ACETAZONE FORTE TABLET

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

CHLORZOXAZONE; ACETAMINOPHEN

Доступна с:

TEVA CANADA LIMITED

код АТС:

M03BB53

ИНН (Международная Имя):

CHLORZOXAZONE, COMBINATIONS EXCL PSYCHOLEPTICS

дозировка:

250MG; 300MG

Фармацевтическая форма:

TABLET

состав:

CHLORZOXAZONE 250MG; ACETAMINOPHEN 300MG

Администрация маршрут:

ORAL

Штук в упаковке:

30/100

Тип рецепта:

OTC

Терапевтические области:

CENTRALLY ACTING SKELETAL MUSCLE RELAXANTS

Обзор продуктов:

Active ingredient group (AIG) number: 0202044001; AHFS:

Статус Авторизация:

CANCELLED POST MARKET

Дата Авторизация:

2018-03-20

Характеристики продукта

PRESCRIBING INFORMATION
ACETAZONE FORTE
CHLORZOXAZONE AND ACETAMINOPHEN, USP
Tablets
250 mg / 300 mg
MUSCLE RELAXANT & PAIN RELIEVER
TEVA CANADA LIMITED
DATE OF PREPARATION
30 NOVOPHARM COURT
JANUARY 18, 2013
TORONTO, CANADA
M1B 2K9
www.tevacanada.com
CONTROL #: 160669
Page 2
PRESCRIBING INFORMATION
ACETAZONE FORTE
CHLORZOXAZONE ACETAMINOPHEN USP TABLETS
MUSCLE RELAXANT - ANALGESIC
ACTION AND CLINICAL PHARMACOLOGY
Acetazone Forte tablets combine the muscle-relaxant effect of
chlorzoxazone with
acetaminophen, a well known analgesic.
Chlorzoxazone is a centrally-acting agent for painful musculoskeletal
conditions. Data
available from animal experiments, as well as human study, indicate
that chlorzoxazone
acts primarily at the level of the spinal cord and subcortical areas
of the brain where it
inhibits multisynaptic reflex arcs involved in producing and
maintaining skeletal muscle
spasm of varied etiology. The clinical result is a reduction of the
skeletal muscle spasm
with relief of pain and increased mobility of the involved muscles.
Blood levels of
chlorzoxazone
can
be
detected
in
humans
during
the
first
30 minutes
after
oral
administration and peak levels may be reached in about 1 to 2 hours.
Chlorzoxazone is
rapidly metabolized and is excreted in the urine, primarily in a
conjugated form as the
glucuronide. Less than 1% of a dose of chlorzoxazone is excreted
unchanged in the
urine in 24 hours.
Acetaminophen provides analgesic action to supplement that which
results secondarily
from muscle relaxation. Acetaminophen is rapidly absorbed after oral
administration,
with peak plasma levels occurring in 1 to 2 hours. After 8 hours, only
negligible
amounts remain in the blood. Only 4% is excreted unchanged; 85% of the
ingested
dose is recovered in the urine in conjugated form as the glucuronide.
Acetaminophen is
distributed throughout most tissues of the body. Acetaminophen is
metabolized primarily
Page 3
in the liver. Little unchanged drug is excreted in the urine, but most
metabolic products
appear in the urine with