Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
METAXALONE (UNII: 1NMA9J598Y) (METAXALONE - UNII:1NMA9J598Y)
STAT Rx USA LLC
METAXALONE
METAXALONE 800 mg
ORAL
PRESCRIPTION DRUG
SKELAXIN (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. Known hypersensitivity to any components of this product. Known tendency to drug induced, hemolytic, or other anemias. Significantly impaired renal or hepatic function.
SKELAXIN (metaxalone) is available as an 800 mg oval, scored pink tablet inscribed with 8667 on the scored side and “S” on the other. Available in: Bottles of 20 16590-207-20 Bottles of 30 16590-207-30 Bottles of 40 16590-207-40 Bottles of 56 16590-207-56 Bottles of 60 16590-207-60 Bottles of 62 16590-207-84 Bottles of 90 16590-207-90 Bottles of 100 16590-207-71 Bottles of 120 16590-207-72 Store at Controlled Room Temperature, between 15°C and 30°C (59°F and 86°F). Rx Only Prescribing Information as of April 2008. Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620 Manufactured by: Corepharma LLC, Middlesex, NJ 08846 Relabeling and Repackaging by: STAT Rx USA LLC Gainesville, GA 30501
New Drug Application
SKELAXIN- METAXALONE TABLET STAT RX USA LLC ---------- SKELAXIN (METAXALONE) TABLETS DESCRIPTION SKELAXIN (metaxalone) is available as an 800 mg oval, scored pink tablet. Chemically, metaxalone 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 is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water. Each tablet contains 800 mg metaxalone and the following inactive ingredients: alginic acid, ammonium calcium alginate, B-Rose Liquid, corn starch, and magnesium stearate. 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 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 SKELAXIN under fasted and fed conditions at doses ranging from 400 mg to 800 mg. _ABSORPTION_ 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 SKELAXIN 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 are shown in Table 1. ® ® 12 15 3 max TABLE 1: MEAN (%CV) METAXALONE PHARMACOKINETIC PARAMETERS DOSE (mg) C (ng/mL) T (h) AUC (ng•h/mL) T (h) CL/F (L/h) 400 983 (5 Baca dokumen lengkap