Remeron

mirtazapine
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Black Box Warnings

Suicidality
incr. risk of suicidality in children, adolescents and young adults w/ major depressive or other psychiatric disorders esp. during 1st months of tx w/ antidepressants vs. placebo; weigh risk vs. benefit; in short-term studies of antidepressants vs. placebo, suicidality risk not increased in pts >24 yo, and risk decreased in pts >65 yo; observe all pts for clinical worsening, suicidality, or unusual behavior changes; not approved for pediatric use

Adult Dosing

Dosage forms: 15,30,45
major depressive disorder
15-45 mg PO qhs
Start: 15 mg PO qhs
renal dosing
not defined
renal impairment: caution advised
hepatic dosing
not defined
hepatic impairment: caution advised

Peds Dosing

This information is currently unavailable or not applicable for this drug.


Contraindications/Cautions

hypersens. to drug/class/compon.
MAO inhibitor use w/in 14 days
caution if impaired liver fxn
caution if impaired renal fxn
caution if bipolar disorder
caution if seizure disorder
caution if cardiovascular dz
caution if cerebrovascular dz
caution if hypotension
caution if hypovolemia
caution if dehydration
caution in elderly pts
caution if <25 yo
caution if alcohol use
caution if PKU (ODT form)

Drug Interactions

Contraindicated

MAOIs, all
Avoid/Use Alternative

central alpha 2 agonists
sodium oxybate
Monitor/Modify Tx

dexmedetomidine
Caution Advised

5-HT1 agonists (triptans)
acetaminophen/butalbital
acetaminophen/caffeine/CNS depressant combos
acetaminophen/codeine
acetaminophen/hydrocodone
acetaminophen/oxycodone
acetaminophen/propoxyphene
acetaminophen/tramadol
amiodarone
amprenavir
antihist/decongest/DM combos
antihist/decongestant combos
antihistamines, sedating
apomorphine
aripiprazole
aspirin/caffeine/CNS depressant combos
aspirin/caffeine/orphenadrine
aspirin/muscle relaxant combos
aspirin/opiate combos
atazanavir
azelastine nasal
barbiturates
bexarotene
buprenorphine
bupropion
butorphanol
butorphanol nasal
BZDs, all
caffeine
cannabinoids
carbamazepine
cetirizine
chlorpheniramine/hydrocodone
cinacalcet
citalopram
clarithromycins
clozapine
cocaine topical
darunavir
decongest/opiate combos
delavirdine
dextromethorphan
droperidol
duloxetine
efavirenz
efavirenz/emtricitabine/tenofovir
ergotamine/caffeine
erythromycins
escitalopram
ethanol
ethosuximide
fluoxetine
fluvoxamine
gefitinib
griseofulvins
haloperidol
hydrocodone/ibuprofen
ibuprofen/oxycodone
itraconazole
ketoconazole
levocetirizine
lindane topical
linezolid
lopinavir/ritonavir
loxapine
maraviroc
meperidine/promethazine
meprobamate
methadone
methoxsalen
metoclopramide
mexiletine
molindone
morphine liposomal
muscle relaxants
nalbuphine
nefazodone
nelfinavir
nevirapine
olanzapine
olanzapine/fluoxetine
opiates
oxcarbazepine
paliperidone
paroxetine
pentazocine
phenothiazines
phenytoins
posaconazole
promethazine/codeine
propafenone
propoxyphene
quetiapine
quinidine
quinine
rifabutin
rifampins
rifapentine
risperidone
ritonavir
ropinirole
rotigotine transdermal
sedative/hypnotics
sertraline
sodium phosphate
telithromycin
terbinafine
thalidomide
thiothixene
tiagabine
ticlopidine
tipranavir
tramadol
trazodone
tricyclic antidepressants
valproic acid derivatives
venlafaxine
voriconazole
ziconotide intrathecal
zileuton
ziprasidone
zonisamide

Adverse Reactions

Serious Reactions
agranulocytosis (rare)
neutropenia (rare)
hypotension, orthostatic
suicidality
depression, worsening
hypomania/mania
seizures
torsades de pointes (rare)
Common Reactions
somnolence
dry mouth
incr. appetite
hypercholesterolemia
constipation
weight gain
asthenia
dizziness
hypertriglyceridemia
flu-like sx
abnormal dreams
abnormal thinking
tremor
confusion
peripheral edema
elevated liver transaminases
myalgia
back pain
urinary frequency

