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baclofen (Rx)Brand and Other Names:Lioresal, Gablofen

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 10mg
  • 20mg

intrathecal solution

  • 50mcg/mL
  • 500mcg/mL

intrathecal solution, preservative free

  • 500mcg/mL
  • 1000mcg/mL
  • 2000mcg/mL
more...

Spasticity

5 mg PO q8hr; may increase by 5 mg/dose q3Days to maximum 80 mg/day

Spasticity (Intrathecal Administration)

Screening phase

  • Test bolus: 50 mcg intrathecal by barbotage over <1 minute; if inadequate response within 8 hours, 75 mcg 24 hours later; if still inadequate, 100 mcg 24 hours later
  • Patients who do not respond to a 100 mcg intrathecal bolus should not be considered candidates for an implanted pump for chronic infusion

Titration (after initial 24 hr)

  • Initial implant dose: 2 times screening dose that gave positive effect (or screening dose if effect lasted >8 hr) administer over 24-hour period
  • Spasticity of spinal cord origin: Increase by 10-30% q24hr until desired clinical effect
  • Spasticity of cerebral origin: Increase by 5-15% q24hr until desired clinical effect

Maintenance

  • Spasticity of spinal cord origin: Increase by 10-40% or decrease by 10-20% during periodic pump refills; usual range 300-800 mcg/day (not to exceed 1000 mcg/day)
  • Spasticity of cerebral origin: Increase by 5-20% or decrease by 10-20% during periodic pump refills; usual range 90-700 mcg/day (not to exceed 1000 mcg/day)

Dosing considerations

  • Lioresal and Gablofen are administered chronically by the Medtronic SynchroMed II pump or other pumps labeled for IT use with these products

Dosage Modifications

Renal failure: Dose reduction may be necessary

Orphan Indications

Treatment of dystonia

Treatment of spasticity associated with cerebral palsy

Treatment of intractable spasticity associated with spinal cord injury or multiple sclerosis

Trigeminal neuralgia

Gablofen: Treatment of complex regional pain syndrome

Sponsors

  • Medtronic Neurological: 710 Medtronic Parkway NE; Minneapolis, MN 55432-5604
  • Osmotica Pharmaceutical Corp: 1205 Culbreth Drive, Suite 200; Wilmington, NC 28405
  • Mallinckrodt, Inc; 675 McDonnell Blvd; St. Louis, Missouri 63134

Dosage Forms & Strengths

tablet

  • 10mg
  • 20mg

intrathecal solution

  • 50mcg/mL
  • 500mcg/mL

intrathecal solution, preservative free

  • 500mcg/mL
  • 1000mcg/mL
  • 2000mcg/mL
more...

Spasticity

<2 years: 10-15 mg PO divided q8hr; increase dose q3Days by 5-15 mg/day; 40 mg/day maximum

Age 2-8 years: 10-15 mg/day PO divided q8hr; increase dose q3Days by 5-15 mg/day; 40 mg/day maximum

>8 years: 10-15 mg/day PO divided q8hr; increase dose q3Days by 5-15 mg/day; 60 mg/day maximum

Spasticity (Intrathecal Administration)

Screening phase

  • Test bolus: 50 mcg intrathecal by barbotage over 1 minute; if inadequate response within 8 hours, 75 mcg 24 hours later; if still inadequate, 100 mcg 24 hours later
  • May start with 25 mcg dose for small patients
  • Patients who do not respond to a 100 mcg intrathecal bolus should not be considered candidates for an implanted pump for chronic infusion

Titration (after initial 24 hr)

  • Initial implant dose: 2 times screening dose that gave positive effect (or screening dose if effect lasted >8 hr) administer over 24 hr period
  • After the first 24 hours, the daily dose should be increased slowly by 5-15% only once q24hr, until desired clinical effect is achieved

Maintenance

  • Maintenance dose: Same as adult with spasticity of cerebral origin (average dose usually lower than adult)
  • Increase by 5-20% or decrease by 10-20% during periodic pump refills
  • Average daily dose for patients <12 years was 274 mcg/day, with a range of 24-1199 mcg/day

Dosing considerations

  • <4 years: Safety and efficacy not established
  • Lioresal and Gablofen are administered chronically by the Medtronic SynchroMed II pump or other pumps labeled for IT use with these products

Spasticity With Cerebral Palsy (Orphan)

Intractable spasticity

Orphan indication sponsor

  • Osmotica Pharmaceutical Corp; 1205 Culbreth Drive, Suite 200; Wilmington, NC 28405
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Interactions

