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

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Nexgen Pharma, Inc.

INN (mednarodno ime):

BUTALBITAL

Sestava:

BUTALBITAL 50 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

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 hard gelatin capsules with a green cap, printed with AP, and a yellow body, printed with 661. The capsules are supplied in bottles of 100 capsules (NDC 00722-7029-01) and 500 capsules (NDC 00722-7029-05). Store at 20°C to 25o C (68°F to 77o F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Rx only Manufactured by: Nexgen Pharma Inc., Irvine, CA 9206, USA Rev. 09/2019

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN,
AND CAFFEINE
CAPSULES CAPSULE
NEXGEN PHARMA, INC.
----------
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULES
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 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: _sodium lauryl sulfate, talc, microcrystalline
cellulose, stearic acid, D&C yellow
#10, FD&C red #40, titanium dioxide, FD&C blue #1, FD&C yellow #6,
gelatin.
Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to
intermediate-acting barbiturate of molecular
weight 224.26. It has the following structural formula:
BUTALBITAL
Acetaminophen (4´-hydroxyacetanilide), is a non-opiate,
non-salicylate analgesic and antipyretic of
molecular weight 151.16. It has the following structural formula:
ACETAMINOPHEN
Caffeine (1,3,7-trimethylxanthine), is a central nervous system
stimulant of molecular weight 194.19. It
has the following structural formula:
CAFFEINE
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 gen