The instruction for medical use
of BETADIN medicine
the Trade name
the International unlicensed name
Is not present
the Dosage form
Ointment for external use of 10% 20 g
of 20 g of ointment contains
active agent – povidone-iodine of 2 g (it is equivalent to active iodine of 200 mg),
excipients: Natrii hydrocarbonas, a macrogoal 400, a macrogoal 1000, a macrogoal 1500, a macrogoal 4000, the water purified.
Homogeneous ointment of brown color with a slight smell of iodine.
of Antiseptics and disinfecting drugs. Iodine drugs. Povidone-iodine.
ATH D08AG 02 code
Pharmacokinetics At properties use povidone-iodine in the form of ointment on the uninjured skin iodine absorption insignificant. Extent of absorption of povidone and its discharge kidneys depends on the average molecular weight (mix). For substances with a molecular weight above 35000 – 50000 the delay in an organism is possible. The fate of the soaked-up iodine or iodide in an organism is generally similar to the fate of the iodine entered in any other way. It is allocated mainly through kidneys.
Active ingredient of Betadin ointment – povidone-iodine is a complex of iodine and polymer of polyvinylpirrolidone from which for some time after putting drug iodine is released and constant concentration of active free iodine is provided. Free iodine (I2) has strong bactericidal effect. In the researches in vitro quickly destroys bacteria, viruses, fungi and some simplest organisms. At contact with skin or mucous membranes from polymer it is marked out constantly increasing amounts of iodine.
Free iodine reacts with the groups of amino-acid links of enzymes and structural proteins of microorganisms oxidized by SH- or OH-, inactivating and destroying these enzymes and proteins. In vitro the majority of microorganisms perishes within less than one minute, at the same time the greatest bactericidal effect is observed within 15-30 seconds. At the same time iodine becomes colourless, in communication with what the intensity of brown coloring serves as the indicator of efficiency of drug. After decolouration perhaps repeated putting drug. The resistance to drug is unknown.
– prevention of an infection of small cuts and grazes, small burns
– treatment of fungal and bacterial infections of skin and also infections of decubituses and trophic ulcers.
A route of administration and doses
Drug for external use.
For treatment of an infection: to put 1 – 2 time a day within no more than 14 days.
For prevention of an infection: to put 1-2 times a week, so far it is necessary.
The affected skin should be cleaned and dried up. To apply Betadin ointment on the struck area. It is possible to apply a bandage to the processed leather.
Seldom (≥ 1/10.000 – & lt, 1/1.000)
– contact dermatitis with formation of psoriazopodobny red small violent elements, an erythema, an itching
Very seldom (& lt, 1/10.000)
– anaphylactic reaction
– the hyperthyroidism (sometimes followed by tachycardia or concern) can be observed at patients with the available disease of a thyroid gland after use of iodine in significant amounts (for example, at prolonged use povidone-iodine for treatment of wounds or burns)
– a Quincke’s disease
Frequency is unknown (frequency cannot be determined on the basis of the available data)
– a hypothyroidism (can develop at long use with processing of big surfaces)
– changes of level of electrolytes of blood serum and osmolarity **, the metabolic acidosis **
– an acute renal failure **
– a corrosive burn of skin ***
** – can be observed after use of iodine in significant amounts (for example, at treatment of burns)
*** – can be observed before surgery if the patient becomes wet in solution Betadin
– hypersensitivity to iodine and other components of drug
– a hyperthyroidism or other significant dysfunctions of a thyroid gland
– herpetiform dermatitis of Dyuringa
– before therapy and a stsintigrafiya using radioiodine
the Complex povidone-iodine possesses antimicrobic action in the range of pH of 2.0-7.0. Interaction with proteins and other nonsaturated organic substances reduces its efficiency.
Simultaneous use of ointment Betadin and fermental ointments for treatment of wounds reduces efficiency of both drugs.
The drugs containing mercury, silver, peroxide of hydrogen or toluidine can interact with a complex povidone-iodine in this connection, their simultaneous use is not recommended.
