Nefazodone instructions for administration

Instructions for administration
Hepatic failure warning Initial treatment''' Elderly or debilitated patients''' Maintenance/continuation/extended treatment''' Switching to/from monoamine oxidase inhibitor'''

Hepatic failure warning
When deciding among the alternative treatments available for depression, the prescriber should consider the risk of hepatic failure associated with Nefazodone hydrochloride treatment. Return to top

Initial treatment
The recommended starting dose for Nefazodone hydrochloride tablets is 200 mg/day, administered in two divided doses (BID). In the controlled clinical trials establishing the antidepressant efficacy of Nefazodone, the effective dose range was generally 300 to 600 mg/day. Consequently, most patients, depending on tolerability and the need for further clinical effect, should have their dose increased. Dose increases should occur in increments of 100 mg/day to 200 mg/day, again on a BID schedule, at intervals of no less than 1 week. As with all antidepressants, several weeks on treatment may be required to obtain a full antidepressant response. Return to top

Elderly or debilitated patients
The recommended initial dose for elderly or debilitated patients is 100 mg/day, administered in two divided doses (BID). These patients often have reduced Nefazodone clearance and/or increased sensitivity to the side effects of CNS-active drugs. It may also be appropriate to modify the rate of subsequent dose titration. As steady-state plasma levels do not change with age, the final target dose based on a careful assessment of the patient’s clinical response may be similar in healthy younger and older patients. Return to top

Maintenance/continuation/extended treatment
There is no body of evidence available from controlled trials to indicate how long the depressed patient should be treated with Nefazodone. It is generally agreed, however, that pharmacological treatment for acute episodes of depression should continue for up to 6 months or longer. Whether the dose of antidepressant needed to induce remission is identical to the dose needed to maintain euthymia is unknown. Systematic evaluation of the efficacy of Nefazodone has shown that efficacy is maintained for periods of up to 36 weeks following 16 weeks of open-label acute treatment (treated for 52 weeks total) at dosages that averaged 438 mg/day. For most patients, their maintenance dose was that associated with response during acute treatment. The safety of Nefazodone in long-term use is supported by data from both double-blind and open-label trials involving more than 250 patients treated for at least one year. Return to top

Switching to/from monoamine oxidase inhibitor
At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with Nefazodone. In addition, at least 7 days should be allowed after stopping Nefazodone before starting an MAOI. Return to top