In the U.S.—

• Antidepressant

Mirtazapine (mir-TAZ-a-peen ) is used to treat mental depression.

REMERON is available only with your doctor's prescription, in the following dosage form(s):

Oral
• Oral Disintegrating Tablets (U.S.)
• Tablets (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For mirtazapine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to mirtazapine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Mirtazapine has not been studied in pregnant women. However, REMERON has been shown to cause death of the fetus in animals given doses many times higher than the usual human dose. Mirtazapine has not been shown to cause birth defects in animals.

Breast-feeding—It is not known whether mirtazapine passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking REMERON and who wish to breast-feed should discuss this with their doctor.

Children—Mirtazapine must be used with caution in children with depression. Studies have shown occurrences of children thinking about suicide or attempting suicide in clinical trials for REMERON. More study is needed to be sure mirtazapine is safe and effective in children.

Mirtazapine must be used with caution in children with depression. Studies have shown occurrences of children thinking about suicide or attempting suicide in clinical trials for REMERON. More study is needed to be sure mirtazapine is safe and effective in children.

Older adults—REMERON has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, it is removed from the body more slowly in older people.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking mirtazapine, it is especially important that your health care professional know if you are taking any of the following:

• Alcohol or
• Central nervous system (CNS) depressants (medicines that cause drowsiness) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])—Using these medicines with mirtazapine may increase the CNS depressant effects

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])— Do not take mirtazapine while you are taking, or within 2 weeks of taking, an MAO inhibitor or you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, and severe convulsions; at least 14 days should be allowed between stopping treatment with one medicine and starting treatment with the other

• Convulsions (seizures) (history of)—Mirtazapine has been reported to cause seizures rarely

• Dehydration or
• Heart disease or
• Stroke (history of)—Mirtazapine may make the condition worse by causing low blood pressure (hypotension)

• Kidney disease—Effects of mirtazapine may be increased because of slower removal from the body

• Liver disease—Mirtazapine may cause liver problems; also, effects of mirtazapine may be increased because of slower removal from the body

• Mania (a type of mental illness) (or history of)—Mirtazapine may cause this problem to recur
• Phenylketonuria (PKU)—The oral disintegrating tablets may contain aspartame, which can make your condition worse

Take REMERON only as directed by your doctor in order to improve your condition as much as possible. Do not take more of it and do not take it more often than your doctor ordered.

Mirtazapine may be taken with or without food, on a full or empty stomach. If your doctor tells you to take it a certain way, follow your doctor's instructions.

For patients using the oral disintegrating tablet form of REMERON:

• Make sure your hands are dry.
• Do not push the tablet through the foil backing of the package. Instead, gently peel back the foil backing and remove the tablet.
• Immediately place the tablet on top of the tongue.
• The tablet will dissolve in seconds, and you may swallow it with your saliva. You do not need to drink water or other liquid to swallow the tablet.

Dosing—

The dose of mirtazapine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of mirtazapine. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine.

• For oral dosage form (tablets and oral disintegrating tablets):
  • For mental depression:
    • Adults—At first, 15 milligrams (mg) once a day, preferably in the evening just before you go to sleep. Your doctor may increase the dose if necessary. However, the dose usually is not more than 45 mg a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of REMERON, take it as soon as possible if you remember it the same day. However, if you don't remember until the next day, skip the missed dose and return to your regular dosing schedule. Do not double doses.

Storage—

To store REMERON:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.