SKELAXIN® Highlights

(metaxalone)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use SKELAXIN safely and effectively. See full prescribing information for SKELAXIN.

SKELAXIN (metaxalone) tablets, for oral use
Initial U.S. Approval: 1962

RECENT MAJOR CHANGES

Dosage and Administration (2)

6/2024

INDICATIONS AND USAGE

SKELAXIN is a muscle relaxant indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions in adults and pediatric patients 13 years of age and older. (1)

DOSAGE AND ADMINISTRATION

•
Recommended dosage of SKELAXIN in adults and pediatric patients 13 years of age and older is 800 mg orally three to four times a day. (2)
•
SKELAXIN (metaxalone) tablets 800 mg are not substitutable on a mg to mg basis with Metaxalone Tablets, 640 mg. When it is appropriate to switch, see the Full Prescribing Information on switching instructions. (2)

DOSAGE FORMS AND STRENGTHS

Tablets: 800 mg oval, pink inscribed with 8667 on one side and "S" on the other side. (3)

CONTRAINDICATIONS

•
Known hypersensitivity to any components of this product. (4)
•
Known tendency to drug induced, hemolytic, or other anemias. (4)
•
Severe renal or hepatic impairment. (4)

WARNINGS AND PRECAUTIONS

•
Serotonin Syndrome: Cases of serotonin syndrome, a potentially life‑threatening condition, have been reported during concomitant use of SKELAXIN (within the recommended dosage range) and other serotonergic drugs and with the use of SKELAXIN as the only serotonergic drug taken at a dosage higher than the recommended dosage. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dosage increases. Discontinue SKELAXIN if serotonin syndrome is suspected or it occurs. (5.1, 7.1)
•
Central Nervous System (CNS) Depression: SKELAXIN may impair mental and/or physical abilities required for the performance of hazardous tasks, such as operating machinery or driving a motor vehicle, especially when used with other CNS depressants including alcohol. Follow patients closely for signs and symptoms of respiratory depression and sedation. If concomitant use is warranted, closely monitor for signs of respiratory depression and sedation, particularly during treatment initiation and dosage increases. (5.2, 7.2)

ADVERSE REACTIONS

Most common adverse reactions (incidence >5%) are nausea and vomiting. (6)

To report SUSPECTED ADVERSE REACTIONS, contact King Pharmaceuticals, Inc. at toll-free phone 1‑800‑438‑1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Geriatric Use: SKELAXIN-treated geriatric patients may be especially susceptible to CNS depression. (8.5)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 6/2024

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use SKELAXIN safely and effectively. See full prescribing information for SKELAXIN.

SKELAXIN (metaxalone) tablets, for oral use
Initial U.S. Approval: 1962

RECENT MAJOR CHANGES

Dosage and Administration (2)

6/2024

INDICATIONS AND USAGE

SKELAXIN is a muscle relaxant indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions in adults and pediatric patients 13 years of age and older. (1)

DOSAGE AND ADMINISTRATION

•
Recommended dosage of SKELAXIN in adults and pediatric patients 13 years of age and older is 800 mg orally three to four times a day. (2)
•
SKELAXIN (metaxalone) tablets 800 mg are not substitutable on a mg to mg basis with Metaxalone Tablets, 640 mg. When it is appropriate to switch, see the Full Prescribing Information on switching instructions. (2)

DOSAGE FORMS AND STRENGTHS

Tablets: 800 mg oval, pink inscribed with 8667 on one side and "S" on the other side. (3)

CONTRAINDICATIONS

•
Known hypersensitivity to any components of this product. (4)
•
Known tendency to drug induced, hemolytic, or other anemias. (4)
•
Severe renal or hepatic impairment. (4)

WARNINGS AND PRECAUTIONS

•
Serotonin Syndrome: Cases of serotonin syndrome, a potentially life‑threatening condition, have been reported during concomitant use of SKELAXIN (within the recommended dosage range) and other serotonergic drugs and with the use of SKELAXIN as the only serotonergic drug taken at a dosage higher than the recommended dosage. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dosage increases. Discontinue SKELAXIN if serotonin syndrome is suspected or it occurs. (5.1, 7.1)
•
Central Nervous System (CNS) Depression: SKELAXIN may impair mental and/or physical abilities required for the performance of hazardous tasks, such as operating machinery or driving a motor vehicle, especially when used with other CNS depressants including alcohol. Follow patients closely for signs and symptoms of respiratory depression and sedation. If concomitant use is warranted, closely monitor for signs of respiratory depression and sedation, particularly during treatment initiation and dosage increases. (5.2, 7.2)

ADVERSE REACTIONS

Most common adverse reactions (incidence >5%) are nausea and vomiting. (6)

To report SUSPECTED ADVERSE REACTIONS, contact King Pharmaceuticals, Inc. at toll-free phone 1‑800‑438‑1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Geriatric Use: SKELAXIN-treated geriatric patients may be especially susceptible to CNS depression. (8.5)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 6/2024
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