ZEBUTAL- butalbital, acetaminophen and caffeine capsule

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Mayne Pharma Inc.

INN（国际名称）:

BUTALBITAL

组成:

BUTALBITAL 50 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Zebutal ® (butalbital, acetaminophen and caffeine capsules) USP 50 mg/325 mg/40 mg is 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 incr

產品總結:

Zebutal ® (butalbital, acetaminophen and caffeine capsules) containing butalbital 50 mg (Warning: May be habit-forming) , acetaminophen 325 mg and caffeine 40 mg, are supplied in bottles of 100 capsules, NDC 68308-554-10. Capsules are opaque white body and cap and are imprinted "59743" and “004” in green ink. 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. Rx only Manufactured by: MIKART, LLC Atlanta, GA 30318 Distributed by: MAYNE PHARMA Greenville, NC 27834 Code 785M00 Rev. 05/2019

授权状态:

Abbreviated New Drug Application

产品特点

ZEBUTAL- BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE
MAYNE PHARMA INC.
----------
ZEBUTAL
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 capsule form
for oral
administration.
Each capsule contains:
Butalbital ................... 50 mg
WARNING: MAY BE HABIT-FORMING.
Acetaminophen ........ 325 mg
Caffeine ...................... 40 mg
In addition, each capsule contains the following inactive ingredients:
colloidal silicon
dioxide, croscarmellose sodium, magnesium stearate and
microcrystalline cellulose with
capsule shell composed of gelatin, titanium dioxide, and green edible
ink.
Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter,
white, odorless, crystalline
powder, is a short to intermediate-acting barbiturate. It has the
following structural
formula:
C
H
N
O
MW = 224.26
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:
C
H
NO
MW = 151.16
Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or
white-glistening needles, is a
central nervous system stimulant. It has the following structural
formula:
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: Butalbital is well absorbed from the gastrointestinal
tract and is expected to
distribute to most