"Medscape Medical News
August 22, 2015
The US Food and Drug Administration (FDA) has granted tentative approval to expand the label for an extended-release formulation of topiramate (Trokendi XR, Supernus "...
(butalbital, acetaminophen and caffeine) Capsules
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, acetaminophen and caffeine are supplied in capsule form for oral administration.
Each capsule contains:
Butalbital .................... 50 mg
Warning: May be habit-forming.
Acetaminophen .......... 325 mg
Caffeine ...................... 40 mg
In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose with capsule shell composed of gelatin (silicon dioxide and sodium lauryl sulfate added as manufacturing aides to the gelatin) and titanium dioxide. Impriting ink composed of n-butyl alcohol, pharmaceutical glaze modified in SD-45, propylene glycol, SDA-3A alcohol, titanium dioxide, D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake.
Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula: C11H16N2O3 MW = 224 .26
Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a nonopiate, non-salicylate analgesic and antipyretic. It has the following structural formula:: C8H9NO2 MW = 151.16
Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula: C8H10N4O2 MW = 194 .19
Last reviewed on RxList: 7/14/2016
This monograph has been modified to include the generic and brand name in many instances.
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