BUTALBITAL, ACETAMINOPHEN AND CAFFEINE- butalbital, acetaminophen and caffeine tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)

Tillgänglig från:

PD-Rx Pharmaceuticals, Inc.

INN (International namn):

BUTALBITAL

Sammansättning:

BUTALBITAL 50 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Butalbital, Acetaminophen, and Caffeine Tablets, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable. This product is contraindicated under the following conditions:  - Hypersensitivity or intolerance to any component of this product - Patients with porphyria. Butalbital : Barbiturates may be habit-forming : Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates.  The average daily dose for the barbiturate addict is usually about 1500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin betw

Produktsammanfattning:

Butalbital, Acetaminophen and Caffeine Tablets, USP 50 mg/325 mg/40 mg are Blue, Round, Unscored, Compressed Tablets; Debossed “West-ward 787”. They are available in     Bottles of 30 tablets     Bottles of 60 tablets Store at 20 o to 25 o C (68 o to 77 o F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN AND
CAFFEINE TABLET
PD-RX PHARMACEUTICALS, INC.
----------
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLETS, USP
R ONLY
REV. 06/17
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:
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,
Croscarmellose Sodium, FD&C Blue No. 1 Aluminum Lake, Magnesium
Stearate, Microcrystalline
Cellulose, Polyvinylpyrrolidone, Pregelatinized Starch, Sodium Starch
Glycolate,and Stearic Acid.
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:
X
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 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