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Fiorinal with Codeine

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Fiorinal with Codeine

Fiorinal® with Codeine
(butalbital, aspirin, caffeine, and codeine phosphate) Capsules, USP

WARNING

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.

DRUG DESCRIPTION

Fiorinal with Codeine (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP) is supplied in capsule form for oral administration.

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:

Butalbital Structural Formula Illustration

C11H16N2O3     molecular weight 224.26

Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory. It has the following structural formula:

Aspirin Structural Formula Illustration

C9H8O4     molecular weight 180.16

Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula:

Caffeine Structural Formula Illustration

C8H10N4O2     molecular weight 194.19

Codeine phosphate (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate) is a narcotic analgesic and antitussive. It has the following structural formula:

Codeine Phosphate Structural Formula Illustration

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;...

Read All Potential Side Effects and See Pictures of Fiorinal with Codeine »

Last reviewed on RxList: 6/3/2013
This monograph has been modified to include the generic and brand name in many instances.

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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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