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, irrespective of whether they are on antidepressants or not; this risk may persist until significant remission occurs
- Short-term placebo-controlled trials of antidepressant drugs showed that children, adolescents, and young adults (ages 18-24) with MDD and other psychiatric disorders are at an increased risk of suicidality; the risk of suicidality did not increase in patients >24 yrs of age and the risk decreased in patients >65 yrs of age [US Black Box Warning]
- Monitor these patients appropriately and observe them closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose modifications [US Black Box Warning]
- Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have occurred in adult and pediatric patients receiving antidepressants for MDD and other psychiatric disorders
- Consider changing the therapeutic regimen or even discontinuation of therapy in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms suggestive of worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, and were not part of the patient's presenting symptoms
- Families and caregivers of patients treated with antidepressants should be alerted about the need 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 healthcare providers. Prescribe the smallest quantity consistent with good patient management to reduce the risk of overdose
- Patients should be appropriately screened for bipolar disorder before initiating antidepressant therapy. The screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. Nortriptyline is not approved for use in treating bipolar depression
- Antidepressant therapy may produce troublesome patient hostility
- Nortriptyline use in schizophrenic patients may cause an exacerbation of psychosis or may activate latent schizophrenic symptoms
- Therapy in manic-depressive patients may cause symptoms of the manic phase to emerge; increased anxiety and agitation may occur when given to overactive or agitated patients
- Use with caution in patients with cardiovascular disease because of the tendency of the drug to cause sinus tachycardia and to prolong the conduction time
- Myocardial infarction, arrhythmia and stroke have also been reported
- Patients receiving nortriptyline should be warned of the risks involved in performing hazardous tasks such as operating machinery or driving a car because the drug may impair the mental and/or physical abilities necessary for performing such tasks
- Hepatic adverse events (characterized by jaundice and increased liver enzymes) have been reported rarely in geriatric patients. Deaths due to cholestatic liver damage have also been reported in isolated instances
- Both elevation as well as lowering of blood sugar levels have been reported during therapy
- Discontinue therapy prior to elective surgery for as long as the clinical situation allows
- Abrupt cessation of therapy may cause nausea, headache, and malaise; to avoid these adverse reactions gradually taper the dose
- Caution should be exercised while administering nortriptyline with drugs that are metabolized by CYP2D6 or those that inhibit CYP2D6
- Patients, their families and caregivers should be informed about the benefits and risks associated with nortriptyline therapy and should be guided about its appropriate use
Cautions: Use cautiously in
Supplemental Patient Information
- Advise patients to refrain from hazardous activities requiring mental alertness such as operating a machinery or driving an automobile
- Advise caregivers to remain alert to the possibility of worsening symptoms and also the risk of suicidality, and to promptly report such symptoms to their healthcare provider
Pregnancy Category:D
Breastfeeding: Nortriptyline and its metabolites are excreted in breastmilk in small amounts. Immediate adverse events have not been reported and a limited amount of follow-up found no adverse effects on growth and development of the infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 18 April 2011). As per the manufacturer's data, the potential benefits should be weighed against the possible hazards if the drug is to be administered in nursing women.
Pricing data from www.DrugStore.com in U.S.A.
- Pamelor 25 MG CAPS [Bottle] (MALLINCKRODT)
30 mg = $695.99
90 mg = $2029.97 - Nortriptyline HCl 25 MG CAPS [Bottle] (TEVA PHARMACEUTICALS USA)
30 mg = $12.99
60 mg = $15.98 - Pamelor 10 MG CAPS [Bottle] (MALLINCKRODT)
30 mg = $695.99
90 mg = $2029.97 - Nortriptyline HCl 10 MG/5ML SOLN [Bottle] (PHARMACEUTICAL ASSOCIATES)
473 5ml = $53.99
1419 5ml = $150.99 - Pamelor 75 MG CAPS [Bottle] (MALLINCKRODT)
30 mg = $541.01
90 mg = $1451.01
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
