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Baclofen

Also known as: Gablofen, Lioresal, Ozobax, Lyvispah +1 more

gamma-Aminobutyric Acid-ergic AgonistGABA A AgonistsGABA B Agonists

Route: Oral

3 interactions on record⛔ Black Box Warning

Baclofen has 3 known drug interactions based on U.S. FDA drug labeling data. 1 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Morphine, Alcohol, Cns Depressants. Patients taking Baclofen should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 3
Major: 1
Moderate: 2

Major (1)

Baclofen + Morphine— Combined use of baclofen injection (intrathecal) and epidural morphine may result in hypotension and dyspnea.

Moderate (2)

Baclofen + Alcohol— Additive CNS depression including drowsiness and sedation when used concomitantly with baclofen oral suspension.
Baclofen + Cns Depressants— Additive CNS depression when used concomitantly, including drowsiness and sedation.

Baclofen + Morphine⚠️Major

Combined use of baclofen injection (intrathecal) and epidural morphine may result in hypotension and dyspnea.

Baclofen + Alcohol🟡Moderate

Additive CNS depression including drowsiness and sedation when used concomitantly with baclofen oral suspension.

Baclofen + Cns Depressants🟡Moderate

Additive CNS depression when used concomitantly, including drowsiness and sedation.

⛔ FDA Black Box Warning

BOXED WARNING WARNING: DO NOT DISCONTINUE ABRUPTLY Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include 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. Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at apparent risk (e.g., spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional post-implant clinician and patient information [see Warnings and Precautions ( 5.4 )] . WARNING: DO NOT DISCONTINUE ABRUPTLY See full prescribing information for complete boxed warning Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include 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. Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at apparent risk (e.g., spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or

Contraindications

4 CONTRAINDICATIONS Baclofen oral suspension is contraindicated in patients with hypersensitivity to baclofen. Hypersensitivity to baclofen ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary There are no adequate data on the risk of major birth defects, miscarriages, or other maternal adverse outcomes associated with the use of baclofen in pregnant women. There are adverse effects on fetal outcomes associated with withdrawal from baclofen after delivery (see Clinical Considerations ) . Oral administration of baclofen to pregnant rats resulted in an increased incidence of fetal structural abnormalities at a dose that was also associated with maternal toxicity. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Baclofen may increase the risk of late-onset neonatal withdrawal symptoms [see Warnings and Precautions ( 5.2 )] . Data Animal Data Baclofen given orally has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times on a mg/kg basis, or 3 times on a mg/m 2 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.

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine, supplemented with a small number of well-established interactions from curated clinical references. For informational purposes only. Always consult your pharmacist or physician.