CAPACET butalbital acetaminophen and caffeine capsule

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK)

Доступно од:

Magna Pharmaceuticals

INN (Међународно име):

BUTALBITAL

Састав:

BUTALBITAL 50 mg

Тип рецептора:

PRESCRIPTION DRUG

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

CAPACET- BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE
MAGNA PHARMACEUTICALS
----------
WARNING
HEPATOTOXICITY
ACETAMINOPHEN HAS BEEN ASSOCIATED WITH CASES OF ACUTE LIVER FAILURE,
AT TIMES RESULTING IN LIVER TRANSPLANT AND DEATH. MOST OF THE CASES
OF LIVER INJURY ARE ASSOCIATED WITH THE USE OF ACETAMINOPHEN AT
DOSES THAT EXCEED 4000 MILLIGRAMS PER DAY, AND OFTEN INVOLVE MORE
THAN ONE ACETAMINOPHEN-CONTAINING PRODUCT.
DESCRIPTION
Butalbital, acetaminophen and caffeine are supplied in capsule form
for oral administration.
Each capsule contains:
Butalbital ................... 50 mg
WARNING: May be habit-forming.
Acetaminophen ........ 325 mg
Caffeine ...................... 40 mg
In addition, each capsule contains the following inactive ingredients:
colloidal silicon dioxide,
croscarmellose sodium, magnesium stearate and microcrystalline
cellulose with capsule shell
composed of gelatin and titanium dioxide.
Imprinting ink composed of n-butyl alcohol, pharmaceutical glaze
modified in SD-45, propylene glycol,
methanol, alcohol, titanium dioxide, D&C Yellow No. 10 Aluminum Lake
and FD&C Blue No. 1
Aluminum Lake.
Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter,
white, odorless, crystalline powder, is a
short to intermediate-acting barbiturate. It has the following
structural formula:
C H N O MW = 224 .26
Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white,
odorless, crystalline powder, is a non-
opiate, non-salicylate analgesic and antipyretic. It has the following
structural formula:
11
16
2
3
C H NO MW = 151.16
Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or
white-glistening needles, is a central
nervous system stimulant. It has the following structural formula:
C H N O MW = 194 .19
CLINICAL PHARMACOLOGY
This combination drug product is intended as a treatment for tension
headache.
It consists of a fixed combination of butalbital, acetaminophen and
caffeine. The role each component
plays in the relief of the complex of symptoms known as tension
headache is incompletely under