Drug formLiquid (for external use)
ATC subcategoryТopical antimicrobials
Generic namePovidone Iodine
Each ml of Betaiodine, 1% mouthwash solution, contains:
active ingredient: povidone iodine – 10 mg;
excipients: saccharin sodium, ethanol 96%, menthol, water purified.
Betaiodine – povidone-iodine – is an iodophore that is used as a disinfectant and antiseptic mainly for the treatment of contaminated wounds and pre-operative preparation of the skin and mucous membranes as well as for the disinfection of equipment.
Iodophores are loose complexes of iodine and carrier polymers. Solutions of povidone-iodine gradually release iodine to exert an effect against bacteria, fungi, viruses, protozoa, cysts, and spores; povidone-iodine is thus less potent than preparations containing free iodine but it is less toxic.
– Renal failure.
– Concomitant use of lithium preparations.
– Children up to age 6 years.
– Pregnancy, breast-feeding.
– Hypersensitivity to the components of preparation.
Can be local manifestation hypersensitivity to iodine (itching, redness, burning, swelling, pain), which requires cancellation of the preparation. Rarely, with high doses – the hyper-or hypothyroidism (especially when it is being used by newborns or mothers during pregnancy and breast feeding).
Can be systemic absorption of iodine when it is used on a large area of mucous membranes , which may cause neutropenia and change thyroid-function activity tests results. Can be iodine intoxication symptoms (including metalic taste in mouth , excessive salivation, swelling of the eyelids or larynx) with prolonged usage (more than 7-10 days) .
Avoid getting into eyes, in case of getting into eyes – wash immediately with water. The dilution of BETAOIDINE solution should be done immediately before usage. Diluted solution can not be stored!
Existence of the inflammation process may increase the absorption of povidone iodine , thereby increasing the risk of development of systemic side effects. Patients should be warned about the need to stop taking the preparation and consult with a doctor if the signs of iodine intoxication appears.
Patients with renal insufficiency should use with caution.
Before the systematic usage of BETAIODINE conduct a trial of its use.
Treatment: reduce the frequency of usage or complete renunciation of the preparation usage.
BETAIODINE is incompatible with other disinfectants.Alkaline medium, the presence of fat, blood, pus, with an acidic reactions substance reduce antiseptic activity. With the simultaneous use of BETAIODINE with preparations containing lithium and amiodarone may increase the effect of povidone iodine on the thyroid gland.
A dark brown colored liquid having a characteristic menthol odor.
Mouthwash solution is filled into 100 ml and 120 ml amber glass bottles closed with caps (inside package).
100 ml and 120-ml amber glass bottle is inserted together with the leaflet into cardboard box (outer package).
3 years. Do not use after the expiration date.
To be dispensed without prescription.
Store at a room temperature, in a dry place, out of the reach of children. Protect from light.