Mirtazapine Tablets, USP
Suicidality and Antidepressant Drugs
DESCRIPTION
CLINICAL PHARMACOLOGY
Pharmacodynamics
Pharmacokinetics
Special Populations
Geriatric
Pediatrics
Gender
Race
Renal Insufficiency
Hepatic Insufficiency
Clinical Trials Showing Effectiveness
INDICATIONS AND USAGE
CONTRAINDICATIONS
WARNINGS
Clinical Worsening and Suicide Risk
| Table 1 |
| 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 |
| >65 | 6 fewer cases |
Screening Patients for Bipolar Disorder
Agranulocytosis
MAO Inhibitors
PRECAUTIONS
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
Alcohol
Diazepam
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis
Mutagenesis
Impairment of Fertility
Pregnancy
Teratogenic effects
Nursing Mothers
Pediatric Use
Geriatric Use
ADVERSE REACTIONS
Associated with Discontinuation of Treatment
| 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% |
Commonly Observed Adverse Events in US Controlled Clinical Trials
| 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% |
Adverse Events Occurring at an Incidence of 1% or More Among Mirtazapine-Treated Patients
| Body System AdverseClinical 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
Other Adverse Events Observed During the Premarketing Evaluation of Mirtazapine
Other Adverse Events Observed During Postmarketing Evaluation of Mirtazapine
DRUG ABUSE AND DEPENDENCE
Controlled Substance Class
Physical and Psychological Dependence
OVERDOSAGE
Human Experience
Overdose Management
DOSAGE AND ADMINISTRATION
Initial Treatment
Elderly and Patients with Renal or Hepatic Impairment
Maintenance/Extended Treatment
Switching Patients To or From a Monoamine Oxidase Inhibitor
HOW SUPPLIED
They are supplied by State of Florida DOH Central Pharmacy as follows:
This Product was Repackaged By:
State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States
| 53808-0482-1 | 15 mg | 30 Tablets in a Blister Pack | YELLOW | 60505-0247 |
| 53808-0483-1 | 30 mg | 30 Tablets in a Blister Pack | PINK | 60505-0248 |
| 53808-0484-1 | 45 mg | 30 Tablets in a Blister Pack | WHITE | 60505-0249 |
Medication Guide
- all risks and benefits of treatment with antidepressant medicines
- all treatment choices for depression or other serious mental illness
15mg Label
30mg Label
45mg Label