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Indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions.

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Metaxalone Tablets

MUSCLE SPASMS and PAIN RELIEF

Metaxalone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties.

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Metaxalone
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Understanding Spasticity Versus Spasm

Muscle relaxants treat 2 conditions: spasticity and spasm. Spasticity is marked by long-term muscle contraction caused by a brain or spinal cord injury. Spasms, on the other hand, are localized and occur because of a musculoskeletal issue.

MThere are numerous painful conditions associated with muscle spasm, most frequently these are musculoskeletal disorders such as muscle strain and central nervous system disorders associated with spasticity

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Metaxalone Tablets, USP 400mg

DOSAGE AND ADMINISTRATION

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

Although grouped under a single drug class, skeletal muscle relaxants are a heterogeneous group of structurally unrelated medications with variable pharmacologic and safety profiles.1-3 Skeletal muscle relaxants are used commonly for the treatment of 2 conditions: spasticity and local musculoskeletal spasms. Approximately 2 million Americans, including more than 300,000 people over 60 years of age, are prescribed muscle relaxants.3

Spasticity and spasms are distinct etiologies, and each condition responds differently to certain medications. Spasticity is a disorder of motor neurons that manifests as increased muscle tone and stiffness.4 Spasms are involuntary localized muscle contractions that arise from acute trauma or muscle strain.

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Important Safety Information

DESCRIPTION

Metaxalone tablets, USP are available as 400 mg, 400 mg tablets are round shaped, light pink tablets.

Chemically, metaxalone, USP is 5-[(3,5-dimethylphenoxy)methyl]-2-oxazolidinone. The empirical formula is C12H15NO3 , which corresponds to a molecular weight of 221.25.

Metaxalone, USP is a white to almost white, crystalline powder freely soluble in dichloromethane, soluble in methanol, sparingly soluble in ethanol and ethyl acetate, slightly soluble in toluene and isopropanol, insoluble in water and n--hexane.

Each tablet contains 400 mg metaxalone, USP and the following inactive ingredients: alginic acid, corn starch, ferric oxide red, copovidone, magnesium stearate, povidone, pregelatinized starch, sodium alginate.

INDICATIONS AND USAGE

Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.

CONTRAINDICATIONS

Known hypersensitivity to any components of this product.

Known tendency to drug induced, hemolytic, or other anemias.

Significantly impaired renal or hepatic function.

PRECAUTIONS

Metaxalone should be administered with great care to patients with pre-existing liver damage. Serial liver function studies should be performed in these patients.

False-positive Benedict’s tests, due to an unknown reducing substance, have been noted. A glucose-specific test will differentiate findings.

Taking metaxalone with food may enhance general CNS depression; elderly patients may be especially susceptible to this CNS effect. (See Warnings in Prescribing Information).

PRESCRIBING INFORMATION

Sterling Knight Pharmaceuticals

Sterling Knight Pharmaceuticals has been dedicated to the development and marketing of branded and generic specialty drugs, targeting specific therapeutic categories. With a strong foundation built upon research, development and advanced technology, it is our goal to continue introducing new, exclusive and proven products to the market. Our experienced management team is here to innovate and meet your needs so you can focus on building a stronger relationship with your patients.

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Sterling Knight Pharmaceuticals

Sterling Knight Pharmaceuticals, LLC

106 E Mulberry St
   Ripley, MS 38663

1-662-661-3232