HYDROXYZINE PAMOATE
Hydroxyzine pamoate is indicated for the symptomatic relief of anxiety and tension associated with psychoneurosis or as an adjunct in organic disease states where anxiety manifests. It is also indicated for the management of pruritus due to allergic conditions, including chronic urticaria, atopic and contact dermatoses, and histamine-mediated pruritus. Additionally, it is used as a sedative for premedication and following general anesthesia. The effectiveness of hydroxyzine for long-term use (exceeding 4 months) has not been systematically evaluated; therefore, its usefulness should be reassessed periodically for individual patients.
How HYDROXYZINE PAMOATE Works
Hydroxyzine is a first-generation antihistamine that acts as a potent H1-receptor inverse agonist. Its anxiolytic and sedative properties are attributed to its activity in the subcortical regions of the central nervous system, specifically the limbic system and reticular formation, rather than the cerebral cortex. Unlike many other anxiolytics, it does not possess affinity for GABA receptors. Additionally, hydroxyzine exhibits antagonistic effects at 5-HT2A, D2, and α1-adrenergic receptors, which may contribute to its clinical profile. It also possesses anticholinergic and antiemetic properties.
Details
- Status
- Prescription
- First Approved
- 1981-12-14
- Routes
- ORAL
- Dosage Forms
- CAPSULE
Companies
HYDROXYZINE PAMOATE Approval History
What HYDROXYZINE PAMOATE Treats
6 indicationsHYDROXYZINE PAMOATE is approved for 6 conditions since its original approval in 1981. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anxiety
- Psychoneurosis
- Pruritus
- Urticaria
- Atopic Dermatitis
- Contact Dermatitis
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Trial Timeline
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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.
HYDROXYZINE PAMOATE FDA Label Details
ProIndications & Usage
INDICATIONS For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine (Demerol ® ) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloi...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.