BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE- butalbital, acetaminophen, and caffeine capsules 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:

Lannett Company, Inc.

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. 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

Sommarju tal-prodott:

Butalbital, Acetaminophen, and Caffeine Capsules, USP 50 mg/300 mg/40 mg Containing 50 mg butalbital, 300 mg acetaminophen, and 40 mg caffeine. Available as size 0 capsule with opaque blue cap imprinted in white with “Lannett ” and opaque aqua blue body imprinted with “4095” in white and filled with powder. The capsules are supplied in bottles of 100 capsules (NDC 0527-4095-37). Store at 20° to 25° C (68° to 77°F) [see USP Controlled Room Temperature]; Dispense in a tight, light-resistant container. Rx only Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 CIB71940C Rev. 07/23

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN,
AND CAFFEINE CAPSULES CAPSULE
LANNETT COMPANY, INC.
----------
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULES, USP
RX ONLY
BOXED 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
hard-gelatin
capsule form for oral administration.
Each capsule contains the following active ingredients:
butalbital USP……………………50 mg
acetaminophen USP…………….300 mg
caffeine USP……………………..40 mg
_Inactive Ingredients: _pregelatinized starch, talc, microcrystalline
cellulose, colloidal silicon
dioxide, stearic acid, gelatin, titanium dioxide, FD&C blue #2, black
iron oxide, yellow iron
oxide, FD&C blue #1. Imprinting ink composed of shellac, dehydrated
alcohol, isopropyl
alcohol, butyl alcohol, propylene glycol, sodium hydroxide, povidone,
titanium dioxide,
ammonium hydroxide, and simethicone.
Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to
intermediate-acting barbiturate
of molecular weight 224.26. It has the following structural formula:
Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate
analgesic and
antipyretic of molecular weight 151.16. It has the following
structural formula:
Caffeine (1,3,7-trimethylxanthine), is a central nervous system
stimulant of molecular
weight 194.19. 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
T