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Betaiodine, 1% solution

Drug formLiquid (for external use)

ATC categoryOtorinolaryngology

ATC subcategoryТopical antimicrobials

Brand nameBetaiodine

Generic namePovidone Iodine

Composition

Each ml of Betaiodine, 1% mouthwash solution, contains:

active ingredient: povidone iodine – 10 mg;
excipients: saccharin sodium, ethanol 96%, menthol, water purified.

Pharmacological group and ATC code
Antiseptic; D08AG02; G01AX11.

Chemical name and CAS number
2-Pyrrolidinone, 1-ethenyl-, homopolymer, compd. with iodine; 25655-41-8.

Pharmacology

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.

Pharmacokinetics
Iodine is slightly absorbed when applied to the skin. When taken by mouth, iodine preparations (which are converted to iodide) are transported to, and concentrated in, the thyroid gland. Iodides not taken up by the thyroid are excreted mainly in the urine, with smaller amounts appearing in the faeces, saliva, and sweat. They cross the placenta and are distributed into breast milk.

Uses
As a mouth wash for routine use. Eliminates or reduces offensive mouth odors. As a mouth wash, as primary or adjunctive therapy in infections of the mouth and throat such as aphthous stomatitis, Vincent’s infection, pharyngitis, oral moniliasis, tonsillitis, laryngitis, tongue ulcers, stomatitis, bronchitis, sinusitis and following oral surgery and dental procedures.
Dosage and administration
In a rinse the mouth and pharynx – 1 h / l solution diluted in 1/4 cup of water. Rinsing is carried out several times / day.

Contraindications
– Hyperthyroidism, thyroid adenoma.

– Renal failure.

– Concomitant use of lithium preparations.

– Children up to age 6 years.

– Pregnancy, breast-feeding.

– Hypersensitivity to the components of preparation.

Adverse effects

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) .

Precautions

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.

Overdosage
Symptoms: local irritation, allergic reactions, hyper-or hypothyroidism, neutropenia, yodizma phenomena (including a metallic taste in the mouth, excessive salivation, swelling of the eyelids or larynx), metabolic acidosis, hypernatremia, renal dysfunction.

Treatment: reduce the frequency of usage or complete renunciation of the preparation usage.

Drug interactions

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.

Identification

A dark brown colored liquid having a characteristic menthol odor.

Presentation

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).

Expiry date

3 years. Do not use after the expiration date.

Prescription status

To be dispensed without prescription.

Storage conditions

Store at a room temperature, in a dry place, out of the reach of children. Protect from light.