METAXALONE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

METAXALONE (UNII: 1NMA9J598Y) (METAXALONE - UNII:1NMA9J598Y)

Disponível em:

Sterling-Knight Pharmaceuticals, LLC

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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.

Resumo do produto:

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

Status de autorização:

Abbreviated New Drug Application

Características técnicas

METAXALONE- METAXALONE TABLET
STERLING-KNIGHT PHARMACEUTICALS, LLC
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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