All Purpose Nipple Ointment (APNO)

We call our nipple ointment “all purpose” since it contains ingredients that help deal with multiple causes or aggravating factors of sore nipples. “Good medicine” calls for the single “right” treatment for the “right” problem, true enough, but mothers with sore nipples don’t have time to try out different treatments that may or may not work, so we have combined various treatments in one ointment. Of course, preventing sore nipples in the first place would be the best treatment and often adjusting how the baby takes the breast can do more than anything to decrease and eliminate the mother’s nipple soreness (See information sheets When baby does not yet latch, Sore nipples as well as the video clips at the website ibconline.ca.

The APNO contains:

Mupirocin 2% ointment.

Mupirocin (Bactroban is the trade name) is an antibiotic that is effective against many bacteria, particularly Staphylococcus aureus including MRSA (methicillin resistant Staphylococcus aureus). Staphylococcus aureus is commonly found growing in abrasions or cracks in the nipples and probably makes worse whatever the initial cause of sore nipples is. Interestingly, mupirocin apparently has some effect against Candida albicans (commonly, but inaccurately called “thrush” or “yeast”). Treatment of sore nipples with an antibiotic alone sometimes seems to work, but we feel that the antibiotic works best in combination with the other ingredients discussed below. Although mupirocin is absorbed when taken by mouth, it is so quickly metabolized in the body that it is destroyed before blood levels can be measured. Moreover most of it gets stuck to the skin so that very little is taken in by the baby. Thus it is safe for the baby to swallow if indeed he gets any.

Betamethasone 0.1% ointment.

Betamethasone is a corticosteroid, which like all corticosteroids, decreases inflammation. A large part of the pain mothers experience when they have sore nipples is due to inflammation. The redness of the nipples and areolas is another sign of inflammation. By decreasing the inflammation, the APNO also decreases the pain the mother feels. Most of the betamethasone in the ointment is absorbed into the skin by the mother, so that the baby takes in very little.

Miconazole powder to a final concentration of 2%.

Miconazole is an antifungal agent. It is very effective against Candida albicans. We feel the concentration of 2% miconazole is a good one, but because the pharmacist adds a powder to the above two ingredients, s/he can change the concentration of miconazole so that it can be increased to 3% or even 4% or decreased to less than 2%. We feel 2% is the best concentration for most situations. Fluconazole powder to 2% may be substituted for miconazole and so can clotrimazole powder to 2%, but we believe that clotrimazole (Canesten) irritates more than the other drugs in the same family. Miconazole cream or gel cannot be substituted for miconazole powder as the compound will usually separate. If you live in a place where miconazole or any of the above mentioned drugs (fluconazole, clotrimazole) are not easily available as powders to be mixed into the APNO, it is probably better to use only the mupirocin and betamethasone ointments mixed together than add a cream or gel or nystatin ointment for example.

By using a powder, the concentration of the other two ingredients is not as decreased as they would be if another ointment were used for the anti-fungal agent (for example, nystatin ointment). Thus, in the above preparation the concentration of the betamethasone become 0.05% (due to combination with the mupirocin) and the mupirocin concentration is decreased to 1%. Note that nystatin ointment, which we used to use and which decreases the concentration of the other ingredients, is far inferior to miconazole and also tastes bad.

I write the prescription this way.

1. Mupirocin ointment 2%: 15 grams
2. Betamethasone ointment 0.1%: 15 grams
3. To which is added miconazole powder to a concentration of 2% miconazole

Total: about 30 grams combined 
Apply sparingly after each feeding. Do not wash or wipe off

NO SUBSTITUTIONS

If possible, try to get the prescription filled at a compounding pharmacy. At least they will not tell you there is no such thing as miconazole powder. You can find a list of compounding pharmacies in Canada and the US and maybe some other countries by going to the website iacprx.org. Click “For Patients, Pet Owners” in the red box on the left side of the page, then click “Finding a Compounding Pharmacist Near You”. You will need to sign in and then you can find your nearest compounding pharmacy. Canadians: make sure that you leave a space between the two sets of 3 letters in the postal code: M2K 2E1, not M2K2E1.

