baclofen

REMS

PO: Reversible spasticity due to multiple sclerosis or spinal cord lesions.
IT: Severe spasticity of cerebral or spinal origin (should be reserved for patients who do not respond or are intolerant to oral baclofen) (should wait at least one yr in patients with traumatic brain injury before considering therapy).

Unlabeled Use:

Pain in trigeminal neuralgia.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity.

Use Cautiously in:

Patients in whom spasticity maintains posture and balance;
Seizure disorders (may ↓ seizure threshold);
Renal impairment (↓ dose may be required);
OB: Safety not established in pregnancy;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Children <4 yr (intrathecal) (safety and effectiveness not established);
Geri: ↑risk of CNS side effects in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

CV: edema, hypotension

Derm: pruritus, rash

EENT: nasal congestion, tinnitus

GI: nausea, constipation

GU: frequency

Metab: ↑weight, hyperglycemia

Neuro: dizziness, drowsiness, fatigue, weakness, ataxia, confusion, depression, headache, insomnia, SEIZURES (IT)

Misc: hypersensitivity reactions, sweating

Interactions ⬆ ⬇

Drug-drug:

↑CNS depression with other CNS depressants, including alcohol, antihistamines, opioid analgesics, and sedative/hypnotics.
Use with MAO inhibitors may lead to ↑ CNS depression or hypotension.

Drug-Natural Products:

Kava-kava, valerian, or chamomile can ↑ CNS depression.

Availability ⬆ ⬇

(Generic available)

Tablets: 5 mg; 10 mg; 15 mg; 20 mg
Oral granules strawberry flavor: 5 mg/pkt; 10 mg/pkt; 20 mg/pkt
Oral solution grape flavor: 1 mg/mL; 2 mg/mL
Oral suspension grape flavor: 5 mg/mL
Solution for intrathecal injection: 50 mcg/mL; 500 mcg/mL; 1000 mcg/mL; 2000 mcg/mL

Route/Dosage ⬆ ⬇

PO (Adults ): 5 mg 3 times daily. May ↑ every 3 days by 5 mg/dose up to 80 mg/day (some patients may have a better response to 4 divided doses).
PO (Children ≥8 yr): 30–40 mg/day divided every 8 hr; titrate to a maximum of 120 mg/day.
PO (Children 2–7 yr): 20–30 mg/day divided every 8 hr; titrate to a maximum of 60 mg/day.
PO (Children <2 yr): 10–20 mg/day divided every 8 hr; titrate to a maximum of 40 mg/day.
IT (Adults ): 100–800 mcg/day infusion; dose is determined by response during screening phase.
IT (Children ≥4 yr): 25–1200 mcg/day infusion (average 275 mcg/day); dose is determined by response during screening phase.

US Brand Names ⬆ ⬇

Fleqsuvy, Gablofen, Lioresal, Lyvispah, Ozobax DS

Action ⬆ ⬇

Inhibits reflexes at the spinal level.

Therapeutic effects:

Decreased muscle spasticity; bowel and bladder function may also be improved.

Classifications ⬆ ⬇

Therapeutic Classification: antispasticity agents, skeletal muscle relaxants (centrally acting)

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed after oral administration.

Distribution: Widely distributed to tissues.

Metabolism/Excretion: 70–80% eliminated unchanged by the kidneys.

Half-Life: 2.5–4 hr.

Time/Action Profile ⬆ ⬇

(effects on spasticity)

ROUTE	ONSET	PEAK	DURATION
PO	hr–wk	unknown	unknown
IT	0.5–1 hr	4 hr	4–8 hr

Patient/Family Teaching ⬆ ⬇

Instruct patient to take baclofen as directed. Take a missed dose within 1 hr; do not double doses. Caution patient to avoid abrupt withdrawal of this medication; may precipitate an acute withdrawal reaction (hallucinations, increased spasticity, seizures, mental changes, restlessness). Discontinue baclofen gradually over 2 wk or more.
May cause dizziness and drowsiness. Advise patient to avoid driving or other activities requiring alertness until response to drug is known.
Instruct patient to change positions slowly to minimize orthostatic hypotension.
Advise patient to avoid concurrent use of alcohol or other CNS depressants while taking this medication.
Instruct patient to notify health care provider if frequent urge to urinate or painful urination, constipation, nausea, headache, insomnia, tinnitus, depression, or confusion persists.
Advise patient to report signs and symptoms of hypersensitivity (rash, itching) promptly.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding. Inform patient that use during pregnancy or breastfeeding may cause withdrawal symptoms (↑ muscle tone, tremor, jitteriness, seizures) in infants starting hours to days after delivery.
IT:
Caution patient and caregiver not to discontinue IT therapy abruptly. May result in fever, mental status changes, exaggerated rebound spasticity, and muscle rigidity. Advise patient not to miss scheduled refill appointments and to notify health care provider promptly if signs of withdrawal occur.

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Indications ⬇