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Asendin

Generic Name: Amoxapine
Drug Category: Tetracyclic Antidepressant
Litigation Alert Level: Low
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 16 weeks.

Approved Uses

Indicated for the relief of symptoms of depression in patients with neurotic or reactive depressive disorders as well as endogenous and psychotic depressions. It is indicated for depression accompanied by anxiety or agitation.

Amoxapine is not approved for use in treating bipolar 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.

Amoxapine should not be given concomitantly with monoamine oxidase inhibitors. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressants and monoamine oxidase inhibitors simultaneously. When it is desired to replace a monoamine oxidase inhibitor with amoxapine, a minimum of 14 days should be allowed to elapse after the former is discontinued. Amoxapine should then be initiated cautiously with gradual increase in dosage until optimum response is achieved.

Amoxapine is not recommended for use during the acute recovery phase following myocardial infarction.

Amoxapine may enhance the response to alcohol and the effects of barbiturates and other CNS depressants.

Amoxapine should be used with caution in patients with a history of urinary retention, angle-closure glaucoma, or increased intraocular pressure. Patients with cardiovascular disorders should be watched closely. Tricyclic antidepressant drugs, particularly when given in high doses, can induce sinus tachycardia, changes in conduction time, and arrhythmias. Myocardial infarction and stroke have been reported with drugs of this class.

Extreme caution should be used in treating patients with a history of convulsive disorder or those with overt or latent seizure disorders.

Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with neuroleptic (i.e., antipsychotic) drugs. (Amoxapine is not an antipsychotic, but it has substantive neuroleptic activity).

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs and with amoxapine.

Paralytic ileus may occur in patients taking tricyclic antidepressants in combination with anticholinergic drugs.

Serum levels of several tricyclic antidepressants have been reported to be significantly increased when cimetidine is administered concurrently.

There are no adequate and well-controlled studies in pregnant women. Animal studies: pancreatic adenocarcinoma.

Amoxapine, like many other systemic drugs, is excreted in human milk. Because effects of the drug on infants are unknown, caution should be exercised when amoxapine is administered to nursing women.

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Off-label Uses

• Out-patient dosage greater than 400 mg daily. GoToSource

• Use in patients under the age of 18. GoToSource

• Schizophrenia. GoToSource

• Reduce diarrhea associated with chemotherapy. GoToSource

• Inhibitor of P-gp. GoToSource

• Irritable bowel syndrome. GoToSource

Adverse Events

Tardive dystonia and dyskinesia (uncontrolled or involuntary movements). GoToSource

Acute respiratory distress with pulmonary infiltrates. GoToSource

Seizures. GoToSource

Neuroleptic malignant syndrome (life-threatening reaction to antipsychotic drugs). GoToSource

Acute renal failure and rhabdomyolysis (rapid breakdown of damaged or injured skeletal muscle). GoToSource   

Suicidal thoughts and behavior. GoToSource

Acute generalized exanthematous pustulosis (allergic skin reaction). GoToSource

Cognitive impairment. GoToSource

Agranulocytosis (decreased number of granulocytes a type of white blood cell). GoToSource

Litigation

No major injury lawsuits reported. 

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Site Last Updated April 24, 2024