Dosing & Uses
Dosage Forms & Strengths
tablet
- 5mg (generic)
- 10mg (generic)
- 20mg (generic)
oral solution
- 5mg/5mL (Ozobax)
oral suspension
- 25mg/5mL (Fleqsuvy)
oral granules
- 5mg/packet (Lyvispah)
- 10mg/packet (Lyvispah)
- 20mg/packet (Lyvispah)
intrathecal solution, preservative free
- 500mcg/mL (generic, Lioresal, Gablofen)
- 1000mcg/mL (generic, Lioresal, Gablofen)
- 2000mcg/mL (generic, Lioresal, Gablofen)
Spasticity
Oral
- Indicated for spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity
- Ozobax and Fleqsuvy: May also be of some value in patients with spinal cord injuries and other spinal cord diseases
- 5 mg PO TID initially
- After 3 days, may gradually increase by 5 mg/dose q3days up to 20 mg PO TID based on clinical response and tolerability
- Not to exceed 80 mg/day (20 mg QID)
Intrathecal
- Management of severe spasticity of spinal cord origin (eg, spinal cord injury, multiple sclerosis) or cerebral origin (eg, cerebral palsy, traumatic brain injury; may be considered as an alternative to destructive neurosurgical procedures
-
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
- Owing to drug primarily excreted unchanged through kidneys, exercise 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
Discontinuation
- When discontinuing oral therapy, reduce dosage slowly and avoid abrupt withdrawal to minimize risk of adverse reactions
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)
oral suspension
- 25mg/5mL (Fleqsuvy)
oral granules
- 5mg/packet (Lyvispah)
- 10mg/packet (Lyvispah)
- 20mg/packet (Lyvispah)
intrathecal solution, preservative free
- 500mcg/mL (generic, Lioresal, Gablofen)
- 1000mcg/mL (generic, Lioresal, Gablofen)
- 2000mcg/mL (generic, Lioresal, Gablofen)
Spasticity
Oral
Indicated for spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity
Ozobax: 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
5 mg PO TID initially
After 3 days, may gradually increase dosage increase by 5 mg/dose q3days up to 20 mg PO TID based on clinical response and tolerability
If necessary, may increase to a maximum of 80 mg/day (20 mg QID)
Intrathecal
- Management of severe spasticity of spinal cord origin (eg, spinal cord injury, multiple sclerosis) or cerebral origin (eg, cerebral palsy, traumatic brain injury) in patients aged ≥4 years; may be considered as an alternative to neurosurgical procedures
-
Screening phase
- Test bolus: 50 mcg intrathecal by barbotage procedure 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
- Owing to drug primarily excreted unchanged through kidneys, exercise 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
Discontinuation
- When discontinuing oral therapy, reduce dosage slowly and avoid abrupt withdrawal to minimize the risk of adverse reactions
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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 (157)
- 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.
- daridorexant
baclofen and daridorexant both increase sedation. Modify Therapy/Monitor Closely. Coadministration increases risk of CNS depression, which can lead to additive impairment of psychomotor performance and cause daytime impairment.
- 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.
- difelikefalin
difelikefalin and baclofen both increase sedation. Use Caution/Monitor.
- 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.
- ganaxolone
baclofen and ganaxolone 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.
