BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE tablet

Land: 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:

RPK Pharmaceuticals, Inc.

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Butalbital, acetaminophen, and caffeine tablets, USP 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 intoxi

Vörulýsing:

Product: 53002-6030 NDC: 53002-6030-1 10 TABLET in a BOTTLE NDC: 53002-6030-2 20 TABLET in a BOTTLE NDC: 53002-6030-3 30 TABLET in a BOTTLE

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN,
AND CAFFEINE TABLET
RPK PHARMACEUTICALS, INC.
----------
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLETS, USP
50 MG/325 MG/40 MG
RX ONLY
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:_ microcrystalline cellulose, crospovidone,
croscarmellose sodium,
corn starch, stearic acid, colloidal silicon dioxide, magnesium
stearate, and FD&C Blue
No. 1.
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