IMPORTANT RISK INFORMATION
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of nortriptyline hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Nortriptyline hydrochloride is not approved for use in pediatric patients.
- Pamelor is contraindicated:
- within 14 days of stopping an MAOI intended to treat psychiatric disorders. The use of MAOIs intended to treat psychiatric disorders with Pamelor or within 14 days of stopping treatment with Pamelor is also contraindicated because of an increased risk of serotonin syndrome.
- in patient who is being treated with MAOIs such as linezolid or intravenous methylene blue because of an increased risk of serotonin syndrome.
- in patients with hypersensitivity to tricyclic antidepressants. Cross-sensitivity between Pamelor and other dibenzazepines is a possibility.
- during the acute recovery period after a myocardial infarction.
WARNINGS and PRECAUTIONS
- All patients being treated with antidepressants for any indication should be monitored appropriately and observed 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 changes, either increases or decreases.
- Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers.
- Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder.
- Patients with cardiovascular disease should be given Pamelor only under close supervision because of the tendency of the drug to produce sinus tachycardia and to prolong the conduction time. Myocardial infarction, arrhythmia, and strokes have occurred.The antihypertensive action of guanethidine and similar agents may be blocked by Pamelor.
- Pamelor should be used with great caution in patients who have glaucoma or a history of urinary retention due to its anticholinergic activity.
- Patients with a history of seizures should be followed closely when Pamelor is administered. This drug is known to lower the convulsive threshold.
- Cardiac arrhythmias may develop in patients with hyperthyroidism or those receiving thyroid medications.
- Pamelor may impair the mental and/or physical abilities required for the performance of hazardous tasks, such as operating machinery or driving a car; therefore, the patient should be warned accordingly.
- Excessive consumption of alcohol in combination with nortriptyline therapy may have a potentiating effect, which may lead to the danger of increased suicidal attempts or overdosage, especially in patients with histories of emotional disturbances or suicidal ideation Deaths may occur from overdosage with this class of drugs.
- The concomitant administration of quinidine and nortriptyline may result in a significantly longer plasma half-life, higher AUC, and lower clearance of nortriptyline.
- The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Pamelor, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
- The use of Pamelor in schizophrenic patients may result in an exacerbation of the psychosis or may activate latent schizophrenic symptoms.
- If Pamelor is given to overactive or agitated patients, increased anxiety and agitation may occur. Troublesome patient hostility may be aroused by the use of Pamelor.
- Pamelor may increase the hazards of electroconvulsive therapy.
- Discontinue the drug for several days, if possible, prior to elective surgery.
- Both elevation and lowering of blood sugar levels have been reported.
- Serious adverse reactions may include clinical worsening of depression and suicidal ideation, precipitation of mania or hypomania, hypotension, hypertension, arrhythmias, heart block, tachycardia, myocardial infarction, confusion, hematologic or endocrine changes, seizures, edema of the face, hallucinations, serotonin syndrome, elevation or lowering of blood sugar, and withdrawal symptoms with abrupt discontinuation of Pamelor including nausea, headache, and malaise.
- Other adverse reactions may include anticholinergic effects (such as dry mouth, constipation, blurred vision, and urinary retention); nausea; vomiting; anorexia; peculiar taste; anorexia; sleep disorders; and anxiety. See full prescribing information for a full listing of adverse reactions.
USE IN SPECIFIC POPULATIONS
- Safety and effectiveness in the pediatric population have not been established Pamelor is not recommended for children.
- Higher plasma concentrations of the active nortriptyline metabolite, 10-hydroxynortriptyline, have also been reported in elderly patients. As with other tricyclic antidepressants, dose selection for an elderly patient should usually be limited to the smallest effective total daily dose.
nortriptyline hydrochloride capsules, USP
Light orange opaque cap printed with "PAMELOR 25 mg" in black and white opaque body printed "M" in the box in black.
For additional information on Pamelor™ (nortriptyline HCl) Capsules, USP 25 mg, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.