Mirtazapine: Difference between revisions

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<!--Pharmacokinetic data-->
<!--Pharmacokinetic data-->
| bioavailability = 50%<ref name="pmid10885584">{{cite journal | author = Timmer, CJ; Sitsen, JM; Delbressine, LP | title = Clinical pharmacokinetics of mirtazapine | journal = Clinical Pharmacokinetics | volume = 38 | issue = 6 | pages = 461–74 |date=June 2000 | pmid = 10885584 | doi = 10.2165/00003088-200038060-00001| url = http://content.wkhealth.com/linkback/openurl?issn=0312-5963&volume=38&issue=6&spage=461}}</ref><ref name = DM/><ref name = AXIT/><ref name = EMC/>
| bioavailability = 50%<ref name="pmid10885584">{{cite journal | author = Timmer, CJ; Sitsen, JM; Delbressine, LP | title = Clinical pharmacokinetics of mirtazapine | journal = Clinical Pharmacokinetics | volume = 38 | issue = 6 | pages = 461–74 |date=June 2000 | pmid = 10885584 | doi = 10.2165/00003088-200038060-00001| url = http://content.wkhealth.com/linkback/openurl?issn=0312-5963&volume=38&issue=6&spage=461}}</ref>
| protein_bound = 85%<ref name="pmid10885584" /><ref name = DM/><ref name = AXIT/><ref name = EMC/>
| protein_bound = 85%<ref name="pmid10885584" /><ref name = DM/><ref name = AXIT/><ref name = EMC/>
| metabolism = [[Liver]] ([[CYP1A2]], [[CYP2D6]], and [[CYP3A4]])<ref name="pmid10885584" /><ref name = DM/><ref name = AXIT/><ref name = EMC/><ref name="pmid11607047">{{cite journal | author = Anttila, SA; Leinonen, EV | title = A review of the pharmacological and clinical profile of mirtazapine | journal = CNS Drug Reviews | volume = 7 | issue = 3 | pages = 249–64 | year = 2001 | pmid = 11607047 | doi = 10.1111/j.1527-3458.2001.tb00198.x| url = }}</ref>
| metabolism = [[Liver]] ([[CYP1A2]], [[CYP2D6]], and [[CYP3A4]])<ref name="pmid10885584" /><ref name="pmid11607047">{{cite journal | author = Anttila, SA; Leinonen, EV | title = A review of the pharmacological and clinical profile of mirtazapine | journal = CNS Drug Reviews | volume = 7 | issue = 3 | pages = 249–64 | year = 2001 | pmid = 11607047 | doi = 10.1111/j.1527-3458.2001.tb00198.x| url = }}</ref>
| elimination_half-life = 20–40 hours<ref name="pmid10885584" /><ref name = DM/><ref name = AXIT/><ref name = EMC/>
| elimination_half-life = 20–40 hours<ref name = DM/><ref name = AXIT/><ref name = EMC/>
| excretion = Urine (75%)<ref name="pmid10885584" /><br />Faeces (15%)<ref name="pmid10885584" /><ref name = DM/><ref name = AXIT/><ref name = EMC/>
| excretion = Urine (75%)<ref name="pmid10885584" /><br />Faeces (15%)<ref name="pmid10885584" />
 
<!--Identifiers-->
<!--Identifiers-->
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number_Ref = {{cascite|correct|??}}

Revision as of 18:56, 26 May 2014

Mirtazapine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Pratik Bahekar, MBBS [2]

Disclaimer

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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

Template:Px
Template:Px
1 : 1 mixture (racemate)Mirtazapine
Systematic (IUPAC) name
(±)-2-methyl-1,2,3,4,10,14b-hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine
Identifiers
CAS number 61337-67-5
ATC code N06AX11
PubChem 4205
DrugBank DB00370
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 265.35 g/mol
SMILES eMolecules & PubChem
Synonyms 6-Azamianserin, Org 3770
Physical data
Density 1.22 g/cm³
Melt. point 114–116 °C (237–241 °F)
Boiling point 432 °C (810 °F)
Solubility in water Soluble in methanol and chloroform mg/mL (20 °C)
Pharmacokinetic data
Bioavailability 50%[1]
Protein binding 85%[1][2][3][4]
Metabolism Liver (CYP1A2, CYP2D6, and CYP3A4)[1][5]
Half life 20–40 hours[2][3][4]
Excretion Urine (75%)[1]
Faeces (15%)[1]
Therapeutic considerations
Licence data

US

Pregnancy cat.

B3(AU) C(US)

Legal status

Prescription Only (S4)(AU) ?(CA) POM(UK) [[Prescription drug|Template:Unicode-only]](US)

Routes Oral

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. ↑ 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. ↑ 2.0 2.1
  3. ↑ 3.0 3.1
  4. ↑ 4.0 4.1
  5. ↑ 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.
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