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GABLOFEN (BACLOFEN)
- Muscle spasticity of cerebral origin
- Muscle spasticity of spinal origin
- Gablofen Intrathecal Syringe
- Gablofen Intrathecal Solution
- Baclofen Intrathecal Solution
- By Indication
10,000 mcg/20 mL (500 mcg/mL) intrathecal syringe
- Infuse 3.75 mcg/hour (90 mcg/day) by cont intrathecal inf route
20,000 mcg/20 mL (1,000 mcg/mL) intrathecal syringe
- Infuse 3.75 mcg/hour (90 mcg/day) by cont intrathecal inf route
40,000 mcg/20 mL (2,000 mcg/mL) intrathecal syringe
- Infuse 3.75 mcg/hour (90 mcg/day) by cont intrathecal inf route
50 mcg/mL (1 mL) intrathecal syringe
- Dosage information is not available
10,000 mcg/20 mL (500 mcg/mL) intrathecal solution
- Infuse 3.75 mcg/hour (90 mcg/day) by cont intrathecal inf route
20,000 mcg/20 mL (1,000 mcg/mL) intrathecal solution
- Infuse 3.75 mcg/hour (90 mcg/day) by cont intrathecal inf route
40,000 mcg/20 mL (2,000 mcg/mL) intrathecal solution
- Infuse 3.75 mcg/hour (90 mcg/day) by cont intrathecal inf route
10,000 mcg/20 mL (500 mcg/mL) intrathecal solution
- Infuse 3.75 mcg/hour (90 mcg/day) by cont intrathecal inf route
2,000 mcg/mL intrathecal solution
- Infuse 3.75 mcg/hour (90 mcg/day) by cont intrathecal inf route
20,000 mcg/20 mL (1,000 mcg/mL) intrathecal solution
- Infuse 3.75 mcg/hour (90 mcg/day) by cont intrathecal inf route
40,000 mcg/20 mL (2,000 mcg/mL) intrathecal solution
- Infuse 3.75 mcg/hour (90 mcg/day) by cont intrathecal inf route
50 mcg/mL intrathecal solution
- Infuse 3.75 mcg/hour (90 mcg/day) by cont intrathecal inf route
500 mcg/mL intrathecal solution
- Dosage information is not available
Muscle spasticity of cerebral origin
- Infuse 0.9 mcg/hour (22 mcg/day) by cont intrathecal inf route
- Infuse 3.75 mcg/hour (90 mcg/day) by cont intrathecal inf route
- Infuse 58.33 mcg/hour (1,400 mcg/day) by cont intrathecal inf route
- Infuse 29.3 mcg/hour (703 mcg/day) by cont intrathecal inf route
Muscle spasticity of spinal origin
- Infuse 0.5 mcg/hour (12 mcg/day) by cont intrathecal inf route
- Infuse 83.46 mcg/hour (2,003 mcg/day) by cont intrathecal inf route
- Infuse 12.5 mcg/hour (300 mcg/day) by cont intrathecal inf route
- Infuse 33.33 mcg/hour (800 mcg/day) by cont intrathecal inf route
- None
Contraindicated
- None
Severe
Moderate
- None
- Chronic kidney disease stage 5 (failure) GFr<15 ml/min
Contraindicated
- Chronic kidney disease stage 3A (moderate) GFR 45-59
- Chronic kidney disease stage 3B (moderate) GFR 30-44
- Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
- Kidney disease with likely reduction in GFR
Severe
Moderate
- Acute confusion
- Autonomic dysreflexia
- Autonomic neuropathy
- Psychotic disorder
- Schizophrenia
GABLOFEN (BACLOFEN)
- Muscle spasticity of cerebral origin
- Muscle spasticity of spinal origin
- Seizure disorder
- Constipation
- Dizziness
- Drowsy
- Headache disorder
- Hypotonia
- Nausea
- Paresthesia
- Vomiting
More Frequent
Severe
Less Severe
- Pneumonia
- Acute confusion
- Administration site infection
- Agitation
- Ataxia
- Chills
- Diarrhea
- Dysphasia
- Dyspnea
- Edema
- Erectile dysfunction
- Hypotension
- Increased urinary frequency
- Insomnia
- Leukocytosis
- Nystagmus
- Pain
- Peripheral edema
- Pruritus of skin
- Tremor
- Urinary incontinence
- Urinary retention
- Urticaria
- Xerostomia
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Abrupt drug withdrawal causing life-threatening sequelae
- Anemia
- Apnea
- Coma
- Depression
- General weakness
- Hallucinations
- Hypertension
- Hyperventilation
- Syncope
- Tinnitus
- Visual changes
Less Severe
- Acute abdominal pain
- Alopecia
- Anorexia
- Diplopia
- Dysarthria
- Fever
- Flatulence
- Gait abnormality
- Hyperhidrosis
- Symptoms of anxiety
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Baclofen
Safety and efficacy not established age <4 years.
