Risk Summary
There are no available data on SKELAXIN use in pregnant patients to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes despite decades of metaxalone use. Reproduction studies in rats have not revealed effects on the fetus due to metaxalone.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Risk Summary
There are no data available to evaluate the presence of metaxalone or its metabolite in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SKELAXIN and any potential adverse effects on the breastfed infant from SKELAXIN or from the underlying maternal condition.
SKELAXIN is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions in pediatric patients 13 years of age and older. The safety and effectiveness of SKELAXIN in pediatric patients 12 years of age or younger have not been established.
Clinical studies of SKELAXIN did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Geriatric patients may be especially susceptible to CNS depression associated with SKELAXIN use [see Warnings and Precautions (5.2)].
The recommended SKELAXIN dosage in patients 65 years of age and older is the same as in younger adult patients. Metaxalone peak plasma concentrations (Cmax) and area under the curve (AUC) were higher in patients 65 years of age and older in the fasted state; however, a clinically significant difference was not observed when metaxalone was administered in the fed state [see Clinical Pharmacology (12.3)].
SKELAXIN is contraindicated in patients with severe hepatic impairment. SKELAXIN should be used with caution and additional follow-up should be considered in patients with mild to moderate hepatic impairment. The effect of hepatic impairment on metaxalone pharmacokinetics is unknown; however, metaxalone undergoes expensive hepatic metabolism [see Clinical Pharmacology (12.3)].
SKELAXIN is contraindicated in patients with severe renal impairment. SKELAXIN should be used with caution and additional follow-up should be considered in patients with mild to moderate renal impairment. The effect of renal impairment on metaxalone pharmacokinetics is unknown; however, metaxalone undergoes renal excretion as unidentified metabolites [see Clinical Pharmacology (12.3)].
Risk Summary
There are no available data on SKELAXIN use in pregnant patients to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes despite decades of metaxalone use. Reproduction studies in rats have not revealed effects on the fetus due to metaxalone.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Risk Summary
There are no data available to evaluate the presence of metaxalone or its metabolite in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SKELAXIN and any potential adverse effects on the breastfed infant from SKELAXIN or from the underlying maternal condition.
SKELAXIN is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions in pediatric patients 13 years of age and older. The safety and effectiveness of SKELAXIN in pediatric patients 12 years of age or younger have not been established.
Clinical studies of SKELAXIN did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Geriatric patients may be especially susceptible to CNS depression associated with SKELAXIN use [see Warnings and Precautions (5.2)].
The recommended SKELAXIN dosage in patients 65 years of age and older is the same as in younger adult patients. Metaxalone peak plasma concentrations (Cmax) and area under the curve (AUC) were higher in patients 65 years of age and older in the fasted state; however, a clinically significant difference was not observed when metaxalone was administered in the fed state [see Clinical Pharmacology (12.3)].
SKELAXIN is contraindicated in patients with severe hepatic impairment. SKELAXIN should be used with caution and additional follow-up should be considered in patients with mild to moderate hepatic impairment. The effect of hepatic impairment on metaxalone pharmacokinetics is unknown; however, metaxalone undergoes expensive hepatic metabolism [see Clinical Pharmacology (12.3)].
SKELAXIN is contraindicated in patients with severe renal impairment. SKELAXIN should be used with caution and additional follow-up should be considered in patients with mild to moderate renal impairment. The effect of renal impairment on metaxalone pharmacokinetics is unknown; however, metaxalone undergoes renal excretion as unidentified metabolites [see Clinical Pharmacology (12.3)].
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