BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Lannett Company, Inc.

INN (International Nazwa):

BUTALBITAL

Skład:

BUTALBITAL 50 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Butalbital, acetaminophen, and caffeine tablets, USP 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. 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 intoxi

Podsumowanie produktu:

Butalbital, Acetaminophen, and Caffeine Tablets, USP contain 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine. Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325mg/40 mg are light-blue, speckled, round uncoated tablets, debossed "1695" on one side and "LCI" on the other side and are supplied in bottles of 100 (NDC 0527-1695-01) and bottles of 500 (NDC 0527-1695-05). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 CIB70307C Rev. 07/20

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN,
AND
CAFFEINE TABLET
LANNETT COMPANY, INC.
----------
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLETS, USP
50 MG/325 MG/40 MG
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 are 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:_ microcrystalline cellulose, crospovidone,
croscarmellose sodium, corn starch,
stearic acid, colloidal silicon dioxide, magnesium stearate, and FD&C
Blue No. 1.
Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to
intermediate-acting barbiturate. It has the
following structural formula:
Acetaminophen (4´-hydroxyacetanilide), is a non-opiate,
non-salicylate analgesic and antipyretic. It has
the following structural formula:
Caffeine (1,3,7-trimethylxanthine), is a central nervous system
stimulant. It has the following structural
formula:
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 tissues in
the body. Barbiturates in general may appear in breast milk and
readily cross the placental barrier. They
are bound to plasma and tissue proteins to a