Overview
Dimehydrinate was first described in the literature in 1949, and patented in 1950. Early research into dimenhydrinate focused on its role as an antihistamine for urticaria; the treatment of motion sickness was an accidental discovery. Dimenhydrinate, also known as B-dimethylaminoethyl benzohydrol ether 8-chlorotheophyllinate, is indicated to prevent nausea, vomiting, and dizziness caused by motion sickness. Dimenhydrinate is a combination of Diphenhydramine and 8-chlorotheophylline in a salt form, with 53%-55.5% dried diphenhydramine, and 44%-47% died 8-chlorotheophylline. The antiemetic properties of dimenhydrinate are primarily thought to be produced by diphenhydramine's antagonism of H1 histamine receptors in the vestibular system while the excitatory effects are thought to be produced by 8-chlorotheophylline's adenosine receptor blockade. When used in large doses, dimenhydrinate has been shown to cause a "high" characterized by hallucinations, excitement, incoordination, and disorientation. Dimenhydrinate was granted FDA approval on 31 May 1972.
Indication
Dimenhydrinate is indicated for the prevention and treatment of nausea, vomiting, or vertigo of motion sickness.
Associated Conditions
- Dizziness
- Labyrinthine disorder
- Menière's Disease
- Morning Sickness
- Motion Sickness
- Nausea
- Nausea and vomiting
- Post Operative Nausea and Vomiting (PONV)
- Radiation-Induced Nausea and Vomiting
- Vertigo
- Vomiting
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/05/01 | Not Applicable | Not yet recruiting | Preeyaporn Jirakittidul | ||
2022/10/21 | Not Applicable | Completed | |||
2020/10/28 | Phase 3 | Recruiting | Jennifer Holder-Murray | ||
2014/10/01 | Phase 4 | Completed | |||
2014/04/14 | Phase 3 | Completed | Apsen Farmaceutica S.A. | ||
2013/07/01 | Phase 4 | Completed | |||
2012/03/05 | Phase 2 | Completed | |||
2008/11/17 | Not Applicable | Completed | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | ||
2005/07/28 | Phase 4 | Completed | St. Justine's Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Medtech Products Inc. | 63029-910 | ORAL | 25 mg in 1 1 | 5/6/2025 | |
| Fresenius Kabi USA, LLC | 63323-366 | INTRAMUSCULAR, INTRAVENOUS | 50 mg in 1 mL | 12/31/2019 | |
| Strategic Sourcing Services LLC | 70677-1087 | ORAL | 50 mg in 1 1 | 4/8/2025 |
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 |
|---|---|---|---|---|---|
| DIMENHYDRINATE TABLETS 50 mg | SIN02765P | TABLET | 50 mg | 5/9/1989 | |
| DIMENATE TABLET 50 mg | SIN03013P | TABLET | 50 mg | 6/1/1989 | |
| SW DIMENHYDRINATE SYRUP 15 mg/5 ml | SIN02790P | SYRUP | 15 mg/5 ml | 5/11/1989 | |
| APO-DIMENHYDRINATE TABLET 50 mg | SIN02519P | TABLET | 50 mg | 4/17/1989 | |
| NOVOMIN TABLET 50 mg | SIN03403P | TABLET | 50 mg | 6/16/1989 | |
| VOTMINE INJECTION 10 ML VIAL (50MG/ML) | SIN11495P | INJECTION | 50 mg/ml | 4/25/2001 | |
| MEDRINATE SYRUP 25 mg/5 ml | SIN07645P | SYRUP | 25 mg/5 ml | 1/10/1994 | |
| DIMENHYDRINATE TABLETS 50 mg | SIN02732P | TABLET | 50 mg | 5/6/1989 | |
| NOVOMIN SYRUP 15 mg/5 ml | SIN03550P | SYRUP | 15 mg/5 ml | 7/4/1989 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Dimenhydrinate Sustained Release Capsules | 国药准字H20090143 | 化学药品 | 胶囊剂 | 9/19/2023 | |
| Dimenhydrinate Buccal Tablets | 国药准字H20000481 | 化学药品 | 片剂 | 5/15/2020 | |
| Dimenhydrinate Buccal Tablets | 国药准字H20070019 | 化学药品 | 片剂 | 5/15/2020 | |
| Dimenhydrinate Tablets | 国药准字H37020069 | 化学药品 | 片剂 | 6/8/2020 | |
| Dimenhydrinate Tablets | 国药准字H31021283 | 化学药品 | 片剂 | 1/10/2020 | |
| Dimenhydrinate Tablets | 国药准字H19983186 | 化学药品 | 片剂 | 7/14/2020 | |
| Dimenhydrinate Tablets | 国药准字H45021214 | 化学药品 | 片剂 | 8/18/2020 | |
| Dimenhydrinate Tablets | 国药准字H37020232 | 化学药品 | 片剂 | 6/8/2020 | |
| Dimenhydrinate Tablets | 国药准字H12020935 | 化学药品 | 片剂 | 8/25/2020 | |
| Dimenhydrinate Tablets | 国药准字H13021480 | 化学药品 | 片剂 | 4/23/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| DIMENHYDRINATE SYR 15MG/5ML | N/A | N/A | N/A | 5/31/1984 | |
| AIRMIT TAB (TAIWAN) | N/A | N/A | N/A | 1/14/2011 | |
| DIMENHYDRINATE TAB 50MG | N/A | N/A | N/A | 5/5/1980 | |
| DIMENHYDRINATE SYRUP 15MG/5ML | N/A | synco (h.k.) limited | N/A | N/A | 6/10/1985 |
| TRIMIN TAB 50MG | N/A | N/A | N/A | 7/30/1988 | |
| UNI-HYDRIN TAB 50MG | N/A | N/A | N/A | 10/7/1991 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PHARMACY HEALTH TRAVEL SICKNESS TABLETS strip pack | 335591 | Medicine | A | 5/1/2020 | |
| DRAMAMINE dimenhydrinate 50mg tablet strip pack | 46980 | Proqualix Pty Ltd - in Administration | Medicine | A | 10/28/1993 |
| AMCAL TRAVEL SICKNESS TABLETS strip pack | 345907 | Medicine | A | 10/14/2020 | |
| TRAVACALM ORIGINAL tablet strip pack | 14864 | Medicine | A | 9/5/1991 | |
| ADIRAMEDICA TRAVEL SICKNESS TABLETS strip pack | 335590 | Medicine | A | 5/1/2020 | |
| TRAVELMED tablet blister pack | 490795 | Medicine | A | 6/4/2025 | |
| TRAVACALM ORIGINAL tablet blister pack | 78192 | Medicine | A | 4/18/2001 | |
| APOHEALTH TRAVEL SICKNESS TABLETS strip pack | 355903 | Medicine | A | 3/1/2021 | |
| BLOOMS THE CHEMIST TRAVEL SICKNESS TABLETS strip pack | 372732 | Medicine | A | 8/12/2021 | |
| CHEMISTS’ OWN TRAVEL SICKNESS TABLETS strip pack | 355893 | Medicine | A | 3/1/2021 |
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