PAMELOR Capsule (2020)

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Storage And Handling

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP) with a child-resistant closure.

1. Description

Pamelor (nortriptyline HCl) is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d] cyclohepten-5-ylidene)-N - methyl -, hydrochloride. The structural formula is as follows: ...

2. Clinical Pharmacology

The mechanism of mood elevation by tricyclic antidepressants is at present unknown. Pamelor is not a monoamine oxidase inhibitor. It inhibits the activity of such diverse agents as histamine, 5-hydroxytryptamine, ...

3. Indications and Usage

Pamelor (nortriptyline HCl) is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.

4. Contraindications

Monoamine Oxidas e Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with Pamelor or within 14 days of stopping treatment with Pamelor is contraindicated because of an increased ...

5. Warnings

Clinical Wors ening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and ...

6.1. General

Clinical Worsening and Suicide Risk Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, ...

6.2. Information for Patients

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with nortriptyline hydrochloride and should ...

6.4. Drug Interactions

Administration of reserpine during therapy with a tricyclic antidepressant has been shown to produce a stimulating effect in some depressed patients. Close supervision and careful adjustment of the dosage ...

6.10. Pediatric Use

Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and WARNINGS, Clinical Wors ening and Suicide Risk). Anyone considering the use of nortriptyline hydrochloride ...

6.11. Geriatric Use

Clinical studies of Pamelor did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience indicates ...

7. 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 ...

8. Postmarketing Experience

The following adverse drug reaction has been reported during post-approval use of Pamelor. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to ...

9. Overdosage

Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic antidepressant overdose. As the management is complex and changing, ...

10. Dosage and Administration

Pamelor is not recommended for children. Pamelor is administered orally in the form of capsules. Lower than usual dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended ...

11. How Supplied

Pamelor (nortriptyline HCl) Capsules USP Pamelor (nortriptyline HCl) Capsules USP, equivalent to 10 mg, 25 mg, 50 mg, and 75 mg base, are available as follows: 10 mg: Light orange opaque cap printed ...