A tricyclic antidepressant - It is used to treat depression
FDA Alerts
Suicidality
Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need. Nortriptyline is not approved for use in pediatric patients. (See Pediatric Use under Cautions.)
In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.
Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.
Appropriately monitor and closely observe all patients who are started on nortriptyline therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process. (See Worsening of Depression and Suicidality Risk under Cautions.)
Results of several studies of TCAs in preadolescent and adolescent patients with major depression indicate lack of overall efficacy in this age group.
Attention Deficit Hyperactivity Disorder
Second-line agent in attention deficit hyperactivity disorder† (ADHD) patients unable to tolerate or unresponsive to stimulants; should be used only under close supervision.
Associated with a narrower margin of safety than some other therapeutic agents; use only if clearly indicated and with careful monitoring, including baseline and subsequent determinations of ECG and other parameters.
Eating Disorders
Has been used for management of eating disorder† (e.g., bulimia†, anorexia nervosa†) with equivocal results; avoid use in underweight individuals and in those exhibiting suicidal ideation.
Smoking Cessation
Second-line agent for the management of nicotine (tobacco) dependence† in patients who received first-line drugs (e.g., bupropion [as extended-release tablets], nicotine polacrilex gum, transdermal nicotine) but were not able to quit smoking or in whom these drugs are contraindicated.
Bipolar Disorder
Has been used for the short-term management of acute depressive episodes in bipolar disorder†.
TCAs associated with a greater risk of precipitating hypomania or manic episodes than other classes of antidepressants; should always be used in combination with a mood stabilizer (e.g., lithium).
Schizophrenia
Has been used for the management of acute depressive episodes (in combination with an antipsychotic) in patients with schizophrenia†.
Anxiety Disorders
Has been used for the management of anxiety† (in combination with anxiolytics, sedatives, or antipsychotics) in patients with depression.
Postherpetic Neuralgia
Among the drugs of choice for the symptomatic treatment of postherpetic neuralgia†.
Insomnia
Less effective for insomnia† and associated with more serious adverse reactions than conventional hypnotics.
Dosage and Administration
General
Allow at least 2 weeks to elapse between discontinuance of therapy with an MAO inhibitor and initiation of nortriptyline and vice versa. Also allow at least 5 weeks to elapse when switching from fluoxetine.
Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments. (See Worsening of Depression and Suicidality Risk under Cautions.)
Sustained therapy may be required; monitor periodically for need for continued therapy.
Avoid abrupt discontinuance in patients receiving high dosages for prolonged periods. To avoid withdrawal reactions, taper dosage gradually.
Administration
Oral Administration
Administer orally in up to 4 divided doses or as a single daily dose.
Initially, 25 mg daily. Gradually adjust to level that produces maximal therapeutic effects (up to 200 mg daily).
Usual dosage: Manufacturer recommends 75–100 mg daily, but some experts state usual dosage range is 50–200 mg daily. After symptoms are controlled, dosage should be gradually reduced to the lowest level that will maintain relief of symptoms.
Hospitalized patients under close supervision may generally be given higher dosages than outpatients.
Smoking Cessation
Oral
25 mg daily, and then gradually increase to a target dosage of 75–100 mg daily.†
Initiate nortriptyline therapy 10–28 days before date set for cessation of smoking.†
Nortriptyline was continued for approximately 12 weeks in clinical studies.†
Prescribing Limits
Adults
Major Depressive Disorder
Oral
Manufacturer does not recommend dosages >150 mg daily, but higher dosages (e.g., 200 mg daily) have been used.
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