Pamelor™ (nortriptyline HCl) Capsules, USP 50 mg

IMPORTANT SAFETY INFORMATION

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.
• The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric.
• 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. Nortriptyline hydrochloride is not approved for use in treating bipolar depression.
• 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 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). Treatment with Pamelor and any concomitant serotonergic agents should be discontinued immediately if serotonin syndrome occurs and supportive symptomatic treatment should be initiated.
• 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 Pamelor for several days, if possible, prior to elective surgery.
• Both elevation and lowering of blood sugar levels have been reported.
• There have been postmarketing reports of an association between treatment with Pamelor and the unmasking of Brugada syndrome, 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.
• The pupillary dilation that occurs following use of many antidepressant drugs including Pamelor may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
• Safe use of Pamelor during pregnancy and lactation has not been established; therefore the potential benefits must be weighed against the possible hazards.

ADVERSE REACTIONS

The following list includes a few adverse reactions that have not been reported with Pamelor. However, the pharmacologic similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when nortriptyline is administered:

Hypotension, hypertension, tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, stroke, confusional states (especially in the elderly) with hallucinations, disorientation, delusions, anxiety, restlessness, agitation, insomnia, panic, nightmares, hypomania, exacerbation of psychosis, numbness, tingling, paresthesias of extremities, incoordination, ataxia, tremors, peripheral neuropathy, extrapyramidal symptoms, seizures, alteration in EEG patterns, tinnitus, dry mouth and, rarely, associated sublingual adenitis, blurred vision, disturbance of accommodation, mydriasis, constipation, paralytic ileus, urinary retention, delayed micturition, dilation of the urinary tract, skin rash, petechiae, urticaria, itching, photosensitization, edema (general or of face and tongue), drug fever, cross-sensitivity with other tricyclic drugs, bone marrow depression including agranulocytosis, eosinophilia, purpura, thrombocytopenia, nausea and vomiting, anorexia, epigastric distress, diarrhea, peculiar taste, stomatitis, abdominal cramps, black tongue, gynecomastia in the male, breast enlargement and galactorrhea in the female, increased or decreased libido, impotence, testicular swelling, elevation or depression of blood sugar levels, syndrome of inappropriate ADH (antidiuretic hormone) secretion, jaundice (simulating obstructive), altered liver function, weight gain or loss, perspiration, flushing, urinary frequency, nocturia, drowsiness, dizziness, weakness, fatigue, headache, parotid swelling and alopecia.

This is not a complete list of potential adverse events associated with Pamelor. Please see Full Prescribing Information for a complete list.