Remeron (MIRTAZAPINE)
Remeron is indicated for the treatment of major depressive disorder. A major depressive episode implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
Side Effects:
Common side effects include:
*Body as a Whole: Asthenia(weakness), Flu Syndrome, Back Pain
*Digestive System: Dry Mouth, Increased Appetite, Constipation
*Metabolic and Nutritional Disorders: Weight Gain, Peripheral Edema(swelling of the arms and/or legs), Edema(body swelling)
*Musculoskeletal System: Myalgia (muscle pain)
*Nervous System: Somnolence(sleepiness), Dizziness, Abnormal Dreams, Abnormal Thinking, Tremor, Confusion
*Respiratory System: Dyspnea(shortness of breath, difficult breathing)
*Urogenital System: Urinary Frequency
Drug Abuse and Dependence
Remeron has not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence. While the clinical trials did not reveal any tendency for any drug-seeking behavior, patients should be evaluated carefully for history of drug abuse, and such patients should be observed closely for signs of Remeron misuse or abuse.
Precautions and drug interactions:
*Alcohol: The impairment of cognitive and motor skills produced by Remeron were shown to be additive with those produced by alcohol. Accordingly, patients should be advised to avoid alcohol while taking Remeron.
Diazapam (Valium).The impairment of motor skills produced by Remeron has been shown to be additive with those caused by diazepam. Accordingly, patients should be advised to avoid diazepam, better known as valium and other similar drugs while taking Remeron.
Other precautions
Remeron has been known to increase cholesterol and triglyceride levels, increase appetite and weight gain.
Remeron may impair judgement, thinking, and particularly, motor skills, because of its prominent sedative effect. The drowsiness associated with Remeron use may impair a patient's ability to drive, use machines or perform tasks that require alertness. Thus, patients should be cautioned about engaging in hazardous activities until they are reasonably certain that Remeron therapy does not adversely affect their ability to engage in such activities.
In depressed patients, the possibility of suicide should always be considered and adequate precautions taken. It is recommended that careful observations of patients undergoing Remeron treatment be maintained until control of depression is achieved. If necessary, additional measures (ECT, hospitalization, etc) should be instituted.
Pregnancy and Nursing Mothers
There are no adequate and well-controlled studies in pregnant women. Because of this, the drug should be used during pregnancy only if clearly needed. It is not known whether mirtazapine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if administered to nursing women.
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Pediatric Use
Remeron is not recommended for pediatric patients under 16 years of age, since there are no controlled studies of safety in this age group
Geriatric Use
Approximately 190 elderly individuals participated in clinical studies with Remeron. This drug is known to be substantially excreted by the kidney (75%), and the risk of decreased clearance of this drug is greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection. Sedating drugs may cause confusion and over-sedation in the elderly.
Recommended Dosage
The recommended starting dose for Remeron is 15 mg/day, administered in a single dose, preferably in the evening prior to sleep.
Overdose
There is very limited experience with Remeron overdose. In premarketing clinical studies, there were eight reports of Remeron overdose alone or in combination with other pharmacological agents.