Safety Monitoring

Pregnancy:C
Lactation: Safety Unknown
Monitoring Parameters: sx suicidality, clinical worsening, and/or unusual behavior changes, especially during initial tx or after dose changes

Pharmacology

Metabolism: liver extensively; CYP450: 1A2, 2D6, 3A4 substrate; Info: active metabolite
Excretion: urine 75%, feces 15%; Half-life: 20-40h
Class: Antidepressants, other
Mechanism Of Action
exact mechanism of action unknown; antagonizes alpha2-adrenergic and serotonin 5-HT2 receptors (tetracyclic)

Manufacturer/Pricing

Manufacturer: Organon
DEA/FDA: Rx
Approximate Retail Price
from www.drugstore.com

tablet:
15 mg (30 ea): $98.99
30 mg (30 ea): $95.99
45 mg (30 ea): $113.73

Patient Education - English

Show Spanish
Generic Name: mirtazapine
Pronounced: mir TAH zah peen
Brand Names: Remeron, Remeron SolTab
What is the most important information I should know about mirtazapine?
You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Do not use mirtazapine if you have used an MAO inhibitor within the past 14 days. Serious, life-threatening side effects can occur if you take mirtazapine before the MAO inhibitor has cleared from your body.

Before taking mirtazapine, tell your doctor if you have bipolar disorder, liver or kidney disease, seizures, heart disease, a history of heart attack or stroke, or a history of drug abuse or suicidal thoughts.

It may take up to several weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 4 weeks of treatment.

Avoid drinking alcohol. It can increase some of the side effects of mirtazapine.

Mirtazapine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What is mirtazapine?
Mirtazapine is an antidepressant. Mirtazapine affects chemicals in the brain that may become unbalanced and cause depression.

Mirtazapine is used to treat major depressive disorder.

Mirtazapine may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking mirtazapine?
You should not take this medication if you are allergic to mirtazapine.

You may have thoughts about suicide while taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Do not use mirtazapine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take mirtazapine before the MAO inhibitor has cleared from your body.

Before taking mirtazapine, tell your doctor if you are allergic to any drugs, or if you have:

liver or kidney disease;
bipolar disorder (manic depression);
seizures or epilepsy;
heart disease, including angina (chest pain);
a history of heart attack or stroke; or
a history of drug abuse or suicidal thoughts.
If you have any of these conditions, you may not be able to use mirtazapine, or you may need a dosage adjustment or special tests during treatment.

Mirtazapine is in the FDA pregnancy category C. This means that it is not known whether mirtazapine will harm an unborn baby. Do not take mirtazapine without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether mirtazapine passes into breast milk. Do not take mirtazapine without first talking to your doctor if you are breast-feeding a baby.

Older adults may be more sensitive to the side effects of this medication.

The orally disintegrating tablet may contain phenylalanine. Talk to your doctor before using this form of mirtazapine if you have phenylketonuria (PKU).

How should I take mirtazapine?
Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take the regular tablet form of mirtazapine with water.

To take mirtazapine orally disintegrating tablets (Remeron SolTab):

Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may break the tablet.
Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away.
Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
Swallow several times as the tablet dissolves. No water is needed.
Mirtazapine is usually taken once a day at bedtime. Follow your doctor's instructions.

It may take up to several weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 4 weeks of treatment.

Store mirtazapine at room temperature, away from moisture and heat.

What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include confusion, memory problems, drowsiness, and fast heart rate.

What should I avoid while taking mirtazapine?
Avoid drinking alcohol. It can increase some of the side effects of mirtazapine.

Mirtazapine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What are the possible side effects of mirtazapine?
Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

fever, chills, body aches, flu symptoms;
white patches or sores inside your mouth or on your lips; or
feeling like you might pass out.
Less serious side effects include:

drowsiness, dizziness, weakness;
nausea, stomach pain;
constipation;
increased appetite, weight gain;
dry mouth; or
thirst.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect mirtazapine?
Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by mirtazapine. Tell your doctor if you need to use any of these other medicines while you are taking mirtazapine.

There may be other drugs that can interact with mirtazapine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?
Your pharmacist can provide more information about mirtazapine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise.

Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides.

The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.