What is the recommended dose of nystatin (antifungal medication) for a 2-month-old infant weighing 9.98 pounds with oral thrush?

From the Guidelines

For a 2-month-old infant weighing 9.98 pounds with oral thrush, the recommended dose of nystatin suspension is 4–6 mL orally 4 times daily, as stated in the guidelines 1. This dose is equivalent to 100,000 units/mL, and the total daily dose would be 1.6-2.4 million units.

Key Considerations

• The medication should be applied to the affected areas in the mouth using a clean finger or cotton swab, or can be divided between each side of the mouth.
• Half of the dose should be placed in each cheek pouch.
• Treatment should continue for at least 48 hours after symptoms have resolved, typically for a total of 7-14 days.
• It's essential to administer the medication after feedings to maximize contact time with the oral tissues.
• The suspension should be shaken well before each use.
• Nystatin works by binding to sterols in the fungal cell membrane, creating pores that lead to cell death.
• It is not significantly absorbed systemically, making it a safe option for infants.
• Parents should be advised to maintain good oral hygiene for the infant and to sterilize pacifiers, bottle nipples, and toys that go into the baby's mouth to prevent reinfection.

Additional Guidance

• According to the clinical practice guidelines for the management of candidiasis, nystatin suspension at a concentration of 100,000 U/mL and a dosage of 4–6 mL 4 times daily is recommended for mild oropharyngeal candidiasis 1.
• The guidelines also suggest that treatment should be continued for 7-14 days, and that chronic suppressive therapy is usually unnecessary for patients with HIV infection 1.

From the FDA Drug Label

DOSAGE AND ADMINISTRATION Infants: 2 mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes). The recommended dose of nystatin for a 2-month-old infant weighing 9.98 pounds with oral thrush is 2 mL (200,000 units) four times daily. It is advised to use a dropper to place one-half of the dose in each side of the mouth and avoid feeding for 5 to 10 minutes 2.

From the Research

Nystatin Dosing for 2-Month-Old Infant

• The recommended dose of nystatin for a 2-month-old infant weighing 9.98 pounds with oral thrush is not explicitly stated in the provided studies 3, 4, 5, 6, 7.
• However, a study on the efficacy of nystatin for the treatment of oral candidiasis in infants, children, or HIV/AIDS patients found that nystatin suspension was not superior to fluconazole in treating oral candidiasis 4.
• Another study compared the efficacy of nystatin suspensions with photodynamic therapy and found that nystatin was effective in reducing the colony-forming units per milliliters (CFU/mL) of Candida species 5.
• The dosage of nystatin used in these studies was not specified for a 2-month-old infant weighing 9.98 pounds.
• A study on the design and optimization of nystatin loaded mucoadhesive spanlastical hard candy lozenges for the treatment of oral candidiasis found that the optimum formula showed higher in-vivo antifungal activity compared to the marketed oral suspension 6.
• However, this study was conducted on rats and not on human infants.

Considerations for Nystatin Administration

• Nystatin is available in various formulations, including suspensions, pastilles, and lozenges 3, 4, 6.
• The choice of formulation and dosage may depend on the severity of the oral thrush and the patient's age and weight.
• It is essential to consult a healthcare professional for proper diagnosis and treatment of oral thrush in infants 7.
• Nystatin is not expected to interfere with warfarin metabolism, making it a safer alternative for patients taking warfarin 7.