BUTALBITAL, ASPIRIN, AND CAFFEINE capsule

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:

STAT RX USA LLC

INN (International Name):

BUTALBITAL

Composition:

BUTALBITAL 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Butalbital, Aspirin, and Caffeine Capsules, USP is 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 Capsules, USP in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable. Butalbital, Aspirin, and Caffeine Capsules, USP is contraindicated under the following conditions: - Hypersensitivity or intolerance to aspirin, caffeine, or butalbital. Hypersensitivity or intolerance to aspirin, caffeine, or butalbital. - Patients with a hemorrhagic diathesis (e.g., hemophilia, hypoprothrombinemia, von Willebrand’s disease, the thrombocytopenias, thrombasthenia and other ill-defined hereditary platelet dysfunctions, severe vitamin K deficiency and severe liver damage). Patients with a hemorrhagic diathesis (e.g., hemophilia, hypoprothrombinemia, von Willebrand’s disease, the thrombocytopenias,

Product summary:

Butalbital, Aspirin, and Caffeine Capsules, USP Green cap with a yellow body. Cap is imprinted with “WATSON” in red. Body is imprinted with “3219” in red. Bottles of 100 are supplied with child-resistant closures. Store and Dispense Below 25°C (77°F); tight container. Protect from moisture. Rx only Address medical inquiries to: WATSON Medical Communications P.O. Box 1953 Morristown, NJ 07962-1953 800-272-5525 Watson Laboratories, Inc . Corona, CA 92880 USA Revised: June 2009 190110 S0609

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

BUTALBITAL, ASPIRIN, AND CAFFEINE - BUTALBITAL, ASPIRIN, AND CAFFEINE
CAPSULE
STAT RX USA LLC
----------
BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULES, USP C-III
REVISED: JUNE 2009
RX ONLY
1901100609
DESCRIPTION
Butalbital, Aspirin, and Caffeine Capsules, USP is supplied in capsule
form for oral administration.
Each capsule contains the following active ingredients:
butalbital, USP . . . . . . . . . . . . .
50 mg
aspirin, USP. . . . . . . . . . . . . . . . 325 mg
caffeine, USP . . . . . . . . . . . . . . 40 mg
Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to
intermediate-acting barbiturate. It has the
following structural formula:
C
H N O molecular weight 224.26
Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic,
and anti-inflammatory. It has the
following structural formula:
C H O molecular weight 180.16
Caffeine (1,3,7-trimethylxanthine) is a central nervous system
stimulant. It has the following structural
formula:
11
16
2
3
9
8
4
C H N O molecular weight 194.19
_Inactive Ingredients:_ microcrystalline cellulose, pregelatinized
starch, and talc. Gelatin capsules contain
D&C Yellow No. 10, FD&C Green No. 3, and gelatin. The capsules are
printed with edible ink
containing red iron oxide.
CLINICAL PHARMACOLOGY
Pharmacologically, Butalbital, Aspirin, and Caffeine Capsules, USP
combines the analgesic properties
of aspirin with the anxiolytic and muscle relaxant properties of
butalbital.
The clinical effectiveness of butalbital, aspirin, and caffeine
capsules in tension headache has been
established in double-blind, placebo-controlled, multi-clinic trials.
A factorial design study compared
butalbital, aspirin, and caffeine capsules with each of its major
components. This study demonstrated that
each component contributes to the efficacy of butalbital, aspirin, and
caffeine capsules in the treatment
of the target symptoms of 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, b