baclofen

BAK-loe-fen

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

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.

Inhibits reflexes at the spinal level.

Therapeutic effects:

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

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.

(effects on spasticity)

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

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.

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

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:

Concomitant use of kava-kava, valerian, or chamomile can ↑ CNS depression.

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.

(Generic available)

Tablets: 5 mg; 10 mg; 15 mg; 20 mg
Oral granulesstrawberry flavor: 5 mg/pkt; 10 mg/pkt; 20 mg/pkt
Oral solutiongrape flavor: 1 mg/mL; 2 mg/mL
Oral suspensiongrape flavor: 5 mg/mL
Solution for intrathecal injection: 50 mcg/mL; 500 mcg/mL; 1000 mcg/mL; 2000 mcg/mL

Assess muscle spasticity before and periodically during therapy.
- Observe patient for drowsiness, dizziness, or ataxia. May be alleviated by a change in dose.
IT: Monitor patient closely during test dose and titration. Have resuscitative equipment immediately available for life-threatening or intolerable side effects.

Lab Test Considerations:

May cause ↑ in serum glucose, alkaline phosphatase, AST, and ALT levels.

PO: Administer with milk or food to minimize gastric irritation.
- Oral suspension: Shake oral suspension well before use. Use a calibrated measuring device to measure and deliver dose accurately; household teaspoon or tablespoon is not an adequate measuring device. Discard unused portion 2 mo after first opening.
- Oral granulesEmpty entire contents of packet of oral granules into mouth. Granules will dissolve in mouth or can be swallowed. May be taken with up to 15 mL of liquids or soft foods (apple sauce, yogurt, pudding).Administer no more than 2 hr after mixing. If multiple packets are to be used, mix each packet separately. May also be administered via enteral feeding tubes (nasogastric [NG] at sizes 8 FR or higher, gastrostomy [G] at sizes 12 FR or higher, percutaneous endoscopic gastrostomy [PEG] at sizes 14 FR or higher, and gastrojejunostomy [GJ] tubes at sizes 16 FR or higher). Flush feeding tube with up to 15 mL of water using a catheter tip syringe. Open and empty full contents of one packet in 15 mL of liquid, such as apple juice or milk, in a clean container. Mix suspension to ensure all granules are wetted. Draw up suspension into a syringe immediately after mixing and administer dose via the feeding tube. Administer no more than 2 hr after mixing. If syringe is allowed to stand for 15 min before administration, invert syringe 3 times. Refill syringe with 15 mL of water and flush feeding tube. If multiple packets are to be administered, mix each packet with a separate volume of liquid.
IT: For screening phase, Diluent: dilute for a concentration of 50 mcg/mL with sterile preservative-free NaCl for injection. Test dose should be administered over at least 1 min. Observe patient for a significant decrease in muscle tone or frequency or severity of spasm. If response is inadequate, 2 additional test doses, each 24 hr apart, 75 mcg/1.5 mL and 100 mcg/2 mL respectively, may be administered. Patients with an inadequate response should not receive chronic IT therapy. Avoid use of prefilled syringes for filling reservoir of pump; prefilled syringes are not sterile.
- Dose titration for implantable IT pumps is based on patient response. If no substantive response after dose increase, check pump function and catheter patency.

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 professional 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 females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Inform patient that use during pregnancy or breastfeeding may cause withdrawal symptoms (increased muscle tone, tremor, jitteriness, seizures) in infants starting hrs 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 professional promptly if signs of withdrawal occur.

Decrease in muscle spasticity and associated musculoskeletal pain with an increased ability to perform activities of daily living.
Decreased pain in patients with trigeminal neuralgia. May take wk to obtain optimal effect.

Fleqsuvy, Gablofen, Lioresal, Lyvispah, Ozobax DS

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Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