Drugs Details

Drugs Info of Fioricet with Codeine, Phrenilin with Caffeine and Codeine
Drugs Details
  • Drugs Type  : Multum
  • Date : 20th Jan 2015 02:30 am
  • Brand Name : Fioricet with Codeine, Phrenilin with Caffeine and Codeine
  • Generic Name : acetaminophen, butalbital, caffeine, and codeine (Pronunciation: a SEET a MIN o fen, bue TAL bi tal, KAF een, and KOE deen)
Descriptions

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 »

This monograph has been modified to include the generic and brand name in many instances.

Indications

Fioricet with Codeine is 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.

Dosage Administration

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

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

How Supplied

Fioricet with Codeine Capsules

Dark blue, opaque cap with a light grey, opaque body. Cap is imprinted twice with "FIORICET" and "CODEINE" in light blue. Body is imprinted twice with four-head profile in red. Bottles of 100 are supplied with child-resistant closures. (NDC 52544-958-01)

Store and Dispense

Below 30°C (86°F); tight container.

Keep out of reach of children.

Address medical inquiries to: WATSON, Medical Communications, P.O. Box 1953 Morristown, NJ 07962-1953. Distributed By: Watson Pharma, Inc. Morristown, NJ 07962. Revised: April 2011

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

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: 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.

Autonomic Nervous: dry mouth, hyperhidrosis.

Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation.

Cardiovascular: tachycardia.

Musculoskeletal: leg pain, muscle fatigue.

Genitourinary: diuresis.

Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions.

The following adverse reactions have been voluntarily reported as temporally associated with Fiorinal® with Codeine, a related product containing aspirin, butalbital, caffeine, and codeine.

Central Nervous: abuse, addiction, anxiety, disorientation, hallucination, hyperactivity, insomnia, libido decrease, nervousness, neuropathy, psychosis, sexual activity increase, slurred speech, twitching, unconsciousness, vertigo.

Autonomic Nervous: epistaxis, flushing, miosis, salivation.

Gastrointestinal: anorexia, appetite increased, diarrhea, esophagitis, gastroenteritis, gastrointestinal spasms, hiccup, mouth burning, pyloric ulcer.

Cardiovascular: chest pain, hypotensive reaction, palpitations, syncope.

Skin: erythema, erythema multiforme, exfoliative dermatitis, hives, rash, toxic epidermal necrolysis.

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.

Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.

Caffeine: cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia.

Codeine: nausea, vomiting, drowsiness, lightheadedness, constipation, pruritus.

Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported for Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets, USP).

Drug Abuse And Dependence

Controlled Substance

Fioricet with Codeine is controlled by the Drug Enforcement Administration and is classified under Schedule III.

Abuse and Dependence

Butalbital

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 two-fold. 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

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 and codeine phosphate capsule) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

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

Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

Codeine

Codeine may increase serum amylase levels.

This monograph has been modified to include the generic and brand name in many instances.

Warnings

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 Fioricet® with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) is not recommended.

Precautions

General

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

Ultra-rapid Metabolizers of Codeine

Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. 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 experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing.

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, 1-10% in Caucasians, 3% in African Americans, and 16-28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups.

When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose. (See PRECAUTIONS, Nursing Mothers)

Laboratory Tests

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

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

Teratogenic Effects

Pregnancy Category C: Animal reproduction studies have not been conducted with Fioricet® with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate). It is also not known whether Fioricet® with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fioricet® with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) should be given to a pregnant woman only when clearly needed.

Nonteratogenic Effects

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.

Nursing Mothers

Caffeine, barbiturates, acetaminophen and codeine are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from Fioricet® with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate), 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.

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 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, 1-10% in Caucasians, 3% in African Americans, and 16-28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups.

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 PRECAUTIONS, General, Ultra-rapid Metabolizers of Codeine)

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of Fioricet® with Codeine (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.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

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.

Signs and Symptoms

Toxicity from barbiturate poisoning include drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock. Toxicity from codeine poisoning includes the opioid triad of: pinpoint pupils, depression of respiration, and loss of consciousness. Convulsions may occur.

