BUTALBITAL ACETAMINOPHEN AND CAFFEINE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)

Διαθέσιμο από:

Northwind Pharmaceuticals

INN (Διεθνής Όνομα):

BUTALBITAL

Σύνθεση:

BUTALBITAL 50 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Butalbital, acetaminophen and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable. Butalbital Caffeine Acetaminophen 50/325/40 Tablet Permanent Link: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a26775c2-cafb-4b13-99ac-d4e8248265fb This product is contraindicated under the following conditions: Hypersensitivity or intolerance to any component of this product. Patients with porphyria. Butalbital Caffeine Acetaminophen 50/325/40 Tablet Permanent Link: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a26775c2-cafb-4b13-99ac-d4e8248265fb Abuse and Dependence Butalbital: Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged

Περίληψη προϊόντος:

Butalbital, acetaminophen and caffeine tablets USP contain butalbital 50 mg (Warning: May be habit-forming), acetaminophen 325 mg and caffeine 40 mg. Tablets are white, capsule-shaped, single-scored with the logo “MIA/110”, and are supplied in bottles of 100 and bottles of 500. Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Butalbital Caffeine Acetaminophen 50/325/40 Tablet Permanent Link: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a26775c2-cafb-4b13-99ac-d4e8248265fb

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

BUTALBITAL ACETAMINOPHEN AND CAFFEINE- BUTALBITAL ACETAMINOPHEN AND
CAFFEINE TABLET
NORTHWIND PHARMACEUTICALS
----------
BUTALBITAL AETAMINOPHEN CAFFEINE
WARNINGS SECTION
HEPATOTOXICITY
ACETAMINOPHEN HAS BEEN ASSOCIATED WITH CASES OF ACUTE LIVER FAILURE,
AT
TIMES RESULTING IN LIVER TRANSPLANT AND DEATH. MOST OF THE CASES OF
LIVER
INJURY ARE ASSOCIATED WITH THE USE OF ACETAMINOPHEN AT DOSES THAT
EXCEED 4000 MILLIGRAMS PER DAY, AND OFTEN INVOLVE MORE THAN ONE
ACETAMINOPHEN-CONTAINING PRODUCT.
Butalbital Caffeine Acetaminophen 50/325/40 Tablet Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a26775c2-cafb-4b13-99ac-d4e8248265fb
DESCRIPTION SECTION
Butalbital, acetaminophen and caffeine are supplied in tablet form for
oral administration.
Each tablet contains the following active ingredients:
Butalbital ...................50 mg
Warning: May be habit-forming.
Acetaminophen ........325 mg
Caffeine ......................40 mg
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
croscarmellose sodium, crospovidone, microcrystalline cellulose,
povidone, pregelatinized corn starch
and stearic acid.
Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to
intermediate acting barbiturate. It has the
following structural formula:
butalbital chemical structure
C11H16N2O3 MW = 224.26
Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate
analgesic and antipyretic. It has
the following structural formula:
acetaminophen chemical structure
C8H9NO2 MW = 151.16
Caffeine (1,3,7-trimethylxanthine), is a central nervous system
stimulant. It has the following structural
formula:
caffeine chemical structure
C8H10N4O2 MW = 194.19
Butalbital Caffeine Acetaminophen 50/325/40 Tablet Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a26775c2-cafb-4b13-99ac-d4e8248265fb
CLINICAL PHARMACOLOGY SECTION
This combination drug product is intended as a treatment for tension
headache.
It consists of a fixed combination of butalbital, acetamino