DESCRIPTION
Pamelor? (nortriptyline HCl) is 1-Propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d] cyclohepten-5-ylidene)-N-methyl-, hydrochloride.
10 mg, 25 mg, 50 mg, and 75 mg Capsules
Active Ingredient: nortriptyline hydrochloride USP.
10 mg, 25 mg, and 75 mg Capsules
Inactive Ingredients: D&C Yellow #10, FD&C Yellow #6, gelatin, silicone fluid, starch, and titanium dioxide.
50 mg Capsules
Inactive Ingredients: gelatin, silicone fluid, starch, and titanium dioxide.
Solution
Active Ingredient: nortriptyline hydrochloride USP.
Inactive Ingredients: alcohol, benzoic acid, flavoring, purified water, and sorbitol.
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.
CONTRAINDICATIONS
The use of Pamelor? (nortriptyline HCl) or other tricyclic antidepressants concurrently with a monoamine oxidase (MAO) inhibitor is contraindicated. Hyperpyretic crises, severe convulsions, and fatalities have occurred when similar tricyclic antidepressants were used in such combinations. It is advisable to have discontinued the MAO inhibitor for at least two weeks before treatment with Pamelor? (nortriptyline HCl) is started. Patients hypersensitive to Pamelor? (nortriptyline HCl) should not be given the drug.
Cross-sensitivity between Pamelor? (nortriptyline HCl) and other dibenzazepines is a possibility.
Pamelor? (nortriptyline HCl) is contraindicated during the acute recovery period after myocardial infarction.
WARNINGS
Clinical Worsening 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 behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. 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 with antidepressants compared to placebo in adults aged 65 and older.