- 1 Day – 4 Years
- Safety and efficacy not established age <4 years.
Baclofen
- Severity Level:
C
- Additional Notes: Insuff. human data; increased incidence of omphalocele in rats at 3 times mrhd
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Baclofen
Limited data suggest amount excreted is minimal, may cause sedation in infant
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Excreted | Not known; no or inclusive data | Limited data suggest amount excreted is minimal, may cause sedation in infant |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
Baclofen
Neuro/Psych- Risk of confusion, sedation and cognitive impair may lead to inc falls. In clinical trials, reported incidence of drowsiness, dizziness, confusion is greater than 15%. Dose cautiously in the elderly. Consider starting oral doses at 5mg three times daily or lower. Renal-Avoid with eGFR <60 mL/min due to inc risk of encephalopathy/hospitalization. Monitor closely if unable to be avoided. Cardiovascular-Hypotension risk; Titrate slowly. Urogenital-Risk for urinary retention.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | Y | N | N | Y | N | N |
BEERS: Y HEDIS: N STOPP: N
No Known Risk
None
- Do not stop using this medication without consulting your doctor. Serious (rarely fatal) withdrawal problems may occur if this medication is suddenly stopped. Get medical help right away if you have any signs of a withdrawal reaction, including: itching, numb/tingling skin, high fever, mental/mood changes (such as confusion), seizures, worsening muscle tightness/stiffness, signs of kidney problems (such as change in the amount of urine).<br /><br />Tell your doctor if you ever had a withdrawal reaction from baclofen. Keep all appointments for refilling the pump to avoid any serious withdrawal problems. Your doctor or another health care professional will check that the pump is programmed and working properly during these appointments.<br /><br />If you must miss a refill appointment, contact your doctor right away to reschedule the appointment before you run out of medication. Also, learn what your pump alarm sounds like. If you hear the alarm, contact your doctor right away.
| Muscle spasticity of cerebral origin | |
| M62.83 | Muscle spasm |
| M62.830 | Muscle spasm of back |
| M62.831 | Muscle spasm of calf |
| M62.838 | Other muscle spasm |
| R25.2 | Cramp and spasm |
| Muscle spasticity of spinal origin | |
| M62.83 | Muscle spasm |
| M62.830 | Muscle spasm of back |
| M62.831 | Muscle spasm of calf |
| M62.838 | Other muscle spasm |
| R25.2 | Cramp and spasm |
| 0-9 | A-Z |
|---|---|
| M62.83 | Muscle spasm |
| M62.83 | Muscle spasm |
| M62.830 | Muscle spasm of back |
| M62.830 | Muscle spasm of back |
| M62.831 | Muscle spasm of calf |
| M62.831 | Muscle spasm of calf |
| M62.838 | Other muscle spasm |
| M62.838 | Other muscle spasm |
| R25.2 | Cramp and spasm |
| R25.2 | Cramp and spasm |
Formulary Reference Tool