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The well baby visit: a good time to talk about products, drugs
Diaper dermatitis product choice can be guided by product ingredients, cost and dose formulation.
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This month’s Pharmacology Consult coincides with the June special issue on well baby care. Although most infants will not have the need for frequent or regular systemic drug therapy — with the possible exception of acetaminophen or ibuprofen for fever or discomfort — the need for topical pharmacotherapy is not uncommon. Topical drug application is mostly used in infancy for diaper dermatitis. Indirect systemic delivery of drugs to infants can occur via breast milk, when the infant’s mother consumes a drug that distributes into breast milk.
Diaper dermatitis
As the etiology of most cases of diaper dermatitis is contact dermatitis induced by diaper occlusion, friction, moisture and skin irritation from urine and stool, the use of a protectant agent is indicated as first-line drug therapy. Many over-the-counter protectant products are available, but only 12 ingredients have been labeled by the FDA as safe and effective. The ingredients labeled by the FDA as safe and effective include zinc oxide, petrolatum (including white petrolatum), mineral oil, calamine, talc, topical cornstarch, kaolin, dimethicone, allantoin and cod liver oil and lanolin (both only when in combination with other effective ingredients).
Several ingredients that have not been proven to be safe and effective yet are commonly included in OTC products are aloe, Peruvian balsam, vitamins A and D, vitamin E and witch hazel. Some products (eg, “butt paste”) contain boric acid, which has been reported to cause systemic toxicity. Products containing boric acid should not be used. Baking soda (sodium bicarbonate) or products containing baking soda should also not be used. It has been reported that some pediatricians recommend Maalox (magnesium hydroxide, aluminum hydroxide; Novartis) applied topically as an aid to treat diaper dermatitis. Although Maalox use may be logical (aluminum can act as an astringent, and the hydroxide salts can buffer urine and fecal acids), no data, other than anecdotal reports, are available to document this product’s safety and efficacy when used for diaper dermatitis. The possibility for enhanced magnesium absorption from skin and systemic toxicity should also be considered. When used, Maalox has often been recommended to combine with Aquaphor (petrolatum, mineral oil) or zinc oxide. As numerous inexpensive products are available OTC (see table), with known safety and efficacy, it is best to avoid using Maalox.
Zinc oxide and petrolatum may be the most useful effective ingredients to guide product choice. Advantages of these agents include inexpensive cost, availability in numerous dose forms and sizes and documented efficacy. The major disadvantage of their use includes their messiness and difficulty of use. Zinc oxide ointment is thick and sticky and can easily stain clothes or carpet. Mineral oil can be used to help remove zinc oxide ointment from skin. Some zinc oxide products are formulated to be creamy and easier to use — these products can be useful, but they are likely to be more expensive. A large tube of generic zinc oxide ointment is quite inexpensive. Petrolatum is also an effective protectant agent for diaper dermatitis, and generic products are also inexpensive. Most infants with diaper dermatitis can successfully be treated with zinc oxide or petrolatum products.
Talc and cornstarch powder are also effective ingredients that can be used. They are available as loose powders, and thus they can reduce friction. Talc and cornstarch should not be used on broken skin, as they can form cake-like adhesions on broken skin and may inhibit healing or increase risk for infection. Additionally, talc and cornstarch may cause respiratory distress in infants if these powders are sufficiently aerosolized. When used, it is best to keep the products away from the infant’s head and to apply as gently as possible, with little aerosolization. Despite some myths, cornstarch does not promote yeast infection.
Diaper dermatitis product choice can be guided by product ingredients, cost and dose formulation. Only products containing one or more of the approved active ingredients listed above should be used. Numerous products are available OTC to caregivers. Many of these contain zinc oxide, petrolatum, mineral oil, lanolin, dimethicone, talc or cornstarch. Products containing these ingredients are acceptable choices. Zinc oxide and petrolatum are likely the most commonly employed ingredients, as both of these agents are excellent barriers. Generic products containing zinc oxide or petrolatum are good products to recommend to caregivers, as they are likely to be effective and large tubes can be obtained for only a few dollars.
The enclosed table lists some product choices. Zinc oxide paste, although an excellent barrier, can be difficult to apply and remove, as it is sticky and can easily stain fabrics. Desitin Creamy (zinc oxide, mineral oil, petrolatum; Johnson & Johnson) is an example of a zinc oxide-containing product formulated as a creamy dose form, which is likely to be easier to apply and remove, although it is more costly. Some products are available with “inviting” names, such as Bottom Better, Flanders Buttocks Ointment (Flanders Inc.), or Boudreaux’s Butt Paste (Blairex). Many of these products contain zinc oxide or petrolatum as the major ingredients, but are likely more expensive than generic zinc oxide or petrolatum products. Boudreaux’s Butt Paste contains boric acid, in addition to several approved active ingredients, and thus should be avoided, as boric acid has been reported to result in toxicity when applied topically.
