BUTALBITAL, ACETAMINOPHEN AND CAFFEINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rebel Distributors Corp

INN (International Name):

BUTALBITAL

Composition:

BUTALBITAL 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dolgic Plus is 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. 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 increased; 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

Product summary:

Dolgic Plus (Butalbital, Acetaminophen and Caffeine Tablets USP), containing butalbital 50 mg (Warning: May be habit forming) , acetaminophen 750 mg and caffeine 40 mg are dark pink, oval shaped tablets with a convex face and are debossed "A 074" on one side. They are supplied in bottles of 60 tablets, NDC 21695-843-60. Store at 20-25o C (68-77o F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured For: Shionogi USA Inc . Florham Park, NJ 07932 Manufactured By: MIKART, INC Atlanta, GA 30318 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN AND
CAFFEINE TABLET
REBEL DISTRIBUTORS CORP
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DOLGIC PLUS BRAND OF BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLETS,
USP
RX ONLY
DESCRIPTION
Dolgic Plus (Butalbital, Acetaminophen, and Caffeine USP) is supplied
in tablet form for oral
administration.
Butalbital (5-allyl-5-isobutyl-barbituric acid), a white, odorless
crystalline powder having a slightly
bitter taste, is a short to intermediate-acting barbiturate. It has
the following structural formula:
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:
Caffeine (1,3,7-trimethylxanthine),a bitter, white crystalline powder
or white-glistening needles, is a
central nervous system stimulant. It has the following structural
formula:
Each Dolgic Plus tablet contains:
Butalbital, USP 50 mg
Acetaminophen, USP 500 mg
Caffeine, USP 40 mg
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
croscarmellose sodium, crospovidone, povidone, microcrystalline
cellulose, pregelatinized corn starch
and stearic acid. Film coating composed of: carnauba wax,
hypromellose, polyethylene glycol, titanium
dioxide, D&C Red No. 27 aluminum lake, FD&C Blue No. 1 aluminum lake,
D&C Red No. 30 aluminum
lake.
CLINICAL PHARMACOLOGY
The 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 tis