In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48-72 hours post-ingestion.

Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia, and extrasystoles.

Treatment

A single or multiple drug overdose with Fioricet with Codeine is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered. For respiratory depression due to overdosage or unusual sensitivity to codeine, parenteral naloxone is a specific and effective antagonist.

Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.

Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.

ContrainDications

Fioricet with Codeine is contraindicated under the following conditions:

  • Hypersensitivity or intolerance to acetaminophen, caffeine, butalbital, or codeine.
  • Patients with porphyria.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Fioricet with Codeine is a combination drug product intended as a treatment for tension headache.

Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets, USP) consists of a fixed combination of butalbital 50 mg, acetaminophen 325 mg and caffeine 40 mg. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood.

Pharmacokinetics

The behavior of the individual components is described below.

Butalbital

Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most tissues in the body. Barbiturates in general may appear in breast milk and readily cross the placental barrier. They are bound to plasma and tissue proteins to a varying degree and binding increases directly as a function of lipid solubility.

Elimination of butalbital is primarily via the kidney (59%-88% of the dose) as unchanged drug or metabolites. The plasma half-life is about 35 hours. Urinary excretion products include parent drug (about 3.6% of the dose), 5-isobutyl-5-(2,3-dihydroxypropyl) barbituric acid (about 24% of the dose), 5-allyl-5(3-hydroxy-2-methyl-l-propyl) barbituric acid (about 4.8% of the dose), products with the barbituric acid ring hydrolyzed with excretion of urea (about 14% of the dose), as well as unidentified materials. Of the material excreted in the urine, 32% is conjugated.

The in vitro plasma protein binding of butalbital is 45% over the concentration range of 0.5-20 mcg/mL. This falls within the range of plasma protein binding (20%-45%) reported with other barbiturates such as phenobarbital, pentobarbital, and secobarbital sodium. The plasma-to-blood concentration ratio was almost unity indicating that there is no preferential distribution of butalbital into either plasma or blood cells.

See OVERDOSAGE for toxicity information.

Acetaminophen

Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25-3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug.

See OVERDOSAGE for toxicity information.

Caffeine

Like most xanthines, caffeine is rapidly absorbed and distributed in all body tissues and fluids, including the CNS, fetal tissues, and breast milk.

Caffeine is cleared through metabolism and excretion in the urine. The plasma half-life is about 3 hours. Hepatic biotransformation prior to excretion results in about equal amounts of 1-methylxanthine and 1-methyluric acid. Of the 70% of the dose that is recovered in the urine, only 3% is unchanged drug.

See OVERDOSAGE for toxicity information.

Codeine

Codeine is readily absorbed from the gastrointestinal tract. It is rapidly distributed from the intravascular spaces to the various body tissues, with preferential uptake by parenchymatous organs such as the liver, spleen and kidney. Codeine crosses the blood-brain barrier, and is found in fetal tissue and breast milk. The plasma concentration does not correlate with brain concentration or relief of pain; however, codeine is not bound to plasma proteins and does not accumulate in body tissues.

The plasma half-life is about 2.9 hours. The elimination of codeine is primarily via the kidneys, and about 90% of an oral dose is excreted by the kidneys within 24 hours of dosing. The urinary secretion products consist of free and glucuronide conjugated codeine (about 70%), free and conjugated norcodeine (about 10%), free and conjugated morphine (about 10%), normorphine (about 4%), and hydrocodone (1%). The remainder of the dose is excreted in the feces.

At therapeutic doses, the analgesic effect reaches a peak within 2 hours and persists between 4 and 6 hours.

See OVERDOSAGE for toxicity information.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Caregivers

  • Do not take Fioricet with Codeine if you are allergic to any of its ingredients.
  • If you develop signs of allergy such as a rash or difficulty breathing, stop taking Fioricet with Codeine and contact your healthcare provider immediately.
  • Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.
  • Fioricet with Codeine may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking Fioricet with Codeine.
  • Alcohol and other CNS depressants may produce an additive CNS depression, when taken with Fioricet with Codeine, and should be avoided.
  • Codeine and butalbital may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.
  • For information on use in geriatric patients, see PRECAUTIONS, Geriatric Use.
  • Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people. These people are ultra-rapid metabolizers and are more likely to have higher-than-normal levels of morphine in their blood after taking codeine which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer.
  • Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services).

