BUTALBITAL AND ACETAMINOPHEN capsule

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Granules Pharmaceuticals Inc.

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Butalbital and acetaminophen 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. 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 occu

Ringkasan produk:

Each butalbital and acetaminophen capsule contains butalbital 50 mg and acetaminophen 300 mg. Capsules are blue opaque cap printed with "GPI (over) 50/300mg" and blue opaque body printed with "054" contains white to off-white blend and are available in bottles of 100’s and 500’s count. Bottles of 100 NDC 70010-054-01 Bottles of 500 NDC 70010-054-05 Store at 20°C to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. Rx Only Manufactured By: Granules Pharmaceuticals Inc., Chantilly, VA 20151 Rev. 05/2019

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

BUTALBITAL AND ACETAMINOPHEN- BUTALBITAL AND ACETAMINOPHEN CAPSULE
GRANULES PHARMACEUTICALS INC.
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BUTALBITAL AND ACETAMINOPHEN – BUTALBITAL AND ACETAMINOPHEN CAPSULE
GRANULES PHARMACEUTICALS INC.
BOXED 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 4000
milligrams
per day, and often involve more than one acetaminophen containing
product.
DESCRIPTION
Each capsule for oral administration contains butalbital USP, 50 mg
and acetaminophen
USP, 300 mg.
In addition, each capsule also contains the following inactive
ingredients: crospovidone,
FD&C Blue #1, FD&C Red #3, gelatin, microcrystalline cellulose,
povidone, pregelatinized
starch, sodium lauryl sulphate, stearic acid, talc and titanium
dioxide. In addition, capsule
printing ink contains ammonium hydroxide, black iron oxide, propylene
glycol and shellac
glaze.
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
MW 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
MW 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 ba