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Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate

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Overview

What is Fioricet with Codeine?

Fioricet with Codeine is supplied in capsule form for oral administration.

Each capsule contains:

Butalbital, USP…………..........50 mgAcetaminophen, 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:

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

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

Codeine phosphate [morphine3methyl ether phosphate (1:1) (salt) hemihydrate], is a narcotic analgesic and antitussive. It has the following structural formula:

Active Ingredients:

Inactive Ingredients:



What does Fioricet with Codeine look like?



What are the available doses of Fioricet with Codeine?

Sorry No records found.

What should I talk to my health care provider before I take Fioricet with Codeine?

Sorry No records found

How should I use Fioricet with Codeine?

Fioricet with Codeine are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

Evidence supporting the efficacy and safety of Fioricet with Codeine in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable.

One or 2 capsules every 4 hours. Total daily dosage should not exceed 6 capsules.

Extended and repeated use of this combination product is not recommended because of the potential for physical dependence.


What interacts with Fioricet with Codeine?


  • This combination product is contraindicated under the following conditions:




What are the warnings of Fioricet with Codeine?

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. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.

Serious skin reactions

Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Death Related to Ultra-Rapid Metabolism of Codeine to Morphine

Respiratory depression and death have occurred in children who received codeine in the post-operative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme 2D6 or high morphine concentrations). Deaths have also occurred in nursing infants who were exposed to high levels of morphine in breast milk because their mothers were ultra-rapid metabolizers of codeine.

Some individuals may be ultra-rapid metabolizers because of a specific CYP2D6 genotype (gene duplications denoted as *1/*1xN or *1/*2xN). The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1 to 10% in Caucasians, 3% in African Americans, and 16 to 28% in North Africans, Ethiopians, and Arabs. Data are not available for other ethnic groups. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience signs of overdose (such as extreme sleepiness, confusion, or shallow breathing).

Children with obstructive sleep apnea who are treated with codeine for post-tonsillectomy and/or adenoidectomy pain may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Fioricet with Codeine is contraindicated for post-operative pain management in all pediatric patients undergoing tonsillectomy and/or adenoidectomy [see

When prescribing Fioricet with Codeine , healthcare providers should choose the lowest effective dose for the shortest period of time and inform patients and caregivers about these risks and the signs of morphine overdose.

Hypersensitivity/anaphylaxis

There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Fioricet with Codeine immediately and seek medical care if they experience these symptoms. Do not prescribe Fioricet with Codeine for patients with acetaminophen allergy.

In the presence of head injury or other intracranial lesions, the respiratory depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid pressure. Narcotics also produce other CNS depressant effects, such as drowsiness, that may further obscure the clinical course of the patients with head injuries.

Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions.

Butalbital and codeine are both habit-forming and potentially abusable. Consequently, the extended use of this combination product is not recommended.


What are the precautions of Fioricet with Codeine?

General

Fioricet with Codeine should be prescribed with caution in certain special risk patients such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, head injuries, elevated intracranial pressure, acute abdominal conditions, hypothyroidism, urethral stricture, Addison's disease, or prostatic hypertrophy.

Information for patients

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Laboratory tests

In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

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In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

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Carcinogenesis, mutagenesis, impairment of fertility

No adequate studies have been conducted in animals to determine whether acetaminophen, codeine and butalbital have a potential for carcinogenesis or mutagenesis. No adequate studies have been conducted in animals to determine whether acetaminophen and butalbital have a potential for impairment of fertility.

Pregnancy

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Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital containing drug during the last 2 months of pregnancy. Butalbital was found in the infant's serum. The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.

Labor and delivery

Use of codeine during labor may lead to respiratory depression in the neonate.

Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants.

The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding. (See WARNINGS — .)

Barbiturates, acetaminophen, and caffeine are also excreted in breast milk in small amounts. Because of potential for serious adverse reactions in nursing infants from Fioricet with Codeine , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

 Pediatric use 

Safety and effectiveness in pediatric patients have not been established.

Respiratory depression and death have occurred in children with obstructive sleep apnea who received codeine in the post-operative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme 2D6 or high morphine concentrations). These children may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. Fioricet with Codeine is contraindicated for post-operative pain management in all pediatric patients undergoing tonsillectomy and/or adenoidectomy [see ]

Geriatric use

Clinical studies of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Butalbital is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.


