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Mirtazapine (Mirtazapine) - Indications and Dosage

 
 



INDICATIONS AND USAGE


Mirtazapine tablets, USP are indicated for the treatment of major depressive disorder. 

The efficacy of mirtazapine in the treatment of major depressive disorder was established in 6-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 5 of the following 9 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 mirtazapine in hospitalized depressed patients has not been adequately studied. 

The efficacy of mirtazapine in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 to 12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use mirtazapine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see CLINICAL PHARMACOLOGY).

DOSAGE AND ADMINISTRATION

Initial Treatment


The recommended starting dose for mirtazapine 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 mirtazapine in the treatment of major depressive disorder, the effective dose range was generally 15 to 45 mg/day. While the relationship between dose and satisfactory response in the treatment of major depressive disorder for mirtazapine 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. Mirtazapine has an elimination half-life of approximately 20 to 40 hours; therefore, dose changes should not be made at intervals of less than 1 to 2 weeks in order to allow sufficient time for evaluation of the therapeutic response to a given dose.

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).

Maintenance/Extended Treatment


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 mirtazapine tablets has demonstrated that its efficacy in major depressive disorder is maintained for periods of up to 40 weeks following 8 to 12 weeks of initial treatment at a dose of 15 to 45 mg/day (see CLINICAL PHARMACOLOGY). Based on these limited data, it is unknown whether or not the dose of mirtazapine 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 a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with mirtazapine tablets. Conversely, at least 14 days should be allowed after stopping mirtazapine tablets before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).

Use of Mirtazapine Tablets With Other MAOIs, Such as Linezolid or Methylene Blue

Do not start mirtazapine tablets in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).

In some cases, a patient already receiving therapy with mirtazapine tablets may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, mirtazapine tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with mirtazapine tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with mirtazapine tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).

Discontinuation of Mirtazapine Tablets Treatment


Symptoms associated with the discontinuation or dose reduction of mirtazapine tablets have been reported. Patients should be monitored for these and other symptoms when discontinuing treatment or during dosage reduction. A gradual reduction in the dose over several weeks, rather than abrupt cessation, is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, dose titration should be managed on the basis of the patient’s clinical response (see PRECAUTIONS and ADVERSE REACTIONS).

HOW SUPPLIED

Repackaged by Aphena Pharma Solutions - TN.
See Repackaging Information for available configurations.


Mirtazapine tablets, USP are supplied as:

7.5 mg Tablets – White, biconvex, capsule shaped film coated tablets with “11” debossed on one side and “A” debossed on the other side.

Bottles of 30                                                    NDC 13107-001-30
Bottles of 60                                                    NDC 13107-001-60
Bottles of 90                                                    NDC 13107-001-90
Bottles of 100                                                  NDC 13107-001-01
Bottles of 500                                                  NDC 13107-001-05

15 mg Tablets – Yellow, biconvex, capsule shaped film coated tablets with a score line in between “0” and “8” on one side and “A” debossed on the other side.

Bottles of 30 (120 cc container)                        NDC 13107-031-30
Bottles of 30(30 cc container)                           NDC 13107-031-34
Bottles of 60                                                    NDC 13107-031-60
Bottles of 90                                                    NDC 13107-031-90
Bottles of 100                                                  NDC 13107-031-01
Bottles of 500                                                  NDC 13107-031-05
30 Unit-of-use packaging                                 NDC 13107-031-32

30 mg Tablets – Reddish Brown, biconvex, capsule shaped film coated tablets with a score line in between “0” and “9” on one side and “A” debossed on the other side.

Bottles of 30 (120 cc container)                        NDC 13107-003-30
Bottles of 30(30 cc container)                           NDC 13107-003-34
Bottles of 60                                                    NDC 13107-003-60
Bottles of 90                                                    NDC 13107-003-90
Bottles of 100                                                  NDC 13107-003-01
Bottles of 500                                                  NDC 13107-003-05
30 Unit-of-use packaging                                 NDC 13107-003-32
 
45 mg Tablets – White, biconvex, capsule shaped film coated tablets with “10” debossed on one side and “A” debossed on the other side.

Bottles of 30(30 cc container)                           NDC 13107-032-34
Bottles of 60                                                    NDC 13107-032-60
Bottles of 90                                                    NDC 13107-032-90
Bottles of 100                                                  NDC 13107-032-01
Bottles of 500                                                  NDC 13107-032-05
30 Unit-of-use packaging                                 NDC 13107-032-32

Storage



Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F) [ see USP Controlled Room Temperature]. Protect from light and moisture.

Manufactured by:
Aurolife Pharma LLC
Dayton, NJ 08810
 
Manufactured for:
Aurobindo Pharma USA, Inc.
Dayton, NJ 08810
 
Revised: 01/2013

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