BUTALBITAL, ASPIRIN, AND CAFFEINE capsule

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Actavis Pharma, Inc.

INN (Algemene Internationale Benaming):

BUTALBITAL

Samenstelling:

BUTALBITAL 50 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Butalbital, Aspirin, and Caffeine Capsules, 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 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: - 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 patient

Product samenvatting:

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 (NDC 0591-3219-01) are supplied with child-resistant closures. Below 25°C (77°F); tight container. Protect from moisture. Rx only For all medical inquiries contact: Actavis Parsippany, NJ 07054 1-888-838-2872 Distributed By: Actavis Pharma, Inc. Parsippany, NJ 07054 Content Updated: April 2021

Autorisatie-status:

New Drug Application Authorized Generic

Productkenmerken

BUTALBITAL, ASPIRIN, AND CAFFEINE- BUTALBITAL, ASPIRIN, AND
CAFFEINE CAPSULE
ACTAVIS PHARMA, INC.
----------
BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULES, USP
C-III
CONTENT UPDATED: APRIL 2021
RX ONLY
DESCRIPTION
Butalbital, Aspirin, and Caffeine Capsules, USP are 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 weight 224.26
Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic,
and anti-inflammatory.
It has the following structural formula:
C H O molecular weight 180.16
11
16
2
3
9
8
4
Caffeine (1,3,7-trimethylxanthine) is a central nervous system
stimulant. It has the
following structural formula:
C H
N O molecular weight 194.19
_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, USP in tension
headache has been established in double-blind, placebo-controlled,
multi-clinic trials. A
factorial design study compared Butalbital, Aspirin, and Caffeine
Capsules, USP with
each of its major components. This study demonstrated that each
component
contributes to the efficacy of Butalbital, Aspirin, and Caffeine
Capsules, USP 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 comple