BUTALBITAL, ACETAMINOPHEN AND CAFFEINE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Bryant Ranch Prepack

INN (Algemene Internationale Benaming):

BUTALBITAL

Samenstelling:

BUTALBITAL 50 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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. 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 between an

Product samenvatting:

NDC: 71335-0347-1: 20 Tablets in a BOTTLE NDC: 71335-0347-2: 30 Tablets in a BOTTLE NDC: 71335-0347-3: 60 Tablets in a BOTTLE NDC: 71335-0347-4: 90 Tablets in a BOTTLE NDC: 71335-0347-5: 50 Tablets in a BOTTLE NDC: 71335-0347-6: 6 Tablets in a BOTTLE NDC: 71335-0347-7: 120 Tablets in a BOTTLE NDC: 71335-0347-8: 40 Tablets in a BOTTLE NDC: 71335-0347-9: 12 Tablets in a BOTTLE NDC: 71335-0347-0: 84 Tablets in a BOTTLE

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN AND
CAFFEINE TABLET
BRYANT RANCH PREPACK
----------
TABLETS
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 tablet form for
oral administration.
Each tablet contains the following active ingredients:
Butalbital ...................50 mg
WARNING: May be habit-forming.
Acetaminophen ........325 mg
Caffeine ......................40 mg
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
croscarmellose sodium, crospovidone, microcrystalline cellulose,
povidone,
pregelatinized corn starch 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:
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 incr