baclofen (Rx)

Brand and Other Names:Lioresal, Gablofen, more...Ozobax
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 5mg (generic)
  • 10mg (generic)
  • 20mg (generic)

oral solution

  • 5mg/5mL (Ozobax)

intrathecal solution, preservative free

  • 500mcg/mL (generic, Lioresal, Gablofen)
  • 1000mcg/mL (generic, Lioresal, Gablofen)
  • 2000mcg/mL (generic, Lioresal, Gablofen)

Spasticity

Indicated for spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity

Oral

  • May also be of some value in patients with spinal cord injuries and other spinal cord diseases
  • Initiate with a low dosage, preferably in divided doses, PO
  • Following suggested gradual increase dosage regimen based on clinical response and tolerability
    • 5 mg PO TID initially; after 3 days, may increase by 5 mg/dose q3days up to 20 mg PO TID
    • If necessary, may increase to a maximum of 80 mg/day (20 mg QID)

Intrathecal

  • Screening phase
    • Test bolus: 50 mcg intrathecal by barbotage over <1 minute; if inadequate response within 8 hr, 75 mcg 24 hr later; if still inadequate, 100 mcg 24 hr 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)

Dosage Modifications

Renal impairment

  • Because baclofen is primarily excreted unchanged through the kidneys, use caution and consider reducing the dosage if necessary

Orphan Indications

Treatment of dystonia

Treatment of spasticity associated with cerebral palsy

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

Dosing Considerations

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

Limitation of use

  • Not indicated for skeletal muscle spasm resulting from rheumatic disorders

Dosage Forms & Strengths

tablet

  • 5mg (generic)
  • 10mg (generic)
  • 20mg (generic)

oral solution

  • 5mg/5mL (Ozobax)

intrathecal solution, preservative free

  • 500mcg/mL (generic, Lioresal, Gablofen)
  • 1000mcg/mL (generic, Lioresal, Gablofen)
  • 2000mcg/mL (generic, Lioresal, Gablofen)

Spasticity

Indicated for spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity

Oral

May also be of some value in patients with spinal cord injuries and other spinal cord diseases

<12 years: Safety and efficacy not established

≥12 years: Initiate with a low dosage, preferably in divided doses, PO

Following suggested gradual increase dosage regimen based on clinical response and tolerability
  • 5 mg PO TID initially; after 3 days, may increase by 5 mg/dose q3days up to 20 mg PO TID
  • If necessary, may increase to a maximum of 80 mg/day (20 mg QID)

Intrathecal

  • Screening phase
    • Test bolus: 50 mcg intrathecal by barbotage over 1 minute; if inadequate response within 8 hr, 75 mcg 24 hr later; if still inadequate, 100 mcg 24 hr 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 hr, 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

Dosage Modifications

Renal impairment

  • Because baclofen is primarily excreted unchanged through the kidneys, use caution and consider reducing the dosage if necessary

Dosing Considerations

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

Limitation of use

  • Not indicated for skeletal muscle spasm resulting from rheumatic disorders

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

and baclofen

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      Serious - Use Alternative

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            Contraindicated (0)

              Serious - Use Alternative (7)

              • benzhydrocodone/acetaminophen

                benzhydrocodone/acetaminophen, baclofen. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

              • calcium/magnesium/potassium/sodium oxybates

                baclofen, calcium/magnesium/potassium/sodium oxybates. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

              • hydrocodone

                hydrocodone, baclofen. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

              • metoclopramide intranasal

                baclofen, metoclopramide intranasal. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid use of metoclopramide intranasal or interacting drug, depending on importance of drug to patient.

              • selinexor

                selinexor, baclofen. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.

              • sodium oxybate

                baclofen, sodium oxybate. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

              • sufentanil SL

                sufentanil SL, baclofen. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration may result in hypotension, profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

              Monitor Closely (154)

              • abobotulinumtoxinA

                baclofen increases effects of abobotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.

              • alfentanil

                baclofen and alfentanil both increase sedation. Use Caution/Monitor.

              • alprazolam

                alprazolam and baclofen both increase sedation. Use Caution/Monitor.

              • amifampridine

                baclofen increases toxicity of amifampridine by Other (see comment). Modify Therapy/Monitor Closely. Comment: Amifampridine can cause seizures. Coadministration with drugs that lower seizure threshold may increase this risk.

