Baclofen: Difference between revisions

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|indicationType=treatment
|indicationType=treatment
|indication=[[spasticity]]
|indication=[[spasticity]]
|adverseReactions=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% )
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)

Revision as of 03:42, 29 July 2014

Baclofen
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

Disclaimer

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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

There is limited information regarding Baclofen Contraindications in the drug label.

Warnings

There is limited information regarding Baclofen Warnings' in the drug label.

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

{{#ask: Page Name::Baclofen |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Baclofen |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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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