How do I use the ointment?

1. Apply it sparingly after each feeding. “Sparingly” means that you apply just enough to make the nipples and areola glossy or shiny.
2. Do not wash it off or wipe it off, even if the baby comes back to the breast earlier than expected.

How long can I use the ointment?

Somehow the “word” has gotten around to use the ointment for only two weeks. This is unfortunate since many mothers are getting so much better, but not pain free, by the time they believe they have to stop the ointment. Apparently pharmacists have said that the steroid in the ointment will cause “thinning” of the skin. This is a concern with any steroid one puts on the skin, but in our experience this has not occurred with our ointment and many mothers have used it for months.

However, any drug should be used for the shortest period of time necessary, whether it’s taken by mouth or put on the skin or any other way it’s being given. The same is true for our ointment. There is no problem using the ointment for 2 or 3 or even more weeks, but if you still need the ointment after two or three weeks, or you pain returns after you have stopped it, you should get “hands on” help again to find out why and fix the way the baby is taking the breast, for example. Indeed, the most important feature of decreasing nipple pain is getting the “best latch possible”. Many teach a method of latching on that is different from what we teach. Naturally, based on our experience and from feedback, we think we have an effective and successful method. See the information sheet When baby does not yet latch, and watch the video clips at the website and ibconline.ca.

All purpose nipple ointment, © 2009

This handout may be copied and distributed without further permission, on the condition that it is not used in any context in which the WHO code on the marketing of breastmilk substitutes is violated

Administration of Contrast Medium to Breastfeeding Mothers

ACR Committee on Drugs and Contrast Media

Administration of an iodinated or gadolinium-based contrast agent occasionally is indicated for an imaging study on a woman who is breastfeeding. Both the patient and the patient’s physician may have concerns regarding potential toxicity to the infant from contrast medium that is excreted into the breast milk. The literature on the excretion of iodinated and gadolinium-based contrast agents into breast milk and the gastrointestinal absorption of these agents from breast milk is very limited. A review of the literature, however, reveals important facts: Less than 1 percent of the administered maternal dose of contrast agent is excreted into breast milk and less than 1 percent of the contrast medium in breast milk ingested by an infant is absorbed from the gastrointestinal tract. Therefore, the expected dose of contrast medium absorbed by an infant from ingested breast milk is extremely low. The ACR Committee on Drugs and Contrast Media has discussed this issue extensively over the past year and has prepared the following summary information and recommendations.

Iodinated X-Ray Contrast Media (Ionic and Nonionic)

Background

The plasma half-life of intravenously administered iodinated contrast medium is about two hours, with nearly 100 percent of the agent cleared from the bloodstream within 24 hours. Because of its low lipid solubility, less than 1 percent of the administered maternal dose of iodinated contrast medium is excreted into the breast milk in the first 24 hours.1,2 Because less than 1 percent of the contrast medium ingested by the infant is absorbed from its gastrointestinal tract,3 the expected dose absorbed by the infant from the breast milk is less than 0.01 percent of the intravascular dose given to the mother. This amount of contrast medium represents less than 1 percent of the recommended dose for an infant undergoing an imaging study, which is 2 mL/kg. The potential risks to the infant include direct toxicity and allergic sensitization or reaction, which are theoretical concerns but have not been reported.

Recommendation

Mothers who are breastfeeding should be given the opportunity to make an informed decision as to whether to continue breastfeeding or temporarily abstain from breastfeeding after receiving intravascularly administered iodinated contrast medium. Because of the very small percentage of iodinated contrast medium that is excreted into the breast milk and absorbed by the infant’s gut, we believe that the available data suggest that it is safe for the mother and infant to continue breastfeeding after receiving such an agent. If the mother remains concerned about any potential ill effects to the infant, she may abstain from breastfeeding for 24 hours with active expression and discarding of breast milk from both breasts during that period. In anticipation of this, she may wish to use a breast pump to collect milk before the contrast study to feed the infant during the 24-hour period following the examination.

