Fiorinal with Codeine
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Fiorinal with Codeine
Fiorinal® with Codeine
(butalbital, aspirin, caffeine, and codeine phosphate) Capsules, USP
DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE
Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism.
Each capsule contains the following active ingredients:
butalbital, USP . . . . . . . . . . . . . 50 mg
aspirin, USP . . . . . . . . . . . . . . . . . 325 mg
caffeine, USP . . . . . . . . . . . . . . . 40 mg
codeine phosphate, USP . . . . . . . 30 mg
Butalbital (5-allyl-5-isobutylbarbituric acid) is a short-to intermediate-acting barbiturate. It has the following structural formula:
C11H16N2O3 molecular weight 224.26
C9H8O4 molecular weight 180.16
is a central nervous system stimulant. It has the following structural formula:
C8H10N4O2 molecular weight 194.19
phosphate (1:1) (salt) hemihydrate) is a narcotic analgesic and antitussive. It
has the following structural formula:
C18H24NO7Panhydrous molecular weight 397.37
Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, talc. Gelatin capsules contain D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 3, FD&C Yellow No. 6, gelatin, titanium dioxide. The capsules are printed with edible ink containing red iron oxide.
What are the possible side effects of this medication (Ascomp with Codeine, Fiorinal with Codeine)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have a serious side effect such as:
- shallow breathing, slow heart rate;
- fast or pounding heart rate, muscle twitching;
- confusion, unusual thoughts or behavior;
- bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- problems with urination;...
Last reviewed on RxList: 6/3/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Fiorinal with Codeine Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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