Gablofen (baclofen)
Central Muscle Relaxants Intrathecal Syringe (Ml); Intrathecal Vial (Ml)
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)
Drug class: Central Muscle Relaxants
Therapeutic class: Locomotor System
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.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Gablofen 10,000 Mcg/20 Ml Syrg | Maintenance | Infuse 3.75 mcg/hour (90 mcg/day) by cont intrathecal inf route. |
| Gablofen 10,000 Mcg/20 Ml Vial | Maintenance | Infuse 3.75 mcg/hour (90 mcg/day) by cont intrathecal inf route. |
| Gablofen 20,000 Mcg/20 Ml Syrg | Maintenance | Infuse 3.75 mcg/hour (90 mcg/day) by cont intrathecal inf route. |
| Gablofen 20,000 Mcg/20 Ml Vial | Maintenance | Infuse 3.75 mcg/hour (90 mcg/day) by cont intrathecal inf route. |
| Gablofen 40,000 Mcg/20 Ml Syrg | Maintenance | Infuse 3.75 mcg/hour (90 mcg/day) by cont intrathecal inf route. |
| Gablofen 40,000 Mcg/20 Ml Vial | Maintenance | Infuse 3.75 mcg/hour (90 mcg/day) by cont intrathecal inf route. |
| Drug label | Dosing type | Instructions |
|---|---|---|
| Baclofen 40,000 Mcg/20 Ml Vial | Maintenance | Infuse 3.75 mcg/hour (90 mcg/day) by cont intrathecal inf route. |
| Baclofen 10 Mg/20 Ml Vial | Maintenance | Infuse 3.75 mcg/hour (90 mcg/day) by cont intrathecal inf route. |
| Baclofen 40 Mg/20 Ml Vial | Maintenance | Infuse 3.75 mcg/hour (90 mcg/day) by cont intrathecal inf route. |
| Baclofen 20,000 Mcg/20 Ml Vial | Maintenance | Infuse 3.75 mcg/hour (90 mcg/day) by cont intrathecal inf route. |
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.
- 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
Adverse reactions
There is no enhanced messaging for this drug.
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
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
| Code | Type | Description |
|---|---|---|
| Muscle spasticity of cerebral origin | ||
| G81.10 | ICD10CM | Spastic hemiplegia affecting unspecified side |
| G81.11 | ICD10CM | Spastic hemiplegia affecting right dominant side |
| G81.12 | ICD10CM | Spastic hemiplegia affecting left dominant side |
| G81.13 | ICD10CM | Spastic hemiplegia affecting right nondominant side |
| G81.14 | ICD10CM | Spastic hemiplegia affecting left nondominant side |
| M62.83 | ICD10CM | Muscle spasm |
| M62.830 | ICD10CM | Muscle spasm of back |
| M62.831 | ICD10CM | Muscle spasm of calf |
| M62.838 | ICD10CM | Other muscle spasm |
| R25.2 | ICD10CM | Cramp and spasm |
| Muscle spasticity of spinal origin | ||
| G81.1 | ICD10CM | Spastic hemiplegia |
| G81.10 | ICD10CM | Spastic hemiplegia affecting unspecified side |
| G81.11 | ICD10CM | Spastic hemiplegia affecting right dominant side |
| G81.12 | ICD10CM | Spastic hemiplegia affecting left dominant side |
| G81.13 | ICD10CM | Spastic hemiplegia affecting right nondominant side |
| G81.14 | ICD10CM | Spastic hemiplegia affecting left nondominant side |
| M62.83 | ICD10CM | Muscle spasm |
| M62.830 | ICD10CM | Muscle spasm of back |
| M62.831 | ICD10CM | Muscle spasm of calf |
| M62.838 | ICD10CM | Other muscle spasm |
| R25.2 | ICD10CM | Cramp and spasm |
ICD code information from First Databank (FDB).
Formulary status
Search health-plan coverage for this drug by ZIP code.
Choose the first character of a health plan name.
Last reviewed · Source: First Databank (FDB) drug data
On this page
Actions
Sign in to save favorites
Saving this drug requires a free Physicians Office Resource account.