This monograph has been modifid to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

CODEINE/BUTALBITAL/ACETAMINOPHEN/CAFFEINE - ORAL

 

(KOE-deen/bue-TAL-bi-tal/a-SEET-a-MIN-oh-fen/KAF-een)

 

COMMON BRAND NAME(S): Fioricet with Codeine, Phrenilin with Codeine

 

WARNING: One ingredient in this product is acetaminophen. Taking too much acetaminophen may cause serious (possibly fatal) liver disease. Adults should not take more than 4000 milligrams (4 grams) of acetaminophen a day. If you have liver problems, consult your doctor or pharmacist for a safe dosage of this medication. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Avoid alcohol. Check with your doctor or pharmacist for more information. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting, stomach/abdominal pain, extreme tiredness, or yellowing eyes/skin.

Acetaminophen is an ingredient found in many nonprescription products and in some combination prescription medications (such as pain/fever drugs or cough-and-cold products). Carefully check the labels on all your medicines because they may also contain acetaminophen. Ask your pharmacist about using those products safely. Get medical help right away if you have taken more than 4000 milligrams of acetaminophen a day, even if you feel well.

Children should not use products that contain codeine after certain surgeries (including tonsil/adenoid removal). Also, for children younger than 12 years, do not use codeine to treat cough or pain unless specifically directed by the doctor. Some children are more sensitive to codeine and have had very serious (rarely fatal) breathing problems such as slow/shallow breathing (see also Side Effects section). Talk with your doctor or pharmacist about the risks and benefits of this medication.

 

USES: See also Warning section.

This combination medication is used to treat tension headaches. Codeine is a narcotic pain reliever (opiate-type) that acts on certain centers in the brain to give you pain relief. Acetaminophen helps to decrease the pain from the headache. Caffeine helps increase the effects of acetaminophen. Butalbital is a sedative which helps to decrease anxiety and cause sleepiness and relaxation.

 

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to treat migraine headaches.

 

HOW TO USE: See also Warning section.

Take this medication by mouth with or without food, usually every 4 hours as needed or as directed by your doctor. Do not take more than 6 capsules in a 24-hour period. If you have nausea, you may take this medication with food. Consult your doctor or pharmacist about other ways to decrease nausea (e.g., antihistamines, lying down for 1-2 hours with as little head movement as possible).

The dosage is based on your medical condition, age, and response to therapy. This medication works best if it is used as the first signs of a headache occur. If you wait until the headache has worsened, the medication may not work as well.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as runny nose, watery eyes, mental/mood changes, seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

Though very unlikely, abnormal drug-seeking behavior (addiction) is possible with this medication. To lessen the risk of becoming addicted, do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.

Inform your doctor if you notice increased use of this medication, a worsening of headaches, an increase in the number of headaches, the medication not working as well, or use of this medication for more than 2 headache episodes a week. Do not take more than recommended. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches.

Consumer Overview Side Effect

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, abdominal pain, shaking (tremor), shortness of breath, constipation, dry mouth, lightheadedness, dizziness, drowsiness, or trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes, fast/irregular heartbeat, increased thirst/urination, signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, change in the amount of urine.

Get medical help right away if you have any very serious side effects, including: fainting, seizure.

