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Serzone (Nefazodone Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

SERZONE (nefazodone hydrochloride) is indicated for the treatment of major depressive disorder. When deciding among the alternative treatments available for this condition, the prescriber should consider the risk of hepatic failure associated with SERZONE treatment (see WARNINGS). In many cases, this would lead to the conclusion that other drugs should be tried first.

The efficacy of SERZONE in the treatment of major depressive disorder was established in 6–8 week controlled trials of outpatients and in a 6-week controlled trial of depressed inpatients whose diagnoses corresponded most closely to the DSM-III or DSM-IIIR category of major depressive disorder (see CLINICAL PHARMACOLOGY).

A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks). It must include either depressed mood or loss of interest or pleasure and at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.

The efficacy of SERZONE in reducing relapse in patients with major depressive disorder who were judged to have had a satisfactory clinical response to 16 weeks of open-label SERZONE treatment for an acute depressive episode has been demonstrated in a randomized placebo-controlled trial (see CLINICAL PHARMACOLOGY). Although remitted patients were followed for as long as 36 weeks in the study cited (ie, 52 weeks total), the physician who elects to use SERZONE for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

DOSAGE AND ADMINISTRATION

When deciding among the alternative treatments available for major depressive disorder, the prescriber should consider the risk of hepatic failure associated with SERZONE treatment (see WARNINGS).

Initial Treatment

The recommended starting dose for SERZONE (nefazodone hydrochloride) is 200 mg/day, administered in two divided doses (BID). In the controlled clinical trials establishing the antidepressant efficacy of SERZONE, 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.

Dosage for 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.

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 SERZONE. It is generally agreed, however, that pharmacological treatment for acute episodes of major depressive disorder 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 SERZONE 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. (See CLINICAL PHARMACOLOGY.) The safety of SERZONE 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.

Switching Patients to or from a Monoamine Oxidase Inhibitor

At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with SERZONE. In addition, at least 7 days should be allowed after stopping SERZONE before starting an MAOI.

HOW SUPPLIED

SERZONE® nefazodone hydrochloride) tablets are hexagonal tablets imprinted with BMS and the strength (ie, 100 mg) on one side and the identification code number on the other. The 100 mg and 150 mg tablets are bisect scored on both tablet faces. The 50 mg, 200 mg, and 250 mg tablets are unscored.

NDC CODEDESCRIPTION
NDC 0087-0031-4750 mg light pink tablet, bottle of 60
NDC 0087-0032-31100 mg white tablet, bottle of 60
NDC 0087-0039-31150 mg peach tablet, bottle of 60
NDC 0087-0033-31200 mg light yellow tablet, bottle of 60
NDC 0087-0041-31250 mg white tablet, bottle of 60
Store at room temperature, below 40º C (104° F) and dispense in a tight container.

SERZONE®is a registered trademark of Bristol-Myers Squibb Company. Other brand names listed are trademarks of their respective owners and are not trademarks of Bristol-Myers Squibb Company.

Bristol-Myers Squibb Company
Princeton, NJ 08543 USA

Revised January 2005





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