METAXALONE tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Preferred Pharmaceuticals Inc.

INN (mednarodno ime):

METAXALONE

Sestava:

METAXALONE 800 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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.

Povzetek izdelek:

Metaxalone Tablets, USP 800 mg are available as pink, capsule shape scored tablet debossed with ‘SG’ on scored side and ‘323’ on the other. 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. You can ask your pharmacist or doctor for information about Metaxalone Tablets USP, or call 1-888-375-3784. Rx Only Repackaged By: Preferred Pharmaceuticals Inc.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

METAXALONE- METAXALONE TABLET
PREFERRED PHARMACEUTICALS INC.
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METAXALONE TABLETS, USP
DESCRIPTION
Metaxalone Tablets, USP are available as an 800 mg, capsule shaped,
scored pink tablet. 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 800 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_
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.
T