Pharmaceutical considerations for the well-baby visit

May 2005

This month’s column shares its topic with the special edition on the well-baby visit. While the need for drug therapy may not be paramount at these visits, it can be worthwhile for clinicians to discuss the use of several medications that are likely to be used during infancy. Conditions common in infancy that may require drug therapy include diarrhea and dehydration – oral rehydration solution, diaper dermatitis – skin protectants, fever – antipyretics and poison prevention – syrup of ipecac is no longer recommended to be routinely stored in the infant’s home.

Oral rehydration solutions

Acute gastroenteritis is a significant cause of morbidity in infants and young children in the United States, resulting in approximately 200,000 hospitalizations and 30 deaths annually. Rotavirus infection is a leading cause of these diarrheal illnesses. Outside the United States, diarrheal diseases result in a significantly greater burden of morbidity and mortality, with 1.5 to 2.5 million deaths in children younger than age 5. Dehydration is usually the greatest threat to child health during diarrheal illness.

Infants are especially susceptible to the development and consequent adverse effects of dehydration because of their body surface:volume ratio, decreased fluid reserves, and higher metabolic rate. The use of oral rehydration solutions (ORS) can be an easy, inexpensive means for caregivers and clinicians (eg, emergency department) to administer fluids and electrolytes to treat and prevent dehydration. ORS use for mild-moderate dehydration has been shown to be as effective as intravenous fluid therapy. It is safe, and it is less expensive. ORS use may also be less discomforting to the child, as it does not involve intravenous line insertion. The American Academy of Pediatrics has stated that ORS is the preferred treatment of fluid and electrolyte loss from diarrhea in children with mild-moderate dehydration. Unfortunately, ORS is underused by clinicians, as has been document by published surveys. This may be secondary to the aura or belief that rehydration through intravenous solution administration is more effective than the use of a relatively simple oral solution.

Several ORS products are available over-the-counter and differ by electrolyte content and flavoring. An additional product is available as a freezer pop, for older children (Pedialyte Freezer Pops, Ross). All of these products contain sodium (45-75 mEq/L), potassium (20-25 mEq/L), chloride (35-65 mEq/L), citrate (30-48 mEq/L) – a source of bicarbonate, and dextrose or glucose (2%-2.5%). Infalyte Oral Solution (Mead Johnson) contains rice syrup solids in place of glucose or dextrose. These carbohydrates primarily function not as a source of calories, but to aid the coupled transport of sodium and glucose at the intestinal brush border, which is the major mechanism of efficacy of ORS. The osmotic gradient formed by the transcellular transport of electrolytes and nutrients allows water to passively follow. Large trials of ORS products containing additional co-transporters of sodium, such as cereals, have not confirmed additional efficacy.

One product, Resol Solution (Wyeth-Ayerst) additionally contains calcium, magnesium, and phosphate. The benefit, if any, of these additional ingredients is not clear. The taste of ORS may be a deterrent to acceptance by some children. Many of the ORS products are available with different flavors, such as bubble gum or fruit. These products may be more acceptable to younger children. Additionally, ORS can be frozen in a popsicle and offered to children, or the Pedialyte Freezer Pops may be given (grape, cherry, orange, or blue raspberry).

While ORS products are relatively inexpensive, generic products are available that are even less costly. It is important to mention to caregivers that they should not add sugar or flavorings in an attempt to improve the taste, as this will increase the product’s osmolarity and may reduce its effectiveness. The osmolarity of these ORS products ranges from 200-305 mOsm/L. Some caregivers who do not have an ORS solution in the home at the time of their child’s diarrheal illness may be tempted to give solutions more commonly found in the home, such as apple juice or coca-cola, with osmolarities of 730 mOsm/L and 650 mOsm/L, respectively. These products are thus hyperosmolar, and they can actually increase fluid loss through an osmotic effect. Another commonly available solution that caregivers may administer is Gatorade. While its osmolarity (330 mOsm/L) is less than juices, Gatorade contains fewer electrolytes as compared to ORS. Water alone is insufficient as well, as it does not contain significant electrolytes. Administration of water alone may potentially result in clinically significant hyponatremia or other dilutional electrolyte deficiencies. Caregivers should be educated on the inappropriate use of ORS. It is also important to counsel caregivers on the benefit of ORS administration — rehydration and prevention of dehydration. Caregivers may falsely believe that ORS products will reduce stool volume or duration of diarrhea, and may potentially halt their administration if this does not occur soon after administration.

