BUTALBITAL, ACETAMINOPHEN AND CAFFEINE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Unit Dose Services

INN (국제 이름):

BUTALBITAL

구성:

BUTALBITAL 50 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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. 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 dosage and fatal dosage becomes smal

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN AND
CAFFEINE TABLET
UNIT DOSE SERVICES
----------
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 are supplied in tablet form for
oral administration.
Each tablet contains the following active ingredients:
Butalbital ...................50 mg
May be habit-forming. WARNING:
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:
C H N O MW = 224 .26
Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate
analgesic and antipyretic. It has
the following structural formula:
C H NO MW = 151.16
Caffeine (1,3,7-trimethylxanthine), is a central nervous system
stimulant. It has the following structural
formula:
111623
892
C H N O MW = 194 .19
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.
PHARMACOKINETICS
The behavior of the individual components is described below.
: 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 tis