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

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Bryant Ranch Prepack

DCI (Denominação Comum Internacional):

BUTALBITAL

Composição:

BUTALBITAL 50 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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. 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 intoxication d

Resumo do produto:

Product: 63629-1774

Status de autorização:

Abbreviated New Drug Application

Características técnicas

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN, AND
CAFFEINE TABLET
BRYANT RANCH PREPACK
----------
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP
50 MG/325 MG/40 MG
RX ONLY
BOXED 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 Tablets, USP are supplied in
tablet form for oral
administration.
Each tablet contains the following active ingredients:
butalbital, USP
......................................................................................
50 mg
acetaminophen, USP
...........................................................................
325 mg
caffeine, USP
........................................................................................
40 mg
_Inactive Ingredients: _colloidal silicon dioxide, croscarmellose
sodium, crospovidone,
magnesium stearate, microcrystalline cellulose, povidone,
pregelatinized 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 gastroin