Desipramine Hydrochloride 75 mg/1
Desipramine Hydrochloride · TABLET · Chartwell RX, LLC
Desipramine Hydrochloride is a tablet containing desipramine hydrochloride at 75 mg/1, taken oral. Manufactured by Chartwell RX, LLC.
Key Facts
- Brand Name
- Desipramine Hydrochloride
- Generic Name
- Desipramine Hydrochloride
- NDC Code (Product)
62135-597- Manufacturer
- Chartwell RX, LLC
- Strength
- 75 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA207433
- Marketing Start
- 11/01/2016
Recall History
Heritage Pharmaceuticals Inc
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Heritage Pharmaceuticals Inc
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Heritage Pharmaceuticals Inc
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Heritage Pharmaceuticals Inc
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Heritage Pharmaceuticals Inc
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Heritage Pharmaceuticals Inc
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 10 other brand versions of Desipramine Hydrochloride.
What is the NDC code for Desipramine Hydrochloride 75 mg/1?
The NDC (National Drug Code) for Desipramine Hydrochloride 75 mg/1 is 62135-597, listed by Chartwell RX, LLC.
Other Desipramine Hydrochloride Dosages
Other Desipramine Brands
See all →- Norpramin100 mg/130698-020
- DESIPRAMINE HYDROCHLORIDE50 mg/162332-317
- DESIPRAMINE HYDROCHLORIDE10 mg/123155-578
- DESIPRAMINE HYDROCHLORIDE100 mg/146708-319
- DESIPRAMINE HYDROCHLORIDE75 mg/150742-115
- DESIPRAMINE HYDROCHLORIDE100 mg/162332-319
- DESIPRAMINE HYDROCHLORIDE150 mg/162332-320
- DESIPRAMINE HYDROCHLORIDE10 mg/146708-315
- DESIPRAMINE HYDROCHLORIDE10 mg/162332-315
- DESIPRAMINE HYDROCHLORIDE75 mg/162332-318
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)