What are the side effects of Fioricet with Codeine?

Frequently Observed

The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.

Infrequently Observed

All adverse events tabulated below are classified as infrequent.

Central Nervous:

Autonomic Nervous:

Gastrointestinal:

Cardiovascular:

Musculoskeletal:

Genitourinary:

Miscellaneous:

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:

Autonomic Nervous:

Gastrointestinal:

Cardiovascular:

Skin:

Urinary:

Miscellaneous:

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

Acetaminophen:

Caffeine:

Codeine:

Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported for Fioricet Tablets.


What should I look out for while using Fioricet with Codeine?

This combination product is contraindicated under the following conditions:


What might happen if I take too much Fioricet with Codeine?

Following an acute overdosage of Fioricet with Codeine, toxicity may result from the barbiturate, the codeine, or the acetaminophen. Toxicity due to the caffeine is less likely, due to the relatively small amounts in this formulation.


How should I store and handle Fioricet with Codeine?

Store at 20°-25°C (68°-77°F). [See USP controlled room temperature].Fioricet with Codeine Capsules 50 mg/300 mg/40 mg/30 mg Store and DispenseStore at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.Rx OnlyFor all medical inquiries contact:ACTAVIS Medical CommunicationsParsippany, NJ 07054800-272-5525Manufactured by: Nexgen Pharma, Inc.Irvine, CA 92614Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USA7028-WBRev. 9/14Fioricet with Codeine Capsules 50 mg/300 mg/40 mg/30 mg Store and DispenseStore at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.Rx OnlyFor all medical inquiries contact:ACTAVIS Medical CommunicationsParsippany, NJ 07054800-272-5525Manufactured by: Nexgen Pharma, Inc.Irvine, CA 92614Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USA7028-WBRev. 9/14Fioricet with Codeine Capsules 50 mg/300 mg/40 mg/30 mg Store and DispenseStore at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.Rx OnlyFor all medical inquiries contact:ACTAVIS Medical CommunicationsParsippany, NJ 07054800-272-5525Manufactured by: Nexgen Pharma, Inc.Irvine, CA 92614Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USA7028-WBRev. 9/14Fioricet with Codeine Capsules 50 mg/300 mg/40 mg/30 mg Store and DispenseStore at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.Rx OnlyFor all medical inquiries contact:ACTAVIS Medical CommunicationsParsippany, NJ 07054800-272-5525Manufactured by: Nexgen Pharma, Inc.Irvine, CA 92614Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USA7028-WBRev. 9/14Fioricet with Codeine Capsules 50 mg/300 mg/40 mg/30 mg Store and DispenseStore at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.Rx OnlyFor all medical inquiries contact:ACTAVIS Medical CommunicationsParsippany, NJ 07054800-272-5525Manufactured by: Nexgen Pharma, Inc.Irvine, CA 92614Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USA7028-WBRev. 9/14Fioricet with Codeine Capsules 50 mg/300 mg/40 mg/30 mg Store and DispenseStore at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.Rx OnlyFor all medical inquiries contact:ACTAVIS Medical CommunicationsParsippany, NJ 07054800-272-5525Manufactured by: Nexgen Pharma, Inc.Irvine, CA 92614Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USA7028-WBRev. 9/14Fioricet with Codeine Capsules 50 mg/300 mg/40 mg/30 mg Store and DispenseStore at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.Rx OnlyFor all medical inquiries contact:ACTAVIS Medical CommunicationsParsippany, NJ 07054800-272-5525Manufactured by: Nexgen Pharma, Inc.Irvine, CA 92614Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USA7028-WBRev. 9/14Fioricet with Codeine Capsules 50 mg/300 mg/40 mg/30 mg Store and DispenseStore at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.Rx OnlyFor all medical inquiries contact:ACTAVIS Medical CommunicationsParsippany, NJ 07054800-272-5525Manufactured by: Nexgen Pharma, Inc.Irvine, CA 92614Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USA7028-WBRev. 9/14Fioricet with Codeine Capsules 50 mg/300 mg/40 mg/30 mg Store and DispenseStore at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.Rx OnlyFor all medical inquiries contact:ACTAVIS Medical CommunicationsParsippany, NJ 07054800-272-5525Manufactured by: Nexgen Pharma, Inc.Irvine, CA 92614Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USA7028-WBRev. 9/14Fioricet with Codeine Capsules 50 mg/300 mg/40 mg/30 mg Store and DispenseStore at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.Rx OnlyFor all medical inquiries contact:ACTAVIS Medical CommunicationsParsippany, NJ 07054800-272-5525Manufactured by: Nexgen Pharma, Inc.Irvine, CA 92614Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USA7028-WBRev. 9/14Fioricet with Codeine Capsules 50 mg/300 mg/40 mg/30 mg Store and DispenseStore at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.Rx OnlyFor all medical inquiries contact:ACTAVIS Medical CommunicationsParsippany, NJ 07054800-272-5525Manufactured by: Nexgen Pharma, Inc.Irvine, CA 92614Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USA7028-WBRev. 9/14Fioricet with Codeine Capsules 50 mg/300 mg/40 mg/30 mg Store and DispenseStore at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.Rx OnlyFor all medical inquiries contact:ACTAVIS Medical CommunicationsParsippany, NJ 07054800-272-5525Manufactured by: Nexgen Pharma, Inc.Irvine, CA 92614Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USA7028-WBRev. 9/14Fioricet with Codeine Capsules 50 mg/300 mg/40 mg/30 mg Store and DispenseStore at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.Rx OnlyFor all medical inquiries contact:ACTAVIS Medical CommunicationsParsippany, NJ 07054800-272-5525Manufactured by: Nexgen Pharma, Inc.Irvine, CA 92614Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USA7028-WBRev. 9/14Fioricet with Codeine Capsules 50 mg/300 mg/40 mg/30 mg Store and DispenseStore at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.Rx OnlyFor all medical inquiries contact:ACTAVIS Medical CommunicationsParsippany, NJ 07054800-272-5525Manufactured by: Nexgen Pharma, Inc.Irvine, CA 92614Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USA7028-WBRev. 9/14Fioricet with Codeine Capsules 50 mg/300 mg/40 mg/30 mg Store and DispenseStore at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.Rx OnlyFor all medical inquiries contact:ACTAVIS Medical CommunicationsParsippany, NJ 07054800-272-5525Manufactured by: Nexgen Pharma, Inc.Irvine, CA 92614Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USA7028-WBRev. 9/14Fioricet with Codeine Capsules 50 mg/300 mg/40 mg/30 mg Store and DispenseStore at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container.Rx OnlyFor all medical inquiries contact:ACTAVIS Medical CommunicationsParsippany, NJ 07054800-272-5525Manufactured by: Nexgen Pharma, Inc.Irvine, CA 92614Distributed By:Actavis Pharma, Inc.Parsippany, NJ 07054 USA7028-WBRev. 9/14


