Remeron® (mirtazapine)

Remeron®

- Tablets: 7.5 mg, 15 mg, 30 mg, 45 mg

Remeron SolTab®

- Orally disintegrating tablets: 15 mg, 30 mg, 45 mg

Generic name: mirtazapine (mir TAZ a peen)

Medication class: Tetracyclic antidepressant

All FDA black box warnings are at the end of this fact sheet. Please review before taking this medication.

What is Remeron ® and what does it treat?

Mirtazapine is an antidepressant medication that works in the brain. It is approved for the treatment of major depressive disorder (MDD).

Symptoms of depression include:

- Depressed mood - feeling sad, empty, or tearful

- Feeling worthless, guilty, hopeless, and helpless

- Loss of interest or pleasure in your usual activities

- Sleep and eat more or less than usual (for most people it is less)

- Low energy, trouble concentrating, or thoughts of death (suicidal thinking)

- Psychomotor agitation ('nervous energy')

- Psychomotor retardation (feeling like you are moving and thinking in slow motion)

- Suicidal thoughts or behaviors

What is the most important information I should know about Remeron ® ?

Do not stop taking mirtazapine, even when you feel better. Only your healthcare provider can determine the length of treatment that is right for you.

Missing doses of mirtazapine may increase your risk for relapse in your symptoms.

Stopping mirtazapine abruptly may result in one or more of the following withdrawal symptoms: irritability, nausea, dizziness, vomiting, nightmares, headache, and/or paresthesias (prickling, tingling sensation on the skin).

Depression is also a part of bipolar illness. People with bipolar disorder who take antidepressants may be at risk for "switching" from depression into mania. Symptoms of mania include "high" or irritable mood, very high self esteem, decreased need for sleep, pressure to keep talking, racing thoughts, being easily distracted, frequently involved in activities with a large risk for bad consequences (for example, excessive buying sprees).

Medical attention should be sought if serotonin syndrome is suspected. Please refer to serious side effects for signs/symptoms.

Are there specific concerns about Remeron ® and pregnancy?

If you are planning on becoming pregnant, notify your healthcare provider to best manage your medications. People living with MDD who wish to become pregnant face important decisions. Untreated MDD has risks to the fetus, as well as the mother. It is important to discuss the risks and benefits of treatment with your doctor and caregivers.

Caution is advised with breastfeeding since mirtazapine does pass into breast milk.

What should I discuss with my healthcare provider before taking Remeron ® ?

- Symptoms of your condition that bother you the most

- If you have thoughts of suicide or harming yourself

- Medications you have taken in the past for your condition, whether they were effective or caused any adverse effects

- If you experience side effects from your medications, discuss them with your provider. Some side effects may pass with time, but others may require changes in the medication.

- Any other psychiatric or medical problems you have, including a history of bipolar disorder

- All other medications you are currently taking (including over the counter products, herbal and nutritional supplements) and any medication allergies you have

- Other non-medication treatment you are receiving, such as talk therapy or substance abuse treatment. Your provider can explain how these different treatments work with the medication.

- If you are pregnant, plan to become pregnant, or are breast-feeding

- If you drink alcohol or use drugs

How should I take Remeron ® ?

Mirtazapine is usually taken 1 time per day at bedtime with or without food.

Typically patients begin at a low dose of medicine and the dose is increased slowly over several weeks.

The dose usually ranges from 15 mg to 45 mg. Only your healthcare provider can determine the correct dose for you.

Mirtazapine orally disintegrating tablets will dissolve in your mouth within seconds and can be swallowed with or without liquid.

Mirtazapine orally disintegrating tablets must remain in their original packaging. Open the package with clean dry hands before each dose. Do not try to put tablets in a pillbox if you take the orally disintegrating tablets.

Consider using a calendar, pillbox, alarm clock, or cell phone alert to help you remember to take your medication. You may also ask a family member or friend to remind you or check in with you to be sure you are taking your medication.

What happens if I miss a dose of Remeron ® ?

If you miss a dose of mirtazapine, take it as soon as you remember, unless it is closer to the time of your next dose. Discuss this with your healthcare provider. Do not double your next dose or take more than what is prescribed.

What should I avoid while taking Remeron ® ?

Avoid drinking alcohol or using illegal drugs while you are taking antidepressant medications. They may decrease the benefits (e.g., worsen your condition) and increase adverse effects (e.g., sedation) of the medication.

What happens if I overdose with Remeron ® ?

If an overdose occurs, call your doctor or 911. You may need urgent medical care. You may also contact the poison control center at 1-800-222-1222.

A specific treatment to reverse the effects of mirtazapine does not exist.

What are the possible side effects of Remeron ® ?

Common Side Effects

Sedation, increased appetite, weight gain, feeling dizzy, increased cholesterol/triglyceride levels

Rare Side Effects

Agranulocytosis (low white blood cell count) can increase the risk of infection. If you develop symptoms of infection, such as fever, chills, sore throat, swelling of the lining the mouth or other possible signs of infection, contact your prescriber.

Serious Side Effects

Serotonin syndrome (symptoms may include shivering, diarrhea, confusion, severe muscle tightness, fever, seizures, and death), seizures

Are there any risks of taking Remeron ® for long periods of time?

To date, there are no known problems associated with long term use of mirtazapine. It is a safe and effective medication when used as directed.

What other medications may interact with Remeron ® ?

Mirtazapine should not be taken with or within 2 weeks of taking monoamine oxidase inhibitors (MAOIs). These include phenelzine (Nardil®), tranylcypromine (Parnate®), isocarboxazid (Marplan®), rasagiline (Azilect®), and selegeline (Emsam ®).

Although rare, there is an increased risk of serotonin syndrome when mirtazapine is used with other medications that increase serotonin, such as other antidepressants, migraine medications called "triptans" (e.g., Imitrex®), some pain medications (e.g., tramadol (Ultram®), and the antibiotic linezolid (Zyvox®).

How long does it take for Remeron ® to work?

Sleep, energy, or appetite may show some improvement within the first 1-2 weeks. Improvement in these physical symptoms can be an important early signal that the medication is working. Depressed mood and lack of interest in activities may need up to 6-8 weeks to fully improve.

Provided by the College of Psychiatric and Neurologic Pharmacists

( January 2013 )

Summary of Black Box Warnings

Suicidal Thoughts or Actions in Children and Adults

- Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide.

- Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications. This risk may persist until significant remission occurs.

- In short-term studies, antidepressants increased the risk of suicidality in children, adolescents, and young adults when compared to placebo. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24. Adults age 65 and older taking antidepressants have a decreased risk of suicidality.

- Patients, their families, and caregivers should be alert to the emergence of anxiety, restlessness, irritability, aggressiveness and insomnia. If these symptoms emerge, they should be reported to the patient's prescriber or healthcare professional.

- All patients being treated with antidepressants for any indication should watch for and notify their healthcare provider for worsening symptoms, suicidality and unusual changes in behavior, especially during the first few months of treatment.