Product Information
Registration Status: ActiveSIN15344P
BETADINE VAGINAL GEL 10% W/W is approved to be sold in Singapore with effective from 2017-10-13. It is marketed by MUNDIPHARMA PHARMACEUTICALS PTE LTD, with the registration number of SIN15344P.
This product contains Povidone-Iodine 10% w/w in the form of GEL. It is approved for VAGINAL 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
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}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: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.