IMIPRAMINE PAMOATE
Imipramine pamoate is indicated for the symptomatic relief of depression. The medication is specifically noted to be more effective in treating endogenous depression compared to other depressive states. Patients typically require a treatment period of one to three weeks before the optimal therapeutic effects of the drug become evident.
How IMIPRAMINE PAMOATE Works
Imipramine is a tricyclic antidepressant (TCA) that primarily functions by inhibiting the presynaptic reuptake of norepinephrine and serotonin (5-HT) in the central nervous system. By increasing the synaptic concentration of these neurotransmitters, it facilitates downstream signaling associated with mood regulation. Additionally, imipramine exhibits antagonistic effects at muscarinic acetylcholine receptors, histaminergic (H1) receptors, and alpha-1 adrenergic receptors, which contribute to its side effect profile.
Details
- Status
- Prescription
- First Approved
- 2010-04-16
- Routes
- ORAL
- Dosage Forms
- CAPSULE
IMIPRAMINE PAMOATE Approval History
What IMIPRAMINE PAMOATE Treats
1 indicationsIMIPRAMINE PAMOATE is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Depression
IMIPRAMINE PAMOATE Boxed Warning
Suicidality and Antidepressant Drugs 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. Anyone considering the use of imipramine pamoate or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suici...
Suicidality and Antidepressant Drugs 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. Anyone considering the use of imipramine pamoate or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. 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. Imipramine pamoate is not approved for use in pediatric patients (see WARNINGS: Clinical Worsening and Suicide Risk , PRECAUTIONS: Information for Patients , and PRECAUTIONS: Pediatric Use ).
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
IMIPRAMINE PAMOATE FDA Label Details
ProIndications & Usage
For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.
Suicidality and Antidepressant Drugs 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. Anyone considering the use ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.