              • amitriptyline

                baclofen and amitriptyline both increase sedation. Use Caution/Monitor.

              • amobarbital

                amobarbital and baclofen both increase sedation. Use Caution/Monitor.

              • amoxapine

                baclofen and amoxapine both increase sedation. Use Caution/Monitor.

              • apomorphine

                baclofen and apomorphine both increase sedation. Use Caution/Monitor.

              • aripiprazole

                baclofen and aripiprazole both increase sedation. Use Caution/Monitor.

              • azelastine

                azelastine and baclofen both increase sedation. Use Caution/Monitor.

              • belladonna and opium

                baclofen and belladonna and opium both increase sedation. Use Caution/Monitor.

              • benperidol

                baclofen and benperidol both increase sedation. Use Caution/Monitor.

              • benzphetamine

                baclofen increases and benzphetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • brexanolone

                brexanolone, baclofen. Either increases toxicity of the other by sedation. Use Caution/Monitor.

              • brompheniramine

                brompheniramine and baclofen both increase sedation. Use Caution/Monitor.

              • buprenorphine

                baclofen and buprenorphine both increase sedation. Use Caution/Monitor.

              • buprenorphine buccal

                baclofen and buprenorphine buccal both increase sedation. Use Caution/Monitor.

              • buprenorphine, long-acting injection

                buprenorphine, long-acting injection increases effects of baclofen by Other (see comment). Modify Therapy/Monitor Closely. Comment: Buprenorphine may enhance the neuromuscular blocking action of skeletal muscle relaxants and increase risk for respiratory depression. Monitor for signs of respiratory depression that may be greater than otherwise expected and decrease muscle relaxant dosage as necessary.

              • butabarbital

                butabarbital and baclofen both increase sedation. Use Caution/Monitor.

              • butalbital

                butalbital and baclofen both increase sedation. Use Caution/Monitor.

              • butorphanol

                baclofen and butorphanol both increase sedation. Use Caution/Monitor.

              • carbinoxamine

                carbinoxamine and baclofen both increase sedation. Use Caution/Monitor.

              • carisoprodol

                baclofen and carisoprodol both increase sedation. Use Caution/Monitor.

              • chloral hydrate

                chloral hydrate and baclofen both increase sedation. Use Caution/Monitor.

              • chlordiazepoxide

                chlordiazepoxide and baclofen both increase sedation. Use Caution/Monitor.

              • chlorpheniramine

                chlorpheniramine and baclofen both increase sedation. Use Caution/Monitor.

              • chlorpromazine

                baclofen and chlorpromazine both increase sedation. Use Caution/Monitor.

              • chlorzoxazone

                baclofen and chlorzoxazone both increase sedation. Use Caution/Monitor.

              • cinnarizine

                cinnarizine and baclofen both increase sedation. Use Caution/Monitor.

              • clemastine

                clemastine and baclofen both increase sedation. Use Caution/Monitor.

              • clobazam

                baclofen, clobazam. Other (see comment). Use Caution/Monitor. Comment: Concomitant administration can increase the potential for CNS effects (e.g., increased sedation or respiratory depression).

              • clomipramine

                baclofen and clomipramine both increase sedation. Use Caution/Monitor.

              • clonazepam

                clonazepam and baclofen both increase sedation. Use Caution/Monitor.

              • clorazepate

                clorazepate and baclofen both increase sedation. Use Caution/Monitor.

              • clozapine

                baclofen and clozapine both increase sedation. Use Caution/Monitor.

              • codeine

                baclofen and codeine both increase sedation. Use Caution/Monitor.

              • cyclizine

                cyclizine and baclofen both increase sedation. Use Caution/Monitor.

              • cyclobenzaprine

                baclofen and cyclobenzaprine both increase sedation. Use Caution/Monitor.

              • cyproheptadine

                cyproheptadine and baclofen both increase sedation. Use Caution/Monitor.

              • dantrolene

                baclofen and dantrolene both increase sedation. Use Caution/Monitor.

              • desflurane

                desflurane and baclofen both increase sedation. Use Caution/Monitor.

              • desipramine

                baclofen and desipramine both increase sedation. Use Caution/Monitor.

              • dexchlorpheniramine

                dexchlorpheniramine and baclofen both increase sedation. Use Caution/Monitor.

              • dexfenfluramine

                baclofen increases and dexfenfluramine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • dexmedetomidine

                dexmedetomidine and baclofen both increase sedation. Use Caution/Monitor.

