Table 4: Mean ± SD Pharmacokinetic Parameter Values of Stavudine a in Adults with Varying Degrees of Renal Function Creatinine ClearanceĪ Single 40-mg oral dose. 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). The mean ± SD hemodialysis clearance value of stavudine was 120 ☑8 mL/min (n=12) the mean ± SD percentage of the stavudine dose recovered in the dialysate, timed to occur between 2-6 hours post-dose, was 31 ± 5%. C max and T max were not significantly altered by renal impairment. d over 12-24 hours.ĭata 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 4). Urinary recovery of stavudine (% of dose) a,dĪ following 1-hour IV infusion. Table 2: Pharmacokinetic Parameters of Stavudine in HIV-Infected Adults: Bioavailability, Distribution, and Clearance Parameter The mean renal clearance was about twice the average endogenous creatinine clearance, indicating active tubular secretion in addition to glomerular filtration. In HIV-infected patients, renal elimination of unchanged drug accounts for about 40% of the overall clearance regardless of the route of administration (Table 2). Mean renal clearance of the parent compound is approximately 272 mL/min, accounting for approximately 67% of the apparent oral clearance

The mean terminal elimination half-life is approximately 2.3 hours following single oral doses. Radioactivity due to parent drug in urine and feces was 73.7% and 62.0%, respectively.

Following an 80-mg dose of 14C-stavudine to healthy subjects, approximately 95% and 3% of the total radioactivity was recovered in urine and feces, respectively.

Ac3d select inverted normals