Gablofen (baclofen)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Baclofen, a gamma-aminobutyric acid (GABA) derivative, is a skeletal muscle relaxant and antispastic agent.
USES: Baclofen is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, cerebral palsy, spinal cord injury/disease). It works by helping to relax the muscles. Baclofen injection is used by patients who do not respond to or who cannot tolerate the side effects of baclofen taken by mouth.
Generic name: baclofen
Pronunciation: (BAK-loe-fen)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Gablofen
Indications
The following indications are listed for Gablofen:
- Muscle Spasticity Of Cerebral Origin
- Muscle Spasticity Of Spinal Origin
Dosing
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.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
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.
Contraindications
There is no enhanced messaging for this drug.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
There is no enhanced messaging for this drug.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
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.
No enhanced messaging available.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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