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:

A-S Medication Solutions

INN (International Name):

BUTALBITAL

Composition:

BUTALBITAL 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Butalbital, aspirin, and caffeine capsules 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 capsules 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 are contraindicated under the following conditions: - 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 the syndrome of nasal polyps, angioedema and bronchospastic reactivity to aspirin or other nonsteroidal anti-inflammatory drugs. Anaphylactoid reactions have occurred in such patients. - Peptic u

Product summary:

Product: 50090-1580 NDC: 50090-1580-0 30 CAPSULE in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUTALBITAL, ASPIRIN, AND CAFFEINE- BUTALBITAL, ASPIRIN, AND
CAFFEINE CAPSULE
A-S MEDICATION SOLUTIONS
----------
BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULES CIII
RX ONLY
DESCRIPTION
Butalbital, aspirin, and caffeine capsules are 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:
Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic,
and anti-inflammatory.
It has the following structural formula:
Caffeine (1, 3, 7-trimethylxanthine) is a central nervous system
stimulant. It has the
following structural formula:
_Inactive Ingredients:_ pregelatinized starch, microcrystalline
cellulose, sodium starch
glycolate, trimyristin, talc, colloidal silicon dioxide, D&C Yellow
No. 10, FD&C Green No. 3,
and gelatin. The capsule imprinting ink contains: shellac glaze in
ethanol, iron oxide black,
n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue No. 2
Aluminum Lake,
FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, and D&C
Yellow
No.10 Aluminum Lake.
CLINICAL PHARMACOLOGY
Pharmacologically, butalbital, aspirin, and caffeine capsules combine
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 hea