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Fioricet with Codeine

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Fioricet with Codeine

Fioricet® with Codeine
(butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules

Hepatotoxicity

Fioricet with Codeine contains butalbital, acetaminophen, caffeine, and codeine phosphate. 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.

DRUG DESCRIPTION

Fioricet with Codeine (Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate) is supplied in capsule form for oral administration.

Each capsule contains the following active ingredients:

butalbital, USP........................50 mg
acetaminophen, 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

Acetaminophen (4'-hydroxyacetanilide) is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

Acetaminophen Structural Formula Illustration

C8H9NO2                      molecular weight 151.16

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

C18H24NO7P                      anhydrous molecular weight 397.37

Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch. Gelatin capsules contain black iron oxide, D&C Red No. 33, FD&C Blue No. 1, gelatin, red iron oxide, and titanium dioxide. The capsules are printed with edible inks containing D&C Red No. 7 Calcium Lake, FD&C Blue No. 1 Aluminum Lake, and titanium dioxide.

What are the possible side effects of acetaminophen, butalbital, caffeine, and codeine (Fioricet with Codeine, Phrenilin with Caffeine and Codeine)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty 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, feeling short of breath;
  • confusion, unusual thoughts or behavior, feeling light-headed, fainting;
  • muscle twitching;
  • easy bruising...

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

What are the precautions when taking butalbital, acetaminophen, caffeine and codeine phosphate capsule (Fioricet with Codeine)?

See also Warning section.

Before taking this medication, tell your doctor or pharmacist if you are allergic to acetaminophen, caffeine, codeine, or butalbital; or to other barbiturates (e.g., phenobarbital), xanthine derivatives (e.g., theophylline) or narcotic pain medications (e.g., morphine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain enzyme disorder (porphyria), brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), breathing problems (e.g., asthma, sleep apnea, chronic obstructive pulmonary...

Read All Potential Precautions of Fioricet with Codeine »

Last reviewed on RxList: 8/8/2011
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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