BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE tablet

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

STAT Rx USA LLC

INN (Alþjóðlegt nafn):

BUTALBITAL

Samsetning:

BUTALBITAL 50 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Butalbital, acetaminophen and caffeine tablets 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. Abuse and Dependence: 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, t

Vörulýsing:

Butalbital, Acetaminophen and Caffeine Tablets 50 mg/325 mg/40 mg are blue, round, unscored tablets; imprinted “West-ward 787”. They are available in: Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured By: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Revised April 2003 Relabeling and Repackaging by : STAT Rx USA LLC Gainesville, GA  30501

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE - BUTALBITAL, ACETAMINOPHEN,
AND
CAFFEINE TABLET
STAT RX USA LLC
----------
BUTALBITAL,
ACETAMINOPHEN, AND
CAFFEINE TABLETS, USP
Revised 04/03
RX ONLY
DESCRIPTION
Each tablet, for oral administration, contains:
Butalbital, USP..................50 mg
Acetaminophen.................325 mg
Caffeine, USP...................40 mg
In addition, each tablet contains the following inactive ingredients:
FD&C Lake Blue #1, Magnesium
Stearate, Microcrystalline Cellulose, Colloidal Silicon Dioxide, and
Sodium Starch Glycolate.
Butalbital (5-allyl-5-isobutylbarbituric acid), a white, odorless,
crystalline powder having a slightly
bitter taste, is a short to intermediate-acting barbiturate. It has
the following structural formula:
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:
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:
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 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 dose) as unchanged drug or
metabolites. The plasma half-life is about 35 hours. Urinary excretion
products in