Mirtazapine
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Pratik Bahekar, MBBS [2]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Overview
Mirtazapine is a noradrenergic and specific serotonergic antidepressant that is FDA approved for the {{{indicationType}}} of major depressive disorder. Common adverse reactions include increased appetite, serum triglycerides raised, weight gain, constipation, xerostomia, ALT/SGPT level raised, asthenia, dizziness, somnolence, disturbance in thinking.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- Major depression
- 15 mg/day PO at bedtime, increase every 1-2 weeks to a max dose of 45 mg/day.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Mirtazapine in adult patients.
Non–Guideline-Supported Use
- Anxiety
- Cancer
- Dysthymia
- Obsessive-compulsive disorder
- Panic disorder
There is limited information about Off-Label Non–Guideline-Supported Use of Mirtazapine in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Safety in pediatric patient has not been established.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Mirtazapine in pediatric patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Mirtazapine in pediatric patients.
Contraindications
There is limited information regarding Mirtazapine Contraindications in the drug label.
Warnings
There is limited information regarding Mirtazapine Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Mirtazapine Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Mirtazapine Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Mirtazapine Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Mirtazapine in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Mirtazapine in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Mirtazapine during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Mirtazapine in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Mirtazapine in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Mirtazapine in geriatric settings.
Gender
There is no FDA guidance on the use of Mirtazapine with respect to specific gender populations.
Race
There is no FDA guidance on the use of Mirtazapine with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Mirtazapine in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Mirtazapine in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Mirtazapine in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Mirtazapine in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Mirtazapine Administration in the drug label.
Monitoring
There is limited information regarding Mirtazapine Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Mirtazapine and IV administrations.
Overdosage
There is limited information regarding Mirtazapine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
Mechanism of Action
There is limited information regarding Mirtazapine Mechanism of Action in the drug label.
Structure
There is limited information regarding Mirtazapine Structure in the drug label.
Pharmacodynamics
There is limited information regarding Mirtazapine Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Mirtazapine Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Mirtazapine Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Mirtazapine Clinical Studies in the drug label.
How Supplied
There is limited information regarding Mirtazapine How Supplied in the drug label.
Storage
There is limited information regarding Mirtazapine Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Mirtazapine |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Mirtazapine |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Mirtazapine Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Mirtazapine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Mirtazapine Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Mirtazapine Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ 1.0 1.1 1.2 1.3 1.4 Timmer, CJ; Sitsen, JM; Delbressine, LP (June 2000). "Clinical pharmacokinetics of mirtazapine". Clinical Pharmacokinetics. 38 (6): 461–74. doi:10.2165/00003088-200038060-00001. PMID 10885584.
- ↑ 2.0 2.1
- ↑ 3.0 3.1
- ↑ 4.0 4.1
- ↑ Anttila, SA; Leinonen, EV (2001). "A review of the pharmacological and clinical profile of mirtazapine". CNS Drug Reviews. 7 (3): 249–64. doi:10.1111/j.1527-3458.2001.tb00198.x. PMID 11607047.