Methocarbamol

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.

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
A Phase 3 Study of F14 for Management of Pain Following Total Knee Replacement	2022/11/03	NCT05603832	Phase 3	Active, not recruiting	Arthritis Innovation Corporation
Methocarbamol in Ventral and Inguinal HR	2022/05/24	NCT05388929	Phase 4	Active, not recruiting	Prisma Health-Upstate
Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure	2021/10/29	NCT05100017	Not Applicable	Recruiting	Northwestern University
Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures	2021/10/13	NCT05076110	Phase 4	Recruiting	Mayo Clinic
Japanese IP-TN Trial	2016/07/13	NCT02831569	Phase 3	Completed	Boehringer Ingelheim
Orphenadrine and Methocarbamol for LBP	2016/01/27	NCT02665286	Phase 4	Completed	Montefiore Medical Center
Methocarbamol in Treatment of Muscle Cramps in Cirrhotic Patients	2015/12/30	NCT02642874	Phase 3	UNKNOWN	Tanta University
Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients	2015/05/04	NCT02432456	Phase 4	Completed	Medical College of Wisconsin

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Methocarbamol	Golden State Medical Supply, Inc.	60429-119	ORAL	750 mg in 1 1	3/10/2022
METHOCARBAMOL	Central Packaging	80175-0534	ORAL	750 mg in 1 1	2/26/2021
ROBAXIN	Hikma Pharmaceuticals USA Inc.	0641-6103	INTRAMUSCULAR, INTRAVENOUS	100 mg in 1 mL	1/18/2024
Methocarbamol	Bryant Ranch Prepack	72162-1363	ORAL	500 mg in 1 1	2/5/2024
Methocarbamol	H.J. Harkins Company, Inc.	52959-167	ORAL	500 mg in 1 1	12/20/2011
Methocarbamol	Somerset Therapeutics, LLC	70069-101	INTRAMUSCULAR, INTRAVENOUS	100 mg in 1 mL	12/18/2023
Methocarbamol	PD-Rx Pharmaceuticals, Inc.	43063-903	ORAL	500 mg in 1 1	7/7/2023
METHOCARBAMOL	Direct_Rx	61919-903	ORAL	750 mg in 1 1	6/6/2023
Methocarbamol	Rebel Distributors Corp.	21695-078	ORAL	500 mg in 1 1	8/19/2009
Methocarbamol	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
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.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
MUSCLE RELAXANT AND ANALGESIC	technilab pharma inc.	02240476	Tablet - Oral	400 MG	1/17/2000
PMS-METHOCARBAMOL INJ 100MG/ML	Pharmascience Inc	00872865	Liquid - Intramuscular , Intravenous	100 MG / ML	12/31/1990
AXISAL-C1/8	technilab pharma inc.	02237997	Tablet - Oral	400 MG	N/A
ANALGESIC AND MUSCLE RELAXANT	Pharmascience Inc	02377462	Tablet - Oral	500 MG	3/20/2012
ROBAXACET	haleon canada ulc	02026805	Tablet - Oral	400 MG	12/31/1993
ROBAXISAL C 1/4	glaxosmithkline consumer healthcare ulc	01934783	Tablet - Oral	400 MG	12/31/1992
MUSCLE AND BACK PAIN RELIEF	teva canada limited	02237995	Tablet - Oral	400 MG	7/30/1999
MUSCLE AND BACK PAIN RELIEF EXTRA STRENGTH	pendopharm division of pharmascience inc	02239741	Tablet - Oral	400 MG	1/31/2000
MUSCLE AND BACK PAIN RELIEF WITH ASA	technilab pharma inc.	02238186	Tablet - Oral	400 MG	8/9/1999
ASPIRIN BACKACHE	Bayer Inc	02242028	Tablet - Oral	400 MG	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
MOLITREM 1500 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Neuraxpharm Spain S.L.	86606	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ROBAXISAL COMPUESTO 380 mg /300 mg COMPRIMIDOS	Faes Farma S.A.	47091	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
MOLITREM 750 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Neuraxpharm Spain S.L.	86621	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
DOLIROBAX 500 MG COMPRIMIDOS	Faes Farma S.A.	89466	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ROBAXIN 500 mg COMPRIMIDOS	Faes Farma S.A.	32899	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
MOLITREM 500 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Neuraxpharm Spain S.L.	86607	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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