BUTALBITAL, ASPIRIN AND CAFFEINE tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)

Inapatikana kutoka:

Rebel Distributors Corp

INN (Jina la Kimataifa):

BUTALBITAL

Tungo:

BUTALBITAL 50 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Butalbital, Aspirin and Caffeine Tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Hypersensitivity to aspirin, caffeine or barbiturates. Patients with porphyria. Butalbital, Aspirin, and Caffeine Tablets are classified as a Schedule III controlled substance. Prolonged use of barbiturates can produce drug dependence, characterized by psychic dependence, and less frequently, physical dependence and tolerance. The abuse liability of Butalbital, Aspirin, and Caffeine Tablets are similar to that of other barbiturate-containing drug combinations. Caution should be exercised when prescribing medication for patients with a known propensity for taking excessive quantities of drugs, which is not uncommon in patients with chronic tension headache.

Bidhaa muhtasari:

Butalbital, Aspirin and Caffeine Tablets, USP 50 mg/325 mg/40 mg: White, round, unscored tablets; imprinted “West-ward 785”. Bottles of 60 tablets, NDC 21695-354-60. Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured By: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Revised April 2003 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

BUTALBITAL, ASPIRIN AND CAFFEINE- BUTALBITAL, ASPIRIN AND CAFFEINE
TABLET
REBEL DISTRIBUTORS CORP
----------
BUTALBITAL, ASPIRIN, AND CAFFEINE TABLETS, USP CIII
REV. 04/03
RX ONLY
DESCRIPTION:
Each Butalbital, Aspirin, and Caffeine Tablet for oral administration
contains:
Butalbital, USP.....................50 mg
Aspirin, USP.......................325 mg
Caffeine, USP.......................40 mg
Butalbital, 5-allyl-5-isobutylbarbituric acid, a white, odorless,
crystalline powder having a slightly
bitter taste, is a short to intermediate-acting barbiturate. It has
the following structural formula:
C
H N O M.W. 224.26
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. It has
the following structural formula:
C H O M.W. 180.16
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 structure
is as follows:
11
16
2
3
9
8
4
C H N O M.W. 194.19
Inactive Ingredients: Corn Starch, Hydrogenated Vegetable Oil,
Microcrystalline Cellulose,
Pregelatinized Starch, Sodium Starch Glycolate and Talc.
CLINICAL PHARMACOLOGY:
Pharmacologically, Butalbital, Aspirin, and Caffeine Tablets combine
the analgesic properties of
aspirin with the anxiolytic and muscle relaxant properties of
butalbital.
The clinical effectiveness of a product containing butalbital,
aspirin, and caffeine in tension headache
has been established in double-blind, placebo-controlled, multiclinic
trials. A factorial design study
compared the combination product with each of its major components.
This study demonstrated that each
component contributes to the efficacy of the combination product 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,
the produ