Remeron

DRUG DESCRIPTION

REMERON® (mirtazapine) Tablets are an orally administered drug. Mirtazapine has a tetra-cyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c] benzazepine and has the empirical formula of C17H19N3. Its molecular weight is 265.36. The structural formula is the following and it is the racemic mixture:

REMERON® (mirtazapine) Structural Formula Illustration

Mirtazapine is a white to creamy white crystalline powder which is slightly soluble in water.

REMERON is supplied for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine, and unscored film-coated tablets containing 45 mg of mirtazapine. Each tablet also contains corn starch, hydroxypropyl cellulose, magnesium stearate, colloidal silicon dioxide, lactose, and other inactive ingredients.

What are the possible side effects of mirtazapine (Remeron, Remeron SolTab)?

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...

Read All Potential Side Effects and See Pictures of Remeron »

What are the precautions when taking mirtazapine (Remeron)?

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...

Read All Potential Precautions of Remeron »


Remeron Consumer (continued)

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.


Remeron Patient Information Including Side Effects

Brand Names: Remeron, Remeron SolTab

Generic Name: mirtazapine (Pronunciation: mir TAH zah peen)

  • What is mirtazapine (Remeron)?
  • What are the possible side effects of mirtazapine (Remeron)?
  • What is the most important information I should know about mirtazapine (Remeron)?
  • What should I discuss with my healthcare provider before taking mirtazapine (Remeron)?
  • How should I take mirtazapine (Remeron)?
  • What happens if I miss a dose (Remeron)?
  • What happens if I overdose (Remeron)?
  • What should I avoid while taking mirtazapine (Remeron)?
  • What other drugs will affect mirtazapine (Remeron)?
  • Where can I get more information?

What is mirtazapine (Remeron)?

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 are the possible side effects of mirtazapine (Remeron)?

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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about mirtazapine (Remeron)?

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.

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  • Remeron
  • Remeron SolTab


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