              • dextromoramide

                baclofen and dextromoramide both increase sedation. Use Caution/Monitor.

              • diamorphine

                baclofen and diamorphine both increase sedation. Use Caution/Monitor.

              • diazepam

                diazepam and baclofen both increase sedation. Use Caution/Monitor.

              • diazepam intranasal

                diazepam intranasal, baclofen. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may potentiate the CNS-depressant effects of each drug.

              • difenoxin hcl

                baclofen and difenoxin hcl both increase sedation. Use Caution/Monitor.

              • dimenhydrinate

                dimenhydrinate and baclofen both increase sedation. Use Caution/Monitor.

              • diphenhydramine

                diphenhydramine and baclofen both increase sedation. Use Caution/Monitor.

              • diphenoxylate hcl

                baclofen and diphenoxylate hcl both increase sedation. Use Caution/Monitor.

              • dipipanone

                baclofen and dipipanone both increase sedation. Use Caution/Monitor.

              • dopexamine

                baclofen increases and dopexamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • dosulepin

                baclofen and dosulepin both increase sedation. Use Caution/Monitor.

              • doxepin

                baclofen and doxepin both increase sedation. Use Caution/Monitor.

              • doxylamine

                doxylamine and baclofen both increase sedation. Use Caution/Monitor.

              • droperidol

                baclofen and droperidol both increase sedation. Use Caution/Monitor.

              • esketamine intranasal

                esketamine intranasal, baclofen. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • estazolam

                estazolam and baclofen both increase sedation. Use Caution/Monitor.

              • ethanol

                baclofen and ethanol both increase sedation. Use Caution/Monitor.

              • etomidate

                etomidate and baclofen both increase sedation. Use Caution/Monitor.

              • fenfluramine

                baclofen increases and fenfluramine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • fluphenazine

                baclofen and fluphenazine both increase sedation. Use Caution/Monitor.

              • flurazepam

                flurazepam and baclofen both increase sedation. Use Caution/Monitor.

              • haloperidol

                baclofen and haloperidol both increase sedation. Use Caution/Monitor.

              • hydromorphone

                baclofen and hydromorphone both increase sedation. Use Caution/Monitor.

              • hydroxyzine

                hydroxyzine and baclofen both increase sedation. Use Caution/Monitor.

              • iloperidone

                baclofen and iloperidone both increase sedation. Use Caution/Monitor.

              • imipramine

                baclofen and imipramine both increase sedation. Use Caution/Monitor.

              • incobotulinumtoxinA

                baclofen, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.

              • ketamine

                ketamine and baclofen both increase sedation. Use Caution/Monitor.

              • ketotifen, ophthalmic

                baclofen and ketotifen, ophthalmic both increase sedation. Use Caution/Monitor.

              • lasmiditan

                lasmiditan, baclofen. Either increases effects of the other by sedation. Use Caution/Monitor. Coadministration of lasmiditan and other CNS depressant drugs, including alcohol have not been evaluated in clinical studies. Lasmiditan may cause sedation, as well as other cognitive and/or neuropsychiatric adverse reactions.

              • lemborexant

                lemborexant, baclofen. Either increases effects of the other by sedation. Modify Therapy/Monitor Closely. Dosage adjustment may be necessary if lemborexant is coadministered with other CNS depressants because of potentially additive effects.

              • levorphanol

                baclofen and levorphanol both increase sedation. Use Caution/Monitor.

              • lofepramine

                baclofen and lofepramine both increase sedation. Use Caution/Monitor.

              • lofexidine

                baclofen and lofexidine both increase sedation. Use Caution/Monitor.

              • loprazolam

                loprazolam and baclofen both increase sedation. Use Caution/Monitor.

              • lorazepam

                lorazepam and baclofen both increase sedation. Use Caution/Monitor.

              • lormetazepam

                lormetazepam and baclofen both increase sedation. Use Caution/Monitor.

              • loxapine

                baclofen and loxapine both increase sedation. Use Caution/Monitor.

              • loxapine inhaled

                baclofen and loxapine inhaled both increase sedation. Use Caution/Monitor.

              • lurasidone

                lurasidone, baclofen. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Potential for increased CNS depressant effects when used concurrently; monitor for increased adverse effects and toxicity.

              • maprotiline

                baclofen and maprotiline both increase sedation. Use Caution/Monitor.

