What are Some Things I Need to Know or do While I Take Fioricet?

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems.

You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take this drug?

  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
  • This drug may be habit-forming with long-term use.
  • If you have been taking this drug for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this drug stops working well. Do not take more than ordered.
  • Do not take this drug for longer than you were told by your doctor.
  • If you have been taking this drug on a regular basis and you stop it all of a sudden, you may have signs of withdrawal. Do not stop taking this drug all of a sudden without calling your doctor. Tell your doctor if you have any bad effects.
  • This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
  • Avoid alcohol, marijuana or other forms of cannabis, or prescription or OTC drugs that may slow your actions.
  • Avoid taking other products that have acetaminophen in them. Check labels closely. Too much acetaminophen may cause liver problems.
  • Follow the directions exactly. Do not take more acetaminophen in a day than directed. If you do not know how much acetaminophen you can take in a day, ask your doctor or pharmacist. Some people may take up to 4,000 mg (milligrams) in a day if told to do so by the doctor. Some people (like people with liver problems and children) should take less acetaminophen. Call your doctor right away if you have taken too much acetaminophen in a day, even if you feel well.
  • Be careful if you have low levels of an enzyme called G6PD. Anemia may happen. Low levels of G6PD may be more likely in patients of African, South Asian, Middle Eastern, and Mediterranean descent.
  • Limit your use of caffeine (for example, tea, coffee, cola) and chocolate. Use with this drug may cause nervousness, shakiness, and a fast heartbeat.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

What Are The Symptoms Of A Fioricet Overdose?

While Butalbital is the addictive ingredient in Fioricet, Acetaminophen is the ingredient which is liable to cause an overdose. Unfortunately, people who misuse Fioricet as a recreational drug or as a way to suppress withdrawal are most likely to suffer an overdose.

When a person overdoses on Fioricet, the Acetaminophen will damage their liver. In severe cases, an overdose can even provoke fatal liver failure. For this reason, it is dangerous to take Fioricet together with another medication which contains Acetaminophen because it increases the risk of overdose and death. Furthermore, drinking alcohol while taking Fioricet may also inflict liver damage.

A Fioricet overdose is a medical emergency, so it’s important to know the symptoms. An overdose on Fioricet may cause jaundice, a yellowing of the skin and eyes. Other symptoms of an overdose include:

  • Confusion
  • Convulsions and seizures
  • Fainting
  • Irregular heartbeat
  • Lack of appetite
  • Nausea and vomiting
  • Restlessness
  • Stomach pain
  • Sweating
  • Tremors

Is Fioricet Addictive?

Although it’s only a prescription headache medication, Fioricet has the potential to cause addiction. If a person follows their prescription guidelines and uses the medication correctly, the risks of addiction are low. However, if someone takes too much Fioricet, they may develop tolerance to its effects.

 A person with tolerance to a certain dose of Fioricet will require higher doses of the medication to alleviate their headaches.

When a person with tolerance starts to take more Fioricet, possibly by obtaining more prescriptions, they may eventually become dependent on it. In other words, they may feel unable to get through the day without taking Fioricet; if they stop, they will experience symptoms of withdrawal. These symptoms arise because their body has grown accustomed to Fioricet in high doses.

If a Fioricet-dependent person attempts to weather withdrawal alone, it’s likely they will take Fioricet again just to relieve the symptoms of withdrawal. This is a hallmark characteristic of addiction. Anyone who compulsively abuses Fioricet to avoid withdrawal likely has an addiction to Fioricet. Additionally, people with an addiction to Fioricet will experience cravings for the medication which further compel them to keeping using it.

Moreover, the ingredient Butalbital is an addictive substance in its own right. Butalbital can cause someone to get “high” because it’s a Central Nervous System (CNS) Depressant. Since Butalbital is part of Fioricet, it is possible for someone to abuse Fioricet as a recreational drug. At high doses, Fioricet can intoxicate a person in a manner similar to alcohol. People who abuse Fioricet for this purpose have as much of a risk of developing an addiction as they would have if they repeatedly used an illegal drug.

What Are The Ingredients In Fioricet?

A Combination Medication is a drug which includes two or more pharmaceutical ingredients in a fixed dose.

There are three ingredients in standard Fioricet: Acetaminophen, Butalbital, and Caffeine. All three ingredients have different effects which combine to soothe headaches.

  • Acetaminophen is a medication which alleviates pain and reduces fever. It’s more widely known by the brand name Tylenol. Acetaminophen works by impairing the production of the prostaglandin chemical in the brain. This chemical activates pain signals in the nervous system.
  • Butalbital is a Sedative Barbiturate which stimulates the brain’s production of GABA. This neurotransmitter calms the nervous system by blocking signals among neurons. It also relaxes muscle tension in the head, thereby alleviating headaches. Butalbital is a Schedule III controlled substance in the United States.
  • Caffeine is a Stimulant which raises a person’s blood pressure. While high blood pressure is not necessarily healthy, low blood pressure worsens headaches by causing blood vessels to expand and push against the brain. By raising blood pressure, Caffeine causes blood vessels to constrict and increases blood flow. This effect helps relieve headaches.

