What are safe oral antifungals for infants?

From the Guidelines

Fluconazole is the safest and most commonly used oral antifungal for infants, with a typical dosage of 3-6 mg/kg once daily. The treatment duration usually ranges from 7-14 days for most superficial infections, though systemic infections may require longer courses 1. Nystatin, while technically an oral medication, is not systemically absorbed and is used primarily for oral thrush at a dose of 100,000 units four times daily 1. It's essential to note that oral antifungals should only be used in infants when prescribed by a healthcare provider, as most fungal infections in infants (like diaper rash or thrush) can be treated with topical agents.

Key Considerations

• Fluconazole has been shown to be effective in reducing invasive candidiasis in premature neonates weighing <1000 g in nurseries with a high incidence of Candida infections 1.
• Nystatin has been shown to be effective in reducing invasive candidiasis in preterm infants, but its use may be limited by the presence of ileus, gastrointestinal disease, feeding intolerance, or hemodynamic instability 1.
• Lactoferrin, a mammalian milk glycoprotein involved in innate immunity, has been shown to reduce the incidence of late-onset sepsis and invasive fungal infections in infants <1500 g, but further confirmation of its efficacy and safety is needed 1.

Safety and Efficacy

The safety and efficacy of fluconazole in infants have been consistently demonstrated in numerous studies, with a typical relative risk of 0.23 and number needed to treat of 9 1. However, it's crucial to be aware of potential side effects, including gastrointestinal upset, and to follow up with a pediatrician if symptoms don't improve within a few days of treatment. Fluconazole is generally recommended as the first-line treatment for infants with fungal infections requiring oral treatment.

From the FDA Drug Label

Based on the prolonged half-life seen in premature newborns (gestational age 26 to 29 weeks), these children, in the first two weeks of life, should receive the same dosage (mg/kg) as in older children, but administered every 72 hours. After the first two weeks, these children should be dosed once daily. Oropharyngeal candidiasis: The recommended dosage of fluconazole tablets for oropharyngeal candidiasis in children is 6 mg/kg on the first day, followed by 3 mg/kg once daily.

For infants, fluconazole is a safe oral antifungal option, but the dosage depends on the age and weight of the infant, as well as the type of fungal infection being treated.

• For premature newborns (gestational age 26 to 29 weeks), the dosage is the same as in older children, but administered every 72 hours for the first two weeks, and then once daily.
• For oropharyngeal candidiasis, the recommended dosage is 6 mg/kg on the first day, followed by 3 mg/kg once daily 2. It is essential to follow the recommended dosage and administration guidelines to ensure safe and effective treatment.

From the Research

Safe Oral Antifungals for Infants

• The safety and efficacy of oral antifungals in infants have been studied in several clinical trials 3, 4, 5, 6, 7.
• Fluconazole has been shown to be effective in treating oral candidiasis in infants, with a clinical cure rate of 100% in one study 3.
• Nystatin is also commonly used to treat oral candidiasis in infants, but its efficacy has been shown to be lower than that of fluconazole in some studies 3, 6.
• Miconazole gel has been shown to be effective in treating oropharyngeal candidiasis in immunocompetent infants, with a clinical cure rate of 96.9% by Day 8 of treatment 7.
• The choice of oral antifungal for infants should be based on the specific clinical situation and the potential risks and benefits of each medication.

Comparison of Oral Antifungals

• A study comparing fluconazole and nystatin oral suspensions for the treatment of oral candidiasis in infants found that fluconazole was superior to nystatin in terms of clinical cure rate 3.
• Another study comparing miconazole gel and nystatin suspension for the treatment of oropharyngeal candidiasis in immunocompetent infants found that miconazole gel was superior to nystatin suspension in terms of efficacy and rapidity of achieving cure 7.
• A systematic review and meta-analysis of the efficacy of nystatin for the treatment of oral candidiasis found that nystatin suspension was not superior to fluconazole in treating oral candidiasis in infants, children, or HIV/AIDS patients 6.

Safety Considerations

• The safety of oral antifungals in infants has been evaluated in several studies, with most studies finding that these medications are well-tolerated in this population 3, 4, 5, 6, 7.
• However, one study found that nystatin was associated with a higher mortality rate than fluconazole in very low birthweight infants, although the difference was not statistically significant 4.
• Another study found that miconazole gel was associated with a lower rate of clinical relapses and side effects compared to nystatin suspension 7.