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Rescriptor

Clinical Pharmacology
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Clinical Pharmacology

Rescriptor

↑Indicates increase
¯ Indicates decrease
« INDICATES NO SIGNIFICANT CHANGE
* RELATIVE TO INDINAVIR 800 MG TID WITHOUT RESCRIPTOR
† Plasma concentrations of the nelfinavir active metabolite (nelfinavir hydroxy-t-butylamide) were significantly reduced by delavirdine, which is more than compensated for by increased nelfinavir concentration
† SAQUINAVIR SOFT GEL CAPSULE 1000 MG TID PLUS RESCRIPTOR 400 MG TID RELATIVE TO SAQUINAVIR SOFT GEL CAPSULE 1200 MG TID WITHOUT RESCRIPTOR
§ RESCRIPTOR taken with didanosine (buffered tablets) relative to doses of RESCRIPTOR and didanosine (buffered tablets) separated by at least 1 hr - Indicates no data available

Table 2. Pharmacokinetic Parameters for Delavirdine in the Presence of Coadministered Drugs

Coadministered
Drug
Dose of
Coadministered
Drug
Dose of
RESCRIPTOR
n
% Change in Delavirdine Pharmacokinetic Parameters (90% CI)
Cmax
AUC
Cmin
HIV-Protease Inhibitors
Indinavir
400 or 600 mg
tid ×7 days
400 mg tid
× 7 days
81
No apparent changes based on a comparison to historical data
Nelfinavir
750 mg tid
× 7 days
400 mg tid
× 14 days
7
¯27
(¯49-↑4)
¯31
(¯57-↑10)
¯33
(¯70-↑49)
Saquinavir
Soft gel capsule 1000 mg tid
× 28 days
400 mg tid
for 7-28 days
23
No apparent changes based on a comparison to historical data
Nucleoside Reverse Transcriptase Inhibitors
Didanosine
(buffered tablets)
125 or 200 mg
bid x 28 days
400 mg tid x
28 days
9
¯32*
(¯48-¯11)
¯19*
(¯37-↑6)
«*
Zidovudine
200 mg tid
for ≥ 7 days
400 mg tid
for 7-14 days
42
No apparent changes based on a comparison to historical data
Anti-infective Agents
Clarithromycin
500 mg bid
x 15 days
300 mg tid
x 30 days
6
«
«
«
Fluconazole
400 mg qd
x 15 days
300 mg tid
x 30 days
8
«
«
«
Ketoconazole
Various
200-400 mg
tid
26
-
-
↑50†
Rifabutin
300 mg qd
x 14 days
400 mg tid
x 28 days
7
¯72
(¯61-¯80)
¯82
(¯74-¯88)
¯94
(¯90-¯96)
Rifampin
600 mg qd
x 15 days
400 mg tid
x 30 days
7
¯90
(¯94-¯83)
¯97
(¯98-¯95)
¯100
Sulfamethoxazole or Trimethoprim & Sulfamethoxazole
Various
200-400 mg tid
311
-
-
Ǡ
Other
Antacid
(MaaloxÒ TC)
20 mL
300 mg
single dose
12
¯52
(¯68-¯29)
¯44
(¯58-¯27)
-
Fluoxetine
Various
200-400 mg
tid
36
-
-
↑50†
Phenytoin,
Phenobarbital,
Carbamazepine
Various
300-400 mg tid
8
-
-
¯90†
Brand Name: Rescriptor
Generic Name: Delavirdine Mesylate
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