BETADINE SORE THROAT SPRAY 0.45% W/V FOR ORAL USE

Product Information

Registration Status: Active

BETADINE SORE THROAT SPRAY 0.45% W/V is approved to be sold in Singapore with effective from 2017-08-07. It is marketed by MUNDIPHARMA PHARMACEUTICALS PTE LTD, with the registration number of SIN15313P.

This product contains Povidone-Iodine 0.45% w/v in the form of SPRAY. It is approved for ORAL use.

This product is manufactured by Mundipharma Pharmaceuticals Ltd in CYPRUS.

It is an Over-the-counter Medicine that can be freely obtained from any retailer

Description

Povidone-iodine is a stable chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine. It contains from 9.0% to 12.0% available iodine, calculated on a dry basis. This unique complex was discovered in 1955 at the Industrial Toxicology Laboratories in Philadelphia by H. A. Shelanski and M. V. Shelanski. They carried out tests in vitro to demonstrate anti-bacterial activity, and found that the complex was less toxic in mice than tincture of iodine. Human clinical trials showed the product to be superior to other iodine formulations. Povidone-iodine was immediately marketed, and has since become the universally preferred iodine antiseptic.

Indication

For topical application in the treatment and prevention of infection in wounds.

Mechanism of Action

Povidone-iodine is called iodophore which means povidone acts as a carrier of iodine. Iodine is considered as the active moiety that mediates microbicidal actions. When released from the complex, free iodine (I2) penetrates the cell wall of microorganisms quickly, and the lethal effects are believed to result from disruption of protein and nucleic acid structure and synthesis. While the full mechanism of action is not fully elucidated, iodine is thought to inhibit vital bacterial cellular mechanisms and structures, and oxidizes nucleotides fatty or amino acids in bacterial cell membranes [A32992]. Additionally, free iodine disrupts the function of the cytosolic enzymes involved in the respiratory chain, causing them to become denatured and deactivated [A32992]. _In vitro_ evidence suggests that iodine also counteracts inflammation elicited by both pathogens and the host response via multifactorial effects. In hosts, povidone-iodine was demonstrated to modulate the redox potential, inhibit the release of inflammatory mediators such as TNF-α and β-galactosidase, inhibit metalloproteinase production, and potentiate the healing signals from pro-inflammatory cytokines by activation of monocytes, T-lymphocytes, and macrophages, _in vitro_ [A32992]. ### in vitro [].

Pharmacokinetics

Absorption: Povidone-Iodine is intended for topical application and is not absorbed.
Distribution: Povidone-Iodine is intended for topical application and has no volume of distribution
Metabolism: Povidone -Iodine is not absorbed or metabolised
Elimination

Clearance

Povidone-Iodine is intended for topical application and is not eliminated

Toxicity

ORAL (LD50): Acute: 8000 mg/kg [Rat]. 8100 mg/kg [Mouse]

Active Ingredient/Synonyms

Povidone iodine | Povidone-iodine |

Source of information: Drugbank (External Link). Last updated on: 3^rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.