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Manufacturer
TARO PHARM USA
SKU
51672400102

nortriptyline hcl 10 mg cap (generic pamelor)

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Dosage and Administration

Administration

Nortriptyline hydrochloride is administered orally. Although nortriptyline has been administered in up to 4 divided doses throughout the day, it is long-acting and the entire daily dose may be administered at one time.

Dosage

Dosage of nortriptyline hydrochloride is expressed in terms of nortriptyline. There is a wide range of dosage requirements and dosage must be carefully individualized. Initial dosages should be low and may be gradually adjusted to the level that produces maximal therapeutic effect with minimal toxicity.

Patients should be monitored for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustment.

Depressive and Other Psychiatric Disorders

The manufacturers state that the usual adult dosage of nortriptyline is 75-100 mg daily and that dosages greater than 150 mg daily are not recommended; if dosage exceeds 100 mg daily, plasma nortriptyline concentrations should be monitored. Hospitalized patients under close supervision may generally be given higher dosages than outpatients. Geriatric and adolescent patients should usually be given lower than average dosages. The manufacturers state that these patients may obtain satisfactory improvement with 30-50 mg of nortriptyline daily. Maximal antidepressant effects may not occur for 2 or more weeks after therapy is begun.

After symptoms are controlled, dosage should be gradually reduced to the lowest level which will maintain relief of symptoms. To avoid the possibility of precipitating withdrawal symptoms, nortriptyline should not be terminated abruptly in patients who have received high dosage for prolonged periods.

Smoking Cessation

For use in the cessation of smoking, nortriptyline therapy has been initiated in clinical studies at a dosage of 25 mg daily, and then gradually increased to a target dosage of 75-100 mg daily. So that steady state can be reached at the targeted dosage, nortriptyline therapy should be initiated 10-28 days before the date set for cessation of smoking. Nortriptyline was continued for approximately 12 weeks in clinical studies for smoking cessation.

Cautions

Nortriptyline shares the pharmacologic actions, uses, and toxic potentials of the tricyclic antidepressants, and the usual precautions of tricyclic antidepressant administration should be observed. Patients should be fully advised about the risks, especially suicidal thinking and behavior (suicidality), associated with tricyclic antidepressant therapy. For a complete discussion, and .

Some commercially available formulations of nortriptyline hydrochloride contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylaxis and life-threatening or less severe asthmatic episodes, in certain susceptible individuals. The overall prevalence of sulfite sensitivity in the general population is unknown but probably low; such sensitivity appears to occur more frequently in asthmatic than in nonasthmatic individuals.

Pediatric Precautions

Safety and efficacy of nortriptyline in children have not been established. Therefore, at least one manufacturer of nortriptyline recommends that the drug not be used in children.

The US Food and Drug Administration (FDA) has determined that antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder and other psychiatric disorders. However, the FDA also states that depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide. Anyone considering the use of nortriptyline in a child or adolescent for any clinical use must therefore balance the potential risk of therapy with the clinical need. ( and .)

Pharmacokinetics

Absorption

No information is available on the rate or degree of absorption of nortriptyline hydrochloride from the GI tract. Peak plasma concentrations occur within 7-8.5 hours after oral administration. Optimal response to the drug appears to be associated with plasma concentrations of 50-150 ng/mL.

Distribution

Nortriptyline is distributed into milk. Nortriptyline concentrations in milk appear to be similar to or slightly greater than those present in maternal serum.

Elimination

The plasma half-life of nortriptyline ranges from 16 to more than 90 hours. Nortriptyline is metabolized via the same pathways as are other tricyclic antidepressants. Approximately one-third of a dose of nortriptyline is excreted in urine as metabolites within 24 hours, and small amounts are excreted in feces via biliary elimination.

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