Codeine is changed into a strong narcotic drug (morphine) in your body. In some people, this change happens faster and more completely than usual, which increases the risk of very serious side effects. Get medical help right away if you notice any of the following: slow/shallow breathing, unusual drowsiness/difficulty waking up, confusion.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Fioricet with Codeine (butalbital, acetaminophen, caffeine and codeine phosphate capsule) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: 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 disease-COPD), disease of the pancreas (e.g., pancreatitis), heart disease (e.g., irregular heartbeat, recent heart attack), liver disease, kidney disease, a certain spinal problem (kyphoscoliosis), gallbladder disease, personal or family history of regular use/abuse of drugs/alcohol, mental/mood disorders, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus, stomach ulcer, colitis), adrenal gland problem (e.g., Addison's disease), difficulty urinating (e.g., due to enlarged prostate or urethral stricture), underactive thyroid (hypothyroidism), recent bowel/abdominal surgery.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

Some children may be more sensitive to very serious side effects of the codeine in this product, such as extreme sleepiness, confusion, or slow/shallow/noisy breathing. (See also Warning section.)

Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, slow/shallow breathing, and trouble falling asleep. Confusion, dizziness, drowsiness, and trouble falling asleep can increase the risk of falling.

Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea.

This medication passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor right away if your infant develops increased sleepiness, trouble breast-feeding, trouble breathing, or unusual limpness. Discuss the risks and benefits with your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: adenosine, anticholinergic medications (e.g., scopolamine), anti-seizure drugs (e.g., carbamazepine, phenytoin), beta agonists (e.g., albuterol), drugs affecting liver enzymes that remove this medication from your body (such as macrolide antibiotics including erythromycin, cimetidine, disulfiram, valproic acid, fluvoxamine), drugs that lower blood pressure (e.g., "water pills"/diuretics such as hydrochlorothiazide, furosemide), isoniazid, lithium, MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), methoxyflurane, naltrexone, other medications for pain (e.g., pentazocine, nalbuphine, morphine), phenothiazines (e.g., chlorpromazine), sodium oxybate.

This drug can speed up the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs include "blood thinners" (e.g., warfarin), cyclosporine, corticosteroids such as prednisone, estrogen, felodipine, metronidazole, quinidine, certain beta-blockers such as metoprolol, theophylline, doxycycline.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and other narcotic pain relievers (such as morphine).

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain caffeine or drowsiness-causing ingredients. Also keep in mind that certain beverages (e.g., coffee, colas, tea) contain caffeine. Ask your pharmacist about using those products safely.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

This medication may interfere with certain medical/laboratory tests (including urine 5-HIAA levels, urine VMA levels, urine catecholamine levels, amylase and lipase levels, dipyridamole-thallium imaging tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, slow/shallow breathing, very small pupils, severe dizziness, persistent nausea/vomiting, unusual sweating.

 

NOTES: Do not share this medication with others. It is against the law.

Massage, hot baths, and other relaxation methods can help with tension headaches. Consult your doctor or pharmacist for more details.

Laboratory and/or medical tests (e.g., liver and kidney function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: Not applicable.

 

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

 

Information last revised February 2014. Copyright(c) 2014 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Fioricet with Codeine, Phrenilin with Caffeine and Codeine

Generic Name: acetaminophen, butalbital, caffeine, and codeine (Pronunciation: a SEET a MIN o fen, bue TAL bi tal, KAF een, and KOE deen)

  • What is acetaminophen, butalbital, caffeine, and codeine (Fioricet with Codeine)?
  • What are the possible side effects of acetaminophen, butalbital, caffeine, and codeine (Fioricet with Codeine)?
  • What is the most important information I should know about acetaminophen, butalbital, caffeine, and codeine (Fioricet with Codeine)?
  • What should I discuss with my healthcare provider before taking acetaminophen, butalbital, caffeine, and codeine (Fioricet with Codeine)?
  • How should I take acetaminophen, butalbital, caffeine, and codeine (Fioricet with Codeine)?
  • What happens if I miss a dose (Fioricet with Codeine)?
  • What happens if I overdose (Fioricet with Codeine)?
  • What should I avoid while taking acetaminophen, butalbital, caffeine, and codeine (Fioricet with Codeine)?
  • What other drugs will affect acetaminophen, butalbital, caffeine, and codeine (Fioricet with Codeine)?
  • Where can I get more information?

What is acetaminophen, butalbital, caffeine, and codeine (Fioricet with Codeine)?

