Indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.

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. 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.

Nortriptyline hydrochloride is contraindicated during the acute recovery period after myocardial infarction.

It should be noted that nortriptyline hydrochloride is not approved for use in treating bipolar depression.

The use of Pamelor in schizophrenic patients may result in an exacerbation of the psychosis or may activate latent schizophrenic symptoms. If the drug is given to overactive or agitated patients, increased anxiety and agitation may occur. In manic-depressive patients, Pamelor may cause symptoms of the manic phase to emerge.

Patients with cardiovascular disease should be given nortriptyline hydrochloride 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.

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.

Because of its anticholinergic activity, nortriptyline hydrochloride should be used with great caution in patients who have a history of urinary retention.

Patients with a history of seizures should be followed closely when nortriptyline hydrochloride is administered, inasmuch as this drug is known to lower the convulsive threshold.

Great care is required if nortriptyline hydrochloride is given to hyperthyroid patients or to those receiving thyroid medication, since cardiac arrhythmias may develop.

The pupillary dilation that occurs following use of many antidepressant drugs including nortriptyline hydrochloride may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

There have been postmarketing reports of a possible association between treatment with Pamelor and the unmasking of Brugada syndrome. Brugada syndrome is a disorder characterized by syncope, abnormal electrocardiographic (ECG) findings, and a risk of sudden death. Pamelor should generally be avoided in patients with Brugada syndrome or those suspected of having Brugada syndrome.

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.

The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including nortriptyline hydrochloride, 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).

If concomitant use of Pamelor with other serotonergic drugs, including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, and St. John’s Wort is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.

The use of MAOIs intended to treat psychiatric disorders with nortriptyline hydrochloride or within 14 days of stopping treatment with nortriptyline hydrochloride is contraindicated because of an increased risk of serotonin syndrome. The use of nortriptyline hydrochloride within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated.

Pamelor is contraindicated during the acute recovery period after myocardial infarction.

The concomitant administration of quinidine and nortriptyline may result in a significantly longer plasma half-life, higher AUC, and lower clearance of nortriptyline.

Concurrent administration of cimetidine and tricyclic antidepressants can produce clinically significant increases in the plasma concentrations of the tricyclic antidepressant. The patient should be informed that the response to alcohol may be exaggerated.

A case of significant hypoglycemia has been reported in a type II diabetic patient maintained on chlorpropamide (250 mg/day), after the addition of nortriptyline (125 mg/day).

An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting P450 2D6 drugs as concomitant therapy. The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition.

Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be co-administered with another drug known to be an inhibitor of P450 2D6.

Safe use of nortriptyline hydrochloride during pregnancy and lactation has not been established; therefore, when the drug is administered to pregnant patients, nursing mothers, or women of childbearing potential, the potential benefits must be weighed against the possible hazards. Animal reproduction studies have yielded inconclusive results.

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• Use in patients under the age of 18. GoToSource

• Huntington’s disease. GoToSource

• Smoking cessation. GoToSource 

• Vulvodynia. GoToSource 

• Chronic obstructive pulmonary disease. GoToSource

• Bipolar disorder and attention-deficit/hyperactivity disorder. GoToSource 

• Severe asthma. GoToSource 

• Non-motor symptoms of parkinson’s disease. GoToSource 

• Use with topiramate for prevention of migraines. GoToSource

• Treatment of substance-related disorders. GoToSource

• Lumbar spinal stenosis pain. GoToSource

• Tinnitus. GoToSource

• Herpes zoster and post-herpetic neuralgia. GoToSource

• Multiple sclerosis symptoms. GoToSource 

• Diabetic neuropathy. GoToSource

• Chronic orchialgia. GoToSource 

• Irritable bowel syndrome. GoToSource

• Neuropathic pain. GoToSource

• Chronic non-cancer pain and fibromyalgia symptoms. GoToSource

• Cancer pain. GoToSource

Sudden cardiac arrest. GoToSource

Hypoglycemia (low blood sugar). GoToSource

Orthostatic hypotension (fall in blood pressure when upright position is assumed) slowing of cardiac conduction and increased heart rate. GoToSource

Prolonged QTc interval (heart rhythm disorder). GoToSource

Brugada syndrome (potentially life-threatening heart rhythm disorder) with convulsive seizure. GoToSource

Suicidal ideation. GoToSource

Liver failure. GoToSource

Xerostomia (dry mouth), constipation, blurred vision, palpitations, impaired coordination, diaphoresis (abnormal sweating), weakness, disorientation, confusion, restlessness, insomnia, anxiety/agitation, urinary retention, urinary frequency, rash, urticaria (hives), pruritus (severe itching), weight gain, impotence, gynecomastia (enlargement of male breasts), galactorrhea (milky breast discharge), tremor, photosensitivity (oversensitivity of skin to light), tardive dyskinesia (movement of disorder), glaucoma (increased fluid pressure inside the eye), agranulocytosis (reduced white blood cells), thrombocytopenia (low blood platelet count), eosinophilia (high levels of eosinophils in the blood), purpura (reddish-purple spots) hallucinations, psychosis, exacerbation of schizophrenia and manic symptoms of bipolar disorder, serotonin syndrome (potentially life-threatening drug reaction), hepatitis (liver inflammation), angioedema (swelling in the deep layers of the skin), hyperthermia (abnormally high body temperature) and heatstroke. GoToSource

Adynamic ileus (normal movement of intestines are interrupted). GoToSource 

Discontinuation syndrome. GoToSource

Lawsuits filed for suicidal ideation and behavior.