Category: Fioricet

Medicines containing acetaminophen

Acetaminophen is the most common drug ingredient in America. More than 600 medicines contain acetaminophen. These include both prescription medicines and medicines available without a prescription, also called “over-the-counter,” or “OTC” medicines. To prevent acetaminophen overdose, you need to be able to read labels and recognize when their medicines contain acetaminophen. The active ingredients in OTC medicines are clearly listed on the label, and the word “acetaminophen,” is listed on the front of the package or bottle and in the Active Ingredient section of the Drug Facts label. On prescription labels, acetaminophen is sometimes listed as “APAP,” “acetam,” or other shorted versions of the word. To know what is in your medicines, read the list of active ingredients on the label each and every time you take a medicine.

You may be surprised to learn just how many medicines contain this acetaminophen:

Common Over-the-Counter Brand Name Medicines Containing Acetaminophen

  • Actifed®
  • Alka-Seltzer Plus LiquidGels®
  • Anacin®
  • Benadryl®
  • Cepacol®
  • Contac®
  • Coricidin®
  • Dayquil®
  • Dimetapp®
  • Dristan®
  • Excedrin®
  • Feverall®
  • Formula 44®
  • Goody’s®
  • Powders Liquiprin®
  • Midol®
  • Nyquil®
  • Panadol®
  • Robitussin®
  • Saint Joseph®
  • Aspirin-Free Singlet®
  • Sinutab®
  • Sudafed®
  • Theraflu®
  • Triaminic®
  • TYLENOL® Brand Products
  • Vanquish®
  • Vicks®
  • Zicam®
  • *And store brands

Common Prescription Medicines Containing Acetaminophen

  • Endocet®
  • Fioricet®
  • Hycotab
  • Hydrocet®
  • Hydrocodone Bitartrate
  • Lortab®
  • Percocet®
  • Phenaphen®
  • Sedapap®
  • Tapanol®
  • Tylenol® with Codeine
  • Tylox®
  • Ultracet®
  • Vicodin®
  • Zydone®
  • *And generic medicines

Important Acetaminophen Warning from FDA

Taking too much acetaminophen can cause liver damage, sometimes serious enough to require liver transplantation or cause death. You might accidentally take too much acetaminophen if you do not follow the directions on the prescription or package label carefully, or if you take more than one product that contains acetaminophen.

To be sure that you take acetaminophen safely, you should

  • not take more than one product that contains acetaminophen at a time. Read the labels of all the prescription and nonprescription medications you are taking to see if they contain acetaminophen. Be aware that abbreviations such as APAP, AC, Acetaminophen, Acetaminoph, Acetaminop, Acetamin, or Acetam. may be written on the label in place of the word acetaminophen. Ask your doctor or pharmacist if you don’t know if a medication that you are taking contains acetaminophen.
  • take acetaminophen exactly as directed on the prescription or package label. Do not take more acetaminophen or take it more often than directed, even if you still have fever or pain. Ask your doctor or pharmacist if you do not know how much medication to take or how often to take your medication. Call your doctor if you still have pain or fever after taking your medication as directed.
  • be aware that you should not take more than 4000 mg of acetaminophen per day. If you need to take more than one product that contains acetaminophen, it may be difficult for you to calculate the total amount of acetaminophen you are taking. Ask your doctor or pharmacist to help you.
  • tell your doctor if you have or have ever had liver disease.
  • not take acetaminophen if you drink three or more alcoholic drinks every day. Talk to your doctor about the safe use of alcohol while you are taking acetaminophen.
  • stop taking your medication and call your doctor right away if you think you have taken too much acetaminophen, even if you feel well.

Talk to your pharmacist or doctor if you have questions about the safe use of acetaminophen or acetaminophen-containing products.

Fioricet dosing information and fioricet overdose treatment

Usual Adult Dose of Fioricet for Headache:

Acetaminophen 300 mg, butalbital 50 mg, and caffeine 40 mg:
1 or 2 capsule(s) orally every 4 hours as needed. Maximum daily dose: 6 doses.

Acetaminophen 325 mg, butalbital 50 mg, and caffeine 40 mg:
1 or 2 tablet(s), capsule(s), or tablespoonful(s) orally every 4 hours.
Maximum daily dose: 6 doses

Acetaminophen 500 mg, butalbital 50 mg, and caffeine 40 mg:
1 tablet or capsule orally every 4 hours.
Maximum daily dose: 6 doses

Acetaminophen 750 mg, butalbital 50 mg, and caffeine 40 mg:
1 tablet orally every 4 hours.
Maximum daily dose: 5 tablets

Usual Pediatric Dose of Fioricet for Headache:

12 years and older:
Acetaminophen 300 mg, butalbital 50 mg, and caffeine 40 mg:
1 or 2 capsule(s) orally every 4 hours as needed. Maximum daily dose: 6 doses.

