BUTALBITAL, ACETAMINOPHEN AND CAFFEINE capsule

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Bryant Ranch Prepack

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Butalbital, acetaminophen and caffeine capsules 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. 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 margin between an

Sommarju tal-prodott:

Butalbital, Acetaminophen and Caffeine Capsules, USP containing butalbital 50 mg, acetaminophen 325 mg and caffeine 40 mg, are supplied in bottles of 100 capsules, NDC: 63629-2087-1. Capsules are opaque white cap imprinted in black with “Lannett ” and opaque white body imprinted with “4094’ in black and filled with powder. 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

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN AND
CAFFEINE CAPSULE
BRYANT RANCH PREPACK
----------
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULES, USP
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 Capsules, USP are supplied in
capsule form for
oral administration.
Each capsule contains:
Butalbital ................... 50 mg
Acetaminophen ........ 325 mg
Caffeine ...................... 40 mg
In addition, each capsule contains the following inactive ingredients:
pregelatinized starch, talc, microcrystalline cellulose, colloidal
silicon dioxide, stearic acid,
gelatin, titanium dioxide, FD&C blue #2, black iron oxide, FD&C blue
#1. Imprinting ink
composed of shellac glaze, black iron oxide, n-butyl alcohol,
propylene glycol, FD&C blue
#2, FD&C red #40, D&C yellow #10, FD&C blue #1.
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 incompl