BETADINE™ BV Gel
Break free from bacterial vaginosis (BV)
Bacterial vaginosis (BV) is the most common cause of abnormal vaginal discharge and has been associated with a range of serious health and reproductive consequences.1,2 Despite the availability of a number of oral and intravaginal antibiotic treatment options, its management remains challenging.1 More than 50 % of women experience recurrent episodes with standard antibiotic-based treatments.1,2 A key factor is the failure of antibiotics to fully eliminate vaginal biofilms adhered to cells lining the vagina that contain abundant Gardnerella vaginalis,1 also known as bacterial vaginosis.
BV’s recurrent nature can have a substantial impact on women’s emotional, sexual and social lives.3 The most distressing symptom of BV is the distinctive, strong, fishy odour that accompanies a thin, grey or white vaginal discharge.3,4 Women report feeling embarrassed, ‘dirty’ and concerned that others may detect the malodour.3
BETADINE™ BV Gel is a new, non-antibiotic treatment distributed by Mundipharma South Africa, that has the potential to fulfil areas of unmet clinical need in the treatment of BV.5,6 BETADINE™ BV Gel contains astodrimer sodium, a novel dendrimer-based therapy with a physical mechanism of action that disrupts vaginal biofilms and prevents harmful vaginal bacteria from adhering to the vaginal lining, reducing their opportunity to grow whilst allowing normal vaginal flora to replenish.5,6,7 This helps to normalise the vaginal pH while relieving odour and discharge.5
BETADINE™ BV Gel has proven clinical efficacy and safety in 3 large randomised trials in over 500 patients.6,7 BETADINE™ BV Gel provides rapid relief from the unpleasant odour in just 24 hours.6 Because it acts locally and is not absorbed systemically, BETADINE™ BV Gel avoids potential issues associated with conventional antibiotics such as systemic side effects, antibiotic resistance, and overgrowth of Candida is minimal.6 It has a favourable safety profile and is well tolerated.6 BETADINE™ BV Gel is applied once daily for 7 days.5 It is available over-the-counter (OTC) from Clicks and other leading pharmacies.
For more information about BETADINE™ BV Gel please visit www.betadine.co.za
BETADINE™ BV Gel. Contains astodrimer sodium 10 mg/g (1 %). BETADINE™ BV Gel also contains purified water, carbomer homopolymer type A, sodium hydroxide, glycerine, propylene glycol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate and edetate disodium dihydrate. Please refer to the instructions for use for full prescribing information. Please report any suspected adverse events to ZAdrugsafety@mundipharma.co.za.
1 Munzy CA, Kardas P. A narrative review of current challenges in the diagnosis and management of bacterial vaginosis. Sex Transm Dis. 2020;47(7):441-446. https://doi.org/10.1097%2FOLQ.0000000000001178.
2 Happel A-U, Singh R, Mitchev N, et al. Results from the first South African Health Products Regulatory Authority-approved randomised trial evaluating supplementation of standard antibiotic therapy with a commercially available probiotic in South African women with bacterial vaginosis. MedRxiv. May 2020;20090282. https://doi.org/10.1101/2020.05.04.20090282.
3 Bilardi JE, Walker S, Temple-Smith M, et al. The burden of bacterial vaginosis: women’s experience of the physical, emotional, sexual and social impact of living with recurrent bacterial vaginosis. PLoS ONE. 2013;8(9):e74378. https://doi.org/10.1371/journal.pone.0074378.
4 Kairys N, Garg M. Bacterial vaginosis. [Updated 2020 Nov 21]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK459216/. Accessed 20 Nov 2020.
5 Betadine BV Gel IFU, April 2020.
6 Chavoustie SE, Carter BA, Waldbaum AS, et al. Two phase 3, double-blind, placebo-controlled studies of the efficacy and safety of Astodrimer 1% Gel for the treatment of bacterial vaginosis. Eur J Obstet Gynecol Reprod Biol. 2020;245:13-18. https://doi.org/10.1016/j.ejogrb.2019.11.032.
7 Data on file. Clinical Evaluation Report, July 2018, Starpharma Pty Ltd.
About Mundipharma South Africa and the BETADINE® brand
Mundipharma (Pty) Ltd is part of the Mundipharma network of independent associated companies covering most of the world’s pharmaceutical markets. Mundipharma is a prime example of an organisation that consistently delivers high-quality products while standing by the values that represent it.
For more information please visit: www.mundipharma.co.za
BETADINE® is an important and well-established consumer healthcare brand in the Mundipharma portfolio with trusted products used by healthcare professionals and consumers around the world for over 60 years. The launch of the BETADINE™ Daily Intimate Care range represented the brand’s expansion into the Feminine Care category in South Africa. It was voted ‘Product of the Year 2019’ in the South African Consumer Survey of Product Innovation. BETADINE™ BV Gel represents a true innovation in the management of BV and is a welcome addition to the BETADINE® Feminine Care range.