See Supplemental Patient Information
- Worsening of depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior may occur in patients with MDD, whether or not they are taking antidepressant drugs; this risk may persist until significant remission occurs
- Children, adolescents, and young adults (ages 18-24) with MDD and other psychiatric disorders are more prone to the risk of suicidality; however, this risk did not increase in patients >24 yrs of age and also decreased in patients >65 yrs of age [US Black Box Warning]
- Monitor patients receiving antidepressant therapy appropriately and observe them closely for clinical worsening, suicidality, or unusual changes in behavior, particularly during the initial few months of a course of drug therapy, or at times of dose modifications [US Black Box Warning]
- Symptoms including anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania have occurred in adults and pediatric patients receiving therapy
- Consider changing the therapeutic regimen or discontinuing the therapy on persistent worsening of depression, or on experiencing emergent suicidality or abrupt onset of severe symptoms suggesting worsening depression or suicidality, especially if these symptoms were not part of the patient's presenting symptoms
- Advise families and caregivers of patients receiving antidepressants to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, emergence of suicidality and other symptoms. Instruct them to promptly report such symptoms to their healthcare providers
- Patients with depressive symptoms should be screened appropriately to determine if they are at risk for bipolar disorder; consider a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression before initiating therapy. Maprotiline is not approved for use in treating bipolar depression
- Use with caution in patients with cardiovascular disease because of the possibility of conduction defects, arrhythmias, myocardial infarction, strokes, and tachycardia
- Patients receiving maprotiline should be warned against performing potentially hazardous tasks because maprotiline may impair the mental or physical abilities required for such activities
- Elevation as well as lowering of blood sugar levels have been reported with the use of this drug
- Discontinue therapy prior to elective surgery for as long as the clinical situation allows
- Avoid abrupt cessation of therapy as it may cause nausea, headache, and malaise; to avoid these events gradually taper the dose
- Seizures have been associated with maprotiline therapy; most of these have occurred in patients without a known history of seizures
Cautions: Use cautiously in
- Angle-closure glaucoma
- Increased IOP
- Urinary retention
- Prostatic hypertrophy
- Seizure disorder
- Diabetes mellitus
- Alcohol abuse
- Thyroid disorder
- Psychotic disorder
- History of schizophrenia
Supplemental Patient Information
- Advise patients to refrain from activities requiring mental alertness such as operating a hazardous machinery or driving an automobile
- Encourage the patients, their families and their caregivers to remain alert to the clinical worsening of symptoms and the risk of suicidality
Pregnancy Category:B
Breastfeeding: Because limited information is available regarding maprotiline use during breastfeeding, other agents may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 17 May 2011). Concentrations of maprotiline in breast milk correspond closely to the concentrations in whole blood at steady-state. Manufacturer advises caution.
