Baclofen (baclofen)

Because baclofen is excreted principally in urine as unchanged drug, it may be necessary to reduce either oral or intrathecal dosage in patients with impaired renal function. (See Cautions: Precautions and Contraindications.)

Baclofen is administered orally or intrathecally. Abrupt discontinuance of the drug, including inadvertent discontinuance of the intrathecal infusion, should be avoided because of the risk of precipitating withdrawal.

Experience with concomitant use of intrathecal baclofen with other drugs is insufficient to predict specific drug-drug interactions.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

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• Chronic kidney disease stage 5 (failure) GFr<15 ml/min

• Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min
• Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min
• Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
• Kidney disease with likely reduction in glomerular filtration rate (GFr)

• Acute cognitive impairment
• Autonomic dysreflexia
• Autonomic neuropathy
• Lower seizure threshold
• Parkinsonism
• Psychotic disorder
• Schizophrenia
• Scoliosis
• Seizure disorder
• Suicidal ideation

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More Frequent

• Seizure disorder

Less Frequent

• Pneumonia

Rare or Very Rare

• Abrupt drug withdrawal causing life-threatening sequelae
• Anemia
• Apnea
• Coma
• Depression
• General weakness
• Hallucinations
• Hypersensitivity drug reaction
• Hypertension
• Hyperventilation
• Syncope
• Tinnitus
• Visual changes

More Frequent

• Constipation
• Dizziness
• Drowsy
• Headache disorder
• Hypotonia
• Nausea
• Paresthesia
• Vomiting

Less Frequent

• Acute cognitive impairment
• Agitation
• Ataxia
• Chills
• Diarrhea
• Dysphasia
• Dyspnea
• Edema
• Erectile dysfunction
• Hypotension
• Increased urinary frequency
• Injection site infection
• Insomnia
• Leukocytosis
• Nystagmus
• Pain
• Peripheral edema
• Pruritus of skin
• Tremor
• Urinary incontinence
• Urinary retention
• Urticaria
• Xerostomia

Rare or Very Rare

• Acute abdominal pain
• Alopecia
• Anorexia
• Diplopia
• Dysarthria
• Fever
• Flatulence
• Gait abnormality
• Hyperhidrosis
• Symptoms of anxiety

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No enhanced messaging available.

Reproduction studies in rats receiving oral baclofen at a dosage approximately 13 or 3 times the maximum recommended human oral dosage on a mg/kg or mg/m2 basis, respectively, demonstrated an increased incidence of omphaloceles (ventral hernias) in the fetuses; substantial reductions in food intake and weight gain occurred in pregnant rats receiving this dosage. An increased incidence of omphaloceles did not occur in mice or rabbit fetuses. An increased incidence of incomplete sternebral ossification occurred in the fetuses of rats receiving approximately 13 times the maximum recommended human dosage, and an increased incidence of unossified phalangeal nuclei of the forelimbs and hindlimbs occurred in the fetuses of rabbits receiving approximately 7 times the maximum recommended dosage. No teratogenic effects occurred in mice, although reduction in mean fetal weight with consequent delay in skeletal ossification occurred in offspring of mice receiving 17 or 34 times the human daily dosage of baclofen. There are no adequate and controlled studies using baclofen in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.

Baclofen is distributed into milk following oral administration; it not known whether the drug distributes into milk following intrathecal administration. At least one manufacturer states that nursing should not be undertaken by women receiving oral baclofen. Nursing should be undertaken by women receiving intrathecal baclofen only if the potential benefit justifies the potential risks to the infant.

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