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Norpramin

Generic Name: Desipramine Hydrochloride
Drug Category: Tricyclic Antidepressant
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 2 years.

Approved Uses

Indicated for the treatment of depression.

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. 

Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.

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.

Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that NORPRAMIN is not approved for use in treating bipolar depression.

In patients who may use alcohol excessively, it should be borne in mind that the potentiation may increase the danger inherent in any suicide attempt or overdosage.

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.

Geriatric dose is 25 mg to 100 mg daily. In more severely ill patients, dosage may be further increased to 150 mg/day.

Extreme caution should be used when this drug is given to patients who have a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances; and that seizures precede cardiac dysrhythmias and death in some patients.

The use of MAOIs intended to treat psychiatric disorders with Norpramin or within 14 days of stopping treatment with Norpramin is contraindicated because of an increased risk of serotonin syndrome. The use of NORPRAMIN within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated.

Starting NORPRAMIN in a patient who is being treated with MAOIs such as linezolid of intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome.

NORPRAMIN is contraindicated in the acute recovery period following myocardial infarction.

The drug may cause exacerbation of psychosis in schizophrenic patients.

Both elevation and lowering of blood sugar levels have been reported.

The pupillary dilation that occurs following use of many antidepressant drugs including Norpramin may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

NORPRAMIN use in the elderly has been associated with a proneness to falling as well as confusional states.

The ratio of 2-hydroxydesipramine to desipramine may be increased in the elderly, most likely due to decreased renal elimination with aging.

The patient should be cautioned that this drug may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.

This drug should be discontinued as soon as possible prior to elective surgery because of possible cardiovascular effects. Hypertensive episodes have been observed during surgery in patients taking desipramine hydrochloride.

Extreme caution should be used when this drug is given in the following situations:

  • In patients with cardiovascular disease, because of the possibility of conduction defects, arrhythmias, tachycardias, strokes, and acute myocardial infarction
  • In patients who have a family history of sudden death, cardiac dysrhythmias, or cardiac conduction disturbances
  • In patients with a history of urinary retention or glaucoma, because of the anticholinergic properties of the drug
  • In patients with thyroid disease or those taking thyroid medication, because of the possibility of cardiovascular toxicity, including arrhythmias
  • In patients with a history of seizure disorder, because this drug has been shown to lower the seizure threshold. Seizures precede cardiac dysrhythmias and death in some patients

This drug is capable of blocking the antihypertensive effect of guanethidine and similarly acting compounds.

The development of a potentially life-threatening serotonin syndrome has been reported with serotonin norepinephrine reuptake inhibitors (SNRIs) and SSRIs, including NORPRAMIN, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type ΙC antiarrhythmics propafenone and  flecainide). While all the SSRIs, e.g., fluoxetine, sertraline, paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition.

Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from cotherapy, an increased dose of tricyclic antidepressant may be required.

If NORPRAMIN is to be combined with other psychotropic agents such as tranquilizers or sedative/hypnotics, careful consideration should be given to the pharmacology of the agents employed since the sedative effects of NORPRAMIN and benzodiazepines (e.g., chlordiazepoxide or diazepam) are additive.

Safe use of NORPRAMIN during pregnancy and lactation has not been established. 

GoToSource

Off-label Uses

• Dosage greater than 300 mg per day. GoToSource

• Geriatric dosage greater than 150 mg per day. GoToSource

• Use in patients under the age of 18. GoToSource

• Irritable bowel syndrome. GoToSource

• Vulvodynia. GoToSource

• Chronic pain including nerve pain from shingles and postherpetic neuralgia. GoToSource

• Conduct disorder, attention deficit hyperactivity disorder and oppositional defiant disorder. GoToSource

• Chronic tension-type headache. GoToSource

• Bulimia nervosa. GoToSource

• Panic disorder. GoToSource

• Post-traumatic stress disorder. GoToSource

• Primary depersonalization disorder. GoToSource 

• Minimal brain dysfunction. GoToSource

• Bedwetting. GoToSource

• Fibromyalgia, rheumatoid conditions and low back pain. GoToSource

• Smoking cessation. GoToSource

• Premenstrual syndrome. GoToSource

Adverse Events

Suicidal thinking and behavior (suicidality). GoToSource

Higher death rate compared to other tricyclic antidepressants. GoToSource 

Acrocyanosis (blueness of the hands and feet). GoToSource 

Painful ejaculation. GoToSource 

Increased risk of breast cancer. GoToSource 

Neuroleptic malignant syndrome (life-threatening neurological disorder). GoToSource

Seizures. GoToSource

Arrhythmias. GoToSource

Tachycardia (rapid heart rate) and sudden death. GoToSource

Orthostatic hypotension (fall in blood pressure when upright position is assumed), fractures, blurred vision, constipation, dry mouth, confusion, delirium, increased dementia risk, urinary retention, ocular crisis in patients with narrow-angle glaucoma, acute hepatitis (liver inflammation), bone marrow toxicity, sexual dysfunction, sedation, tremors and diaphoresis (excessive sweating). GoToSource

Discontinuation syndrome (insomnia, nausea, dizziness, gastrointestinal complaints, imbalance, sensory disturbances, and hyperarousal) and serotonin syndrome. GoToSource

Induction of mania and extrapyramidal symptoms (tardive dyskinesia, akathisia, myoclonus, rabbit syndrome and dystonia). GoToSource

Litigation

Lawsuits filed for death, cardiac dysrhythmias and seizures. 

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 29, 2024