BUTALBITAL AND ACETAMINOPHEN tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Lacer Pharma, LLC

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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. Controlled Substance - Butalbital is a Schedule III drug. Dependence - 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

Tóm tắt sản phẩm:

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 100 tablets (NDC 73159-003-01). 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: Lacer Pharma, LLC Biloxi, MS 39532 www.lacerpharma.com Rev. 11/2022 500537-02

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

BUTALBITAL AND ACETAMINOPHEN- BUTALBITAL AND ACETAMINOPHEN TABLET
LACER PHARMA, LLC
----------
BUTALBITAL AND ACETAMINOPHEN 25 MG/ 325 MG TABLET, CIII
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 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:
11
16
2
3
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 butalbital and acetaminophen.
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 varying degree and binding increases directly as a f