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Pharmacokinetics of acyclovir suspension in infants and children
W M Sullender1, A M Arvin, P S Diaz
1Department of Pediatrics, Stanford University School of Medicine, California 94305.
Insights
Oral acyclovir suspension is safe and well-tolerated for treating herpes simplex and varicella-zoster virus infections in children. Dosing regimens of 600 mg/m2 and 300 mg/m2 showed favorable pharmacokinetic profiles in pediatric patients.
Area of Science:
- Pediatric Pharmacology
- Infectious Diseases
- Antiviral Therapy
Background:
- Herpes simplex virus (HSV) and varicella-zoster virus (VZV) infections are common in children.
- Effective and safe antiviral treatments are crucial for pediatric populations.
- Acyclovir is a widely used antiviral, but its pharmacokinetic properties and safety in young children require specific evaluation.
Purpose of the Study:
- To evaluate the pharmacokinetics and safety of an oral acyclovir suspension in pediatric patients.
- To determine appropriate dosing for infants and young children with HSV or VZV infections.
- To assess the tolerability of oral acyclovir suspension in a pediatric cohort.
Main Methods:
- A cohort of 18 children (3 weeks to 6.9 years) received oral acyclovir suspension.
- Two dosing regimens were used: 600 mg/m2 per dose for older children and 300 mg/m2 per dose for infants and younger children.
- Pharmacokinetic parameters including Cmax, Tmax, AUC, and t1/2 were measured. Safety and tolerability were monitored.
Main Results:
- Children receiving 600 mg/m2 had a mean Cmax of 0.99 µg/mL, Tmax of 3.0 h, AUC of 5.56 µg·h/mL, and t1/2 of 2.59 h.
- Infants receiving 300 mg/m2 had a mean Cmax of 1.88 µg/mL, Tmax of 4.1 h, AUC of 6.54 µg·h/mL, and t1/2 of 3.26 h.
- The acyclovir suspension was well tolerated, with no adverse effects necessitating drug discontinuation.
Conclusions:
- Oral acyclovir suspension demonstrates favorable pharmacokinetic profiles in pediatric patients across different age groups.
- The established dosing regimens (600 mg/m2 and 300 mg/m2) appear safe and effective for treating HSV and VZV infections in children.
- Acyclovir suspension is a viable and well-tolerated therapeutic option for pediatric viral infections.
Abstract:
Eighteen children from 3 weeks to 6.9 years of age were given an oral acyclovir suspension for herpes simplex or varicella-zoster virus infections. Thirteen patients who were 6 months to 6.9 years old received 600 mg/m2 per dose, and three infants and two children less than 2 years old were given 300 mg/m2 per dose. The drug was given four times a day, except to one infant who was treated with three doses a day. Among the 13 children who received the 600-mg/m2 dose, the maximum concentration in plasma (Cmax) was 0.99 +/- 0.38 microgram/ml (mean +/- standard deviation), the time to maximum concentration (Tmax) was 3.0 +/- 0.86 h, the area under the curve (AUC) was 5.56 +/- 2.17 micrograms.h/ml, and the elimination half-life (t1/2) was 2.59 +/- 0.78 h. The three infants less than 2 months of age who received the 300-mg/m2 dose had a Cmax of 1.88 +/- 1.11 micrograms/ml, a Tmax of 4.10 +/- 0.48 h, an AUC of 6.54 +/- 4.32 micrograms.h/ml, and a t1/2 of 3.26 +/- 0.33 h. The acyclovir suspension was well tolerated by young children. No adverse effects requiring discontinuation of the drug occurred.