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:

DIRECT RX

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. 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 ma

Product summary:

Butalbital, acetaminophen and caffeine tablets USP contain butalbital 50 mg (Warning: May be habit-forming), acetaminophen 325 mg and caffeine 40 mg. Tablets are white, capsule-shaped, single-scored with the logo “MIA/110”, and are supplied in bottles of 100 and bottles of 500. Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN AND
CAFFEINE TABLET
DIRECT RX
----------
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
WARNINGS SECTION
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 SECTION
Butalbital, acetaminophen and caffeine are supplied in tablet form for
oral administration.
Each tablet contains the following active ingredients:
Butalbital ...................50 mg
Warning: May be habit-forming.
Acetaminophen ........325 mg
Caffeine ......................40 mg
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
croscarmellose sodium, crospovidone, microcrystalline cellulose,
povidone,
pregelatinized corn starch and stearic acid.
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.
Caffeine (1,3,7-trimethylxanthine), is a central nervous system
stimulant.
CLINICAL PHARMACOLOGY SECTION
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 to
a varying degree and binding increases directly as a function of lipid
s