Overview
Meclizine is a histamine H1 antagonist with antiemetic and antivertigo properties. It is used in the symptomatic treatment of motion sickness and control of vertigo associated with vestibular system diseases. It also exhibits anticholinergic, central nervous system depressant, and local anesthetic effects. Commonly marketed under the brand name Antivert in the U.S., meclizine is available as oral tablets.
Background
Meclizine is a histamine H1 antagonist with antiemetic and antivertigo properties. It is used in the symptomatic treatment of motion sickness and control of vertigo associated with vestibular system diseases. It also exhibits anticholinergic, central nervous system depressant, and local anesthetic effects. Commonly marketed under the brand name Antivert in the U.S., meclizine is available as oral tablets.
Indication
Indicated for the symptomatic treatment of nausea, vomiting, and dizziness associated with motion sickness, and management of vertigo due to various causes, including radiation sickness, Meniere’s syndrome, labyrinthitis and other vestibular disturbances.
Associated Conditions
- Motion Sickness
- Vertigo
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/09/25 | Phase 1 | UNKNOWN | |||
2020/07/23 | Phase 4 | UNKNOWN | Medical Corps, Israel Defense Force | ||
2017/09/01 | Phase 4 | UNKNOWN | Medical Corps, Israel Defense Force | ||
2017/08/17 | Phase 1 | Completed | Tannaz Armaghnay | ||
2015/12/09 | Not Applicable | Completed | |||
2014/04/14 | Phase 3 | Completed | Apsen Farmaceutica S.A. | ||
2012/02/23 | Phase 1 | Completed | |||
2011/09/30 | Phase 2 | Completed | |||
2008/03/24 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Proficient Rx LP | 71205-416 | ORAL | 12.5 mg in 1 1 | 1/1/2023 | |
| DOH CENTRAL PHARMACY | 53808-1116 | ORAL | 25 mg in 1 1 | 1/18/2019 | |
| Aurobindo Pharma Limited | 59651-808 | ORAL | 25 mg in 1 1 | 9/15/2023 | |
| St. Mary's Medical Park Pharmacy | 60760-087 | ORAL | 25 mg in 1 1 | 12/8/2022 | |
| Quality Care Products, LLC | 55700-919 | ORAL | 12.5 mg in 1 1 | 9/22/2021 | |
| Epic Pharma LLC | 42806-012 | ORAL | 12.5 mg in 1 1 | 8/21/2020 | |
| STAT Rx USA LLC | 16590-301 | ORAL | 12.5 mg in 1 1 | 9/20/2012 | |
| NuCare Pharmaceuticals,Inc. | 68071-2697 | ORAL | 25 mg in 1 1 | 9/8/2022 | |
| AvPAK | 50268-523 | ORAL | 25 mg in 1 1 | 10/26/2023 | |
| Bryant Ranch Prepack | 71335-1825 | ORAL | 25 mg in 1 1 | 1/17/2020 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||