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. Unit dose packages of 30 (3 x 10) NDC 60687-663-21 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]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. You can ask your pharmacist or doctor for information about Metaxalone Tablets USP, or call Dr. Reddy's Laboratories, Inc. at 1-888-375-3784. For more information about the packaging or labeling, call American Health Packaging at 1-800-707-4621. Rx Only; Package/Label Display Panel – Carton – 800 mg NDC 60687- 663 -21 Metaxalone Tablets, USP 800 mg 30 Tablets (3 x 10) Rx Only Each Tablet Contains: Metaxalone, USP....................................................................800 mg Usual Dosage: The recommended dose for adults and children over 12 years of age is one tablet (800 mg) three to four times a day. See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 68001-485, BluePoint Laboratories. Distributed by: American Health Packaging, Columbus, Ohio 43217 766321 0466321/0824 800mg Metaxalone Tablets Carton; Package/Label Display Panel – Blister – 800 mg Metaxalone Tablet, USP 800 mg 800 mg Metaxalone Tablet Blister
- 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. Unit dose packages of 30 (3 x 10) NDC 60687-663-21 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]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. You can ask your pharmacist or doctor for information about Metaxalone Tablets USP, or call Dr. Reddy's Laboratories, Inc. at 1-888-375-3784. For more information about the packaging or labeling, call American Health Packaging at 1-800-707-4621. Rx Only
- Package/Label Display Panel – Carton – 800 mg NDC 60687- 663 -21 Metaxalone Tablets, USP 800 mg 30 Tablets (3 x 10) Rx Only Each Tablet Contains: Metaxalone, USP....................................................................800 mg Usual Dosage: The recommended dose for adults and children over 12 years of age is one tablet (800 mg) three to four times a day. See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 68001-485, BluePoint Laboratories. Distributed by: American Health Packaging, Columbus, Ohio 43217 766321 0466321/0824 800mg Metaxalone Tablets Carton
- Package/Label Display Panel – Blister – 800 mg Metaxalone Tablet, USP 800 mg 800 mg Metaxalone Tablet Blister
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. Structural Formula
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 Serotonin Syndrome Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of serotonergic drugs with metaxalone used within the recommended dosage range (see PRECAUTIONS: Drug Interactions ) and with metaxalone as a single agent taken at doses higher than the recommended dose (see OVERDOSAGE ). Serotonergic drugs include selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, opioids (particularly fentanyl, meperidine, and methadone), drugs that affect the serotonergic neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and drugs that impair metabolism of serotonin (including monoamine oxidase (MAO) inhibitors, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue) (see PRECAUTIONS: Drug Interactions ). Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms generally occurs within several hours to a few days, but may occur later than that. Discontinue metaxalone if serotonin syndrome is suspected. Risks from Concomitant Use with Alcohol or other CNS Depressants The sedative effects of metaxalone and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants (TCAs)) may be additive. Exercise caution with patients who take more than one of these CNS depressants simultaneously. Follow patients closely for signs and symptoms of respiratory depression and sedation (see PRECAUTIONS: Drug Interactions ).
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: anaphylaxis, hypersensitivity reaction, rash with or without pruritus; Hematologic: leukopenia; hemolytic anemia; Hepatobiliary: jaundice. CNS: cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of serotonergic drugs with metaxalone used within the recommended dosage range and with metaxalone as a single agent taken at doses higher than the recommended dose (see WARNINGS , PRECAUTIONS: Drug Interactions , and OVERDOSAGE ). 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
CNS Depressants: The sedative effects of metaxalone and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants (TCAs)) may be additive. Exercise caution with patients who take more than one of these CNS depressants simultaneously. Follow patients closely for signs and symptoms of respiratory depression and sedation (see WARNINGS ). Serotonergic Drugs: Serotonin syndrome has resulted from concomitant use of serotonergic drugs with metaxalone used within the recommended dosage range (see WARNINGS ). If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue metaxalone if serotonin syndrome is suspected. Examples of serotonergic drugs include: selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, opioids (particularly fentanyl, meperidine, and methadone), drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
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