País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
METAXALONE (UNII: 1NMA9J598Y) (METAXALONE - UNII:1NMA9J598Y)
Sterling-Knight Pharmaceuticals, LLC
ORAL
PRESCRIPTION DRUG
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. Known hypersensitivity to any components of this product. Known tendency to drug induced, hemolytic, or other anemias. Significantly impaired renal or hepatic function.
Metaxalone Tablets, USP 400 mg are available as light pink, round shaped tablet debossed with ‘SG 474’ on one side and plain on the other. NDC 69336-130-30: Bottles of 30 Tablets NDC 69336-130-01: Bottles of 100 Tablets NDC 69336-130-10: Bottles of 1,000 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. Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Distributed by: Sterling Knight Pharmaceuticals, LLC Ripley, MS 38663 Rev: 05/20
Abbreviated New Drug Application
METAXALONE- METAXALONE TABLET STERLING-KNIGHT PHARMACEUTICALS, LLC ---------- METAXALONE TABLETS, USP 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 C H NO , 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 400 mg metaxalone, USP and the following inactive ingredients: alginic acid, corn starch, ferric oxide red, copovidone, magnesium stearate, povidone, pregelatinized starch, sodium alginate. CLINICAL PHARMACOLOGY MECHANISM OF ACTION The mechanism of action of metaxalone in humans has not been established, but may be due to general central nervous system (CNS) depression. Metaxalone has no direct action on the contractile mechanism of striated muscle, the motor end plate, or the nerve fiber. PHARMACOKINETICS The pharmacokinetics of metaxalone have been evaluated in healthy adult volunteers after single dose administration of metaxalone under fasted and fed conditions at doses ranging from 400 mg to 800 mg. _ABSORPTION_ 12 15 3 Peak plasma concentrations of metaxalone occur approximately 3 hours after a 400 mg oral dose under fasted conditions. Thereafter, metaxalone concentrations decline log-linearly with a terminal half-life of 9.0 ± 4.8 hours. Doubling the dose of metaxalone from 400 mg to 800 mg results in a roughly proportional increase in metaxalone exposure as indicated by peak plasma concentrations (C and area under the curve (AUC). Dose proportionality at doses above 800 mg has not been studied. The absolute bioavailability of metaxalone is not known. The single-dose pharmacokinetic parameters of metaxalone in two groups of healthy volunteers Leer el documento completo