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

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

Butalbital (UNII: KHS0AZ4JVK) (Butalbital - UNII:KHS0AZ4JVK), Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D), Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E)

Tillgänglig från:

Alvogen Inc.

INN (International namn):

Butalbital

Sammansättning:

Butalbital 50 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 this 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 Butalbital, Acetaminophen, and Caffeine Tablets USP - 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

Produktsammanfattning:

Butalbital, Acetaminophen, and Caffeine Tablets USP Containing 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine. Available as blue, round uncoated tablets, engraved “t 247” on one side and plain on other side. Bottles of 100 (NDC 47781-536-01) and 500 (NDC 47781-536-05). Store at 20º to 25°C (68° to 77°F); excursions permitted within 15º to 30º C (59º to 86º F). [see USP Controlled Room Temperature]

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE - BUTALBITAL, ACETAMINOPHEN,
AND
CAFFEINE TABLET
ALVOGEN INC.
----------
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLETS 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 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
_Inactive Ingredients:_ crospovidone, croscarmellose sodium, FD&C Blue
#1, magnesium stearate,
microcrystalline cellulose, povidone, pregelatinized starch and
stearic acid.
Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to
intermediate-acting barbiturate. It has the
following structural formula:
C
H N O Mol. wt. 224.26
Acetaminophen (4′-hydroxyacetanilide), is a non-opiate,
non-salicylate analgesic and antipyretic. It has
the following structural formula:
C H NO Mol. wt. 151.17
Caffeine (1,3,7-trimethylxanthine), is a central nervous system
stimulant. It has the following structural
formula:
11
16
2
3
8
9
2
C H N O Mol. wt. 194.19
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
rea