METAXALONE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

BluePoint Laboratories

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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.

제품 요약:

Metaxalone Tablets, USP 800 mg are available as pink, capsule shape scored tablet debossed with ‘SG’ on scored side and ‘323’ on the other. NDC 68001-485-00: 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. You can ask your pharmacist or doctor for information about Metaxalone Tablets USP, or call 1-888-375-3784. Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, For BluePoint Laboratories Rev: 08/21

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

METAXALONE- METAXALONE TABLET
BLUEPOINT LABORATORIES
----------
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
12
15
3
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.