BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE capsule

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

Butalbital (UNII: KHS0AZ4JVK) (Butalbital - UNII:KHS0AZ4JVK), Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D), Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E), Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine - UNII:Q830PW7520)

Disponível em:

Dispensing Solutions, Inc.

DCI (Denominação Comum Internacional):

Butalbital

Composição:

Butalbital 50 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable. This combination product is contraindicated under the following conditions: - Hypersensitivity or intolerance to acetaminophen, caffeine, butalbital, or codeine. - Patients with porphyria. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules is controlled by the Drug Enforcement Administration and is classified under Schedule III. Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration and it sho

Resumo do produto:

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules: Dark blue, opaque cap with a gray, opaque body, and body is imprinted with "B 073" in black ink. Bottles of 100's (NDC 51991-073-01) Store at 20° to 25°C (68° to 77°F) in a tight, light-resistant container. [see USP Controlled Room Temperature].

Status de autorização:

Abbreviated New Drug Application

Características técnicas

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE -
BUTALBITAL,
ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE
DISPENSING SOLUTIONS, INC.
----------
BUTALBITAL, ACETAMINOPHEN, CAFFEINE,
AND CODEINE PHOSPHATE CAPSULES
CIII
RX ONLY
DESCRIPTION
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate is supplied
in capsule form for oral
administration.
Each capsule contains the following active ingredients:
Codeine
Phosphate,
USP
........................................
30 mg
Butalbital,
USP
........................................................
50 mg
Caffeine,
USP
.........................................................
40 mg
Acetaminophen,
USP
..............................................
325 mg
Codeine phosphate
[7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol
phosphate (1:1)
(salt) hemihydrate, C
H N0 P, anhydrous mw 397.37], is a narcotic analgesic and antitussive.
The
structural formula of codeine phosphate is:
Butalbital (5-allyl-5-isobutylbarbituric acid, C
H N 0 , mw 224.26), is a short-to intermediate- acting
barbiturate. The structural formula of butalbital is:
18
24
7
11
16
2
3
Caffeine (1,3,7-trimethylxanthine, C H N O , mw 194.19), is a central
nervous system stimulant. The
structural formula of caffeine is:
Acetaminophen (4'-hydroxyacetanilide, C H NO , mw 151.16), is a
non-opiate, non-salicylate analgesic
and antipyretic. The structural formula of acetaminophen is:
_Active Ingredients:_ Codeine Phosphate, USP, Butalbital, USP,
Caffeine, USP, and Acetaminophen, USP.
_Inactive Ingredients:_ FD&C Blue No. 1, FD&C Red No. 3, FD&C Red No.
40, *FD&C Yellow No.5
(see PRECAUTIONS), Gelatin, Microcrystalline Cellulose, Sodium Lauryl
Sulfate, Stearic Acid,
Talc, Titanium Dioxide.
CLINICAL PHARMACOLOGY
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules is
a combination drug product
intended as a treatment for tension headache. Butalbital,
Acetaminophen, Caffeine and Codeine
Phosphate Capsules consists of a fixed combination of butalbital 50
mg, acetaminophen 3