Diaper dermatitis

Diaper dermatitis is common among infants. While numerous products and pharmacologic agents are available over-the-counter, only skin protectants are considered appropriate by the FDA to use by caregivers without consulting a physician. Skin protectants function as a physical barrier between the skin and the skin irritants, and they absorb moisture and shield the skin from moisture. Twelve protectants are considered safe and effective by the FDA, with zinc oxide, petrolatum, mineral oil, talc and calamine perhaps the more recognizable agents (Table). Zinc oxide is available in many products (eg, Desitin) and in many concentrations (up to 40%). Although zinc oxide is an excellent protectant, it can be messy and difficulty to apply and remove, as it has a thick, sticky texture (which allows it be so beneficial as a protectant). Mineral oil can aid in its removal. Some products containing zinc oxide are available in a creamier, ointment form (with mineral oil), and they can be somewhat easier to use. Zinc oxide is available as generic formulations, which are often much less expensive. Petrolatum is another excellent protectant. It is also messy and may be difficult to remove. Generically available petrolatum is inexpensive. Some diaper dermatitis products contain vitamins A and D – these ingredients, however, likely do not contribute to the product’s efficacy. It is the products base, often petrolatum or lanolin, which gives the product its efficacy. Talc and cornstarch may also be effectively used for diaper dermatitis. When products containing talc or cornstarch are used, however, it is important to caution caregivers about the potential for these powders to result in complications from inhalation. Many diaper dermatitis products are available to caregivers, with any of the FDA-approved ingredients, or combinations thereof. Product choice depends upon cost, personal preference, or ease of use.

The FDA has assessed that OTC diaper dermatitis products should not contain antibacterial, antifungal, or anti-inflammatory ingredients, as these agents should not be used without the consent and counseling of a physician. When anti-inflammatory agents (eg, hydrocortisone) are recommended for use by clinicians, it is important that their use be appropriate. Diaper dermatitis increases the risk of systemic absorption of topically applied medications, as the skin’s normal barrier to absorption is not intact, and the use of an occlusive dressing (ie, diaper) additionally may increase absorption. If an anti-inflammatory agent is needed for inflamed skin associated with diaper dermatitis, 1% hydrocortisone is generally the most potent topical corticosteroid that should be used. Case reports of significant systemic adverse effects from use of topically applied corticosteroids have been published. If hydrocortisone is used, it should be applied sparingly (as opposed to liberal application for the skin protectants described above) and for as short a time period as possible. Topical corticosteroid potency varies and is classified from low to high potency. Hydrocortisone (0.5%-2.5%) is the lowest, as compared to triamcinolone acetonide (Kenalog) – low intermediate potency, fluocinolone acetonide (Synalar) – high intermediate potency, or betamethasone dipropionate (Diprosone) – high potency. The use of higher potency topical corticosteroid products may rarely be necessary, if at all, in the treatment of diaper dermatitis.

Poison prevention

While it is beneficial for caregivers to have the above products in the home at all times, a product that until recently was also recommended to be kept in the home with young children was syrup of ipecac. This recommendation was reversed in 2003 when a reevaluation of data on the efficacy of syrup of ipecac demonstrated that ipecac administration does not improve poisoning outcomes overall. While syrup of ipecac may induce vomiting, it often does not completely remove stomach contents. Other concerns related to the use of syrup of ipecac in the home environment by caregivers include the potential for inappropriate use (ie, administration when not necessary or without first consulting a health professional), the potential for continued emesis to delay administration of other treatments (eg, N-acetylcysteine), or the potential for abuse. The AAP now recommends that syrup of ipecac not be routinely stored in the home, and if it is currently in the home, it should be disposed of. The most effective means of poison prevention may be a review of poison threats in the child’s home and environment (eg, grandparents’ home, where numerous medications may be stored with easy-open lids), and recommendations to caregivers to call a poison control center at the first sign of a potential poisoning – 800-222-1222 (national telephone number, regardless of geographical location). Similar to syrup of ipecac, neither should activated charcoal be routinely recommended to be stored in the home, as efficacy and safety have not been adequately demonstrated.

Acetaminophen and Ibuprofen

These medications are likely the most commonly used pharmaceutical agents for infants and children. Important issues related to their appropriate use include: differentiation of dosage forms (eg, infant vs. children products and differences in concentrations of the liquid products and strength of tablets and capsules), similar efficacy, and the lack of benefit of alternating doses. Dosing is also important to review with caregivers, as caregivers often under-dose acetaminophen or ibuprofen. Clinicians should encourage caregivers to contact the medical office or a pharmacist for proper dosing. While age-based dosing may be appropriate for some children, weight-based dosing is likely the most accurate and the most likely means to control discomfort from fever or pain. Recent surveys have documented that many caregivers continue to have “fever phobia,” and thus education of caregivers on fever may be quite helpful. Related to poison prevention, it is important that caregivers understand that acetaminophen is a safe medication when used appropriately, but that it can be fatal if administered or stored carelessly.

For more information:

• CDC. Managing acute gastroenteritis among children. MMWR. 2003;52,RR-16Ú1-1616.
• Committee on Injury, Violence, and Poison Prevention, American Academy of Pediatrics. Poison prevention in the home. Pediatrics. 2003;112:1182-1185.
• Boiko S. Making rash decisions in the diaper area. Pediatr Annals. 2000;29:50-56.

• Edward A. Bell, PharmD, BCPS, is an associate professor of pharmacy practice at Drake University College of Pharmacy and a clinical specialist at Blank Children’s Hospital, Des Moines, Iowa.