IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
MIRTAZAPINE – ORAL
COMMON BRAND NAME(S): Remeron
WARNING: Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.
Tell the doctor immediately if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.
USES: Mirtazapine is used to treat depression. It improves mood and feelings of well-being. Mirtazapine is an antidepressant that works by restoring the balance of natural chemicals (neurotransmitters) in the brain.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using mirtazapine and each time you get a refill because new information may be available. If you have any questions regarding the information, consult your doctor or pharmacist.
Take this medication by mouth, with or without food, usually once daily at bedtime or as directed by your doctor. The dosage is based on your medical condition and response to therapy, but should not exceed 45 milligrams per day.
Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. It may take between 1-4 weeks to notice improvement in your symptoms. Therefore, do not increase your dose or take it more often than prescribed.
It is important to continue taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased.
Inform your doctor if your condition persists or worsens.
SIDE EFFECTS: See also the Warning section.
Dizziness, drowsiness, lightheadedness, increased appetite, weight gain, dry mouth, or constipation may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: swelling of the hands/feet, shaking (tremor), confusion.
Tell your doctor immediately if any of these rare but very serious side effects occur: unusual or severe mental/mood changes, signs of infection (e.g., fever, persistent sore throat).
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is used with certain other drugs (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: hallucinations, unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, unexplained fever, severe nausea/vomiting/diarrhea, twitching muscles.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US –
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it, or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: history or family history of psychiatric disorders (e.g., bipolar/manic-depressive disorder), history or family history of suicide attempts, liver disease, kidney disease, seizures, high blood cholesterol or triglyceride levels, heart disease (e.g., recent heart attack, angina), stroke, severe loss of body fluids (dehydration), low blood pressure.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.
Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially drowsiness.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
If this medication is used during the last 3 months of pregnancy, infrequently your newborn may develop symptoms including feeding or breathing difficulties, seizures, muscle stiffness, jitteriness, or constant crying. However, do not stop taking this medication unless your doctor directs you to do so. Report any such symptoms to your doctor promptly.
It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop, or change the dosage of any medicine before checking with them first.
This drug should not be used with the following medication because very serious interactions may occur: cisapride.
If you are currently using this medication listed above, tell your doctor or pharmacist before starting mirtazapine.
Avoid taking MAO inhibitors (such as isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) within 2 weeks before, during, and after treatment with this medication. In some cases a serious (possibly fatal) drug interaction may occur.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: bupropion, drugs that lower blood pressure (e.g., ACE inhibitors, calcium channel blockers, “water pills”/diuretics).
Before using mirtazapine, report the use of other drugs that increase serotonin, such as dextromethorphan, lithium, St. John’s wort, sibutramine, street drugs such as MDMA/”ecstasy,” tramadol, tryptophan, certain antidepressants including SSRIs (such as citalopram, paroxetine) and SNRIs (such as duloxetine, venlafaxine), “triptans” used to treat migraine headaches (such as eletriptan, sumatriptan), among others. The risk of serotonin syndrome may be more likely when you start or increase the dose of these medications.
Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-anxiety drugs (e.g., diazepam), anti-seizure drugs (e.g., carbamazepine), medicine for sleep (e.g., sedatives), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine, or tricyclics such as amitriptyline), tranquilizers.
Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: very fast/irregular heartbeat.
NOTES: Psychiatric/medical checkups (and possibly laboratory tests) must be done periodically to monitor your progress and check for side effects. Consult your doctor for more details.
Do not share this medication with others.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature (77 degrees F or 25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).
Information last revised July 2010 Copyright(c) 2010 First DataBank, Inc.