Interaction Checker

baclofen and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Drowsiness, transient (10-63%)

            Dizziness (5-15%)

            Nausea (4-12%)

            Confusion (1-11%)

            1-10%

            Headache (4-8%)

            Insomnia (2-7%)

            Constipation (2-6%)

            Urinary frequency (2-6%)

            Fatigue (2-4%)

            <1%

            Abdominal pain

            Ankle edema

            Anorexia

            Ataxia

            Blurred vision

            Chest pain

            Coordination disorder

            Depression

            Diarrhea

            Dry mouth

            Diplopia

            Dysarthria

            Dyspnea

            Dystonia

            Enuresis

            Euphoria

            Excitement

            Hallucinations

            Hematuria

            Hypotension

            Impotence

            Miosis

            Muscle pain

            Mydriasis

            Nasal congestion

            Nocturia

            Nystagmus

            Palpitation

            Paresthesia

            Excessive perspiration

            Pruritus

            Rash

            Rigidity

            Seizure

            Strabismus

            Slurred speech

            Syncope

            Tinnitus

            Tremor

            Urinary retention

            Vomiting

            Weight gain

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            Warnings

            Black Box Warnings

            Abrupt discontinuation, of intrathecal baclofen, has resulted in high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity that, in rare cases, advances to rhabdomyolysis, multiple organ system failure, and death

            Prevention of abrupt discontinuation requires careful attention to programming and monitoring of infusion system, refill scheduling and procedures, and pump alarms; advice patients and caregivers of importance of keeping scheduled refill visits and educate on the early symptoms of baclofen withdrawal; give special attention to patients at apparent risk (eg, spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen)

            Contraindications

            Hypersensitivity

            Intravenous, intramuscular, subcutaneous or epidural administration

            Cautions

            May cause drowsiness/dizziness

            Not indicated for spasm with rheumatic disease, stroke, Parkinson

            May take with food to avoid stomach upset

            Not significantly beneficial for patient with stroke

            Use with caution in seizure disorders and renal impairment

            Abrupt drug discontinuation may result in hallucinations and seizures

            May cause acute urinary retention that may be related to underlying disease; use caution in patients with urinary obstruction

            Animal studies have shown increased incidence in ovarian cysts; effect in humans inconclusive

            Use with caution in patients with decreased GI motility, peptic ulcer disease, and/or gastrointestinal obstructive disorders

            Use caution in respiratory disease and in the elderly

            Potential toxic dose if <6 years: 5 mg/kg (PO)

            Monitor: EEG

            Intrathecal administration

            • Intrathecal used with implanted pump
            • Not for injection into pump catheter access port, as this may cause a life-threatening overdose
            • Potential for contamination due to non-sterile external surface of prefilled syringe; use of baclofen prefilled syringe in an aseptic setting (e.g., operating room) to fill sterile intrathecal pumps prior to implantation in patients not recommended, unless external surface of prefilled syringe is treated to ensure sterility
            • Potentially life-threatening CNS depression, cardiovascular collapse, and/or respiratory failure
            • Resuscitative equipment and trained staff must be available during screening, dose titration, and refills
            • Overdose may cause drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma
            • Possible exacerbation of psychotic disorders, schizophrenia or confusional states may occur
            • Intrathecal mass: Cases of intrathecal mass at the tip of the implanted catheter have been reported, most of them involving pharmacy-compounded analgesic admixtures; the most frequent symptoms associated with intrathecal mass include decreased therapeutic response (worsening spasticity, return of spasticity when previously well controlled, withdrawal symptoms, poor response to escalating doses, or frequent or large dosage increases), pain, and neurologic deficit/dysfunction
            • Inadvertent injection into the SC tissue can occur if the intrathecal reservoir refill septum is not properly accessed; SC injection may result in symptoms of a systemic overdose or early depletion of the reservoir
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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Enters breast milk in small amounts; not recommended

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Inhibits synaptic transmission through spinal reflex arcs, via hyperpolarization of primary afferent fiber terminals, which may result in muscle spasticity

            Absorption

            Onset: 3-4 days

            Duration: 4-8 hr

            Peak plasma time: 2-3 hr

            Peak plasma concentration: 500-600 ng/mL

            Peak effect: 5-10 days

            Distribution

            Protein bound: 30%

            Metabolism

            Metabolized by liver (15%), mostly by deamination

            Elimination

            Half-life: 2.5-4 hr

            Excretion: Urine and feces (85%; unchanged)

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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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