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Mirtazapine Tablets, USP30 mg Rx Only | Mirtazapine [H.J. Harkins Company, Inc.] | BioPortfolio

12:11 EST 27th January 2019 | BioPortfolio
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Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.  Anyone considering the use of mirtazapine tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older.  Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Mirtazapine is not approved for use in pediatric patients. (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use)

Mirtazapine tablets are supplied for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine USP, and unscored film-coated tablets containing 7.5 or   45 mg of mirtazapine. Each tablet also contains corn starch, hydroxypropyl cellulose, magnesium stearate, colloidal silicon dioxide, lactose monohydrate, hypromellose and titanium dioxide. In addition, the 15 mg contains iron oxide yellow and 30 mg contains iron oxide red, iron oxide black and iron oxide yellow.

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. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.  There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment.  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 18-24) with major depressive disorder (MDD) and other psychiatric disorders.  Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older. 

The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.  

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.  

Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers.  Prescriptions for mirtazapine should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose. 

Table 1
Age Range

Drug-Placebo Difference in
Number of Cases of Suicidality
 per 1000 Patients Treated
 
Increases Compared to Placebo
<18
14 additional cases
18-24
5 additional cases
 
Decreases Compared to Placebo
25-64
1 fewer case
≥65
6 fewer cases

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with mirtazapine and should counsel them in its appropriate use.  A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for mirtazapine.  The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents.  Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have.  The complete text of the Medication Guide is reprinted at the end of this document.  

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking mirtazapine.  

Agranulocytosis

Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and WARNINGS—Clinical Worsening and Suicide Risk). Two placebo-controlled trials in 258 pediatric patients with MDD have been conducted with mirtazapine tablets, and the data were not sufficient to support a claim for use in pediatric patients. Anyone considering the use of mirtazapine tablets in a child or adolescent must balance the potential risks with the clinical need. 

In an 8-week long pediatric clinical trial of doses between 15 to 45 mg/day, 49% of mirtazapine-treated patients had a weight gain of at least 7%, compared to 5.7% of placebo-treated patients.  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 PRECAUTIONS-Increased Appetite/Weight Gain).

Common Adverse Events Associated with Discontinuation of Treatment in 6-Week US
Mirtazapine Trials
Adverse Event
Percentage of Patients Discontinuing with Adverse Event
Mirtazapine
(n=453)
Placebo
(n=361)
Somnolence
10.4%
2.2%
Nausea
1.5%
0%
Common Treatment –Emergent Adverse Events Associated with the Use of Mirtazapine
in 6-Week US Trials
Adverse Event
Percentage of Patients Reporting Adverse Event
Mirtazapine
(n=453)
Placebo
(n=361)
Somnolence
54%
18%
Increased Appetite
17%
2%
Weight Gain
12%
2%
Dizziness
7%
3%

The table that follows enumerates adverse events that occurred at an incidence of 1% or more, and were more frequent than in the placebo group, among mirtazapine tablets-treated patients who participated in short-term US placebo-controlled trials in which patients were dosed in a range of 5 to 60 mg/day. 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. Reported adverse events were classified using a standard COSTART-based dictionary terminology.

Body System Adverse Clinical Experience Mirtazapine
(n=453)
Placebo
(n=361)
1Events reported by at least 1% of patients treated with mirtazapine are included, except the following events which had an incidence on placebo grater than or equal to mirtazapine: headache, infection, pain, chest pain, palpitation, tachycardia, postural hypotension, nausea, dyspepsia, diarrhea, flatulence, insomnia, nervousness, libido decreased, hypertonia, pharyngitis, rhinitis, sweating, amblyopia, tinnitus, taste perversion
Body as a Whole
Asthenia
8%
5%
Flu Syndrome
5%
3%
Back Pain
2%
1%
Digestive System
 
 
Dry Mouth
25%
15%
Increased Appetite
17%
2%
Constipation
13%
7%
Metabolic and Nutritional Disorders
Weight Gain
12%
2%
Peripheral Edema
2%
1%
Edema
1%
0%
Musculoskeletal System
Myalgia
2%
1%
Nervous System
Somnolence
54%
18%
Dizziness
7%
3%
Abnormal Dreams
4%
1%
Thinking Abnormal
3%
1%
Tremor
2%
1%
Confusion
2%
0%
Respiratory System
Dyspnea
1%
0%
Urogenital System
Urinary Frequency
2%
1%

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? 

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

What should I avoid while taking mirtazapine tablets?  

Manufacturer

H.J. Harkins Company, Inc.

Active Ingredients

Source

Drugs and Medications [66 Associated Drugs and Medications listed on BioPortfolio]

Mirtazapine [directrx]

MIRTAZAPINE

Mirtazapine [state of florida doh central pharmacy]

Mirtazapine Tablets, USP

Mirtazapine [tya pharmaceuticals]

Mirtazapine Tablets, USP  15 mg, 30 mg and 45 mg Rx Only

Mirtazapine [rpk pharmaceuticals, inc.]

MIRTAZAPINE TABLETS, USP 15 mg, 30 mg and 45 mg Rx Only

Mirtazapine [remedyrepack inc.]

MIRTAZAPINE TABLETS, USP 15 mg, 30 mg and 45 mg Rx Only

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PubMed Articles [12 Associated PubMed Articles listed on BioPortfolio]

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Mirtazapine, a dopamine receptor inhibitor, as a secondary prophylactic for delayed nausea and vomiting following highly emetogenic chemotherapy: an open label, randomized, multicenter phase III trial.

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