Baclofen

Baclofen

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Questions & Answers

Side Effects & Adverse Reactions

a. Abrupt Drug Withdrawal: Hallucinations and seizures have occurred on abrupt withdrawal of baclofen. Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued.

b. Impaired Renal Function: Because baclofen is primarily excreted unchanged through the kidneys, it should be given with caution, and it may be necessary to reduce the dosage.

c. Stroke: Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug.

d. Pregnancy: Baclofen has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times the maximum dose recommended for human use, at a dose which caused significant reductions in food intake and weight gain in dams. This abnormality was not seen in mice or rabbits.

There was also an increased incidence of incomplete sternebral ossification in fetuses of rats given approximately 13 times the maximum recommended human dose, and an increased incidence of unossified phalangeal nuclei of forelimbs and hindlimbs in fetuses of rabbits given approximately 7 times the maximum recommended human dose. In mice, no teratogenic effects were observed, although reductions in mean fetal weight with consequent delays in skeletal ossification were present when dams were given 17 and 34 times the human daily dose. There are no studies in pregnant women. Baclofen should be used during pregnancy only if the benefit clearly justifies the potential risk to the fetus.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Baclofen is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.

Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function.

Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.

History

There is currently no drug history available for this drug.

Other Information

Baclofen USP is a muscle relaxant and antispastic.

Its chemical name is 4-amino-3-(-4-chlorophenyl)-butanoic acid. The structural formula is:

Chemical Structure

Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform.

Each tablet, for oral administration, contains 10 mg or 20 mg baclofen. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate.

Baclofen Manufacturers


  • Major Pharmaceuticals
    Baclofen Tablet [Major Pharmaceuticals]
  • Remedyrepack Inc.
    Baclofen Tablet [Remedyrepack Inc. ]
  • Marlex Pharmaceuticals Inc
    Baclofen Tablet [Marlex Pharmaceuticals Inc]
  • Cardinal Health
    Baclofen Tablet [Cardinal Health]
  • Remedyrepack Inc.
    Baclofen Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Baclofen Tablet [Remedyrepack Inc. ]
  • American Health Packaging
    Baclofen Tablet [American Health Packaging]
  • Blenheim Pharmacal, Inc.
    Baclofen Tablet [Blenheim Pharmacal, Inc.]
  • Direct Rx
    Baclofen Tablet [Direct Rx]
  • Direct Rx
    Baclofen Tablet [Direct Rx]
  • Proficient Rx Lp
    Baclofen Tablet [Proficient Rx Lp]
  • Preferred Pharmaceuticals, Inc.
    Baclofen Tablet [Preferred Pharmaceuticals, Inc.]
  • Caraco Pharmaceutical Laboratories, Ltd.
    Baclofen (Baclofen) Tablet [Caraco Pharmaceutical Laboratories, Ltd.]
  • Alphapharm Pty Ltd
    Baclofen Tablet [Alphapharm Pty Ltd]
  • Rebel Distributors Corp.
    Baclofen Tablet [Rebel Distributors Corp.]
  • Stat Rx Usa Llc
    Baclofen Tablet [Stat Rx Usa Llc]
  • Med Health Pharma, Llc
    Baclofen Tablet [Med Health Pharma, Llc]
  • Remedyrepack Inc.
    Baclofen Tablet [Remedyrepack Inc. ]
  • American Health Packaging
    Baclofen Tablet [American Health Packaging]
  • Bryant Ranch Rrepack
    Baclofen Tablet [Bryant Ranch Rrepack]
  • Pd-rx Pharmaceuticals, Inc.
    Baclofen Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Remedyrepack Inc.
    Baclofen Tablet [Remedyrepack Inc. ]
  • Pd-rx Pharmaceuticals, Inc.
    Baclofen Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Lake Erie Medical Dba Quality Care Products Llc
    Baclofen Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • Lake Erie Medical Dba Quality Care Products Llc
    Baclofen Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • H.j. Harkins Company, Inc.
    Baclofen Tablet [H.j. Harkins Company, Inc.]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Baclofen Tablet [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Remedyrepack Inc.
    Baclofen Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Baclofen Tablet [Remedyrepack Inc. ]
  • Rebel Distributors Corp
    Baclofen Tablet [Rebel Distributors Corp]
  • Mckesson Contract Packaging
    Baclofen Tablet [Mckesson Contract Packaging]
  • Unit Dose Services
    Baclofen Tablet [Unit Dose Services]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Baclofen Tablet [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • American Health Packaging
    Baclofen Tablet [American Health Packaging]
  • Remedyrepack Inc.
    Baclofen Tablet [Remedyrepack Inc. ]
  • Preferred Pharmaceuticals, Inc
    Baclofen Tablet [Preferred Pharmaceuticals, Inc]
  • Qualitest Pharmaceuticals
    Baclofen Tablet [Qualitest Pharmaceuticals]
  • Cardinal Health
    Baclofen Tablet [Cardinal Health]
  • Preferred Pharmaceuticals, Inc
    Baclofen Tablet [Preferred Pharmaceuticals, Inc]
  • Dispensing Solutions, Inc.
    Baclofen Tablet [Dispensing Solutions, Inc.]
  • Ivax Pharmaceuticals, Inc.
    Baclofen Tablet [Ivax Pharmaceuticals, Inc.]
  • Major Pharmaceuticals
    Baclofen Tablet [Major Pharmaceuticals]
  • Northstar Rxllc
    Baclofen Tablet [Northstar Rxllc]
  • New Horizon Rx Group, Llc
    Baclofen Tablet [New Horizon Rx Group, Llc]
  • Aidarex Pharmaceuticals Llc
    Baclofen Tablet [Aidarex Pharmaceuticals Llc]
  • Remedyrepack Inc.
    Baclofen Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Baclofen Tablet [Remedyrepack Inc. ]
  • Physicians Total Care, Inc.
    Baclofen Tablet [Physicians Total Care, Inc.]
  • Direct Rx
    Baclofen Tablet [Direct Rx]
  • Unit Dose Services
    Baclofen Tablet [Unit Dose Services]
  • Mckesson Packaging Services A Business Unit Of Mckesson Corporation
    Baclofen Tablet [Mckesson Packaging Services A Business Unit Of Mckesson Corporation]
  • St Marys Medical Park Pharmacy
    Baclofen Tablet [St Marys Medical Park Pharmacy]
  • Lannett Company, Inc.
    Baclofen Tablet [Lannett Company, Inc.]
  • Mylan Pharmaceuticals Inc.
    Baclofen Tablet [Mylan Pharmaceuticals Inc.]
  • Upsher-smith Laboratories, Inc.
    Baclofen Tablet [Upsher-smith Laboratories, Inc.]
  • Preferred Pharmaceuticals, Inc.
    Baclofen Tablet [Preferred Pharmaceuticals, Inc.]
  • Avkare, Inc.
    Baclofen (Baclofen) Tablet [Avkare, Inc.]
  • Clinical Solutions Wholesale
    Baclofen Tablet [Clinical Solutions Wholesale]
  • St Marys Medical Park Pharmacy
    Baclofen Tablet [St Marys Medical Park Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Baclofen Tablet [State Of Florida Doh Central Pharmacy]
  • Proficient Rx Lp
    Baclofen Tablet [Proficient Rx Lp]
  • Mckesson Packaging Services A Business Unit Of Mckesson Corporation
    Baclofen Tablet [Mckesson Packaging Services A Business Unit Of Mckesson Corporation]
  • Clinical Solutions Wholesale, Llc
    Baclofen Tablet [Clinical Solutions Wholesale, Llc]

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