Fioricet with Codeine
"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.
Fioricet with Codeine
Fioricet with Codeine
(butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules
HEPATOTOXICITY AND DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE
- 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.
- 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.
Fioricet with Codeine is supplied in capsule form for oral administration.
Each capsule contains:
Butalbital, USP ................... 50 mg
Acetaminophen, USP ...................300 mg
Caffeine, USP ...................40 mg
Codeine Phosphate, USP ...................30 mg
Butalbital (5allyl5isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula:
C11H16N2O3 ................... MW 224.26
C8H9NO2 ................... MW 151.16
Caffeine (1,3,7trimethylxanthine), is a central nervous system stimulant. It has the following structural formula:
C8H10N4O2 ................... MW 194.19
Codeine phosphate [morphine3methyl ether phosphate (1:1) (salt) hemihydrate], is a narcotic analgesic and antitussive. It has the following structural formula:
C18H24NO7P anhydrous ................... MW 397.37
Active Ingredients: Butalbital, USP, Caffeine, USP, Acetaminophen, USP, and Codeine Phosphate, USP.
Inactive Ingredients: FD&C blue #1, FD&C yellow #6, FD&C red #40, gelatin, microcrystalline cellulose, stearic acid, sodium lauryl sulfate, talc, 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...
What are the precautions when taking butalbital acetaminophen caffeine capsules (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...
Last reviewed on RxList: 4/4/2016
This monograph has been modified to include the generic and brand name in many instances.
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