Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. Mirtazapine is a widely used antidepressant for major depressive disorder and has a unique pharmacologic profile. Based on plasma levels, the mirtazapine dose taken was 30 to 45 mg, while plasma levels of amitriptyline and chlorprothixene were found to be at toxic levels. Because some mirtazapine may be excreted into breast milk, caution should be exercised when mirtazapine tablets are administered to nursing women.Safety and effectiveness in the pediatric population have not been established (see

Symptoms associated with the discontinuation or dose reduction of mirtazapine tablets have been reported. Patients who are to receive mirtazapine should be warned about the risk of developing agranulocytosis. Clipboard, Search History, and several other advanced features are temporarily unavailable. Mirtazapine tablets, USP are an orally administered drug.
However, the impairment of motor skills produced by mirtazapine has been shown to be additive with those caused by diazepam. For more information, ask your healthcare provider or pharmacist. 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.The clearance of mirtazapine is reduced in elderly patients and in patients with moderate to severe renal or hepatic impairment. (See The efficacy of mirtazapine tablets as a treatment for major depressive disorder was established in 4 placebo-controlled, 6-week trials in adult outpatients meeting DSM-III criteria for major depressive disorder. The mean increase in weight was 4 kg (2 kg SD) for mirtazapine-treated patients versus 1 kg (2 kg SD) for placebo-treated patients (see They may harm them.

The complete text of the Medication Guide is reprinted at the end of this document. General supportive and symptomatic measures are also recommended.

No unusual adverse age-related phenomena were identified in this group. The only drug overdose death reported while taking mirtazapine was in combination with amitriptyline and chlorprothixene in a non-US clinical study. This table shows the percentage of patients in each group who had at least 1 episode of an event at some time during their treatment. Patients were titrated with mirtazapine from a dose range of 5 mg up to 35 mg/day. Epub 2018 Dec 2.J Nutr Health Aging. "What is the most important information I should know about mirtazapine tablets?" 2020 Jun 4;10(6):855. doi: 10.3390/biom10060855.

Do not use mirtazapine tablets for a condition for which it was not prescribed. 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.

2009 Apr;29(4):383-97. doi: 10.1592/phco.29.4.383.Clin Geriatr Med. Common possible side effects in people who take mirtazapine tablets include:Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. The recommended starting dose for mirtazapine tablets is 15 mg/day, administered in a single dose, preferably in the evening prior to sleep. Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with mirtazapine tablets and should counsel them in its appropriate use. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. Mirtazapine tablets are not a controlled substance. This Medication Guide summarizes the most important information about mirtazapine tablets. Mirtazapine is not approved for use in pediatric patients. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.Keep mirtazapine tablets and all medicines out of the reach of children. Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. The most common events (≥ 1%) associated with discontinuation and considered to be drug related (i.e., those events associated with dropout at a rate at least twice that of placebo) included in Table 2.Table 2: Common Adverse Events Associated With Discontinuation of Treatment in 6-Week U.S. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.