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I am working with some mothers who have tried conventional methods plus review of attachment to correct long standing cracked nipples. In conjuntion with a wound care nurse, the above solution has been suggested to help with treatment of the deep nipple fissures. What we are wondering is the effect on the baby as we can't find any literature on this product with regard to breastfeeding. We have suggested to mums that they express and rest their nipples while using this solution due to the unknown factor. Has anyone tried this solution? There is no information in medications and mother's milk and the drug and information services locally were unable to help with any information.
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skrap:
My staff and I have done a pretty thorough review of this product Prontosan. Prontosan, a wound healing product, contains an antimicrobial called polyhexanide, and betaine which is a surfactant.
Neither of these two products appear very toxic at all except in animal studies at extraordinary high oral and inhaled doses. These were far higher than anything possible from the solution above. Betaine (see abstract below) was studied and appears to nontoxic. Polyhexanide is a broad-spectrum antimicrobial. It too appears to be relatively non-toxic at ordinary concentrations. Polyhexanide is a polymer that is 2670 and 4216 Daltons in size. Thus it is poorly orally bioavailable (about 8% or less).
At this point I'd suggest this product appears reasonably safe to use on breastfeeding mother's nipples. We do not know at this time if it would alter the GI flora in human infants. It's possible that some change in gut flora could result.
I'd suggest a brief wash of the nipples to remove residual product prior to breastfeeding.
Tom Hale Ph.D.
Infantrisk Center
For a complete review of the animal toxicity studies see: http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_157.pdf
References:
Food Chem Toxicol. 2003 Dec;41(12):1685-700.
Betaine in sub-acute and sub-chronic rat studies.
Hayes KC1, Pronczuk A, Cook MW, Robbins MC.
Author information
Abstract
To evaluate the sub-acute and sub-chronic effect of large doses of betaine, this trimethyl glycine compound was fed to rats. Initial studies at BIBRA in the UK evaluated intakes of 0, 1, 2, and 5% betaine added to a maintenance chow designed for use in toxicology studies. Male and female Sprague-Dawley rats were followed for up to 90 days. No toxicity occurred, but at higher betaine intakes several serum chemistries were altered slightly, the MCV, MCH, and MCHC of red cells were reduced, and hepatocytes developed fatty droplets in direct proportion to betaine intake. Females were more affected than males. In a second study to assess reversibility in females, betaine effects were induced for 28 days, followed by a 28 day betaine-free period. All perturbations, except the reduced MCV and MCH, were reversed. As a follow up to BIBRA investigations, both 28 and 90 day feeding trials were conducted at Brandeis University using a rat chow with higher levels of energy, protein, and fat, with betaine added at 0, 0.5, 0.75, 1.0 and 5.0% of the diet. A similar broad range of clinical chemistries and physiological parameters were monitored, and hepatic lipid droplets were investigated in more detail. Liver lipid was actually reduced by betaine, and no significant adverse effects of clinical importance resulted from any dose. However, the MCV was again reduced at 5% betaine in the 28 day study. By 90 days all parameters were normal and comparable to controls. Based on these collective data, it was concluded that even at these high doses, betaine is nontoxic. Differences observed between the BIBRA and Brandeis studies were attributed to differences in the dietary formulations. Significant betainexdietxgrowth interactions were thought to reflect primary disparities in protein and energy concentrations, more than the addition of betaine per se.
PMID: 14563394
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Skin Pharmacol Physiol. 2010;23 Suppl:17-27. doi: 10.1159/000318264. Epub 2010 Sep 8.
Review on the efficacy, safety and clinical applications of polihexanide, a modern wound antiseptic.
H?bner NO1, Kramer A.
Author information
Abstract
Infected wounds are still one of the great challenges in medicine. In the last decade, it has become increasingly clear that antimicrobial chemotherapy is limited by the spread of antimicrobial resistance. Fortunately, new, highly effective antiseptic substances with a broad antimicrobial spectrum are available, so local treatment is expected to get increasingly more important in wound therapy. This paper reviews the antiseptic agent polihexanide (polyhexamethylene biguanide, PHMB), one of the most promising substances available today, from a clinical point of view, focusing on efficacy, safety and clinical applications.
Copyright ? 2010 S. Karger AG, Basel.
PMID: 20829658
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