butalbital, aspirin, and caffeine- butalbital, aspirin, and caffeine capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

butalbital (UNII: KHS0AZ4JVK) (butalbital - UNII:KHS0AZ4JVK), aspirin (UNII: R16CO5Y76E) (aspirin - UNII:R16CO5Y76E), caffeine (UNII: 3G6A5W338E) (caffeine - UNII:3G6A5W338E)

Tilgængelig fra:

MUTUAL PHARMACEUTICAL COMPANY, INC.

INN (International Name):

butalbital, aspirin, and caffeine

Lægemiddelform:

CAPSULE

Sammensætning:

50 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 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 ulcer

Produkt oversigt:

Butalbital, aspirin, and caffeine capsules, USP are supplied as follows: Butalbital 50 mg, aspirin 325 mg, caffeine 40 mg capsules are green opaque/white opaque, imprinted MUTUAL/779, on both the cap and the body. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from moisture. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Produktets egenskaber

BUTALBITAL, ASPIRIN, AND CAFFEINE- BUTALBITAL, ASPIRIN, AND CAFFEINE
CAPSULE
MUTUAL PHARMACEUTICAL COMPANY, INC.
----------
BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULES USP 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-isobutyl-barbituric acid, has a molecular
formula of C
H N O and a molecular
weight of 224.26.
Aspirin, benzoic acid, 2-(acetyloxy)-, has a molecular formula of C H
O and a molecular weight of
180.16.
Caffeine, 1, 3, 7-trimethylxanthine, has a molecular formula of C H N
O and a molecular weight of
194.19.
_Active Ingredients:_ aspirin, USP, butalbital, USP, and caffeine,
USP.
_Inactive Ingredients:_ alginic acid, corn starch, pregelatinized
starch, sodium lauryl sulfate, and talc. The
capsule contains: FD&C Blue #2, FDA/E172 yellow iron oxide, gelatin
and titanium dioxide. The
imprinting ink contains: D&C Yellow #10, FD&C Blue #1, FD&C Blue #2,
FD&C Red #40, iron oxide
black, and propylene glycol.
CLINICAL PHARMACOLOGY
Pharmacologically, butalbital, aspirin, and caffeine capsules 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, butalbital,
aspirin, and caffeine capsules were shown to have significantly
superior clinical effects to either
component alone.
PHARMACOKINETICS
The behavior of the ind