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:

Mayne Pharma

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 occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient's regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.

Ringkasan produk:

Each butalbital and acetaminophen capsule contains butalbital 50 mg (Warning: May be habit-forming) and acetaminophen 300 mg. It is available in bottles of 100 capsules, NDC 51862-544-01 and 500 capsules, NDC 51862-544-05. Capsules are opaque purple, imprinted “mayne” over “544” in white on the cap and the body. 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 for: Mayne Pharma Greenville, NC 27834 Manufactured by: Mikart, LLC Atlanta, GA 30318 Code 1244A00 Rev. 05/2019

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

BUTALBITAL AND ACETAMINOPHEN- BUTALBITAL AND ACETAMINOPHEN CAPSULE
MAYNE PHARMA
----------
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: croscarmellose
sodium, crospovidone, silicified microcrystalline cellulose, silicon
dioxide, stearic acid,
povidone, and pregelatanized starch. Capsule shells are composed of
gelatin, titanium
dioxide, FD&C Blue #1 and FD&C Red #3, with white edible ink.
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 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 prim