NORTRIPTYLINE

3 Pediatrics). • NORTRIPTYLINE is contraindicated for concomitant use with MAO inhibitors (see 2 CONTRAINDICATIONS). NORTRIPTYLINE should not be used within 14 days of initiating or discontinuing MAO inhibitors. • Clinical findings should predominate over plasma concentrations as primary determinants of dosage changes.

2 Recommended Dose and Dosage Adjustment). • The use of lower dosages for outpatients is more important than for hospitalized patients, who will be treated under close supervision. • Dosages should be titrated, beginning at a low level and increasing gradually over several weeks, while carefully monitoring for clinical response and noting any evidence of intolerance.

Improvement may not occur during the first few weeks or more of treatment. 5 Post-Market Adverse Reactions, Withdrawal Symptoms). • Following remission, maintenance medication may be required for a long period of time at the lowest dose that will maintain remission.

• If a patient develops minor side effects, the dosage should be reduced. The drug should be discontinued promptly if adverse effects of a serious nature or allergic manifestations occur. 2 Recommended Dose and Dosage Adjustment • Adults (≥ 18 years): The recommended dose of NORTRIPTYLINE is 25 mg, taken orally 3 to 4 times daily.

When initiating treatment with NORTRIPTYLINE, dosage should begin at a low level and increase gradually, as required. Doses above 100 mg/day are not recommended. • Pediatrics (< 18 years): Health Canada has not authorized an indication for pediatric use.

The use of NORTRIPTYLINE in children is not recommended. When considering the use of nortriptyline in adolescents, the clinical need should outweigh the potential risks and uncertainties. 3 Pediatrics). • Geriatrics: There is limited data available involving the use of nortriptyline in patients aged 65 and over.

Caution should be exercised when using NORTRIPTYLINE in elderly NORTRIPTYLINE (Nortriptyline Hydrochloride Capsules) Page 7 of 44 patients. 4 Geriatrics). 3 Pharmacokinetics, Special Populations and Conditions). In patients with hepatic impairment, use caution when initiating treatment with NORTRIPTYLINE.

Lower doses may be required. 1 Discontinuing Treatment When discontinuing NORTRIPTYLINE, the patient should be closely monitored, while the dosage is gradually tapered over several weeks. Though not indicative of addiction, abrupt cessation of treatment following prolonged therapy may produce withdrawal symptoms, including flu-like symptoms, dizziness, nausea, headache, agitation, malaise, and abdominal cramping.

5 Post-Market Adverse Reactions, Withdrawal Symptoms). 4 Administration NORTRIPTYLINE is administered orally, in the form of capsules. 5 Missed Dose If the patient misses a dose of NORTRIPTYLINE, the patient should be instructed to skip the missed dose and take the next dose at the regular dosing schedule.

1 Adverse Reaction Overview Clinical trial data on which the indication was originally authorized is not available. 5 Post-Market Adverse Reactions. The most serious adverse effects include orthostatic hypotension, syncope, ventricular arrhythmias, AV block, myocardial infarction, stroke, paralytic ileus, glaucoma, increased intraocular pressure, agranulocytosis, leukopenia, thrombocytopenia, hepatitis, angioedema.

2 Clinical Trial Adverse Reactions The clinical trial data on which the indication was originally authorized is not available. 5 Post-Market Adverse Reactions, below. 3 Less Common Clinical Trial Adverse Reactions The clinical trial data on which the indication was originally authorized is not available.

4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data The clinical trial data on which the indication was originally authorized is not available. 5 Post-Market Adverse Reactions Note: Included in the following list are a few adverse reactions that have not been reported with this specific drug.

However, the pharmacologic similarities among the tricyclic antidepressant drugs require that each of these reactions be considered when nortriptyline is administered. Blood and lymphatic system disorders: bone marrow depression, including agranulocytosis, aplastic anemia, eosinophilia, purpura, thrombocytopenia, leukopenia.

Cardiac disorders: tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, QT prolongation (especially in the elderly), Brugada syndrome, changes in AV conduction, asystole, syncope, ventricular tachycardia, fibrillation, unexpected death in patients with cardiovascular disorders.

Endocrine disorders: gynecomastia in the male; syndrome of inappropriate ADH (antidiuretic hormone) secretion. Eye disorders: angle-closure glaucoma, blurred vision, disturbance of accommodation, mydriasis, precipitation of latent glaucoma, aggravation of existing glaucoma.

1 Pregnant Women 11/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................

2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................

5 1 INDICATION ................................................................................................................. 1 Pediatrics .................................................................................................................

2 Geriatrics ................................................................................................................. 5 2 CONTRAINDICATIONS ..................................................................................................

5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 5 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations .............................................................................................

2 Recommended Dose and Dosage Adjustment ........................................................ 1 Discontinuing Treatment.......................................................................................... 4 Administration .........................................................................................................

5 Missed Dose ............................................................................................................ 7 5 OVERDOSAGE...............................................................................................................

NORTRIPTYLINE is contraindicated: • in patients with hypersensitivity to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.

Cross- sensitivity between nortriptyline and other dibenzazepines is a possibility. 4 Drug-Drug Interactions; 5 OVERDOSAGE). • during the acute recovery period following myocardial infarction.