Fioricet Overdose Treatment

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 insomnia, restlessness, tremor, diarrhea, increased shallow breathing, uneven heartbeats, seizure (convulsions), or fainting.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Fioricet 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 insomnia, restlessness, tremor, diarrhea, increased shallow breathing, uneven heartbeats, seizure (convulsions), or fainting.

A single or multiple drug overdose with this combination product 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.

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.

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  1. You have porphyria;
  2. You have recently used alcohol;
  3. You have recently used sedatives, tranquilizers, or other narcotic medications;
  4. You have taken a MAO inhibitor in the past 14 days because A dangerous drug interaction could occur;
  5. You have liver , heart disease, kidney disease;
  6. You have  a history of alcoholism or drug addiction;
  7. You have asthma, sleep apnea, or other breathing disorder;
  8. You have stomach ulcer or bleeding;
  9. You have a history of skin rash caused by any medication;
  10. You have a history of mental illness or suicidal thoughts;
  11.  You use medicine to prevent blood clots;
  12. You are pregnant because your baby could become dependent on the drug;
  13. You are now breast feeding because Fioricet can pass into breast milk and may harm a nursing baby.

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What is Fioricet and why it can relieve headaches ?

Fioricet (Butalbital, Acetaminophen, and Caffeine Tablets, USP) is supplied in tablet form for oral administration.

Each tablet contains the following active ingredients:
butalbital USP . . . . . . . . . .50 mg
acetaminophen USP . . . . 325 mg
caffeine USP . . . . . . . . . . .40 mg

Fioricet contains Butalbital, Acetaminophen, and Caffeine. Acetaminophen is a pain reliever and fever reducer.  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.

Butalbital

fioricetpharmacyButalbital 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% to 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-1-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.

Acetaminophen

Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 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.

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.

What is the most important information I should know about Fioricet?

    • Butalbital, one of the drugs found in Fioricet, is habit-forming and has potential for abuse. Extended use is not recommended.Fioricet can affect your ability to drive a car or operate machinery. Do not drive a car or operate machinery while taking Fioricet until you know how this drug affects you.Avoid alcohol and other drugs that affect your central nervous system (brain and spinal cord) because they can further affect your ability to concentrate.
    • Who should not take Fioricet?Do not take Fioricet if you are allergic to butalbital, acetaminophen, or caffeine.Do not take Fioricet if you have an inherited disorder that affects the liver or bone marrow (porphyria).

What should I tell my doctor before I take the first dose of Fioricet?

    • Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Fioricet. Also, talk to your doctor about your complete medical history, especially if you have porphyria, kidney or liver disease, a history of prior substance abuse, if you drink alcohol, are pregnant, plan to become pregnant, or are breastfeeding.

What is the usual dosage?

  • The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor’s approval.Adults: The usual dose of Fioricet is 1 or 2 tablets taken every 4 hours as needed. One tablet contains 50 milligrams (mg) of butalbital, 325 mg of acetaminophen, and 40 mg of caffeine. Do not take more than 6 tablets per day.Elderly: Your doctor may prescribe a lower dose than the usual recommended dose to suit your needs.Children: Fioricet is not recommended in children <12 years old.

How should I take Fioricet?

  • Take Fioricet exactly as prescribed. Do not increase the amount you take without your doctor’s approval. Do not take more than 6 tablets per day.

What should I avoid while taking Fioricet?

      • Fioricet can cause drowsiness or dizziness. Avoid driving, operating machinery, or performing other hazardous activities while taking Fioricet.Avoid taking Fioricet with medications that affect your concentration, such as other narcotic pain relievers, general anesthetics, sleeping pills, anti-allergy medications, sedative-hypnotics, and tranquilizers (such as chlordiazepoxide). These may cause further drowsiness.Do not drink alcohol while taking Fioricet. Doing so may result in increased drowsiness and dizziness.Avoid taking other medications that contain acetaminophen, such as Tylenol. Avoid taking too much caffeine.

What are possible food and drug interactions associated with Fioricet?

    • If Fioricet is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Fioricet with any of the following: alcohol, general anesthetics, antidepressant medications in a class called monoamine oxidase (MAO) inhibitors such as phenelzine and tranylcypromine, narcotic pain relievers such as codeine or propoxyphene, other medicines that affect your brain and spinal cord (CNS depressants), sedative-hypnotics, and tranquilizers such as chlordiazepoxide.

What are the possible side effects of Fioricet?

    • Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.Side effects may include: fatal skin reactions, seizure, confusion, depression, excitement, stomach pain, dizziness, drowsiness, intoxicated feeling, lightheadedness, nausea, sedation, shortness of breath, vomiting, excessive sweating

Can I receive Fioricet if I am pregnant or breastfeeding?

    • The effects of Fioricet during pregnancy and breastfeeding are unknown. Do not breastfeed while taking Fioricet. Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding.

What should I do if I miss a dose of Fioricet?

    • Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular dosing schedule. Do not take two doses at once.

How should I store Fioricet?

    • Store at room temperature in a tight, light-resistant container.

Fioricet 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% to 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-1-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.

Acetaminophen

Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 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.

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.