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Mirtazapine

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Overview

What is Mirtazapine?



What does Mirtazapine look like?



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

 

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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
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)
] and a third patient developed severe neutropenia (ANC
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:

Common Adverse Events Associated with Discontinuation of Treatment in 6-Week U.S. Mirtazapine Trials
Adverse EventPercentage of Patients Discontinuing with Adverse Event
Mirtazapine (n = 453)Placebo (n = 361)
Somnolence10.4%2.2%
Nausea1.5%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:

Common Treatment Emergent Adverse Events Associated with the Use of Mirtazapine in 6-Week U.S. Trials
Adverse EventPercentage of Patients Reporting Adverse Event
Mirtazapine (n = 453)Placebo(n = 361)
Somnolence54%18%
Increased Appetite17%2%
Weight Gain12%2%
Dizziness7%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.

INCIDENCE OF ADVERSE CLINICAL EXPERIENCES (≥ 1%) IN SHORT-TERM U.S. CONTROLLED STUDIES)
Body System   Adverse Clinical   ExperienceMirtazapine (n = 453)Placebo(n = 361)
Body as a Whole
   Asthenia8%5%
   Flu Syndrome5%3%
   Back Pain2%1%
Digestive System
   Dry Mouth25%15%
   Increased Appetite17%2%
   Constipation13%7%
Metabolic and Nutritional Disorders
   Weight Gain12%2%
   Peripheral Edema2%1%
   Edema1%0%
Musculoskeletal System
   Myalgia2%1%
Nervous System
   Somnolence54%18%
   Dizziness7%3%
   Abnormal Dreams4%1%
   Thinking Abnormal3%1%
   Tremor2%1%
   Confusion2%0%
Respiratory System
   Dyspnea1%0%
Urogenital System
   Urinary Frequency2%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


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Non-Clinical Toxicology
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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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Review

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Professional

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. 315.72
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Tips

Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).