Combined or consecutive use povidone-iodine with the antiseptics containing oktenidin can cause temporary darkening of a surface of skin on which these means were applied.
instructions Drug it is intended only for topical administration.
Drug use can cause irritation, in rare instances heavy reactions on skin for a long time. At emergence of signs of irritation or hypersensitivity the putting drug should be stopped.
It is not necessary to heat ointment before use.
Significant amounts of iodine can cause a hyperthyroidism in patients with dysfunction of a thyroid gland (for example, with a nodal colloidal or endemic craw). At such patients the ointment use Betadin has to be limited in time and the area of the processed surface of skin. If during a course of treatment there are hyperthyroidism symptoms, it is necessary to check function of a thyroid gland.
Drug cannot be used before and after a stsintigrafiya and also during treatment of a carcinoma of a thyroid gland radioiodine.
Due to the oxidizing properties povidone-iodine, its traces when carrying out some types of researches using toluidine or guaiac pitch for detection of the occult blood (hemoglobin) in Calais and also blood or glucose in urine, can result in false positive results.
During use, povidone-iodine can decrease iodine absorption by a thyroid gland that can affect results of some diagnostic tests (for example, stsintigrafiya of a thyroid gland, definition of the proteinaceous and connected iodine, measurements using radioiodine) and also can interact with the iodine drugs used for treatment of diseases of a thyroid gland. For obtaining undistorted results of researches after long therapy povidone-iodine is recommended to sustain rather long span (1-2 weeks) without this drug.
Use in pediatrics
Use of drug for newborns and children of early age perhaps only in case of need, after the research of function of a thyroid gland. At the same time the thicket should avoid use of high doses for newborns and children of early age since their skin has more high-permeability and for them the high sensitivity to iodine is observed that increases risk of developing a hyperthyroidism. It is necessary not to allow accidental hit of drug in a mouth and digestive tract at children.
Pregnancy and the period of a lactation
Iodine gets through a placental barrier and is allocated in breast milk. Use of drug during pregnancy can cause development of a tranzitorny gipoterioz with increase in level of thyroid stimulating hormone in a fruit and the newborn. There can be a need of a research of function of a thyroid gland at the child.
Use of drug at duration of gestation over two months and also during breastfeeding is possible only according to strict indications and demands careful observation of function of a thyroid gland of mother and the child.
In these cases it is possible to use drug only quickly.
Use of drug from the second trimester of pregnancy is not recommended. Features of influence on ability of driving and work with potentially dangerous mechanisms
Use of drug does not affect ability of control of transport and especially dangerous mechanisms.
the following symptoms are characteristic Of acute iodic intoxication: the metal taste in a mouth, the increased salivation, burning sensation or mouth or throat pain, irritation also swelled an eye, skin reactions, gastrointestinal disorders and diarrhea, a renal failure and an anury, a circulatory unefficiency, a laryngeal edema with secondary asphyxia, a fluid lungs, a metabolic acidosis, a hypernatremia.
Treatment: symptomatic and maintenance therapy with special control of electrolytic balance, function of kidneys and a thyroid gland.
The form of release and packing
On 20 g of drug place in tubas aluminum lithographed with the white screwing-up cap from polyethylene.
On 1 tuba together with the instruction for medical use in the state and Russian languages put in a pack from cardboard.
To Store storage conditions at a temperature from 15 °C to 25 °C.
To store out of children’s reach!
not to use a period of storage after an expiration date.
BUDAPEST CJSC EGIS PHARMACEUTICAL PLANT Producer 1106, Keresturi St., 30-38 Hungary
Phone number: (36-1) 803-5555, fax: (36-1) 803-5529
according to the license of MUNDIFARM AG, Switzerland
the Owner of the registration certificate
of CJSC EGIS Pharmaceutical Plant, Hungary
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Representation in RK CJSC EGIS Pharmaceutical Plant 050060, Almaty, Zharokov St. of 286 G ph. + 7 (727) 247 63 34, + 7 (727) 247 63 33, fax: + 7 (727) 247 61 41, e-mail:
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