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Norpramin

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Norpramin

Norpramin

INDICATIONS

NORPRAMIN (desipramine hydrochloride) 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 (desipramine hydrochloride) 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.

HOW SUPPLIED

10 mg blue coated tablets imprinted 68-7

NDC 0068-0007-01: bottles of 100

25 mg yellow coated tablets imprinted NORPRAMIN (desipramine hydrochloride) 25

NDC 0068-0011-01: bottles of 100

50 mg green coated tablets imprinted NORPRAMIN (desipramine hydrochloride) 50

NDC 0068-0015-01: bottles of 100

75 mg orange coated tablets imprinted NORPRAMIN (desipramine hydrochloride) 75

NDC 0068-0019-01: bottles of 100

100 mg peach coated tablets imprinted NORPRAMIN (desipramine hydrochloride) 100

NDC 0068-0020-01: bottles of 100

150 mg white coated tablets imprinted NORPRAMIN (desipramine hydrochloride) 150

NDC 0068-0021-50: bottles of 50

NORPRAMIN (desipramine hydrochloride) tablets should be stored at room temperature, preferably below 86°F (30°C). Protect from excessive heat. Dispense in tight container.

Rev. October 2009. Mfd for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807 © 2009 sanofi-aventis U.S. LLC

Last reviewed on RxList: 12/7/2009
This monograph has been modified to include the generic and brand name in many instances.

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