Mirtazapine (Systemic)

Brand Names : Remeron, Remeron SolTab

Before Using This Medicine

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, this medicine 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 this medicine and who wish to breast-feed should discuss this with their doctor.

Children - Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of mirtazapine in children with use in other age groups.

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 this medicine. More study is needed to be sure mirtazapine is safe and effective in children.

Older adults - This medicine 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

Other medical problems - The presence of other medical problems may affect the use of mirtazapine. Make sure you tell your doctor if you have any other medical problems, especially:

• 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