BUTALBITAL AND ACETAMINOPHEN tablet BUTALBITAL AND ACETAMINOPHEN tablet ALLZITAL- butalbital and acetaminophen tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Διαθέσιμο από:

Larken Laboratories, Inc.

INN (Διεθνής Όνομα):

BUTALBITAL

Σύνθεση:

BUTALBITAL 50 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Butalbital and Acetaminophen 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: - Hypersensitivity or intolerance to any component of this product. - Patients with porphyria. Abuse and Dependence: 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 occur

Περίληψη προϊόντος:

Butalbital and Acetaminophen, 50 mg/ 325 mg: White, capsule shaped tablet debossed “LL 721” on one side and plain on the other, in bottles of 30 tablets (NDC 68047-721-30), and 100 tablets (NDC 68047-721-01). Butalbital and Acetaminophen, 25 mg / 325 mg: White, capsule shaped tablet debossed “LL 722” on one side and plain on the other, in bottles of 30 tablets (NDC 68047-753-30) and 100 tablets (NDC 68047-753-01). ALLZITAL (butalbital and acetaminophen, 25 mg / 325 mg): White, capsule shaped tablet debossed “LL 722” on one side and plain on the other, in bottles of 30 tablets (NDC 68047-752-30) and 100 tablets (NDC 68047-752-01). Protect from light and moisture. Store Butalbital and Acetaminophen tablets at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F). Dispense in a tight, light-resistant container with a child-resistant closure. Distributed by: Larken Laboratories, Inc. Canton, MS 39046 www.larkenlabs.com Rev. 06/2022 500411-07

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

BUTALBITAL AND ACETAMINOPHEN- BUTALBITAL AND ACETAMINOPHEN TABLET
BUTALBITAL AND ACETAMINOPHEN- BUTALBITAL AND ACETAMINOPHEN TABLET
ALLZITAL- BUTALBITAL AND ACETAMINOPHEN TABLET
LARKEN LABORATORIES, INC.
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BUTALBITAL AND ACETAMINOPHEN 50 MG/ 325 MG TABLET
BUTALBITAL AND ACETAMINOPHEN 25 MG/ 325 MG TABLET
ALLZITAL (BUTALBITAL AND ACETAMINOPHEN 25 MG/ 325 MG) TABLET
RX ONLY
WARNING
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 4,000 milligrams per day, and often involve more than one
acetaminophen-containing product.
DESCRIPTION
Each Butalbital and Acetaminophen 50 mg/ 325 mg tablet for oral
administration contains:
Butalbital, USP ………...….. 50 mg
Acetaminophen, USP ……. 325 mg
Each Butalbital and Acetaminophen 25 mg/ 325 mg tablet for oral
administration contains:
Butalbital, USP ………...….. 25 mg
Acetaminophen, USP ……. 325 mg
Each ALLZITAL (butalbital and acetaminophen 25 mg/ 325 mg) tablet for
oral administration contains:
Butalbital, USP ………...….. 25 mg
Acetaminophen, USP ……. 325 mg
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide, croscarmellose
sodium, crospovidone, magnesium stearate, microcrystalline cellulose,
povidone, pregelatinized starch, and
stearic acid.
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 M.W. = 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 M.W. = 151.16
CLINICAL PHARMACOLOGY
This combination drug product is intended as a treatment for tension
headache.
It consists of a fixed combination of butalbi