Drugplain

DESIPRAMINE HYDROCHLORIDE 10 mg/1

desipramine hydrochloride · TABLET · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

No Recall HistoryCurrently in Shortage
Plain English

DESIPRAMINE HYDROCHLORIDE is a tablet containing desipramine hydrochloride at 10 mg/1, taken oral. Manufactured by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc..

Key Facts

Brand Name
DESIPRAMINE HYDROCHLORIDE
Generic Name
desipramine hydrochloride
NDC Code (Product)
23155-578
Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Strength
10 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA207433
Marketing Start
11/01/2016

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective126 reports
fatigue119 reports
completed suicide116 reports
nausea77 reports
headache71 reports
weight increased69 reports
dizziness63 reports
off label use61 reports
arthralgia60 reports
pain60 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Desipramine hydrochloride tablets is indicated for the treatment of depression.

Dosage & 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 is prolongation of the QRS or QT intervals on the …

Warnings

WARNINGS Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long- standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (selective serotonin reuptake inhibitors [SSRIs] and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants c…

Contraindications

CONTRAINDICATIONS The use of MAOIs intended to treat psychiatric disorders with desipramine hydrochloride or within 14 days of stopping treatment with desipramine hydrochloride is contraindicated because of an increased risk of serotonin syndrome. The use of desipramine hydrochloride within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated ( see WARNINGS and DOSAGE AND ADMINISTRATION ). Starting desipramine hydrochloride in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE AND ADMINISTRATION ). Desipramine hydrochloride is contraindicated in the acute recovery period following myocardial infarction. It should not be used in those who have shown prior hypersensitivity to the drug. Cross-sensitivity between this and other dibenzazepines is a possibility.

Adverse Reactions

ADVERSE REACTIONS Included in the following listing are a few adverse reactions that have not been reported with this specific drug. However, the pharmacologic similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when desipramine hydrochloride is given. Cardiovascular: Hypotension, hypertension, palpitations, heart block, myocardial infarction, stroke, arrhythmias, premature ventricular contractions, tachycardia, ventricular tachycardia, ventricular fibrillation, sudden death There has been a report of an "acute collapse" and "sudden death" in an 8-year-old (18 kg) male, treated for 2 years for hyperactivity. There have been additional reports of sudden death in children ( See PRECAUTIONS- Pediatric Use ) Psychiatric: Confusional states (especially in the elderly) with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia and nightmares; hypomania; exacerbation of psychosis Neurologic: Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures; alterations in EEG patterns; tinnitus . Symptoms attributed to Neuroleptic Mali…

Frequently Asked Questions

What is DESIPRAMINE HYDROCHLORIDE used for?

DESIPRAMINE HYDROCHLORIDE contains desipramine hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.

Is DESIPRAMINE HYDROCHLORIDE a controlled substance?

DESIPRAMINE HYDROCHLORIDE is not classified as a controlled substance by the DEA.

What is the generic name for DESIPRAMINE HYDROCHLORIDE?

The generic name for DESIPRAMINE HYDROCHLORIDE is desipramine hydrochloride. There are 3 other brand versions of desipramine hydrochloride.

What is the NDC code for DESIPRAMINE HYDROCHLORIDE 10 mg/1?

The NDC (National Drug Code) for DESIPRAMINE HYDROCHLORIDE 10 mg/1 is 23155-578, listed by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc..

Product NDC

23155-578

Package NDC

23155-578-01

Other Desipramine Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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