Codeine is an opioid pain medication. An opioid is sometimes called a narcotic. Acetaminophen is a less potent pain reliever that increases the effects of codeine.

Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache.

Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

The combination of acetaminophen, butalbital, caffeine, and codeine is used to treat tension headaches. This medicine is not for treating headaches that come and go.

Acetaminophen, butalbital, caffeine, and codeine may also be used for purposes not listed in this medication guide.

Fioricet with Codeine

capsule, blue/gray, imprinted with FIORICET CODEINE, LOGO

What are the possible side effects of acetaminophen, butalbital, caffeine, and codeine (Fioricet with 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 or bleeding; or
  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects include:

  • feeling dizzy or drowsy, shaky or agitated;
  • mild nausea, vomiting, upset stomach, constipation, diarrhea;
  • increased appetite, mood changes, sleep problems (insomnia); or
  • dry mouth, sweating, urinating more than usual.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Fioricet with Codeine (butalbital, acetaminophen, caffeine and codeine phosphate capsule) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about acetaminophen, butalbital, caffeine, and codeine (Fioricet with Codeine)?

Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Codeine and butalbital may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

Side Effects Centers
  • Fioricet with Codeine

Patient Detailed How Take

What should I discuss with my healthcare provider before taking acetaminophen, butalbital, caffeine, and codeine (Fioricet with Codeine)?

Do not use this medication if you are allergic to acetaminophen (Tylenol) or codeine, or if you have porphyria.

Codeine and butalbital may be habit forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

To make sure you can safely take acetaminophen, butalbital, caffeine, and codeine, tell your doctor if you have any of these other conditions:

  • asthma, COPD, sleep apnea, or other breathing disorders;
  • liver or kidney disease;
  • a history of head injury or brain tumor;
  • low blood pressure;
  • a stomach or intestinal disorder;
  • curvature of the spine;
  • mental illness; or
  • a history of drug or alcohol addiction.

Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

This medication can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take acetaminophen, butalbital, caffeine, and codeine (Fioricet with Codeine)?

Take exactly as prescribed. Never take this medicine in larger amounts, or for longer than recommended by your doctor. An overdose of acetaminophen can damage your liver or cause death. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

One acetaminophen, butalbital, caffeine, and codeine capsule contains 325 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

Take with food or milk to ease stomach upset.

Do not stop using this medication suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using acetaminophen, butalbital, caffeine, and codeine. If you need surgery, tell the surgeon ahead of time that you are using this medication. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Acetaminophen, butalbital, caffeine, and codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Side Effects Centers
  • Fioricet with Codeine

Patient Detailed Avoid Taking

What happens if I miss a dose (Fioricet with Codeine)?

Since this medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Fioricet with Codeine)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen, butalbital, caffeine, and codeine can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include extreme drowsiness or insomnia, restless feeling, tremors, fast heart rate, pinpoint pupils, fainting, weak pulse, coma, blue lips, shallow breathing, or no breathing.

What should I avoid while taking acetaminophen, butalbital, caffeine, and codeine (Fioricet with Codeine)?

This medication may cause blurred vision and may impair your thinking or reactions. Avoid driving or operating machinery until you know how the medication will affect you.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

While you are taking this medication, avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice.

What other drugs will affect acetaminophen, butalbital, caffeine, and codeine (Fioricet with Codeine)?

Do not take acetaminophen, butalbital, caffeine, and codeine with any other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Tell your doctor about all other medicines you use, especially:

  • glycopyrrolate (Robinul);
  • mepenzolate (Cantil);
  • ciprofloxacin (Cipro);
  • atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
  • bladder or urinary medications such as darifenacin (Enablex), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
  • a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva);
  • irritable bowel medications such as dicyclomine (Bentyl) or hyoscyamine (Anaspaz, Cystospaz, and others); or
  • an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate).

This list is not complete and other drugs may interact with acetaminophen, butalbital, caffeine, and codeine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about acetaminophen, butalbital, caffeine, and codeine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 9.02. Revision date: 2/2/2012.

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