BUTALBITAL AND ACETAMINOPHEN tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Доступно од:

Alvogen Inc.

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Butalbital and Acetaminophen 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, the margin b

Резиме производа:

White, round, unscored tablets with “A ” above “290 ” on one side and plain on the other, in bottles of 100 (NDC 47781-644-01). Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 300 mg. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

BUTALBITAL AND ACETAMINOPHEN- BUTALBITAL AND ACETAMINOPHEN TABLET
ALVOGEN INC.
----------
BUTALBITAL AND ACETAMINOPHEN TABLETS
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
Each Butalbital and Acetaminophen Tablet for oral administration,
contains Butalbital,
USP 50 mg, Acetaminophen, USP 300 mg.
In addition each Butalbital and Acetaminophen Tablet contains the
following inactive
ingredients: Pregelatinized Starch, Microcrystalline Cellulose,
Croscarmellose Sodium,
Povidone, Crospovidone, Stearic acid and Magnesium Stearate.
Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter,
white, odorless, crystalline
powder, 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:
CLINICAL PHARMACOLOGY
This combination drug product is intended as a treatment for tension
headache.
It consists of a fixed combination of butalbital and acetaminophen.
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