BUTALBITAL AND ACETAMINOPHEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aarkish Pharmaceuticals NJ Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens.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.

Product summary:

White to off white, round-shaped, biconvex tablets debossed “S8” on one side and plain on the other side, in bottles of 100 (81005-123-01). Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 300 mg. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. Distributed by: Aarkish Pharmaceuticals NJ Inc. Fairfield, NJ 07004 MADE IN USA I-106 Rev. 00, 08/23

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUTALBITAL AND ACETAMINOPHEN- BUTALBITAL AND ACETAMINOPHEN TABLET
AARKISH PHARMACEUTICALS NJ INC.
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BUTALBITAL AND ACETAMINOPHEN TABLETS
50 MG/ 300 MG
HETATOTOXICITY
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, Acetaminophen, USP 300 mg.
In addition, each Butalbital and Acetaminophen Tablet contains the
following inactive
ingredients: Pregelatinized Starch, Microcrystalline Cellulose,
Colloidal Silicon Dioxide,
Crospovidone, Magnesium Stearate, Povidone, 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:
MOLECULAR WEIGHT = 224.26 C11H16N2O3
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:
MOLECULAR WEIGHT = 151.16 C8H9NO2
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.
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