BUTALBITAL, ACETAMINOPHEN, CAFFEINE- butalbital, acetaminophen, and caffeine tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)

Saatavilla:

Preferred Pharmaceuticals Inc.

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Butalbital, acetaminophen and caffeine 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: 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 Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens.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.

Tuoteyhteenveto:

Tablet containing 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine. Available as white to off-white round tablets, debossed "BAC" on one side and debossed "123" on the other side. Store at 20°-25°C (68°-77°F) with excursions permitted between 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]; dispense in a tight, light resistant container as directed in the USP.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

BUTALBITAL, ACETAMINOPHEN, CAFFEINE- BUTALBITAL, ACETAMINOPHEN, AND
CAFFEINE TABLET
PREFERRED PHARMACEUTICALS INC.
----------
BUTALBITAL, ACETAMINOPHEN
AND CAFFEINE TABLETS, USP
50 MG/325 MG/40 MG
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
Butalbital, Acetaminophen and Caffeine Tablets, USP are supplied in
tablet form for oral
administration.
Each tablet contains the following active ingredients:
butalbital, USP
50 mg
acetaminophen, USP
325 mg
caffeine, USP
40 mg
_Inactive Ingredients:_ silicon dioxide, crospovidone, magnesium
stearate, microcrystalline
cellulose, povidone, pregelatinized starch, and stearic acid.
Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to
intermediate-acting barbiturate.
It has the following structural formula:
C11H16N2O3 M.W. 224.26
Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate
analgesic and
antipyretic. It has the following structural formula:
C8H9NO2 M.W. 151.16
Caffeine (1,3,7-trimethylxanthine), is a central nervous system
stimulant. It has the
following structural formula:
C8H10N4O2 M.W. 194.19
CLINICAL PHARMACOLOGY
This combination drug product is intended as a treatment for tension
headache.
It consists of a fixed combination of butalbital, acetaminophen and
caffeine. 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