BUTALBITAL, ACETAMINOPHEN AND CAFFEINE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Rebel Distributors Corp.

INN (Nome Internazionale):

BUTALBITAL

Composizione:

BUTALBITAL 50 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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,

Dettagli prodotto:

Butalbital 50 mg, Acetaminophen 500 mg and Caffeine 40 mg Tablets are white, oblong, scored tablets; embossed "WW 115" and are available in: Bottles of 8 tablets. Bottles of 28 tablets. Bottles of 30 tablets. Bottles of 60 tablets. Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. 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 November 2003 Repackaged by: Rebel Distributors Corp. Thousand Oaks, CA 91320

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN AND
CAFFEINE TABLET
REBEL DISTRIBUTORS CORP.
----------
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLETS, USP
50 MG/500 MG/40 MG
RX ONLY
REV. 11/03
DESCRIPTION:
Butalbital, Acetaminophen and Caffeine is supplied in tablet form for
oral administration. Each tablet
contains:
Butalbital, USP . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . 50 mg
Acetaminophen . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . .500 mg
Caffeine, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . 40 mg
In addition, each tablet contains the following inactive ingredients:
Colloidal Silicon Dioxide, Corn
Starch, Croscarmellose Sodium, Magnesium Stearate, Microcrystalline
Cellulose, Pregelatinized
Starch, Povidone, Sodium Starch Glycolate, and Stearic Acid.
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:
C
H N O M.W. 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:
C H NO M.W. 151.17
Caffeine (1,3,7,-trimethylxanthine), a bitter, white crystalline
powder or white-glistening needles, is a
central nervous system stimulant. It has the following structural
formula:
11
16
2
3
8
9
2
C H N O M.W. 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 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