METAXALL- metaxalone tablet

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Sircle Laboratories, LLC

INN (আন্তর্জাতিক নাম):

METAXALONE

রচনা:

METAXALONE 800 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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.

পণ্য সারাংশ:

Metaxalone is available as an 800 mg , light pink to pink, capsule shaped, scored uncoated tablet with debossing 'AN' on the left side of the scoring and '553' on the right side of the scoring. Other side of the tablet is plain. They are available as follows: Bottles of 30: NDC 51021-333-30 Bottles of 60: NDC 51021-333-60 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].

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

METAXALL- METAXALONE TABLET
SIRCLE LABORATORIES, LLC
----------
METAXALL ™
METAXALONE 800MG TABLETS
DESCRIPTION
Metaxalone is available as an 800 mg, light pink to pink, capsule
shaped, scored uncoated 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: calcium carbonate, FD&
C Red # 40, hypromellose, lactose monohydrate, microcrystalline
cellulose, povidone, silicone
dioxide, sodium starch glycol ate and sodium stearyl fumarate.
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 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.
12
15
3
max
TABL