METAXALONE tablet

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Rebel Distributors Corp

INN (আন্তর্জাতিক নাম):

METAXALONE

রচনা:

METAXALONE 800 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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.

পণ্য সারাংশ:

Metaxalone tablets are available as an 800 mg oval, convex, pink tablet with one side debossed "M" and other side debossed "58/59".                     Bottles of 30            NDC 42254-040-30   Store at Controlled Room Temperature, between 15°C and 30°C (59°F and 86°F). Rx Only Manufactured and Distributed by: Corepharma LLC Middlesex, NJ  08846                                                                                        MF#  704-01                                                      April 2010 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

অনুমোদন অবস্থা:

New Drug Application

পণ্য বৈশিষ্ট্য

METAXALONE- METAXALONE TABLET
REBEL DISTRIBUTORS CORP
----------
METAXALONE TABLETS 800 MG
DESCRIPTION
Metaxalone tablets are available as an 800 mg oval, convex 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 Metaxalone tablets under fasted and fed conditions
at doses ranging from 400 mg to
800 mg.
ABS ORPTION
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 tablets 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.
TABLE 1: MEAN (%CV) METAXALONE PHARMACOKINETIC PARAMETERS
DOSE (mg) C
(ng/mL) T
(h) AUC (ng•h/mL) T
(h)
CL/F (L/h)
12
15