BUTALBITAL, ASPIRIN, AND CAFFEINE- 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:

Lake Erie Medical DBA Quality Care Products LLC

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 ul

Product summary:

Butalbital, aspirin, and caffeine capsules are dark green and light green in color, imprinted with logo "LANNETT" on the cap and "1552" on the body. Each capsule contains: butalbital USP, 50 mg; aspirin USP, 325 mg; caffeine USP, 40 mg and is available as follows: Dispense in a tight container as defined in the USP. Use child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Manufactured by: Lannett Company, Inc. Philadelphia, PA 19136 Made in the USA 10-917 Rev. 10/10; Revision 1

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUTALBITAL, ASPIRIN, AND CAFFEINE- BUTALBITAL, ASPIRIN, AND CAFFEINE
CAPSULE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULES CIII
RX ONLY
DESCRIPTION
Each butalbital, aspirin, and caffeine capsule for oral administration
contains: 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:
_Active Ingredients:_ aspirin, USP, butalbital, USP, and caffeine,
USP.
_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 head, neck, and shoulder region). For each symptom and th