METAXALONE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Keltman Pharmaceuticals Inc.

INN (International Adı):

METAXALONE

Kompozisyon:

METAXALONE 800 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Metaxalone tablets are 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. Deaths by deliberate or accidental overdose have occurred with metaxalone, particularly in combination with antidepressants and have been reported with this class of drug in combination with alcohol. When determining the LD50 in rats and mice, progressive sedation, hypnosis and finally respiratory failure were noted as the dosage increased. In dogs, no LD50 could be determined as the higher doses produced an emetic action in 15 to 30 minutes. Treatment Gastric lavage and supportive therapy.

Ürün özeti:

Metaxalone Tablets are available as an 800mg oval, convex, pink tablet with one side debossed “M” and the other side and scored on the other side debossed "58/59". They are supplied by Keltman Pharmaceuticals Inc. as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Rx Only . Manufactured and Distributed by: Corepharma LLC Middlesex, NJ 08846 This Product was Repackaged By Sandhills Packaging for: Keltman Pharmaceuticals Inc. 1 Lakeland Square, Suite A Flowood, MS 39232 United States

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

METAXALONE - METAXALONE TABLET
KELTMAN PHARMACEUTICALS INC.
----------
METAXALONE TABLETS, 800 MG
DESCRIPTION
Metaxalone tablets are available as an 800 mg tablet.
Chemically, metaxalone is
5-[(3,5-dimethylphenoxy)methyl]-2-oxazolidinone. The empirical formula
is
C
H1 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.
12
5
3
max
TABLE 1: MEAN (%CV) METAXALONE PHARMACOKINETIC
PARAMETERS
*
†
DOS E
(MG)
C
(NG/ML)
T (H)
AUC∞
(NG H/ML)
T (H)
CL/F
(L/H)