              • marijuana

                baclofen and marijuana both increase sedation. Use Caution/Monitor.

              • melatonin

                baclofen and melatonin both increase sedation. Use Caution/Monitor.

              • meperidine

                baclofen and meperidine both increase sedation. Use Caution/Monitor.

              • meprobamate

                baclofen and meprobamate both increase sedation. Use Caution/Monitor.

              • metaxalone

                baclofen and metaxalone both increase sedation. Use Caution/Monitor.

              • methadone

                baclofen and methadone both increase sedation. Use Caution/Monitor.

              • methocarbamol

                baclofen and methocarbamol both increase sedation. Use Caution/Monitor.

              • methylenedioxymethamphetamine

                baclofen increases and methylenedioxymethamphetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • midazolam

                midazolam and baclofen both increase sedation. Use Caution/Monitor.

              • midazolam intranasal

                midazolam intranasal, baclofen. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Concomitant use of barbiturates, alcohol, or other CNS depressants may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.

              • mipomersen

                mipomersen, baclofen. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Both drugs have potential to increase hepatic enzymes; monitor LFTs.

              • mirtazapine

                baclofen and mirtazapine both increase sedation. Use Caution/Monitor.

              • morphine

                baclofen and morphine both increase sedation. Use Caution/Monitor.

              • motherwort

                baclofen and motherwort both increase sedation. Use Caution/Monitor.

              • moxonidine

                baclofen and moxonidine both increase sedation. Use Caution/Monitor.

              • nabilone

                baclofen and nabilone both increase sedation. Use Caution/Monitor.

              • nalbuphine

                baclofen and nalbuphine both increase sedation. Use Caution/Monitor.

              • nortriptyline

                baclofen and nortriptyline both increase sedation. Use Caution/Monitor.

              • olanzapine

                baclofen and olanzapine both increase sedation. Use Caution/Monitor.

              • oliceridine

                oliceridine, baclofen. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

                baclofen increases toxicity of oliceridine by Other (see comment). Modify Therapy/Monitor Closely. Comment: Anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Monitor for signs of urinary retention or reduced gastric motility if oliceridine is coadministered with anticholinergics.

              • opium tincture

                baclofen and opium tincture both increase sedation. Use Caution/Monitor.

              • orphenadrine

                baclofen and orphenadrine both increase sedation. Use Caution/Monitor.

              • oxazepam

                oxazepam and baclofen both increase sedation. Use Caution/Monitor.

              • oxycodone

                baclofen and oxycodone both increase sedation. Use Caution/Monitor.

              • oxymorphone

                baclofen and oxymorphone both increase sedation. Use Caution/Monitor.

              • paliperidone

                baclofen and paliperidone both increase sedation. Use Caution/Monitor.

              • papaveretum

                baclofen and papaveretum both increase sedation. Use Caution/Monitor.

              • papaverine

                baclofen and papaverine both increase sedation. Use Caution/Monitor.

              • pentazocine

                baclofen and pentazocine both increase sedation. Use Caution/Monitor.

              • pentobarbital

                pentobarbital and baclofen both increase sedation. Use Caution/Monitor.

              • perphenazine

                baclofen and perphenazine both increase sedation. Use Caution/Monitor.

              • phenobarbital

                phenobarbital and baclofen both increase sedation. Use Caution/Monitor.

              • phenylephrine PO

                baclofen increases and phenylephrine PO decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor. .

              • pholcodine

                baclofen and pholcodine both increase sedation. Use Caution/Monitor.

              • pimozide

                baclofen and pimozide both increase sedation. Use Caution/Monitor.

              • prabotulinumtoxinA

                baclofen increases effects of prabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.

              • primidone

                primidone and baclofen both increase sedation. Use Caution/Monitor.

              • prochlorperazine

                baclofen and prochlorperazine both increase sedation. Use Caution/Monitor.

              • promethazine

                promethazine and baclofen both increase sedation. Use Caution/Monitor.

              • propofol

                propofol and baclofen both increase sedation. Use Caution/Monitor.

              • propylhexedrine

                baclofen increases and propylhexedrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • protriptyline

                baclofen and protriptyline both increase sedation. Use Caution/Monitor.

              • quazepam

                quazepam and baclofen both increase sedation. Use Caution/Monitor.

              • quetiapine

                baclofen and quetiapine both increase sedation. Use Caution/Monitor.

              • ramelteon

                baclofen and ramelteon both increase sedation. Use Caution/Monitor.