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
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
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.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
- IT: 28-48 hr
- Tablets: 0.75 hr
- Granules: 1 hr
Effects of food
- Granules administered with a high-fat meal resulted in 10% decrease in AUC and 29% decrease in peak plasma concentration
Elimination
Clearance: 30 mL/hr (IT)
Half-life
- IT: 1.51 hr
- Tablets: 5.7 hr
- Granules: 5.5 hr
Excretion
- Urine and feces (85%; unchanged)
Administration
Oral Administration
Take with or without food
Oral suspension
- Use a calibrated measuring device to deliver dose accurately; a household teaspoon or tablespoon is not an adequate measuring device
- Fleqsuvy only: Shake well before administering; discard unused portion 2 months after first opening
Granules
- May mix with liquids or soft foods (eg, applesauce, yogurt, pudding)
- Empty contents of 1 packet and mix with up to 15 mL of liquid or soft food
- Administer mixture ≤2 hr after mixing
- If administering multiple packets, mix each packet with a separate volume of liquid or soft food
-
Administration via feeding tube
- Flush feeding tube with up to 15 mL of water using a catheter tip syringe
- Open and empty the full contents of 1 packet in 15 mL of liquid (eg, apple juice, milk), in a clean container; mix suspension to ensure all granules are wetted
- Draw up suspension into a dosing syringe immediately and administer dose via the feeding tube
- Administer suspension ≤2 hr after mixing
- If syringe is allowed to stand for 15 minutes before administration, invert syringe 3 times
- Refill dosing syringe with 15 mL of water and flush the feeding tube
- If administering multiple packets, mix each packet with a separate volume of liquid
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
Tablet: Store at 20-25ºC (68-77ºF)
Granules: Store at room temperature, 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
Injection: Does not require refrigeration; do not store above 86ºF (30ºC); do not freeze; do not heat sterilize
Oral solution
- Ozobax: Refrigerate at 2-8ºC (36-46ºF); dispense in a tight, light-resistant container with a child-resistant closure
- Fleqsuvy: Store at room temperature, 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF); discard after 2 months of first opening
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| baclofen oral - | 10 mg tablet |  | |
| baclofen oral - | 5 mg tablet |  | |
| baclofen oral - | 20 mg tablet |  | |
| baclofen oral - | 10 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 - | 20 mg tablet |  | |
| baclofen oral - | 10 mg tablet |  | |
| baclofen oral - | 20 mg tablet |  | |
| baclofen oral - | 10 mg tablet |  | |
| baclofen oral - | 5 mg tablet |  | |
| baclofen oral - | 20 mg tablet |  | |
| baclofen oral - | 10 mg tablet |  | |
| baclofen oral - | 5 mg tablet |  | |
| baclofen oral - | 5 mg tablet |  | |
| baclofen oral - | 10 mg tablet |  | |
| baclofen oral - | 20 mg tablet |  | |
| baclofen oral - | 20 mg tablet |  | |
| Fleqsuvy oral - | 5 mg/mL suspension |  | |
| Fleqsuvy oral - | 5 mg/mL suspension |  | |
| Gablofen intrathecal - | 40,000 mcg/20mL (2,000 mcg/mL) solution |  | |
| baclofen intrathecal - | 20,000 mcg/20mL (1,000 mcg/mL) vial |  | |
| baclofen intrathecal - | 10,000 mcg/20mL (500 mcg/mL) vial |  | |
| baclofen intrathecal - | 50 mcg/mL (1 mL) solution |  | |
| Ozobax oral - | 5 mg/5 mL solution |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
baclofen oral
BACLOFEN - ORAL
(BAK-loe-fen)
COMMON BRAND NAME(S): Fleqsuvy, Lioresal, Lyvispah, 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: Read the Patient Information Leaflet if available from your pharmacist before you start taking baclofen and each time you get a refill. If you have any questions, ask your doctor or pharmacist.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. If your liquid form is a suspension, shake the bottle well before each dose.If you are taking the granules form of this medication, gently shake the packet before use. Open the packet and empty the entire contents of the packet into your mouth and swallow. You may drink water after swallowing the granules if needed. You may also mix the contents of each packet with 1 tablespoonful (15 milliliters) of soft food or liquid (such as yogurt, applesauce, pudding, milk, or apple juice). After mixing, take all of the mixture within 2 hours. If you are using more than 1 packet, mix each packet in a separate amount of soft food or liquid.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 get better or if it gets worse.
SIDE EFFECTS: Drowsiness, dizziness, weakness, tiredness, headache, trouble sleeping, nausea, increased urination, or constipation may occur. If any of these effects last or get worse, 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 and granules form of this medication at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.If you are using the liquid form of this medication, first check if your liquid is a suspension or not. If your liquid is a suspension, store the bottle at room temperature and discard any unused portion after 2 months. If your liquid form is not a suspension, store the medication in the refrigerator in a tightly closed container away from light. Ask your pharmacist if you have any questions about your dosage form.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 May 2022. Copyright(c) 2022 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.
Formulary
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.
