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Remeron® (mirtazapine)


Remeron® (mirtazapine, Zispin)

What is Remeron?

Remeron (mirtazapine, Zispin), manufactured by Organon Inc., is a medication that was approved by the Food and Drug Administration (FDA) for the treatment of depression in June 1997. Remeron was the first drug in a new class of antidepressants with a unique ability to target specific serotonin receptors. Along with its efficacy in the treatment of moderate to severe depression, Remeron has proven to be effective for treating anxiety, motor retardation, and cognitive and sleep disturbances associated with depression.

How is Remeron different from other antidepressants?

Remeron has a tetracyclic chemical structure that causes it to act differently from other common antidepressants (SSRIs, MAOIs, and tricyclics). While stimulating norepinephrine and serotonin release, Remeron also has the unique ability to block two specific serotonin receptors, thus causing fewer serotonergic side effects (such as decreased interest in sex, nausea, nervousness, insomnia, and diarrhea). In studies, the use of Remeron, compared with tricyclic antidepressants, also resulted in fewer anticholinergic symptoms (blurred vision, dry mouth, indigestion, and constipation), cardiovascular symptoms, and cognitive disturbances. Additionally, Remeron has a relatively high safety margin in case of overdose and a low tendency to cause seizures. It causes no significant changes in vital signs (heart rate, blood pressure, or body temperature) or ECG.

What are the side effects of Remeron?

The most commonly reported drug-related side effects were drowsiness, increased appetite, weight gain, and dizziness. In studies, drowsiness generally appeared during the first week of treatment but decreased in intensity over time, even as dosages increased. Other side effects may also lessen in severity, or go away, with prolonged use of the drug. However, weight gain can sometimes be a persistent problem.

In clinical trials, two out of 2,796 consumers treated with Remeron developed agranulocytosis and a third consumer developed severe neutropenia — both potentially dangerous decreases in white blood cell counts that cause extreme vulnerability to infection. These consumers recovered after Remeron was stopped. However, it should be noted that if a consumer develops a sore throat, fever, inflammation of the mouth, or other signs of infection, he or she should discontinue treatment with Remeron under the supervision of a doctor. Since the introduction of Remeron in the U.S. in 1997, agranulocytosis has not been a problem and most scientists now believe it is not a specific side effect of Remeron

How does Remeron interact with other medications?

Remeron does not cause problematic interactions with most other drugs and it is frequently prescribed in combination with other antidepressants. Use of other drugs that cause drowsiness (antihistamines, prescription painkillers, Valium, Xanax) may increase this effect and impair driving or other motor or coordination skills. Use with central nervous system stimulants (Fastin, Dexedrine, Ritalin) may cause an increase in agitation or even mania, especially in bipolar patients.

Immunocompromised consumers, consumers with HIV, and consumers on steroid therapy should call their physician at the first sign of sore throat, fever, chills, sores in and around the soft tissue of the mouth, or any general flu-like symptoms.

What is the recommended dosage of Remeron?

Remeron is available in both 15 mg (yellow) and 30 mg (red-brown) tablets. It is also available in Sol-Tabs preparation that is dissolved under the tongue for those who have difficulty swallowing pills. The recommended starting dose is 15 mg per day given in a single dose before bedtime, and it can be taken with or without food. It is recommended that one to two weeks pass before making upward dosage adjustments, in small increments. The effective dose range of Remeron is generally 15-45 mg/day, but some patients do well with even higher doses. In patients with liver and kidney disease, a smaller dose may be appropriate. As with other antidepressants, it may take several weeks of therapy before improvement is noticeable.

For further information please contact the pharmaceutical company listed below.

Organon

375 Mt. Pleasant Ave.

West Orange, NJ 07052

800-631-1253

www.organon.com

Free or low-cost medications provided by pharmaceutical companies

Some pharmaceutical companies offer medication assistance programs to low-income individuals and families. These programs typically require a doctor’s consent and proof of financial status. They may also require that you have either no health insurance, or no prescription drug benefit through your health insurance. Please contact the pharmaceutical company directly for specific eligibility requirements and application information.

Remeron Rx Assistance Program: 1-800-241-8812
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FDA ALERT Suicidal Thoughts or Actions in Children and Adults

Patients with depression or other mental illnesses often think about or attempt suicide. Closely watch anyone taking antidepressants, especially early in treatment or when the dose is changed. Patients who become irritable or anxious, or have new or increased thoughts of suicide or other changes in mood or behavior (or their care givers) should contact their healthcare professional right away.

Children

Taking antidepressants may increase suicidal thoughts and actions in about 1 out of 50 people 18 years or younger. Although mirtazapine is prescribed for children, FDA has not approved mirtazapine for use in children.

Adults

Several recent scientific publications report the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications. Even before these reports became available, FDA began a complete review of all available data to determine whether there is an increased risk of suicidal thinking or behavior in adults being treated with antidepressant medications. It is expected that this review will take a year or longer to complete. In the meantime, FDA is highlighting that adults being treated with antidepressant medication, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior.

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information.

Reviewed by Jack Gorman, M.D., Chair NAMI Scientific Council, Sept 2002

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