Overview
Methocarbamol was developed in the early 1950s as a treatment for muscle spasticity and the associated pain. It is a guaiacol glyceryl ether. Methocarbamol tablets and intramuscular injections are prescription medicines indicated in the United States as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. In Canada, methocarbamol can be sold as an over the counter oral medicine at a lower dose that may be combined with acetaminophen or ibuprofen. A combination product with acetylsalicylic acid and codeine is available in Canada by prescription. Methocarbamol was FDA approved on 16 July 1957.
Background
Methocarbamol was developed in the early 1950s as a treatment for muscle spasticity and the associated pain. It is a guaiacol glyceryl ether. Methocarbamol tablets and intramuscular injections are prescription medicines indicated in the United States as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. In Canada, methocarbamol can be sold as an over the counter oral medicine at a lower dose that may be combined with acetaminophen or ibuprofen. A combination product with acetylsalicylic acid and codeine is available in Canada by prescription. Methocarbamol was FDA approved on 16 July 1957.
Indication
Methocarbamol tablets and intramuscular injections are indicated in the United States as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. Oral methocarbamol in America may be given up to 1500mg 4 times daily for 2-3 days. In Canada, methocarbamol containing oral formulations are sold over the counter for pain associated with muscle spasm. However, if these combination formulations include codeine, they are prescription only.
Associated Conditions
- Discomfort
- Gout
- Muscle Spasms
- Myalgia
- Pain
- Rheumatism
- Tetanus
- Articular inflammation
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/11/03 | Phase 3 | Active, not recruiting | |||
2022/05/24 | Phase 4 | Active, not recruiting | |||
2021/10/29 | Not Applicable | Recruiting | |||
2021/10/13 | Phase 4 | Recruiting | |||
2016/07/13 | Phase 3 | Completed | |||
2016/01/27 | Phase 4 | Completed | |||
2015/12/30 | Phase 3 | UNKNOWN | |||
2015/05/04 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Golden State Medical Supply, Inc. | 60429-119 | ORAL | 750 mg in 1 1 | 3/10/2022 | |
| Central Packaging | 80175-0534 | ORAL | 750 mg in 1 1 | 2/26/2021 | |
| Hikma Pharmaceuticals USA Inc. | 0641-6103 | INTRAMUSCULAR, INTRAVENOUS | 100 mg in 1 mL | 1/18/2024 | |
| Bryant Ranch Prepack | 72162-1363 | ORAL | 500 mg in 1 1 | 2/5/2024 | |
| H.J. Harkins Company, Inc. | 52959-167 | ORAL | 500 mg in 1 1 | 12/20/2011 | |
| Somerset Therapeutics, LLC | 70069-101 | INTRAMUSCULAR, INTRAVENOUS | 100 mg in 1 mL | 12/18/2023 | |
| PD-Rx Pharmaceuticals, Inc. | 43063-903 | ORAL | 500 mg in 1 1 | 7/7/2023 | |
| Direct_Rx | 61919-903 | ORAL | 750 mg in 1 1 | 6/6/2023 | |
| Rebel Distributors Corp. | 21695-078 | ORAL | 500 mg in 1 1 | 8/19/2009 | |
| Bryant Ranch Prepack | 72162-1929 | ORAL | 500 mg in 1 1 | 2/5/2024 |
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 |
|---|---|---|---|---|---|
| Methocarbamol Dispersible Tablets | 国药准字H20080273 | 化学药品 | 片剂 | 3/12/2018 | |
| Methocarbamol Injection | 国药准字H20253529 | 化学药品 | 注射剂 | 3/4/2025 | |
| Methocarbamol Injection | 国药准字H20253879 | 化学药品 | 注射剂 | 4/15/2025 | |
| Methocarbamol Injection | 国药准字H20253875 | 化学药品 | 注射剂 | 4/15/2025 | |
| Methocarbamol Injection | 国药准字H20253880 | 化学药品 | 注射剂 | 4/15/2025 | |
| Methocarbamol Injection | 国药准字H20253181 | 化学药品 | 注射剂 | 1/14/2025 | |
| Methocarbamol Injection | 国药准字H50021638 | 化学药品 | 注射剂 | 9/30/2020 | |
| Methocarbamol Injection | 国药准字H32025725 | 化学药品 | 注射剂 | 11/21/2022 | |
| Methocarbamol Injection | 国药准字HJ20240009 | 化学药品 | 注射剂 | 4/17/2024 | |
| Methocarbamol Injection | 国药准字H20244157 | 化学药品 | 注射剂 | 6/25/2024 |
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. | |||||