Stavudine (Page 5 of 9)

Special Populations

Pediatric

Pharmacokinetic properties of stavudine in pediatric patients are presented in Table 9.

Table 9: Pharmacokinetic Parameters (Mean ± SD) of Stavudine in HIV-1-Exposed or -Infected Pediatric Patients
ND = Not determined.
*
Following 1-hour IV infusion.
At median time of 2.5 hours (range 2 to 3 hours) following multiple oral doses.
Following single oral dose.
§
Over 8 hours.
Parameter

Ages 5 weeks

n

Ages 14

n Day of Birth n
Oral bioavailability (%) 76.9 ± 31.7 20 ND ND
Volume of distribution (L/kg)* 0.73 ± 0.32 21 ND ND

Ratio of CSF:plasma

59 ± 35 8 ND ND

Total body clearance

9.75 ± 3.76 21 ND ND

Apparent oral clearance

13.75 ± 4.29 20 11.52 ± 5.93 30 5.08 ± 2.80 17
Elimination half-life, IV dose (h)* 1.11 ± 0.28 21 ND ND
Elimination half-life, oral dose (h) 0.96 ± 0.26 20 1.59 ± 0.29 30 5.27 ± 2.01 17

Urinary recovery of stavudine

34 ± 16 19 ND ND

Renal Impairment

Data from two studies in adults indicated that the apparent oral clearance of stavudine decreased and the terminal elimination half-life increased as creatinine clearance decreased (see Table 10). Cmax and Tmax were not significantly altered by renal impairment. The mean ± SD hemodialysis clearance value of stavudine was 120 ± 18 mL/min (n = 12); the mean ± SD percentage of the stavudine dose recovered in the dialysate, timed to occur between 2 to 6 hours post-dose, was 31 ± 5%. Based on these observations, it is recommended that stavudine dosage be modified in patients with reduced creatinine clearance and in patients receiving maintenance hemodialysis [see Dosage and Administration (2.3)].

Table 10: Mean ± SD Pharmacokinetic Parameter Values of Stavudine * in Adults with Varying Degrees of Renal Function
T1/2 = Terminal elimination half-life NA = Not applicable
*
Single 40 mg oral dose
Determined while patients were off dialysis
Creatinine Clearance

Hemodialysis Patients

> 50 mL/min

26 to 50 mL/min

9 to 25 mL/min

Creatinine clearance (mL/min) 104 ± 28 41 ± 5 17 ± 3 NA
Apparent oral clearance (mL/min) 335 ± 57 191 ± 39 116 ± 25 105 ± 17
Renal clearance (mL/min) 167 ± 65 73 ± 18 17 ± 3 NA
T1/2 (h) 1.7 ± 0.4 3.5 ± 2.5 4.6 ± 0.9 5.4 ± 1.4

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