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Brand Name

Mylan-Mirtazapine

Common Name

mirtazapine

How does this medication work? What will it do for me?

Mirtazapine belongs to the group of medications known as tetracyclic antidepressants. Antidepressants are used to help relieve the symptoms of depression such as feeling low, sleeping problems, loss of appetite, and loss of interest in activities that you would normally enjoy doing.

When you have depression, certain chemicals in the brain are out of their normal balance. Antidepressants such as mirtazapine work by helping to bring the chemicals back into balance. Antidepressants usually take at least a few weeks to achieve their beneficial effect, so it is important to have patience and take the medication exactly as prescribed by your doctor.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The recommended starting dose of mirtazapine for adults is 15 mg (½ tablet) taken once daily in the evening before going to bed. The doctor may increase the dose to 30 mg after 1 to 2 weeks, depending on circumstances. The maximum recommended dose of mirtazapine is 45 mg daily.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is normal to not feel any difference for the first 2 to 4 weeks of taking this medication. If you have side effects from this medication, talk with your doctor or pharmacist before stopping it.

It is important to take this medication exactly as prescribed by your doctor.If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

What form(s) does this medication come in?

15 mg
Each yellow, oval shaped, normal convex, film-coated tablet, with "MR" scoreline "15" on one side and "G" on the other side, contains mirtazapine 15 mg. Nonmedicinal ingredients: colloidal anhydrous silica, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose anhydrous, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, titanium dioxide, triacetin, and yellow iron oxide.

30 mg
Each buff, oval shaped, normal convex, film-coated tablet, with "MR" scoreline "30" on one side and "G" on the other side, contains mirtazapine 30 mg. Nonmedicinal ingredients: black iron oxide, colloidal anhydrous silica, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose anhydrous, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, red iron oxide, titanium dioxide, triacetin, and yellow iron oxide.

45 mg
Each white, oval shaped, normal convex, film-coated tablet, with "MR 45" on one side and "G" on the other side, contains mirtazapine 45 mg. Nonmedicinal ingredients: colloidal anhydrous silica, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose anhydrous, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, titanium dioxide, and triacetin.

Some medications may have other generic brands available. Always ask your doctor or pharmacist about the safety of switching between brands of the same medication.

Who should NOT take this medication?

Mirtazapine should not be taken by anyone who:

• is allergic to mirtazapine or to any of the ingredients of the medication
• has taken any MAO inhibitors (e.g., phenelzine, tranylcypromine) in the previous 2 weeks

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abnormal dreams
• constipation
• dizziness
• drowsiness
• dry mouth
• increased appetite
• muscle pain
• nausea
• weakness
• weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• agitation
• anxiety
• decreased sexual ability
• hallucinations (hearing, seeing, or feeling things that are not there)
• menstrual difficulties
• mood changes (undesirable)
• mood swings
• rash
• restless legs
• signs of infection (such as sore throat, chills, and fever, mouth sores)
• swelling of feet and hands due to fluid retention
• uncontrolled sudden movement
• unusual excitement
• vision problems

Stop taking the medication and seek immediate medical attention if any of the following occur:

• breathing problems
• chest pain
• confusion or changes in thought patterns
• irregular heartbeat
• seizures
• signs of an allergic reaction (such as difficulty breathing, hives, swelling of the face or throat)
• signs of liver damage (yellow skin or eyes, dark urine, loss of appetite, abdominal pain, fever, and fatigue)
• swelling of the hands or feet with shortness of breath
• tremors

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

Blood disorders: Mirtazapine can affect the production of blood cells in your body. It may cause a reduced number of white blood cells to be available to fight infection. If you notice any signs of infection, such as sore throat or flu-like symptoms, contact your doctor as soon as possible.

Diabetes: Reduction in blood glucose control has been observed in some people receiving mirtazapine. For this reason, people with diabetes should carefully monitor their blood glucose while taking mirtazapine.

Drowsiness/reduced alertness: Mirtazapine may cause drowsiness. People taking mirtazapine should avoid operating hazardous machinery (including cars) until they are certain that the medication does not impair their mental alertness, judgment, or physical coordination.

Medical conditions: Mirtazapine may worsen a number of medical conditions. People with glaucoma, low blood pressure (especially low blood pressure upon standing up (orthostatic hypotension), prostate problems, or urinary retention should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If symptoms of any of these conditions worsen, contact your doctor as soon as possible.

Kidney disease: People with kidney disease should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver disease: People with liver disease should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Seizures: People with seizure disorder or a history of seizures should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Stopping the medication: Stopping this medication suddenly may cause side effects. A gradual reduction in dose over a period of time is recommended. If you are thinking of stopping the medication, check with your doctor first.

Suicidal or agitated behaviour: Adults and children taking this medication may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These symptoms may occur within several weeks after starting this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. Your doctor will monitor you closely for these side effects while you are taking this medication.

Mirtazapine may cause symptoms of mania to worsen or to return. People with a history of manic symptoms or bipolar disorder should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. It has been reported that babies born to women who have taken mirtazapine during the last trimester of pregnancy may experience complications that results in an increase in the length of hospital stay. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if mirtazapine passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children and adolescents: The safety and effectiveness of this medication have not been established for children and adolescents under 18 years of age. There have been reports that the use of this medication by children and adolescents younger than 18 years may cause behavioural and emotional changes, such as suicidal thoughts and behaviour. Children and adolescents who take this medication should be closely monitored and encouraged to report all changes in feelings to their doctor and caregiver.

What other drugs could interact with this medication?

There may be an interaction between mirtazapine and any of the following:

alcohol amiodarone anti-HIV medications (e.g., indinavir, lopinavir, ritonavir, saquinavir) "azole" antifungals (e.g., itraconazole, voriconazole) benzodiazepines (e.g., diazepam, lorazepam, oxazepam) bupropion calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil) certain antihistamines (e.g., dimenhydrinate, diphenhydramine) certain seizure medications (e.g., carbamazepine, phenytoin, primidone) cincalcet clonidine cyclosporine estrogen fluoroquinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin) gemfibrozil isoniazid lidocaine linezolid lithium macrolide antiobiotics (e.g., clarithromycin, erythromycin)

MAO inhibitors (e.g., phenelzine, tranylcypromine, moclobamide) - mirtazapine should not be taken with these medications or within 2 weeks before or after taking them medroxyprogesterone opioid pain relievers (e.g., codeine, fentanyl, meperidine, morphine, oxycodone) primaquine quinidine quinine tricyclic antidepressants (e.g., amitriptyline, nortriptyline, doxepin, moxapine) St. John's wort selegiline sibutramine sildenafil sirolimus SSRI antidepressants (e.g., fluoxetine, paroxetine, sertraline) "statin" cholesterol-lowering medications (e.g., atorvastatin, pravastatin) tacrolimus thioridazine tramadol trazodone tricyclic antidepressants (e.g., amitriptyline, desipramine, imipramine) "triptan" medications for migraine (e.g, rizatriptan, sumatriptan) zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Disclaimer

The information within this website is for Canadian audiences only. This content is for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. It should not be construed to indicate that the use of a particular drug is safe, appropriate or effective for you. It should not be relied upon or interpreted as a recommendation for any specific treatment plan, product or course of action. The information on the site is not intended as a substitute of any kind for professional medical advice, diagnosis or treatment. Speak to your healthcare professional before taking any product, changing your lifestyle, or beginning or discontinuing any course of treatment. If you suspect that you are ill or may have a medical emergency, contact a physician, a health professional or call 911 immediately.