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

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

STAT RX USA LLC

INN (Tên quốc tế):

BUTALBITAL

Thành phần:

BUTALBITAL 50 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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: 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 margin between an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturate is far les

Tóm tắt sản phẩm:

Butalbital, Acetaminophen and Caffeine Tablets, USP Containing butalbital 50 mg, acetaminophen 500 mg and caffeine 40 mg, are white, caplet-shaped tablets, bisected, debossed "23/57" on one side, and debossed "V" on the reverse side. Bottles of 10, 100, 500 and 1000. Store at 20°-25°C (68°-77°F) with excursions permitted between 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE PLUS- BUTALBITAL, ACETAMINOPHEN
AND
CAFFEINE TABLET
STAT RX USA LLC
----------
RX ONLY
DESCRIPTION
Butalbital, Acetaminophen and Caffeine Tablets, USP are supplied in
tablet form for oral administration.
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:
BUTALBITAL
STRUCTURE IMAGE
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:
ACETAMINOPHEN
STRUCTURE IMAGE
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:
CAFFEINE
STRUCTURE IMAGE
Each Butalbital, Acetaminophen and Caffeine Tablet contains:
Butalbital
......................................................................................
50 mg Acetaminophen
..........................................................................
500 mg Caffeine
........................................................................................
40 mg
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
croscarmellose sodium, magnesium stearate, microcrystalline cellulose,
and stearic acid.
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.
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 an