ATC categoryAntiseptics and disinfectants
ATC subcategoryDrugs for topical and local use
Generic namePovidone Iodine
Each gram of Betaiodine, 10% cream, contains:
active ingredient: povidone iodine – 100 mg;
excipients: ceteareth 12, ceteareth 20, cetostearyl alcohol, paraffin liquid, glycerin, sodium dibasic phosphate, citric acid, water purified.
2-Pyrrolidinone, 1-ethenyl-, homopolymer, compd. with iodine; 25655-41-8.
Antiseptic; D08AG02; G01AX11.
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.
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.
Clean the affected area. Apply a small amount of Betaiodine Cream to the affected area.
Betaiodine can cause hypersensitivity reactions and irritation of the skin, although severe reactions are rare and povidone-iodine is considered to be less irritant than iodine.
The application of Betaiodine to severe burns or to large areas otherwise denuded of skin may produce the systemic adverse effects associated with iodine and metabolic acidosis, hypernatraemia, and renal impairment. Hyperthyroidism or hypothyroidism may occur after ingestion or absorption of large quantities. Hypothyroidism has occurred in neonates both as a result of absorption of iodine from Betaiodine applied to the neonate and also to the mother during pregnancy or breast feeding. Betaiodine application is contra-indicated in premature neonates or those weighing less than 1.5 kg.
Regular or prolonged use should be avoided in patients with thyroid disorders or those receiving lithium therapy.
The effects of povidone-iodine on the thyroid may be altered by other compounds including amiodarone and lithium.
A brown colored cream having a characteristic iodine odor.
15 g and 20 g of cream is filled into aluminum tubes (inside package).
The tubes are packed and inserted with the leaflet into cardboard boxes (outer package).
Store in a cool and dry place, out of the reach of children. Protect from light.