Mirtazapine is an antidepressant. The way this medication works is still not fully understood. It is thought to positively affect communication between nerve cells in the central nervous system and/or restore chemical balance in the brain.

Mirtazapine is used to treat major depressive disorder in adults.

It is not known if mirtazapine is safe and effective for use to treat MDD in children.

You should not take mirtazapine if you are also taking tryptophan (sometimes called L-tryptophan).

Do not use mirtazapine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine and others.

Some people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using mirtazapine. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not give this medicine to anyone younger than 18 years old without the advice of a doctor. This medicine is not approved for use in children.

It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment.

Drinking alcohol can increase certain side effects of mirtazapine.

Mirtazapine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Do not stop taking this medicine abruptly. Talk to your doctor before stopping this medicine.

Take mirtazapine exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Take the medicine at the same time each day, usually at bedtime.

Take the regular tablet form of mirtazapine with water.

You may take mirtazapine with or without food.

Remove an orally disintegrating tablet from the package only when you are ready to take the medicine. Place the tablet on your tongue and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves.

It may take a few weeks for your symptoms to improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment.

Do not stop using mirtazapine suddenly, or you could have unpleasant symptoms (such as dizziness, vomiting, agitation, sweating, confusion, numbness, tingling, or electric shock feelings). Ask your doctor how to safely stop using this medicine.

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

Usual Adult Dose for Depression:

Initial dose: 15 mg orally once a day at bedtime
Maintenance dose: 15 to 45 mg orally once a day
Maximum dose: 45 mg/day

Comments:
-May increase the dose every 1 to 2 weeks to a maximum 45 mg/day according to patient response.
-Patients should be periodically reassessed to determine the need for continued use of this drug.

Use: Treatment of major depressive disorder

You should not take this medicine if you are allergic to mirtazapine.

Do not use mirtazapine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• low white blood cell counts;

• glaucoma;

• liver or kidney disease;

• low sodium levels in your blood;

• a seizure;

• depression, suicidal thoughts or actions;

• bipolar disorder (manic depression) in you or a family member;

• heart problems or stroke;

• high cholesterol or triglycerides;

• long QT syndrome (in you or a family member); or

• low blood pressure.

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with mirtazapine and cause a serious condition called serotonin syndrome.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Tell your doctor if you are pregnant or breastfeeding.

The orally disintegrating tablet may contain phenylalanine and could be harmful if you have phenylketonuria (PKU).

Mirtazapine is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Drinking alcohol with mirtazapine can cause side effects.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction to mirtazapine (hives, joint pain, fever, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Report any new or worsening symptoms to your doctor, 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:

• racing thoughts, decreased need for sleep, unusual risk-taking behavior, feelings of extreme happiness or sadness, being more talkative than usual;

• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;

• a light-headed feeling, like you might pass out;

• severe rash, blisters, or swelling on the palms of your hands or the soles of your feet;

• a seizure;

• low white blood cell counts - fever, chills, sore throat, cough, sores in your mouth or nose, flu-like symptoms, trouble breathing; or

• low sodium level - headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common mirtazapine side effects include:

• drowsiness, dizziness;

• increased appetite; or

• weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using mirtazapine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your current medicines. Many drugs can affect mirtazapine, especially:

• cimetidine;

• diazepam;

• St. John's wort;

• tramadol;

• tryptophan (sometimes called L-tryptophan);

• an antibiotic - clarithromycin, rifampin, rifampicin, telithromycin;

• antifungal medicine - itraconazole, ketoconazole;

• antiviral medicine to treat HIV/AIDS - indinavir, nelfinavir, ritonavir, saquinavir;

• medicine to treat mood disorders, thought disorders, or mental illness - such as lithium, other antidepressants, or antipsychotics;

• migraine headache medicine - sumatriptan, rizatriptan, Imitrex, Maxalt, and others; or

• seizure medicine - carbamazepine, phenytoin.

This list is not complete and many Other drugs may interact with mirtazapine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your response to mirtazapine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

You may start to notice an improvement in symptoms after about a week of using mirtazapine, but it usually takes between four to six weeks to experience the full benefits.

Don’t stop using this medicine without talking to your doctor.

Your dosage of mirtazapine will depend on your medical condition, your response to the treatment, and other factors.

Your doctor might start you on a lower dose of this medicine and increase it, up to a maximum of 45 milligrams (mg) per day.

Mirtazapine is sometimes used “off-label” to treat other medical conditions, including:

• Panic disorder
• Insomnia
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)
• Generalized anxiety disorder
• Social anxiety disorder
• Headache or migraine