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Baclofen

Generic Name
Baclofen
Brand Names
Fleqsuvy, Gablofen, Kemstro, Lioresal, Lyvispah, Ozobax
Drug Type
Small Molecule
Chemical Formula
C10H12ClNO2
CAS Number
1134-47-0
Unique Ingredient Identifier
H789N3FKE8

Overview

Baclofen is a gamma-aminobutyric acid (GABA) agonist used as a skeletal muscle relaxant. Although originally designed in 1962 to treat epilepsy, baclofen was not effective in treating this condition but instead was shown to reduce spasticity in selected patients. Baclofen was reintroduced in 1971 as a treatment for spasticity and was later approved by the FDA in 1977. Baclofen is used to manage severe muscle spasms of cerebral or spinal cord origins, including multiple sclerosis and traumatic brain injury. Baclofen was investigated for use in alcohol dependence and withdrawal; however, evidence is limited and there is inconsistent evidence to suggest its clinical efficacy in managing alcohol dependence or withdrawal symptoms.

Background

Baclofen is a gamma-aminobutyric acid (GABA) agonist used as a skeletal muscle relaxant. Although originally designed in 1962 to treat epilepsy, baclofen was not effective in treating this condition but instead was shown to reduce spasticity in selected patients. Baclofen was reintroduced in 1971 as a treatment for spasticity and was later approved by the FDA in 1977. Baclofen is used to manage severe muscle spasms of cerebral or spinal cord origins, including multiple sclerosis and traumatic brain injury. Baclofen was investigated for use in alcohol dependence and withdrawal; however, evidence is limited and there is inconsistent evidence to suggest its clinical efficacy in managing alcohol dependence or withdrawal symptoms.

Indication

Oral baclofen is indicated for the treatment of spasticity resulting from multiple sclerosis and is particularly useful for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. It may also be used to treat patients with spinal cord injuries and other spinal cord diseases. Baclofen should not be used to treat skeletal muscle spasms resulting from rheumatic disorders. Intrathecal baclofen is also indicated for the management of severe spasticity of the cerebral or spinal original in patients 4 years of age and older. It is reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable central nervous system side effects at effective doses. For use in spasticity due to traumatic brain injury, baclofen should be considered after at least one year of injury.

Associated Conditions

  • Alcohol Dependency
  • Severe Spasticity
  • Spasticity
  • Flexor spasm
  • Severe cerebral origin Spasticity
  • Severe spinal cord origin Spasticity

FDA Approved Products

BACLOFEN
Manufacturer:Quality Care Products, LLC
Route:ORAL
Strength:20 mg in 1 1
Approved: 2023/08/02
NDC:83008-018
Baclofen
Manufacturer:A-S Medication Solutions
Route:ORAL
Strength:10 mg in 1 1
Approved: 2022/01/07
NDC:50090-6149
Baclofen
Manufacturer:NuCare Pharmaceuticals, Inc.
Route:ORAL
Strength:20 mg in 1 1
Approved: 2023/07/12
NDC:68071-3001
Baclofen
Manufacturer:Marlex Pharmaceuticals, Inc.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2023/10/01
NDC:10135-781
Lyvispah
Manufacturer:Saol Therapeutics Inc
Route:ORAL
Strength:5 mg in 1 1
Approved: 2023/01/13
NDC:70257-412

Singapore Approved Products

LIORESAL 10 TABLET 10 mg
Manufacturer:NOVARTIS FARMA S P A
Form:TABLET
Strength:10 mg
Online:Yes
Approved: 1991/01/07
Approval:SIN05330P
COLMIFEN 10 TABLET 10 mg
Manufacturer:REMEDICA LTD
Form:TABLET
Strength:10 mg
Online:Yes
Approved: 1992/02/15
Approval:SIN06831P
APO-BACLOFEN TABLET 10 mg
Manufacturer:APOTEX INC
Form:TABLET
Strength:10 mg
Online:Yes
Approved: 1996/12/20
Approval:SIN09087P
PMS-BACLOFEN TABLET 10 mg
Manufacturer:Pharmascience Inc.
Form:TABLET
Strength:10 mg
Online:Yes
Approved: 1998/09/22
Approval:SIN10026P

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