BUTALBITAL, ASPIRIN AND CAFFEINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)

Available from:

H.J. Harkins Company

INN (International Name):

BUTALBITAL

Composition:

BUTALBITAL 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Butalbital, aspirin, 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 butalbital, aspirin, and caffeine in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable. Hypersensitivity to aspirin, caffeine, or barbiturates. Patients with porphyria.

Product summary:

Butalbital, Aspirin, and Caffeine Tablets, USP 50 mg/325 mg/40 mg are White, Round, Unscored Compressed Tablets Imprinted “West-ward 785”. Bottles of 30 tablets Bottles of 50 tablets Bottles of 100 tablets Bottles of 500 tablets Bottles of 1000 tablets Unit Dose Boxes of 100 tablets 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 By: West-ward Pharmaceutical Corp Eatontown, NJ 07724 Revised. January 2009

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUTALBITAL, ASPIRIN AND CAFFEINE - BUTALBITAL, ASPIRIN AND CAFFEINE
TABLET
H.J. HARKINS COMPANY
----------
BUTALBITAL, ASPIRIN AND CAFFEINE TABLETS, USP
Butalbital, Aspirin and Caffeine Tablets, USP
R ONLY
Rev. 01/09
DESCRIPTION:
Each Butalbital, Aspirin, and Caffeine tablet for oral administration
contains:
Butalbital, USP 50 mg
Aspirin, USP 325 mg
Caffeine, USP 40 mg
Butalbital, 5-allyl-5-isobutyl-barbituric acid, a white odorless
crystalline powder; is a short-to
intermediate-acting barbiturate. Its structural formula is as follows:
Aspirin, salicylic acid acetate, is a non-opiate analgesic,
anti-inflammatory and antipyretic agent. It
occurs as a white, crystalline tabular or needle-like powder and is
odorless or has a faint odor. Its
structural formula is as follows:
Caffeine, 1,3,7-trimethylxanthine, is a central nervous system
stimulant which occurs as a white powder
or white glistening needles. It also has a bitter taste. Its
structural formula is as follows:
Inactive Ingredients: Hydrogenated Vegetable Oil, Microcrystalline
Cellulose, Sodium Starch
Glycolate, Starch 1500 and Talc.
CLINICAL PHARMACOLOGY
Pharmacologically, butalbital, aspirin, and caffeine combines the
analgesic properties of aspirin with
the anxiolytic and muscle relaxant properties of butalbital.
The clinical effectiveness of butalbital, aspirin, and caffeine in
tension headache has been established in
double-blind, placebo-controlled, multi-clinic trials. A factorial
design study compared butalbital,
aspirin, and caffeine with each of its major components. This study
demonstrated that each component
contributes to the efficacy of butalbital, aspirin, and caffeine in
the treatment of the target symptoms of
CIII
X
tension headache (headache pain, psychic tension, and muscle
contraction in the head, neck, and shoulder
region). For each symptom and the symptom complex as a whole,
butalbital, aspirin, and caffeine was
shown to have significantly superior clinical effects to either
component alone.
PHARMACOKINETICS :
The behavior of the indivi