              • remimazolam

                remimazolam, baclofen. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely. Coadministration may result in profound sedation, respiratory depression, coma, and/or death. Continuously monitor vital signs during sedation and recovery period if coadministered. Carefully titrate remimazolam dose if administered with opioid analgesics and/or sedative/hypnotics.

              • risperidone

                baclofen and risperidone both increase sedation. Use Caution/Monitor.

              • scullcap

                baclofen and scullcap both increase sedation. Use Caution/Monitor.

              • secobarbital

                secobarbital and baclofen both increase sedation. Use Caution/Monitor.

              • sevoflurane

                sevoflurane and baclofen both increase sedation. Use Caution/Monitor.

              • shepherd's purse

                baclofen and shepherd's purse both increase sedation. Use Caution/Monitor.

              • stiripentol

                stiripentol, baclofen. Either increases effects of the other by sedation. Use Caution/Monitor. Concomitant use stiripentol with other CNS depressants, including alcohol, may increase the risk of sedation and somnolence.

              • sufentanil

                baclofen and sufentanil both increase sedation. Use Caution/Monitor.

              • tapentadol

                baclofen and tapentadol both increase sedation. Use Caution/Monitor.

              • temazepam

                temazepam and baclofen both increase sedation. Use Caution/Monitor.

              • thioridazine

                baclofen and thioridazine both increase sedation. Use Caution/Monitor.

              • thiothixene

                baclofen and thiothixene both increase sedation. Use Caution/Monitor.

              • topiramate

                baclofen and topiramate both increase sedation. Modify Therapy/Monitor Closely.

              • tramadol

                baclofen and tramadol both increase sedation. Use Caution/Monitor.

              • trazodone

                baclofen and trazodone both increase sedation. Use Caution/Monitor.

              • triazolam

                triazolam and baclofen both increase sedation. Use Caution/Monitor.

              • triclofos

                triclofos and baclofen both increase sedation. Use Caution/Monitor.

              • trifluoperazine

                baclofen and trifluoperazine both increase sedation. Use Caution/Monitor.

              • trimipramine

                baclofen and trimipramine both increase sedation. Use Caution/Monitor.

              • xylometazoline

                baclofen increases and xylometazoline decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • ziconotide

                baclofen and ziconotide both increase sedation. Use Caution/Monitor.

              • ziprasidone

                baclofen and ziprasidone both increase sedation. Use Caution/Monitor.

              • zotepine

                baclofen and zotepine both increase sedation. Use Caution/Monitor.

              Minor (2)

              • eucalyptus

                baclofen and eucalyptus both increase sedation. Minor/Significance Unknown.

              • sage

                baclofen and sage both increase sedation. Minor/Significance Unknown.

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              Adverse Effects

              >10%

              Oral solution/tablets

              • Drowsiness (10-63%)
              • Dizziness (5-15%)
              • Weakness (5-15%)
              • Nausea (4-12%)
              • Confusion (1-11%)
              • Intrathecal H4
              • Hypotonia (2.4-34.7%)
              • Somnolence (5.7-20.9%)

              1-10%

              Oral solution/tablets

              • Hypotension (0-9%)
              • Headache (4-8%)
              • Insomnia (2-7%)
              • Constipation (2-6%)
              • Urinary frequency (2-6%)
              • Fatigue (2-4%)

              Intrathecal

              • Convulsion (0.5-10%)
              • Urinary retention (0.9-8%)
              • Dizziness (1.7-8%)
              • Paresthesia (2.1-6.7%)
              • Nausea and vomiting (1.4-7.3%)
              • Headache (1.6-10.7%)
              • Constipation (0.2-5.1%)
              • Pruritus (4%)
              • Hypotension (0.2-4%)
              • Pain (0.6-4%)
              • Accidental injury (0.2-3.5%)
              • Speech disorder (0.2-3.5%)
              • Dry mouth (0.2-3.3%)
              • Peripheral edema (2.3-3.3%)
              • Death (0.2-3%)
              • Increased salivation (2.6-2.7%)
              • Ambylopia (0.2-2.3%)
              • Diarrhea (0.5-2.3%)
              • Confusion (0.5-2.3%)
              • Hypoventilation (0.2-2.1%)
              • Back pain (0.9-2%)
              • Urinary incontinence (0.8-2%)
              • Pneumonia (0.2-2%)
              • Urinary retention (0.7-1.9%)
              • Impotence (0.2-1.6%)
              • Insomnia (0.4-1.6%)
              • Depression (1.6%)
              • Thinking abnormal (0.5-1.3%)
              • Agitation (0.5-1.3%)
              • Asthenia (0.7-1.4%)
              • Tremor (1.3%)
              • Coma (0.9-1.2%)
              • Urticaria (0.2-1.2%)
              • Dyspnea (0.3-1.2%)

