is virtually no absorption of iodine.
Testimony
-treatment and prevention of wound infections in surgery, Traumatology, combustiology, Dentistry;
— treatment bacterial, fungal and viral skin infections, Prevention of superinfection in dermatological practice;
-treatment of bedsores, trophic ulcers, diabetic foot;
— disinfection of skin and mucous of patients in preparation for operational interventions, invasive research (incl. puncture, Biopsy, injection);
— disinfection of the skin around the drainage, kateterov, probes;
— disinfection of oral cavity in dental operations;
— disinfection of ancestral ways, during “small” gynecological operations (incl. abortion, IUD insertion, coagulation of erosion and polyp).
Dosage regimen
To handle skin and mucous Betadina solution® apply undiluted to lubricate, rinse or as wet compress. For use in drainage systems 10% solution diluted from 10 to 100 time. Solution prepared immediately before use, do not store diluted solutions.
Side effect
Allergic reactions: hypersensitivity reaction to the drug; requires the preparation of an allergic reaction – hyperemia, burning, itch, edema, pain.
Contraindications
- Thyroid dysfunction (hyperthyroidism);
- Thyroid adenoma;
- Dermatitis herpetiformis Duhring;
- Simultaneous use of radioactive iodine;
- Premature and newborn babies;
- Hypersensitivity to iodine and other ingredients.
FROM caution use in patients with chronic renal failure.
Pregnancy and lactation
Application of Betadine® It is not recommended with the third month of pregnancy and lactation (breast-feeding). If necessary, in these cases the treatment is possible for the individual medical supervision.
Cautions
Frequent use of a large area of the wound surface and mucous membranes can occur systemic reabsorption of iodine, that can affect the tests of functional activity of the thyroid gland.
When thyroid dysfunction drug application is only possible under strict medical supervision.
Use of the drug in newborns is possible only in case of emergency, After studies of thyroid function.
Caution must be exercised with regular use on broken skin in patients with chronic renal insufficiency.
Care should be taken, that the patient is not left over solution. Do not heat the solution before use.
The application site is formed painted film, continuing to release the total number of active iodine, which means the cessation of the drug. Painting on the skin and tissues easily washed off with water.
Do not use insect bites, domestic and wild animals.
Overdose
Data on drug overdose Betadine® not provided.
Drug Interactions
Betadine® incompatible with other antiseptics, particularly those containing alkali, enzymes and mercury.
In the presence of blood bactericidal effect can be reduced, However, when you increase the concentration of a solution of bactericidal activity can be increased.
Conditions of supply of pharmacies
The drug is resolved to application as an agent Valium holidays.
Conditions and terms
List B. The drug should be kept out of reach of children, dry, the dark place at a temperature between 5° c to 15° c. Shelf life – 3 year.