Gadolinium-Based Contrast Agents

Background

Gadolinium compounds are safe and useful as magnetic resonance imaging contrast agents. Although free gadolinium is neurotoxic, when complexed to one of a variety of chelates it is safe for use in adults and children. These hydrophilic gadolinium chelate agents have pharmacokinetic properties very similar to those of iodinated X-ray contrast media. Like iodinated contrast agents, gadolinium contrast agents have a plasma half-life of about 2 hours and are nearly completely cleared from the bloodstream within 24 hours. Less than 0.04 percent of the intravascular dose given to the mother is excreted into the breast milk in the first 24 hours.4-6 Because less than 1 percent of the contrast medium ingested by the infant is absorbed from its gastrointestinal tract,7 the expected dose absorbed by the infant from the breast milk is less than 0.0004 percent of the intravascular dose given to the mother. Even in the extreme circumstance of a mother weighing 150 kg and receiving a dose of 0.2 mmol/kg, the absolute amount of gadolinium excreted in the breast milk in the first 24 hours after administration would be no more than 0.012 mmol. Thus, the dose of gadolinium absorbed from the gastrointestinal tract of a breastfeeding infant weighing 1,500 g or more would be no more than 0.00008 mmol/kg, or 0.04 percent (four ten-thousandths) of the permitted adult or pediatric (2 years or older) intravenous dose of 0.2 mmol/kg. The potential risks to the infant include direct toxicity (including toxicity from free gadolinium, because it is unknown how much, if any, of the gadolinium in breast milk is in the unchelated form) and allergic sensitization or reaction, which are theoretical concerns but have not been reported.

Recommendation

Review of the literature shows no evidence to suggest that oral ingestion by an infant of the tiny amount of gadolinium contrast agent excreted into breast milk would cause toxic effects. We believe, therefore, that the available data suggest that it is safe for the mother and infant to continue breastfeeding after receiving such an agent. If the mother remains concerned about any potential ill effects, she should be given the opportunity to make an informed decision as to whether to continue breastfeeding or temporarily abstain from breastfeeding after receiving a gadolinium contrast agent. If the mother so desires, she may abstain from breastfeeding for 24 hours with active expression and discarding of breast milk from both breasts during that period. In anticipation of this, she may wish to use a breast pump to collect milk before the contrast study to feed the infant during the 24-hour period following the examination.

References

1. Nielsen ST, Matheson I, Rasmussen JN, Skinnemoen K, Andrew E, Hafsahl G. Excretion of iohexol and metrizoate in human breast milk. Acta Radiol 1987; 28(5):523-526.
2. Ilett KF, Hackett LP, Paterson JW, McCormick CC. Excretion of metrizamide in milk. Br J Radiol 1981;54(642): 537-538.
3. Johansen JG. Assessment of a nonionic contrast medium (Amipaque) in the gastrointestinal tract. Invest Radiol 1978; 13(6):523-527.
4. Schmiedl U, Maravilla KR, Gerlach R, Dowling CA. Excretion of gadopentetate dimeglumine in human breast milk. AJR1990;154(6):1305-1306.
5. Rofsky NM, Weinreb JC, Litt AW. Quantitative analysis of gadopentetate dimeglumine excreted in breast milk. J Magn Reson Imag 1993;3(1):131-132.
6. Kubik-Huch RA, Gottstein-Aalame NM, Frenzel T, et al. Gadopentetate dimeglumine excretion into human breast milk during lactation. Radiology 2000;216(2): 555-558.
7. Weinmann HJ, Brasch RC, Press WR, Wesby GE. Characteristics of gadolinium-DTPA complex: A potential NMR contrast agent. AJR1984;142(3):619-624.

ACR Committee on Drugs and Contrast Media