              <1%

              Intrathecal

              • Anorexia (0.4-0.9%)
              • Diplopia (0.4-0.9%)
              • Dysautonomia (0.2-0.9%)
              • Anxiety (0.2-0.9%)
              • Urinary frequency (0.6-0.9%)
              • Fever (0.2-0.7%)
              • Hypertension (0.2-0.6%)
              • Hallucinations (0.3-0.5%)

              Frequency Not Defined

              Oral solution/tablets

              • Neuropsychiatric: Euphoria, excitement, depression, hallucinations, paresthesia, muscle pain, tinnitus, slurred speech, coordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizure
              • Cardiovascular: dyspnea, palpitation, chest pain, syncope Gastrointestinal: dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool
              • Genitourinary: Enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, hematuria
              • Other: Rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion

              Postmarketing Reports

              Onset of scoliosis or worsening of a pre-existing scoliosis

              Sexual dysfunction in men and women, including decreased libido and orgasm dysfunction

              Erectile dysfunction in men following baclofen withdrawal

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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

              Intrathecal use: IV, IM, SC or epidural administration

              Cautions

              Use with caution in patients who have had a stroke; baclofen has not significantly benefited patients with stroke; patients have also shown poor tolerability to the drug

              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 has resulted in adverse reactions that include hallucinations, seizures, high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death

              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 with caution in patients with a history of autonomic dysreflexia; presence of nociceptive stimuli or abrupt withdrawal may cause autonomic dysreflexia episode

              Possible exacerbation of psychotic disorders, schizophrenia or confusional state

              Neonatal withdrawal symptoms can occur; gradually reduce the dosage and discontinue oral baclofen before delivery

              Patients should avoid the operation of automobiles or other dangerous machinery until they know how the drug affects them; advise patients that the central nervous system effects may be additive to those of alcohol and other CNS depressants

              Use with caution in patients where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain increased function

              Intrathecal administration

              • Intrathecal used with implanted pump
              • Not for injection into pump catheter access port, as this may cause a life-threatening overdose
              • Delivery of more drug volume than the programmed rate (over infusion) can result in unexpected overdose, or withdrawal caused by early emptying of pump reservoir; refer to manufacturer's pump manual and instructions for refilling the reservoir
              • Potential for contamination due to non-sterile external surface of prefilled syringe; use of baclofen prefilled syringe in an aseptic setting (eg, 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
              • 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

              Drug interaction overview

              • Baclofen may cause CNS depression, including drowsiness and sedation, which may be additive when used concomitantly with other CNS depressants or alcohol
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              Pregnancy & Lactation

              Pregnancy

              There are no adequate data on the developmental risk associated with the use in pregnant women

              Clinical considerations

              • May increase the risk of late-onset neonatal withdrawal symptoms

              Animal data

              • Oral administration of baclofen to pregnant rats resulted in an increased incidence of fetal structural abnormalities at a dose which was also associated with maternal toxicity
              • Given orally drug has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given ~13 times on a mg/kg basis, or 3 times on a mg/m2 basis, the maximum oral dose recommended for human use; this dose also caused reductions in food intake and weight gain in the dams
              • This abnormality was not seen in mice or rabbits

              Lactation

              At recommended oral doses, baclofen is present in human milk

              There are no human data on the effects of baclofen on milk production

              There are no adequate data on the effects of baclofen on the breastfed infant

              Withdrawal symptoms can occur in breastfed infants when maternal administration is stopped, or when breastfeeding is stopped

              Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed infant or from the underlying maternal condition

              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.

