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:

Actavis Pharma, Inc.

INN (International Name):

BUTALBITAL

Composition:

BUTALBITAL 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Butalbital, acetaminophen, and caffeine tablets USP is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of butalbital, acetaminophen, and caffeine tablets USP in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable. Butalbital, acetaminophen, and caffeine tablets USP 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

Product summary:

Butalbital, acetaminophen, and caffeine tablets USP Containing 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine. Available as white, round uncoated tablets, engraved WATSON on one side and 3369 on other side supplied in bottles of 100 and 500. Bottles of 100 are supplied with child-resistant closures. Store below 30°C (86°F); dispense in a tight container. Keep out of reach of children. Rx only For all medical inquiries contact: ACTAVIS Medical Communications Parsippany, NJ 07054 1-800-272-5525 Manufactured By: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed By: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Content Updated: August 2014 174241-5

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN,
AND
CAFFEINE TABLET
ACTAVIS PHARMA, INC.
----------
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLETS USP
CONTENT UPDATED: AUGUST 2014
RX ONLY
174241-5
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 is 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
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:
_Inactive Ingredients: _crospovidone, magnesium stearate,
microcrystalline cellulose, povidone,
pregelatinized starch, and stearic acid.
CLINICAL PHARMACOLOGY
Butalbital, acetaminophen, and caffeine tablets USP 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 prote