BUTALBITAL, ASPIRIN, AND CAFFEINE capsule

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Rebel Distributors Corp

INN (Tarptautinis Pavadinimas):

butalbital

Sudėtis:

butalbital 50 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Butalbital, Aspirin, and Caffeine Capsules, USP is 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, USP 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, USP is contraindicated under the following conditions: Butalbital, Aspirin, and Caffeine Capsules, USP is controlled by the Drug Enforcement Administration and is classified under Schedule III. Butalbital Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1,500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to

Produkto santrauka:

Butalbital, Aspirin, and Caffeine Capsules, USP Green cap with a yellow body. Cap is imprinted with “WATSON” in red. Body is imprinted with “3219” in red. Bottles of 100 are supplied with child-resistant closures. Store and Dispense Below 25°C (77°F); tight container. Protect from moisture. Rx only Watson Laboratories, Inc . Corona, CA 92880 USA BASPC01/07 S0107 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

BUTALBITAL, ASPIRIN, AND CAFFEINE- BUTALBITAL, ASPIRIN, AND CAFFEINE
CAPSULE
REBEL DISTRIBUTORS CORP
----------
BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULES
RX ONLY
DESCRIPTION
Butalbital, Aspirin, and Caffeine Capsules, USP is 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:
C H N O MOLECULAR WEIG HT 224 .26
Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic,
and anti-inflammatory. It has the
following structural formula:
C H O MOLECULAR WEIG HT 180.16
Caffeine (1,3,7-trimethylxanthine) is a central nervous system
stimulant. It has the following structural
formula:
C H N O MOLECULAR WEIG HT 194 .19
_Inactive Ingredients:_ microcrystalline cellulose, pregelatinized
starch, and talc. Gelatin capsules contain
11
16
2
3
9
8
4
8
10
4
2
_Inactive Ingredients:_ microcrystalline cellulose, pregelatinized
starch, and talc. Gelatin capsules contain
D&C Yellow No. 10, FD&C Green No. 3, and gelatin. The capsules are
printed with edible ink
containing red iron oxide.
CLINICAL PHARMACOLOGY
Pharmacologically, Butalbital, Aspirin, and Caffeine Capsules, USP
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
th