BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)

Διαθέσιμο από:

Lannett Company, Inc.

INN (Διεθνής Όνομα):

BUTALBITAL

Σύνθεση:

BUTALBITAL 50 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Butalbital, Aspirin, Caffeine and Codeine Phosphate Capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy of butalbital, aspirin, caffeine and codeine phosphate capsules is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: 1) butalbital, aspirin, caffeine and codeine; 2) codeine; 3) butalbital, aspirin and caffeine; 4) placebo. Response was assessed over the course of the first 4 hours of each of 2 distinct headaches, separated by at least 24 hours. The combination product of butalbital, aspirin, caffeine and codeine proved statistically significantly superior to each of its components and to placebo on measures of pain relief. Evidence supporting the efficacy and safety of butalbital, aspirin, caffeine and codeine in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit

Περίληψη προϊόντος:

Each yellow and blue Butalbital, Aspirin, Caffeine and Codeine Phosphate Capsule USP 50 mg/325 mg/ 40 mg/30 mg is imprinted JSP 507 Bottles of 100 NDC 0527-1312-01 Bottles of 500 NDC 0527-1312-05 Store and Dispense Below 25°C (77°F); in a tight, light resistant container. Manufactured for: Lannett Company, Inc. Philadelphia, PA 19136 Manufactured by: Jerome Stevens Pharmaceuticals, Inc. Bohemia, NY 11716 Rev. 02/08 MG #11583

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE- BUTALBITAL,
ASPIRIN,
CAFFEINE AND CODEINE PHOSPHATE CAPSULE
LANNETT COMPANY, INC.
----------
BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULES, USP
CIII
RX ONLY
DESCRIPTION
Each capsule for oral administration contains:
codeine phosphate, USP . . . . . . . . . . . . 30 mg (1/2 gr)
butalbital, USP . . . . . . . . . . . . . . . . . . . . . . . . . . 50
mg
caffeine, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
mg
aspirin, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . 325
mg
Codeine phosphate occurs as fine, white, needle-shaped crystals, or
white, crystalline powder. It is
affected by light. Its chemical name is
7,8-didehydro-4,5α-epoxy-3-methoxy-17- methylmorphinan-6α-
ol phosphate (1:1) (salt) hemihydrate. Its molecular weight is 406.37
and its molecular formula
is C
H NO •H PO •½H O.
Butalbital, 5-allyl-5-isobutyl-barbituric acid, a white odorless
crystalline powder, is a short- to
intermediate-acting barbiturate. Its molecular weight is 224.26 and
its molecular formula is
C
H N O .
Caffeine, 1,3,7-trimethylxanthine, is a central nervous stimulant
which occurs as a white powder or
white glistening needles. Its molecular weight is (anhydrous) 194.19
and its molecular formula is
C H N O .
18
21
3
3
4
2
11
16
2
3
8
10
4
2
Aspirin is benzoic acid, 2-(acetyloxy)-, with a molecular formula of C
H O and its molecular weight
is 180.16.
_Inactive Ingredients:_ D&C Yellow #10, D&C Yellow #10 Aluminum Lake,
D&C Red #33, D&C Red
#28, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum
Lake, FD&C Blue #10
Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, microcrystalline
cellulose, pregelatinized
starch, talc, titanium dioxide, stearic acid, colloidal silicon
dioxide.
CLINICAL PHARMACOLOGY
Butalbital, Aspirin, Caffeine and Codeine Phosphate Capsules is a
combination drug product intended as
a treatment for tension headache.
PHARMACOKINETICS
Bioavailability: The bioavailability of the components of the fixed
combina