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Mirtazapine
Overview
What is Mirtazapine?
What does Mirtazapine look like?
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What are the available doses of Mirtazapine?
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What should I talk to my health care provider before I take Mirtazapine?
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How should I use Mirtazapine?
What interacts with Mirtazapine?
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What are the warnings of Mirtazapine?
Clinical Worsening and Suicide Risk
Array
Array
Such monitoring should include daily observation by families and caregivers.
| Age Range | Drug-Placebo Difference in Number of Cases of Suicidality per 1000 PatientsTreated | |
| Increases Compared to Placebo | ||
| <18 | 14 additional cases | |
| 18-24 | 5 additional cases | |
| Decreases Compared to Placebo | ||
| 25-64 | 1 fewer case | |
| > | 6 fewer cases |
Screening Patients for Bipolar Disorder
Agranulocytosis
In premarketing clinical trials, two (one with Sjögren’s Syndrome) out of 2,796 patients treated with mirtazapine tablets developed agranulocytosis
[absolute neutrophil count (ANC) < 500/mm with associated signs and symptoms, e.g., fever, infection, etc.
] and a third patient developed severe neutropenia (ANC < 500/mm without any associated symptoms). For these three patients, onset of severe neutropenia was detected on days 61, 9, and 14 of treatment, respectively. All three patients recovered after mirtazapine
was stopped. These three cases yield a crude incidence of severe neutropenia (with or without associated infection) of approximately 1.1 per thousand patients exposed, with a very wide 95% confidence interval i.e., 2.2 cases per 10,000 to 3.1 cases per 1,000. If a patient develops a sore throat, fever, stomatitis or other signs of infection, along with a low WBC count, treatment with mirtazapine should be discontinued and the patient should be closely monitored.
MAO Inhibitors
In patients receiving other drugs for major depressive disorder in combination with a monoamine oxidase inhibitor (MAOI) and in patients who have recently discontinued a drug for major depressive disorder and then are started on an MAOI, there have been reports of serious, and sometimes fatal, reactions, e.g., including nausea, vomiting, flushing, dizziness, tremor, myoclonus, rigidity, diaphoresis, hyperthermia, autonomic instability with rapid fluctuations of vital signs, seizures, and mental status changes ranging from agitation to coma. Although there are no human data pertinent to such an interaction with mirtazapine tablets, it is recommended that mirtazapine not be used in combination with an MAOI, or within 14 days of initiating or discontinuing therapy with an MAOI.
What are the precautions of Mirtazapine?
General
Somnolence
Dizziness
Increased Appetite/Weight Gain
Cholesterol/Triglycerides
Transaminase Elevations
Activation of Mania/Hypomania
Seizure
Use in Patients with Concomitant Illness
Information for Patients
Clinical Worsening and Suicide Risk
Agranulocytosis
Interference with Cognitive and Motor Performance
Completing Course of Therapy
Concomitant Medication
Alcohol
Pregnancy
Nursing
Laboratory Tests
Drug Interactions
Drugs Affecting Hepatic Metabolism
Drugs that are Metabolized by and/or Inhibit Cytochrome P450 Enzymes
In vitro
in vitro
Alcohol
Diazepam
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis
Mutagenesis
in vitro
in vitro
in vivo
Impairment of Fertility
Pregnancy
Teratogenic effects
Pregnancy Category C.
Nursing Mothers
Pediatric Use
Geriatric Use
What are the side effects of Mirtazapine?
Associated with Discontinuation of Treatment
Approximately 16 percent of the 453 patients who received mirtazapine tablets in U.S. 6-week controlled clinical trials discontinued treatment due to an adverse experience, compared to 7 percent of 361 placebo-treated patients in those studies. 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:
| Adverse Event | Percentage of Patients Discontinuing with Adverse Event | |
| Mirtazapine (n = 453) | Placebo (n = 361) | |
| Somnolence | 10.4% | 2.2% |
| Nausea | 1.5% | 0% |
Commonly Observed Adverse Events in U.S. Controlled Clinical Trials
The most commonly observed adverse events associated with the use of mirtazapine (incidence of 5% or greater) and not observed at an equivalent incidence among placebo-treated patients (mirtazapine incidence at least twice that for placebo) were:
| 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% |
Adverse Events Occurring at an Incidence of 1% or More Among Mirtazapine-Treated Patients
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-treated patients who participated in short-term U.S. 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 one episode of an event at some time during their treatment. Reported adverse events were classified using a standard COSTART-based dictionary terminology.
The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other investigations involving different treatments, uses and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non drug factors to the side effect incidence rate in the population studied.
| Body System Adverse Clinical Experience | Mirtazapine (n = 453) | Placebo(n = 361) | 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% |
ECG Changes
The electrocardiograms for 338 patients who received mirtazapine and 261 patients who received placebo in 6-week, placebo-controlled trials were analyzed. Prolongation in QTc ≥ 500 msec was not observed among mirtazapine-treated patients; mean change in QTc was +1.6 msec for mirtazapine and –3.1 msec for placebo. Mirtazapine was associated with a mean increase in heart rate of 3.4 bpm, compared to 0.8 bpm for placebo. The clinical significance of these changes is unknown.
Other Adverse Events Observed During the Premarketing Evaluation of Mirtazapine
During its premarketing assessment, multiple doses of mirtazapine tablets were administered to 2,796 patients in clinical studies. The conditions and duration of exposure to mirtazapine varied greatly, and included (in overlapping categories) open and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, fixed dose and titration studies. Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. 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.
In the tabulations that follow, reported adverse events were classified using a standard COSTART-based dictionary terminology. The frequencies presented, therefore, represent the proportion of the 2,796 patients exposed to multiple doses of mirtazapine who experienced an event of the type cited on at least one occasion while receiving mirtazapine. All reported events are included except those already listed in the previous table, those adverse experiences subsumed under COSTART terms that are either overly general or excessively specific so as to be uninformative, and those events for which a drug cause was very remote.
It is important to emphasize that, although the events reported occurred during treatment with mirtazapine, they were not necessarily caused by it.
Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1,000 patients; rare events are those occurring in fewer than 1/1,000 patients. Only those events not already listed in the previous table appear in this listing. Events of major clinical importance are also described in the and sections.
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Other Adverse Events Observed During Post-marketing Evaluation of Mirtazapine
Adverse events reported since market introduction, which were temporally (but not necessarily causally) related to mirtazapine therapy, include four cases of the ventricular arrhythmia torsades de pointes. In three of the four cases, however, concomitant drugs were implicated. All patients recovered.
What should I look out for while using Mirtazapine?
What might happen if I take too much Mirtazapine?
How should I store and handle Mirtazapine?
StorageStore Pantoprazole sodium delayed-release tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]StorageStore Pantoprazole sodium delayed-release tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]They are supplied by as follows:This Product was Repackaged By:State of Florida DOH Central PharmacyThey are supplied by as follows:This Product was Repackaged By:State of Florida DOH Central PharmacyThey are supplied by as follows:This Product was Repackaged By:State of Florida DOH Central Pharmacy
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
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