Dosing and uses of Skelaxin (metaxalone)
Adult dosage forms and strengths
tablet
- 800mg
Acute Painful Musculoskeletal Conditions
800 mg PO q6-8hr
Systemic Sclerosis (Orphan)
Uvadex
In conjunction with the UVAR photopheresis to treat diffuse systemic sclerosis
Orphan indication sponsor
- Therakos, Inc; Oaklands Corporate Center; 437 Creamery Way; Exton, PA 19341
Cardiac Allograft Rejection (Orphan)
Uvadex
Prevention of acute rejection of cardiac allografts
Orphan indication sponsor
- Therakos, Inc; Oaklands Corporate Center; 437 Creamery Way; Exton, PA 19341
Dosing Modifications
Renal impairment
- Mild to moderate impairment: Use caution
- Severe impairment: Contraindicated
Hepatic impairment
- Mild to moderate impairment: Use caution
- Severe impairment: Contraindicated
Pediatric dosage forms and strengths
tablet
- 800mg
Musculoskeletal Pain
<12 years: Safety and efficacy not established
>12 years: 800 mg PO q6-8hr
Systemic Sclerosis (Orphan)
Uvadex
In conjunction with the UVAR photopheresis to treat diffuse systemic sclerosis
Orphan indication sponsor
- Therakos, Inc; Oaklands Corporate Center; 437 Creamery Way; Exton, PA 19341
Cardiac Allograft Rejection (Orphan)
Uvadex
Prevention of acute rejection of cardiac allografts
Orphan indication sponsor
- Therakos, Inc; Oaklands Corporate Center; 437 Creamery Way; Exton, PA 19341
Skelaxin (metaxalone) adverse (side) effects
Frequency not defined
Drug-induced gastrointestinal disturbance
Nausea
Vomiting
Dizziness
Headache
Somnolence
Nervousness
Hemolytic anemia (rare)
Leukopenia (rare)
Jaundice (rare)
Immune hypersensitivity reaction (rare)
Warnings
Contraindications
Hypersensitivity
History of drug-induced hemolytic anemia
Significant renal/hepatic impairment
Cautions
CNS depression may occur
Sedative effects may be potentiated when used with other sedatives
Medication is poorly tolerated by the elderly
Bioavailability may increase in female patients
Use caution in renal and hepatic impairment
Safety and efficacy not established in children <12 years
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown if excreted in breast milk; not recommended
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Skelaxin (metaxalone)
Mechanism of action
General CNS depression; no direct effect on skeletal muscle; may disrupt the spasm-pain-spasm cycle; does not havae direct effect on skeletal muscle
Absorption
Onset: Within 1 hr
Duration: 4-6 hr
Peak plasma time: 3 hr
Peak plasma concentration: 296 mcg/mL
Distribution
Vd: 800 L
Metabolism
Liver
Metabolites: Unidentified
Elimination
Half-life elimination: 4-14 hr
Excretion: Urine
