BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE capsule

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:

West-Ward Pharmaceutical Corp

INN (International Name):

BUTALBITAL

Composition:

BUTALBITAL 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Butalbital, Acetaminophen, and Caffeine Capsules, 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. 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 ma

Product summary:

Butalbital 50 mg, Acetaminophen 500 mg and Caffeine 40 mg Capsules, USP are supplied as salmon/red capsules printed “170” in white ink and are available in:       Bottles of 100 capsules Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured By: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724 Revised November 2013

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN,
AND
CAFFEINE CAPSULE
WEST-WARD PHARMACEUTICAL CORP
----------
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULES
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULES, USP
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 is supplied in capsule form
for oral administration. Each
capsule contains:
Butalbital, USP……………………..50 mg
Acetaminophen, USP………………500 mg
Caffeine, USP…………………… …40 mg
In addition, each capsule contains the following inactive ingredients:
colloidal silicon dioxide,
magnesium stearate, sodium lauryl sulfate, and sodium starch
glycolate.
Capsule shell contains: D&C Red #33, D&C Yellow #10, FD&C Red #40,
Gelatin and Titanium
Dioxide. The imprinting ink contains Titanium Dioxide.
Butalbital (5-allyl-5-isobutylbarbituric acid), a white, odorless,
crystalline powder having a slightly
bitter taste, 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 crystalline
powder or white-glistening needles, 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.
PHARMACOKINET