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
The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.
All adverse events tabulated below are classified as infrequent.
Central Nervous: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital.
Musculoskeletal: leg pain, muscle fatigue.
The following adverse reactions have been voluntarily reported as temporally associated with Fiorinal® with Codeine, a related product containing aspirin, butalbital, caffeine, and codeine phosphate.
Central Nervous: abuse, addiction, anxiety, disorientation, hallucination, hyperactivity, insomnia, libido decrease, nervousness, neuropathy, psychosis, sexual activity increase, slurred speech, twitching, unconsciousness, vertigo.
Urinary: kidney impairment, urinary difficulty.
Miscellaneous: allergic reaction, anaphylactic shock, cholangiocarcinoma, drug interaction with erythromycin (stomach upset), edema.
The following adverse drug events may be borne in mind as potential effects of the components of Fioricet with Codeine. Potential effects of high dosage are listed in the OVERDOSAGE section.
Codeine: nausea, vomiting, drowsiness, lightheadedness, constipation, pruritus.
Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported for Butalbital, Acetaminophen, and Caffeine Tablets, USP.
Drug Abuse And Dependence
Fioricet with Codeine is controlled by the Drug Enforcement Administration and is classified under Schedule III.
Abuse And Dependence
Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1,500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than twofold. As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient's regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.
Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications.
Read the Fioricet with Codeine (butalbital acetaminophen caffeine capsules) Side Effects Center for a complete guide to possible side effects
The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.
Fioricet with Codeine may enhance the effects of:
- Other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative hypnotics, or other CNS depressants, causing increased CNS depression.
Drug/Laboratory Test Interactions
Acetaminophen may produce false positive test results for urinary 5hydroxyindoleacetic acid.
Codeine may increase serum amylase levels.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/4/2016
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