BUTALBITAL AND ACETAMINOPHEN- butalbital and acetaminophen tablet

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

STI Pharma LLC

INN (International Name):

BUTALBITAL

রচনা:

BUTALBITAL 50 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 occurs, the margin

পণ্য সারাংশ:

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 100 tablets (NDC 54879-026-01). 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: STI Pharma LLC  Newtown, PA 18940 Rev. 12/2016 500411

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

BUTALBITAL AND ACETAMINOPHEN- BUTALBITAL AND ACETAMINOPHEN TABLET
STI PHARMA LLC
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BUTALBITAL AND ACETAMINOPHEN 50 MG/ 325 MG TABLET
RX ONLY
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
In addition butalbital and acetaminophen 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
11
16
2
3
8
9
2
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 d