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Norpramin

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Norpramin

Indications
Dosage
How Supplied

INDICATIONS

NORPRAMIN is indicated for the treatment of depression.

DOSAGE AND ADMINISTRATION

Not recommended for use in children (see WARNINGS).

Lower dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients compared to hospitalized patients, who are closely supervised. Dosage should be initiated at a low level and increased according to clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a period of time and should be at the lowest dose that will maintain remission.

Usual Adult Dose

The usual adult dose is 100 to 200 mg per day. In more severely ill patients, dosage may be further increased gradually to 300 mg/day if necessary. Dosages above 300 mg/day are not recommended.

Dosage should be initiated at a lower level and increased according to tolerance and clinical response.

Treatment of patients requiring as much as 300 mg should generally be initiated in hospitals, where regular visits by the physician, skilled nursing care, and frequent electrocardiograms (ECGs) are available.

The best available evidence of impending toxicity from very high doses of NORPRAMIN is prolongation of the QRS or QT intervals on the ECG. Prolongation of the PR interval is also significant, but less closely correlated with plasma levels. Clinical symptoms of intolerance, especially drowsiness, dizziness, and postural hypotension, should also alert the physician to the need for reduction in dosage.

Initial therapy may be administered in divided doses or a single daily dose.

Maintenance therapy may be given on a once-daily schedule for patient convenience and compliance.

Adolescent And Geriatric Dose

The usual adolescent and geriatric dose is 25 to 100 mg daily.

Dosage should be initiated at a lower level and increased according to tolerance and clinical response to a usual maximum of 100 mg daily. In more severely ill patients, dosage may be further increased to 150 mg/day. Doses above 150 mg/day are not recommended in these age groups.

Initial therapy may be administered in divided doses or a single daily dose.

Maintenance therapy may be given on a once-daily schedule for patient convenience and compliance.

Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with NORPRAMIN. Conversely, at least 14 days should be allowed after stopping NORPRAMIN before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).

Use Of NORPRAMIN With Other MAOI's Such As Linezolid Or Methylene Blue

Do not start NORPRAMIN in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).

In some cases, a patient already receiving NORPRAMIN therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, NORPRAMIN should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with NORPRAMIN may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with NORPRAMIN is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).

HOW SUPPLIED

10 mg blue coated tablets imprinted 68-7

NDC 0068-0007-01: bottles of 100

25 mg yellow coated tablets imprinted NORPRAMIN 25

NDC 0068-0011-01: bottles of 100

50 mg green coated tablets imprinted NORPRAMIN 50

NDC 0068-0015-01: bottles of 100

75 mg orange coated tablets imprinted NORPRAMIN 75

NDC 0068-0019-01: bottles of 100

100 mg peach coated tablets imprinted NORPRAMIN 100

NDC 0068-0020-01: bottles of 100

150 mg white coated tablets imprinted NORPRAMIN 150

NDC 0068-0021-50: bottles of 50

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from excessive heat. Dispense in tight container.

Mfd for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807. A Sanofi Company. Revised: June 2014.

Last reviewed on RxList: 7/18/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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