METAXALONE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

Metaxalone (UNII: 1NMA9J598Y) (Metaxalone - UNII:1NMA9J598Y)

Dostupno od:

Cameron Pharmaceuticals

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Metaxalone tablets 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.

Proizvod sažetak:

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 42494-449-10: Bottles of 100 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.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

METAXALONE- METAXALONE TABLET
CAMERON PHARMACEUTICALS
----------
METAXALONE TABLETS, USP
DESCRIPTION
Metaxalone tablets, USP are available as 400 mg 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, odorless 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 are shown in Table 1.