Although diaper dermatitis commonly occurs in infants and results from the combination of an occlusive diaper, moisture trapping and skin maceration and irritant effects from urine and stool, a recent report described five infants with allergic contact dermatitis from dyes in the diapers used. The location of the rash in these infants, distinct from distribution of the diaper dye coloring and skin contact, was used, in part, to differentiate the dermatitis these infants presented with.
Antifungal agents and topical corticosteroids may be indicated in some infants with diaper dermatitis, complicated by fungal infection or significant inflammation, respectively. As the FDA does not desire caregivers to be treating complicated diaper dermatitis without a physician’s guidance, OTC topical antifungal and corticosteroid products are not labeled for this use in infants aged younger than 2 years. Several antifungal agents are available as OTC products (creams, lotions) – butenafine (Lotrimin; Schering-Plough), clotrimazole (Lotrimin AF, Desitin, generic), miconazole (Micatin, generic), terbinafine (Desenex Max, Novartis; Lamisil AT, Novartis), tolnaftate (Tinactin, Schering-Plough; generic) and undecylenic acid (Cruex).
When a topical corticosteroid is indicated for inflammatory diaper dermatitis, a low potency corticosteroid agent should be used initially, such as hydrocortisone, which is available OTC. The potential for increased drug absorption from skin exists with diaper dermatitis, as the involved skin is non-intact, is covered by an occlusive dressing and it represents a relatively large portion of the infant’s body surface area. Several published studies have evaluated the potential for topically applied corticosteroid products to produce systemic adverse effects and adrenal suppression. Results of these studies have been mixed. One product that has been reported to be commonly used by primary care physicians for the treatment of diaper dermatitis, Lotrisone (betamethasone dipropionate and clotrimazole; Schering-Plough), should not be used by pediatricians, as this product contains a potent corticosteroid. When hydrocortisone is used for diaper dermatitis, caregivers should be informed to apply it sparingly, and its use should be limited to less than two weeks.
Maternal use of medications during infant breast-feeding
A topic that may be easily overlooked during the well baby visit is medication use by the breast-fed infant’s mother. As the potential for drug transfer into breast milk exists for maternal medications, the actual risk to the infant is likely limited or insignificant for most therapeutically used drugs.
The AAP published a guide to maternal medication use during lactation in 2001. A useful literature review of case reports was published in 2003. Briggs et al published a text specific to this topic, Drugs in Pregnancy and Lactation.
Most drugs distribute into breast milk to some extent, and more than 25% distribute into milk to a greater extent than maternal blood (ie, a milk-to-plasma drug concentration ratio less than one). However, this does not necessarily imply an infant is at high risk when the mother is using such a drug. Numerous factors determine the relative risk to the infant, including the age of the infant, amount of breast milk consumed, the therapeutic index (toxicity) of the drug and other factors. General treatment guidelines for maternal medication use during infant breast-feeding include avoidance of OTC liquid products containing alcohol (eg, cough products), maternal medication administration directly after nursing or just prior to the infant’s expected longest sleep period, avoidance of multidose OTC products (ie, use single ingredient products), avoidance of long-acting products when possible, and use of lower doses (ie, avoidance of “maximum strength” OTC products).
Many commonly used medications can be safely taken by nursing mothers, including acetaminophen, ibuprofen, loratadine, chlorpheniramine and dextromethorphan. Some drugs have been reported to possibly cause significant adverse effects in nursing infants, including many central nervous system-active agents (fluoxetine, diazepam), beta-blockers, some anticonvulsants, antibiotics (most commonly reported adverse effect is diarrhea) and opioids. Alcohol intake by a nursing mother should not occur or be limited (eg, no more than one drink two to three hours prior to breast-feeding). Thus, it is important for clinicians to document a complete drug history from mothers who are, or wish to nurse their infants. The use of several published guides can assist clinicians to appropriately assess infant safety during maternal breast-feeding.
For more information:
- Edward A Bell, PharmD, BCPS, is a Professor of Pharmacy Practice at Drake University College Pharmacy and a Clinical Specialist at Blank Children’s Hospital, Des Moines, Iowa.
- Scheinfeld N. Diaper dermatitis: a review and brief survey of eruptions of the diaper area. Amer J Clin Derm. 2005;6:273-281.
- Levin C, Maibach HI. Topical corticosteroid-induced adrenocortical insufficiency. Amer J Clin Derm. 2002;3:141-147.
- Alberta L, Sweeney SM, Wiss K. Diaper dye dermatitis. Pediatrics. 2005;116:e450-e452;doi:101542/peds.2004-2066. Accessed May 15, 2007.
- Anderson PO, Pochop SL, Manoguerra AS. Adverse drug reactions in breastfed infants: less than imagined. Clinical Pediatrics 2003;42:325-40
- Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics. 2001;108:776-789.
- Ito S. Drug therapy for breast-feeding women. N Engl J Med. 2000;343:118-126.