Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Metaxalone Tablets, USP 800 mg are available as pink, capsule shape scored tablet debossed with ‘SG’ on scored side and ‘323’ on the other. NDC 71205-016-10: Bottles of 10 Tablets NDC 71205-016-30: Bottles of 30 Tablets NDC 71205-016-60: Bottles of 60 Tablets NDC 71205-016-90: Bottles of 90 Tablets Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in well-closed, light-resistant containers. You can ask your pharmacist or doctor for information about Metaxalone Tablets USP, or call 1-888-375-3784. Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, USA Manufactured for: Dr.Reddy’s Laboratories Inc. Princeton, New Jersey 08540, USA Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Issued: 06/17; PRINCIPAL DISPLAY PANEL NDC 71205-016-60 This container is not intended for household use. Metaxalone Tablets, USP 800 mg Rx Only 60 Tablets SEALED FOR YOUR PROTECTION 71205-016-60
- HOW SUPPLIED Metaxalone Tablets, USP 800 mg are available as pink, capsule shape scored tablet debossed with ‘SG’ on scored side and ‘323’ on the other. NDC 71205-016-10: Bottles of 10 Tablets NDC 71205-016-30: Bottles of 30 Tablets NDC 71205-016-60: Bottles of 60 Tablets NDC 71205-016-90: Bottles of 90 Tablets Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in well-closed, light-resistant containers. You can ask your pharmacist or doctor for information about Metaxalone Tablets USP, or call 1-888-375-3784. Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, USA Manufactured for: Dr.Reddy’s Laboratories Inc. Princeton, New Jersey 08540, USA Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Issued: 06/17
- PRINCIPAL DISPLAY PANEL NDC 71205-016-60 This container is not intended for household use. Metaxalone Tablets, USP 800 mg Rx Only 60 Tablets SEALED FOR YOUR PROTECTION 71205-016-60
Overview
Metaxalone Tablets, USP are available as an 800 mg, capsule shaped, scored pink tablet. Chemically, metaxalone, USP is 5-[(3,5-dimethylphenoxy)methyl]-2-oxazolidinone. The empirical formula is C 12 H 15 NO 3 , which corresponds to a molecular weight of 221.25. The structural formula is: 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 800 mg metaxalone, USP and the following inactive ingredients: alginic acid, corn starch, ferric oxide red, copovidone, magnesium stearate, povidone, pregelatinized starch, sodium alginate. Metaxalone 800 mg - Chemical Structure
Indications & Usage
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. Metaxalone does not directly relax tense skeletal muscles in man.
Dosage & Administration
The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.
Warnings & Precautions
WARNINGS Metaxalone may enhance the effects of alcohol and other CNS depressants.
Contraindications
Known hypersensitivity to any components of this product. Known tendency to drug induced, hemolytic, or other anemias. Significantly impaired renal or hepatic function.
Adverse Reactions
The most frequent reactions to metaxalone include: CNS: drowsiness, dizziness, headache, and nervousness or “irritability”; Digestive: nausea, vomiting, gastrointestinal upset. Other adverse reactions are: Immune System: hypersensitivity reaction, rash with or without pruritus; Hematologic: leukopenia; hemolytic anemia; Hepatobiliary: jaundice. Though rare, anaphylactoid reactions have been reported with metaxalone. To report SUSPECTED ADVERSE REACTIONS, contact Dr.Reddy’s Laboratories, Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch
Drug Interactions
The sedative effects of metaxalone and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously.
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