BUTALBITAL AND ACETAMINOPHEN- butalbital and acetaminophen tablets tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Oceanside Pharmaceuticals

ІПН (Міжнародна Ім'я):

BUTALBITAL

Склад:

BUTALBITAL 50 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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: 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 occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturat

Огляд продуктів:

Yellowish round, unscored tablets with BA 300 on one side and plain on the other, in bottles of 100 (NDC 68682-306-01). Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 300 mg. 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. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA © 2020 Bausch Health Companies Inc. or its affiliates 7075-AG 9592801 Rev. 04/2020

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

BUTALBITAL AND ACETAMINOPHEN- BUTALBITAL AND ACETAMINOPHEN TABLETS
TABLET
OCEANSIDE PHARMACEUTICALS
----------
BUTALBITAL AND ACETAMINOPHEN TABLETS
50 MG/300 MG
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
Each Butalbital and Acetaminophen Tablet for oral administration,
contains Butalbital, USP 50 mg and
Acetaminophen, USP 300 mg.
In addition, each Butalbital and Acetaminophen Tablet contains the
following inactive ingredients:
Pregelatinized Starch, Microcrystalline Cellulose, Croscarmellose
Sodium, Magnesium Stearate, D&C
Yellow #10 Lake, and FD&C Red #40 Lake.
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:
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:
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 function of lipid solubility.
Elimination of butalbital is primarily via the kidney (59% to 88% of
t