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REMERONSolTab® (mirtazapine) Orally Disintegrating Tablets are indicated for the treatment of major depressive disorder.
The efficacy of REMERON® (mirtazapine) Tablets in the treatment of major depressive disorder was established in six-week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders - 3rd edition (DSM-III) category of major depressive disorder (see CLINICAL PHARMACOLOGY).
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes 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 effectiveness of REMERONSolTab® (mirtazapine) in hospitalized depressed patients has not been adequately studied.
The efficacy of REMERON® in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8-12 weeks of initial open-label treatment was demonstrated in a placebo- controlled trial. Nevertheless, the physician who elects to use REMERON® for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see CLINICAL PHARMACOLOGY).
DOSAGE AND ADMINISTRATION
The recommended starting dose for REMERONSolTab® (mirtazapine) Orally Disintegrating Tablets is 15 mg/day, administered in a single dose, preferably in the evening prior to sleep. In the controlled clinical trials establishing the efficacy of REMERON® in the treatment of major depressive disorder, the effective dose range was generally 15-45 mg/day. While the relationship between dose and satisfactory response in the treatment of major depressive disorder for REMERON® has not been adequately explored, patients not responding to the initial 15 mg dose may benefit from dose increases up to a maximum of 45 mg/day. REMERON® has an elimination half-life of approximately 20-40 hours; therefore, dose changes should not be made at intervals of less than one to two weeks in order to allow sufficient time for evaluation of the therapeutic response to a given dose.
Administration of REMERONSolTab® (mirtazapine) Orally Disintegrating Tablets
Patients should be instructed to open tablet blister pack with dry hands and place the tablet on the tongue. The tablet should be used immediately after removal from its blister; once removed, it cannot be stored. REMERONSolTab® (mirtazapine) Orally Disintegrating Tablets will disintegrate rapidly on the tongue and can be swallowed with saliva. No water is needed for taking the tablet. Patients should not attempt to split the tablet.
Elderly and Patients with Renal or Hepatic Impairment
The clearance of mirtazapine is reduced in elderly patients and in patients with moderate to severe renal or hepatic impairment. Consequently, the prescriber should be aware that plasma mirtazapine levels may be increased in these patient groups, compared to levels observed in younger adults without renal or hepatic impairment (see PRECAUTIONS and CLINICAL PHARMACOLOGY).
It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacological therapy beyond response to the acute episode. Systematic evaluation of REMERON® (mirtazapine) has demonstrated that its efficacy in major depressive disorder is maintained for periods of up to 40 weeks following 8-12 weeks of initial treatment at a dose of 15-45 mg/day (see CLINICAL PHARMACOLOGY). Based on these limited data, it is unknown whether or not the dose of REMERON® needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
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 REMERONSolTab® (mirtazapine) Orally Disintegrating Tablets. In addition, at least 14 days should be allowed after stopping REMERONSolTab® (mirtazapine) before starting an MAOI.
REMERONSolTab® (mirtazapine) Orally Disintegrating Tablets are supplied as:
15 mg Tablets — round, white, with “T1Z” debossed on one side.
Box of 30...............5 x 6 Unit Dose Blisters..................NDC 0052-0106-30
Long Term Care Carton
Box of 30...............5 x 6 Unit Dose Blisters..................NDC 0052-0106-93
30 mg Tablets — round, white, with “T2Z” debossed on one side.
Box of 30...............5 x 6 Unit Dose Blisters..................NDC 0052-0108-30
Long Term Care Carton
Box of 30..................5 x 6 Unit Dose Blisters..................NDC 0052-0108-93
45 mg Tablets — round, white, with T4Z” debossed on one side.
Box of 30..................5 x 6 Unit Dose Blisters..................NDC 0052-0110-30
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Use immediately upon opening individual tablet blister.
Manufactured for Organon USA Inc., Roseland, NJ 07068 by CIMA Labs Inc., Eden Prairie, MN 55344. FDA Rev date: 7/30/2007
Last reviewed on RxList: 9/28/2007
This monograph has been modified to include the generic and brand name in many instances.
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