Paxil

[Paroxetine]

Distribution

Paroxetine distributes throughout the body, including the CNS, with only 1% remaining in the plasma.

Protein Binding
Approximately 95% and 93% of paroxetine is bound to plasma protein at 100 ng/ mL and 400 ng/ mL, respectively. Under clinical conditions, paroxetine concentrations would normally be less than 400 ng/ mL. Paroxetine does not alter the in vitro protein binding of phenytoin or warfarin.

Text Continues Below

---

Renal and Liver Disease

Increased plasma concentrations of paroxetine occur in subjects with renal and hepatic impairment. The mean plasma concentrations in patients with creatinine clearance below 30 mL/ min. was approximately 4 times greater than seen in normal volunteers.

Patients with creatinine clearance of 30 to 60 mL/ min. and patients with hepatic functional impairment had about a 2-fold increase in plasma concentrations (AUC, Cmax).

The initial dosage should therefore be reduced in patients with severe renal or hepatic impairment, and upward titration, if necessary, should be at increased intervals (see DOSAGE AND ADMINISTRATION).

Elderly Patients:

In a multiple-dose study in the elderly at daily paroxetine doses of 20, 30, and 40 mg, Cmin concentrations were about 70% to 80% greater than the respective Cmin concentrations in nonelderly subjects. Therefore the initial dosage in the elderly should be reduced (see DOSAGE AND ADMINISTRATION).

Clinical Trials Major Depressive Disorder

The efficacy of PAXIL as a treatment for major depressive disorder has been established in 6 placebo-controlled studies of patients with major depressive disorder (aged 18 to 73). In these studies, PAXIL was shown to be significantly more effective than placebo in treating major depressive disorder by at least 2 of the following measures:
Hamilton Depression Rating Scale (HDRS), the Hamilton depressed mood item, and the Clinical Global Impression (CGI)-Severity of Illness. PAXIL was significantly better than placebo in improvement of the HDRS sub-factor scores, including the depressed mood item, sleep disturbance factor, and anxiety factor.

Page:  << Prev | 1 | 2 | 3 | 4 | 5 | Next >>