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Fioricet with Codeine is a combination drug product intended as a treatment for tension headache. It consists of a fixed combination of butalbital 50 mg, acetaminophen 300 mg, caffeine 40 mg, and codeine phosphate 30 mg. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood.

Non-Clinical Toxicology
This combination product is contraindicated under the following conditions:

Amiodarone is metabolized to desethylamiodarone by the cytochrome P450 (CYP450) enzyme group, specifically cytochrome P450 3A4 (CYP3A4) and CYP2C8. The CYP3A4 isoenzyme is present in both the liver and intestines (see Amiodarone is an inhabitor of CYP3A4 and p-glycoprotein. Therefore, amiodarone has the potential for interactions with drugs or substances that may be substrates, inhibitors or inducers of CYP3A4 and substrates of p-glycoprotein. While only a limited number of drug-drug interactions with amiodarone have been reported, the potential for other interactions should be anticipated. This is especially important for drugs associated with serious toxicity, such as other antiarrhythmics. If such drugs are needed, their dose should be reassessed and, where appropriate, plasma concentration measured. In view of the long and variable half-life of amiodarone, potential for drug interactions exists, not only with concomitant medication, but also with drugs administered after discontinuation of amiodarone.

Since amiodarone is a substrate for CYP3A4 and CYP2C8, drugs/substances that inhibit CYP3A4 may decrease the metabolism and increase serum concentrations of amiodarone. Reported examples include the following:

Fioricet with Codeine should be prescribed with caution in certain special risk patients such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, head injuries, elevated intracranial pressure, acute abdominal conditions, hypothyroidism, urethral stricture, Addison's disease, or prostatic hypertrophy.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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