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BACLOFEN (BACLOFEN)
- Muscle spasticity of spinal origin
10 mg tablet
- 1 tablet (10 mg) by oral route 4 times per day
20 mg tablet
- 1 tablet (20 mg) by oral route 4 times per day
5 mg tablet
- 1 tablet (5 mg) by oral route 3 times per day
Muscle spasticity of spinal origin
- 1 tablet (5 mg) by oral route 3 times per day
- 1 tablet (5 mg) by oral route 4 times per day
- 2 tablets (10 mg) by oral route 4 times per day
- 1 tablet (10 mg) by oral route 4 times per day
- 1 tablet (10 mg) by oral route 3 times per day
- 2 tablets (10 mg) by oral route 3 times per day
- 2 tablets (20 mg) by oral route 3 times per day
- 2 tablets (20 mg) by oral route 4 times per day
- 1 tablet (20 mg) by oral route 3 times per day
- 1 tablet (20 mg) by oral route 4 times per day
- 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
- Cerebrovascular accident
- Functional disorder of bladder neck and sphincter
- Psychotic disorder
- Schizophrenia
- Seizure disorder
BACLOFEN (BACLOFEN)
- Muscle spasticity of spinal origin
- None
- Acute confusion
- Constipation
- Dizziness
- Drowsy
- General weakness
- Headache disorder
- Hypotension
- Increased urinary frequency
- Insomnia
- Muscle weakness
- Nausea
More Frequent
Severe
Less Severe
- None
- Fatigue
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Abnormal hepatic function tests
- Chest pain
- Drug-induced hepatitis
- Hematuria
- Pruritus of skin
- Skin rash
- Syncope
- Urine discoloration
Less Severe
- Anorexia
- Body fluid retention
- Dysuria
- Erectile dysfunction
- False sense of well-being
- Gastrointestinal irritation
- Nasal congestion
- Oliguria
- Palpitations
- Tremor
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
- None
| 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 |
| M62.830 | Muscle spasm of back |
| M62.831 | Muscle spasm of calf |
| M62.838 | Other muscle spasm |
| R25.2 | Cramp and spasm |
Formulary Reference Tool