Baclofen
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
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Overview
Baclofen is a skeletal muscle relaxants, spasmolytic that is FDA approved for the treatment of spasticity. Common adverse reactions include Cardiovascular: Hypotension (0% to 9% ), Gastrointestinal: Constipation (intrathecal bolus, 0.2%; intrathecal titration, 1.5%; intrathecal maintenance, 5.1% ; oral, 2% to 6% ), Nausea (oral, 4% to 12% ), Vomiting (intrathecal bolus, 6.2%; intrathecal titration, 8.5%; intrathecal maintenance, 4% ), Musculoskeletal: Poor muscle tone (intrathecal bolus, 2.4% to 5.4%; intrathecal titration, 13.5% to 14.4%; intrathecal maintenance, 25.3% to 34.7% ), Neurologic: Asthenia (0.7% to 15% ), Dizziness (intrathecal bolus, 1.7% to 2.4%; intrathecal titration, 1.9% to 2.6%; intrathecal maintenance, 7.9% to 8% ; oral, 5% to 15% ), Headache (intrathecal bolus, 1.6% to 6.6%; intrathecal titration, 2.5% to 7.8%; intrathecal maintenance, 5.1% to 10.7% ; oral, 4% to 8% ), Somnolence (intrathecal bolus, 5.7% to 7.6%; intrathecal titration, 5.9% to 10.5%; intrathecal maintenance, 18.7% to 20.9% ; oral, 10% to 63% ), Renal: Urinary complication (2% to 6% ), Other: Fatigue (2% to 4% ), Shivering (0.5% to 1.3% ).
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Baclofen FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Baclofen in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Baclofen in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Baclofen FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Baclofen in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Baclofen in pediatric patients.
Contraindications
Hypersensitivity to baclofen.
Warnings
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.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Baclofen Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Baclofen Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Baclofen Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Baclofen in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Baclofen in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Baclofen during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Baclofen in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Baclofen in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Baclofen in geriatric settings.
Gender
There is no FDA guidance on the use of Baclofen with respect to specific gender populations.
Race
There is no FDA guidance on the use of Baclofen with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Baclofen in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Baclofen in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Baclofen in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Baclofen in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Baclofen Administration in the drug label.
Monitoring
There is limited information regarding Baclofen Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Baclofen and IV administrations.
Overdosage
There is limited information regarding Baclofen overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Baclofen Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Baclofen Mechanism of Action in the drug label.
Structure
There is limited information regarding Baclofen Structure in the drug label.
Pharmacodynamics
There is limited information regarding Baclofen Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Baclofen Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Baclofen Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Baclofen Clinical Studies in the drug label.
How Supplied
There is limited information regarding Baclofen How Supplied in the drug label.
Storage
There is limited information regarding Baclofen Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Baclofen Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Baclofen interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Baclofen Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Baclofen Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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Pill Images
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