SKELAXIN- metaxalone tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

STAT Rx USA LLC

INN (Международно Name):

METAXALONE

Композиция:

METAXALONE 800 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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.

Каталог на резюме:

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

Статус Оторизация:

New Drug Application

Данни за продукта

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