Intended for U.S. healthcare professionals only.
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PamelorTM (nortriptyline HCl) capsules USP are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.
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.
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.
|Generic Name||nortriptyline hydrochloride capsules, USP|
|Dosage Strength||50 mg|
|Identification Code||White opaque cap printed "PAMELOR 50 mg" in black and white opaque body printed "M" in the box in black.|
|NDC #||Package Size||Case Quantity|
For additional information on Pamelor™ (nortriptyline HCl) Capsules, USP 10 mg, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.