RVP

Drug Catalog - Product Detail

DESIPRAMINE HCL 50MG TAB 100CT

NDC Mfr Size Str Form
64720-0417-10 ANI PHARMACEUTICALS 100 50MG NA
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Description
DESCRIPTION Desipramine hydrochloride, USP is an antidepressant drug of the tricyclic type, and is chemically: 5 H -Dibenz[ bƒ ]azepine-5-propanamine,10,11-dihydro- N -methyl-, monohydrochloride. Chemical Structure
How Supplied
HOW SUPPLIED 10 mg white to off-white, round “film coated” tablets debossed CP on one side and 10 on the other side Bottles of 100 (NDC 64720-415-10) 25 mg white to off-white, round “film coated” tablets debossed CP over 25 on one side and plain on the other side Bottles of 100 (NDC 64720-416-10) 50 mg white to off-white, round “film coated” tablets debossed CP over 50 on one side and plain on the other side Bottles of 100 (NDC 64720-417-10) 75 mg white to off-white, round “film coated” tablets debossed CP over 75 on one side and plain on the other side Bottles of 100 (NDC 64720-418-10) 100 mg white to off-white, round “film coated” tablets debossed CP over 100 on one side and plain on the other side Bottles of 100 (NDC 64720-419-10) 150 mg white to off-white, round “film coated” tablets debossed CP over 150 on one side and plain on the other side Bottles of 50 (NDC 64720-420-05) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from excessive heat. Dispense in tight container.
Indications & Usage
INDICATIONS AND USAGE Desipramine hydrochloride tablets, USP are indicated for the treatment of depression.
Dosage and Administration
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 desipramine hydrochloride tablets 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 desipramine hydrochloride tablets. Conversely, at least 14 days should be allowed after stopping desipramine hydrochloride tablets before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS ). Use of Desipramine Hydrochloride Tablets with Other MAOI’s, Such as Linezolid or Methylene Blue: Do not start desipramine hydrochloride tablets 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 desipramine hydrochloride tablets 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, desipramine hydrochloride tablets 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 desipramine hydrochloride tablets 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 desipramine hydrochloride tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS ).