BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

Butalbital (UNII: KHS0AZ4JVK) (Butalbital - UNII:KHS0AZ4JVK)

Disponible depuis:

Cardinal Health

DCI (Dénomination commune internationale):

Butalbital

Composition:

Butalbital 50 mg

Type d'ordonnance:

PRESCRIPTION DRUG

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN,
AND
CAFFEINE TABLET
CARDINAL HEALTH
----------
BUTALBITAL,
ACETAMINOPHEN, AND
CAFFEINE TABLETS, USP
Rev. 01/09
RX ONLY
DESCRIPTION
Each tablet, for oral administration contains:
Butalbital,
USP.......................................................................................50
mg
Acetaminophen,
USP...........................................................................325
mg
Caffeine,
USP.........................................................................................40
mg
In addition, each tablet contains the following inactive ingredients:
Colloidal Silicon Dioxide, FD&C
Blue No. 1 Aluminum Lake, Magnesium Stearate, Microcrystalline
Cellulose, and Sodium Starch
Glycolate.
Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to
intermediate-acting barbiturate. It has the
following structural formula:
Acetaminophen (4’-hydroxyacetanilide), is a non-opiate,
non-salicylate analgesic and antipyretic. It has
the following structural formula:
Caffeine (1,3,7-trimethylxanthine), is a central nervous system
stimulant. It has the following structural
formula:
CLINICAL PHARMACOLOGY
This combination drug product is intended as a treatment for tension
headache.
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 understood.
PHARMACOKINETICS
The behavior of the individual components is described below.
Butalbital
Butalbital is well absorbed from the gastrointestinal tract and is
expected to distribute to most tissues in
the body. Barbiturates in general may appear in breast milk and
readily cross the placental barrier. They
are bound to plasma and tissue proteins to a varying degree and
binding increases directly as a function
of lipid solubility.
Elimination of butalbital is primarily via the kidney (59% to 88% of
the