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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

H.J. Harkins Company, Inc.

INN (International Name):

BUTALBITAL

Composition:

BUTALBITAL 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Butalbital, Acetaminophen and Caffeine Tablets, USP Containing butalbital 50 mg, acetaminophen 500 mg and caffeine 40 mg, are white, caplet-shaped tablets, bisected, debossed "23/57" on one side, and debossed "V" on the reverse side. Bottles of 10, 100, 500 and 1000.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE - BUTALBITAL, ACETAMINOPHEN,
AND
CAFFEINE TABLET
H.J. HARKINS COMPANY, INC.
----------
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP
50 MG/500 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.
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:
Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or
white-glistening needles, is a central
nervous system stimulant. It has the following structural formula:
Each Butalbital, Acetaminophen and Caffeine Tablet contains:
Butalbital
......................................................................................
50 mg
Acetaminophen
..........................................................................
500 mg
Caffeine
.......................................................................................
40 mg
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
croscarmellose sodium, magnesium stearate, microcrystalline cellulose,
and stearic acid.
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 in