Drug Catalog - Product Detail
DESIPRAMINE HCL TB 25MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00781-1972-01 | SANDOZ | 100 | 25MG | TABLET |
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Description
DESCRIPTION Desipramine hydrochloride USP is an antidepressant drug of the tricyclic type available as tablets of 10 mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg for oral administration. Its chemical name is 5H-Dibenz[bf]azepine-5-propanamine, 10, 11-dihydro-N-methyl-, monohydrochloride. Inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch (corn), and titanium dioxide. MM1
How Supplied
HOW SUPPLIED Desipramine hydrochloride tablets, USP for oral administration are round, film-coated white tablets available as: 10 mg: debossed GG 63 on one side and plain on the reverse side, and supplied as: NDC 0781-1971-01 bottles of 100 NDC 0781-1971-10 bottles of 1000 25 mg: debossed GG 64 on one side and plain on the reverse side, and supplied as: NDC 0781-1972-01 bottles of 100 NDC 0781-1972-10 bottles of 1000 NDC 0781-1972-13 unit dose packages of 100 50 mg: debossed GG 65 on one side and plain on the reverse side, and supplied as: NDC 0781-1973-01 bottles of 100 NDC 0781-1973-10 bottles of 1000 NDC 0781-1973-13 unit dose packages of 100 75 mg: debossed GG 166 on one side and plain on the reverse side, and supplied as: NDC 0781-1974-01 bottles of 100 NDC 0781-1974-10 bottles of 1000 100 mg: debossed GG 167 on one side and plain on the reverse side, and supplied as: NDC 0781-1975-01 bottles of 100 NDC 0781-1975-10 bottles of 1000 150 mg: debossed GG 168 on one side and plain on the reverse side, and supplied as: NDC 0781-1976-50 bottles of 50 NDC 0781-1976-10 bottles of 1000
Indications & Usage
INDICATIONS & USAGE Desipramine hydrochloride is indicated for the treatment of depression.
Dosage and Administration
DOSAGE & 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 (ECG's) are available. The best available evidence of impending toxicity from very high doses of desipramine 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.