BUTALBITAL, ASPIRIN AND CAFFEINE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

Butalbital (UNII: KHS0AZ4JVK) (Butalbital - UNII:KHS0AZ4JVK), Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E), Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E)

Dostupno od:

Vensun Pharmaceuticals, Inc.

INN (International ime):

Butalbital

Sastav:

Butalbital 50 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Butalbital, Aspirin, and Caffeine Tablets, USP 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. Butalbital, aspirin and caffeine tablets 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 ulcer or

Proizvod sažetak:

Butalbital, Aspirin, and Caffeine Tablets, USP 50 mg/325 mg/40 mg are white, round, unscored tablets debossed with a “P201” on one side. NDC 42543-098-01: Bottles of 100 tablets Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in tight, light-resistant container as defined in the USP using a child-resistant closure. The brands listed are trademarks or registered trademarks of their respective owners Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067 Manufactured by: Pharmaceutics International, Inc. Hunt Valley, MD 21031 Rev. 00, July 2016

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

BUTALBITAL, ASPIRIN AND CAFFEINE- BUTALBITAL, ASPIRIN AND CAFFEINE
TABLET
VENSUN PHARMACEUTICALS, INC.
----------
BUTALBITAL, ASPIRIN AND CAFFEINE TABLETS, USP CIII
RX ONLY
DESCRIPTION:
Each Butalbital, Aspirin, and Caffeine Tablet, USP 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: microcrystalline cellulose, sodium starch
glycolate, pregelatinized starch (corn),
colloidal silicon dioxide, talc and hydrogenated vegetable oil
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 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 individua