Overview
Hydroxyzine is a first-generation histamine H-receptor antagonist of the dephenylmethane and piperazine classes that exhibits sedative, anxiolytic, and antiemetic properties. It was first developed in 1955, and has since remained a relatively common treatment for allergic conditions such as pruritus, urticaria, dermatoses, and histamine-mediated pruritus. The active metabolite of hydroxyzine, cetirizine, is also available as an active ingredient in allergic medications, and is responsible for much of its hydroxyzine's antihistaminic effect. Hydroxyzine is also used for generalized anxiety disorder, tension caused by psychoneurosis, and other conditions with manifestations of anxiety.
Background
Hydroxyzine is a first-generation histamine H-receptor antagonist of the dephenylmethane and piperazine classes that exhibits sedative, anxiolytic, and antiemetic properties. It was first developed in 1955, and has since remained a relatively common treatment for allergic conditions such as pruritus, urticaria, dermatoses, and histamine-mediated pruritus. The active metabolite of hydroxyzine, cetirizine, is also available as an active ingredient in allergic medications, and is responsible for much of its hydroxyzine's antihistaminic effect. Hydroxyzine is also used for generalized anxiety disorder, tension caused by psychoneurosis, and other conditions with manifestations of anxiety.
Indication
Hydroxyzine is indicated for the symptomatic relief of anxiety and tension associated with psychoneuroses, and as an adjunct in organic disease states in which anxiety is manifested. It is also indicated in the treatment of histamine-mediated pruritus and pruritus due to allergic conditions such as chronic urticaria. Canadian labeling states that hydroxyzine is also indicated in adults and children as a premedication prior to medical procedures, such as dental surgery. It is also used in the control of nausea and vomiting, excluding nausea and vomiting of pregnancy.
Associated Conditions
- Anxiety
- Nausea and vomiting
- Pruritus
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/22 | Phase 2 | Not yet recruiting | The University of Texas Health Science Center, Houston | ||
2023/02/21 | Phase 4 | Not yet recruiting | |||
2023/01/11 | Phase 1 | Recruiting | Minia University | ||
2022/08/09 | Not Applicable | Completed | |||
2022/02/04 | Not Applicable | UNKNOWN | |||
2019/12/05 | Phase 4 | Completed | |||
2019/12/03 | Phase 4 | UNKNOWN | Istanbul Medeniyet University | ||
2019/08/28 | Phase 4 | Completed | |||
2019/01/18 | Phase 3 | UNKNOWN | |||
2019/01/16 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-501 | ORAL | 25 mg in 1 1 | 3/9/2022 | |
| Caraco Pharmaceutical Laboratories, Ltd. | 57664-112 | ORAL | 10 mg in 1 1 | 2/4/2010 | |
| ATLANTIC BIOLOGICALS CORP. | 17856-0507 | ORAL | 10 mg in 5 mL | 12/1/2022 | |
| Proficient Rx LP | 71205-155 | ORAL | 25 mg in 1 1 | 2/1/2023 | |
| State of Florida DOH Central Pharmacy | 53808-0632 | ORAL | 50 mg in 1 1 | 9/11/2013 | |
| PD-Rx Pharmaceuticals, Inc. | 43063-943 | ORAL | 10 mg in 1 1 | 4/27/2023 | |
| Pharmaceutical Associates, Inc. | 0121-4822 | ORAL | 10 mg in 5 mL | 3/9/2015 | |
| PD-Rx Pharmaceuticals, Inc. | 72789-216 | ORAL | 25 mg in 1 1 | 8/17/2023 | |
| REMEDYREPACK INC. | 70518-3574 | ORAL | 50 mg in 1 1 | 1/15/2024 | |
| KVK-Tech, Inc. | 10702-012 | ORAL | 50 mg in 1 1 | 1/4/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| HYDROXYZINE MEVON FILM-COATED TABLETS 10 MG | SIN16329P | TABLET, FILM COATED | 10.000 mg | 9/21/2021 | |
| HIZIN TABLET 10 mg | SIN03423P | TABLET | 10 mg | 6/16/1989 | |
| HYDROXYZINE MEVON FILM-COATED TABLETS 25 MG | SIN16328P | TABLET, FILM COATED | 25.000 mg | 9/21/2021 | |
| HIZIN 25 TABLET 25 mg | SIN03422P | TABLET | 25 mg | 6/16/1989 | |
| AA PHARMA HYDROXYZINE CAPSULE 10 mg | SIN04096P | CAPSULE | 10 mg | 3/7/1990 | |
| AA PHARMA HYDROXYZINE CAPSULE 25 mg | SIN04142P | CAPSULE, LIQUID FILLED | 25 mg | 4/20/1990 | |
| PHYMORAX TABLET 10 mg | SIN09981P | TABLET | 10 mg | 9/8/1998 | |
| HIZIN LIQUID 10 mg/5 ml | SIN03569P | SOLUTION | 10 mg/5 ml | 7/4/1989 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| 盐酸羟嗪片 | 国药准字H31021426 | 化学药品 | 片剂(糖衣) | 1/10/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| APO-HYDROXYZINE CAP 10MG | N/A | hind wing co ltd | N/A | N/A | 1/3/1996 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||