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              Pharmacology

              Mechanism of Action

              Precise mechanism of action of baclofen is not fully understood

              Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level, possibly by decreasing excitatory neurotransmitter release from afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect

              It is a structural analog of the inhibitory neurotransmitter gamma aminobutyric acid (GABA), and may exert its effects by stimulation of the GABAB receptor subtype

              Absorption

              Onset: 6-8 hr (IT)

              Duration: 4-8 hr

              Peak plasma time: 28-48 hr (IT); 0.75 hr (PO)

              Elimination

              Half-life: 1.51 hr (IT); 5.7 hr (PO)

              Clearance: 30 mL/hr (IT)

              Excretion: Urine and feces (85%; unchanged)

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              Administration

              Oral Administration

              Take with or without food

              Discontinuing: slowly reduce dose and avoid abrupt withdrawal to minimize risk of serious adverse events (eg, hallucinations, seizures, high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, rhabdomyolysis, multiple-organ failure, death)

              Intrathecal Preparation

              Inspect ampules for particulate matter and discoloration before administration, whenever solution and container permit

              Screening use

              • The 1 mL screening ampule only (50 mcg/mL) for bolus injection into the subarachnoid space
              • For a 50 mcg bolus dose, use 1 mL of the screening ampule
              • Use 1.5 mL of 50 mcg/mL baclofen injection for a 75 mcg bolus dose
              • For the maximum screening dose of 100 mcg, use 2 mL of 50 mcg/mL baclofen injection (2 screening ampules)

              Maintenance

              • Concentrations other than 500 mcg/mL or 2000 mcg/mL, drug must be diluted
              • Dilute with sterile preservative free NaCl

              Intrathecal Administration

              Often administered in a continuous infusion mode immediately following implant

              Patients implanted with programmable pumps who have achieved relatively satisfactory control on continuous infusion, further benefit may be attained using more complex schedules of drug delivery (eg, patients who have increased spasms at night may require a 20% increase in their hourly infusion rate; changes in flow rate should be programmed to start 2 hr before the time of desired clinical effect)

              Storage

              Oral solution: Refrigerate at 2-8ºC (36-46ºF); dispense in a tight, light-resistant container with a child-resistant closure

              Tablet: Store at 2-25ºC (68-77ºF)

              Injection: Does not require refrigeration; do not store above 86ºF (30ºC); do not freeze; do not heat sterilize

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              baclofen oral
              -
              5 mg tablet
              baclofen oral
              -
              20 mg tablet
              baclofen oral
              -
              20 mg tablet
              baclofen oral
              -
              10 mg tablet
              baclofen oral
              -
              20 mg tablet
              baclofen oral
              -
              20 mg tablet
              baclofen oral
              -
              20 mg tablet
              baclofen oral
              -
              10 mg tablet
              baclofen oral
              -
              10 mg tablet
              baclofen oral
              -
              20 mg tablet
              baclofen oral
              -
              10 mg tablet
              baclofen oral
              -
              20 mg tablet
              baclofen oral
              -
              10 mg tablet
              baclofen oral
              -
              10 mg tablet
              baclofen oral
              -
              20 mg tablet
              baclofen oral
              -
              10 mg tablet
              Ozobax oral
              -
              5 mg/5 mL solution

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Select a drug:
              Patient Education
              baclofen oral

              BACLOFEN - ORAL

              (BAK-loe-fen)

              COMMON BRAND NAME(S): Lioresal, Ozobax

              USES: Baclofen is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, spinal cord injury/disease). It works by helping to relax the muscles.

              HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually 3 times a day. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.The dosage is based on your medical condition and response to treatment. Do not increase your dose or take it more often than prescribed.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. If you suddenly stop using this medication, you may also have withdrawal symptoms (such as hallucinations and seizures). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used baclofen for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.Tell your doctor if your condition does not improve or if it worsens.

              SIDE EFFECTS: Drowsiness, dizziness, weakness, tiredness, headache, trouble sleeping, nausea, increased urination, or constipation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as confusion, depression, hallucinations).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before taking baclofen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, mental/mood disorders (such as schizophrenia), brain disorders (such as seizures, stroke).This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this drug, especially drowsiness and mental/mood changes (such as confusion).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Babies born to mothers who have used this drug during pregnancy may rarely develop withdrawal symptoms such as tremor or seizures. If you notice any of these symptoms in your newborn, tell the doctor right away.This drug passes into breast milk. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), other muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: vomiting, severe drowsiness, slow/shallow breathing, seizures.

              NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another condition unless your doctor directs you to do so. A different medication may be necessary in that case.

              MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

              STORAGE: Store the tablet form of this medication at room temperature away from light and moisture. Do not store in the bathroom. Store the liquid form of this medication in the refrigerator in a tightly closed container away from light. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

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

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • 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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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.