Renal Impairment: After oral administration of hydromorphone at a single 4 mg dose ( 2 mg Dilaudid IR Tablets), exposure to hydromorphone ( C_max and AUC_0-48) is increased in patients with impaired renal function by 2-fold in moderate (CLcr = 40 - 60 mL/min) and 3-fold in severe (CLcr < 30 mL/min) renal impairment compared with normal subjects (CLcr > 80 mL/min). In addition, in patients with severe renal impairment hydromorphone appeared to be more slowly eliminated with longer terminal elimination half-life (40 hr) compared to patients with normal renal function (15 hr). Patients with moderate renal impairment should be started on a lower dose. Starting doses for patients with severe renal impairment should be even lower. Patients with renal impairment should be closely monitored during dose titration. Use of oral liquid is recommended to adjust the dose (see DOSAGE AND ADMINISTRATION).

Pediatrics: Pharmacokinetics of hydromorphone have not been evaluated in children.

Geriatric: Age has no effect on the pharmacokinetics of hydromorphone.

Gender: Gender has little effect on the pharmacokinetics of hydromorphone. Females appear to have higher C_max (25%) than males with comparable AUC_0-24 values. The difference observed in C_max may not be clinically relevant.

Pregnancy and nursing mothers: Hydromorphone crosses the placenta. Hydromorphone is also found in low levels in breast milk, and may cause respiratory compromise in newborns when administered during labor or delivery.

CLINICAL TRIALS

Analgesic effects of single doses of DILAUDID ORAL LIQUID administered to patients with post-surgical pain have been studied in double-blind controlled trials. In one study , both 5 mg and 10 mg of DILAUDID ORAL LIQUID provided significantly more analgesia than placebo. In another trial, 5 mg and 10 mg of DILAUDID ORAL LIQUID were compared to 30 mg and 60 mg of morphine sulfate oral liquid. The pain relief provided by 5 mg and 10 mg DILAUDID ORAL LIQUID was comparable to 30 mg and 60 mg oral morphine sulfate, respectively.

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