With these three ingredients at work, Fioricet can be an effective source of headache relief. However, the medication also poses risks for side effects, overdose, and addiction. For this reason, doctors usually refrain from prescribing Fioricet until safer over-the-counter medications fail to help their patients.

How to Use Fioricet ?

Take this medication by mouth with or without food as directed by your doctor, usually every 4 hours as needed.If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

Fioricet is a prescription medication used to treat tension headaches. It is a combination of acetaminophen, butalbital, and caffeine. Here are detailed instructions on how to use Fioricet effectively and safely:

How to Use Fioricet

  1. Follow Your Doctor’s Instructions:
    • Always take Fioricet exactly as prescribed by your healthcare provider. Do not take more or less of the medication, or take it more frequently than directed.
  2. Dosage:
    • Typical Dosage: The usual dose for adults is one to two tablets every four hours as needed for pain relief.
    • Maximum Dosage: Do not exceed six tablets in a 24-hour period to avoid the risk of overdose, particularly of acetaminophen, which can cause severe liver damage.
  3. Administration:
    • Oral Use: Fioricet is taken by mouth with or without food. If it causes stomach upset, taking it with food or milk may help.
  4. Duration of Use:
    • Short-Term Use: Fioricet is intended for short-term use to manage acute headaches. Prolonged use can lead to dependence and medication overuse headaches.
    • Avoid Long-Term Use: Do not use Fioricet for more than a few days unless specifically instructed by your doctor.
  5. Missed Dose:
    • If Missed: If you miss a dose and are using Fioricet regularly, take the missed dose as soon as you remember. If it’s almost time for your next dose, skip the missed dose. Do not double the dose to catch up.

Important Considerations

  1. Avoid Alcohol:
    • Risk of Liver Damage: Combining alcohol with Fioricet can increase the risk of liver damage due to acetaminophen and enhance the sedative effects of butalbital, leading to severe drowsiness or dizziness.
  2. Be Cautious with Other Medications:
    • Drug Interactions: Fioricet can interact with other medications, particularly other CNS depressants, certain pain medications, and medications that also contain acetaminophen. Inform your healthcare provider about all the medications and supplements you are taking.
  3. Side Effects:
    • Common Side Effects: Drowsiness, dizziness, lightheadedness, nausea, vomiting, and abdominal pain.
    • Serious Side Effects: Allergic reactions (rash, itching, swelling, severe dizziness, trouble breathing), signs of liver problems (persistent nausea, vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine), and mood changes (confusion, hallucinations).
  4. Dependence and Withdrawal:
    • Butalbital: Fioricet contains butalbital, a barbiturate that can be habit-forming. Use it only as prescribed and do not suddenly stop using it without consulting your doctor, as this can lead to withdrawal symptoms.
  5. Pregnancy and Breastfeeding:
    • Consult Your Doctor: If you are pregnant, planning to become pregnant, or breastfeeding, discuss the risks and benefits of using Fioricet with your healthcare provider.

The dosage is based on your medical condition, age, and response to treatment. 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 nausea/vomiting, mental/mood changes, seizures) may occur if you suddenly stop using this medication.

To prevent withdrawal reactions, your doctor may reduce your dose gradually. Report any withdrawal reactions immediately.Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past.

Take this medication exactly as prescribed to lessen the risk of addiction.Tell 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.

Treatment of Fioricet Overdose

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 to 20 mcg/mL. This falls within the range of plasma protein binding (20% to 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

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.

Signs And Symptoms of Fioricet Overdose

Fioricet (butalbital, acetaminophen and caffeine capsules USP 50 mg/325 mg/40 mg) are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.

Toxicity from barbiturate poisoning includes drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock.

In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necroses, 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 to 72 hours post-ingestion.

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

Butalbital is Habit-forming and Potentially Abusable.

Butalbital in Fioricet is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.

Hepatotoxicity

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.

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 Esgic® Capsules immediately and seek medical care if they experience these symptoms. Do not prescribe Esgic® Capsules for patients with acetaminophen allergy.

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 1500 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.

Fioricet Warnings

What are Common Fioricet Doses?

  • Capsule 50-300-40mg

Common Fioricet Prescriptions

  • Fioricet 50-300-40mg capsuleFioricet
    50-300-40mg capsule

How to Take Fioricet

  • Take your medicine as directed. Do not use more medicine or take it more often than your doctor tells you to.
  • Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
  • This medicine is not for long-term use.
  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
  • This medicine is not for long-term use.
  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
  • Take your medicine as directed. Do not use more medicine or take it more often than your doctor tells you to.
  • Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.

Fioricet Contraindications

  • This medicine is not right for everyone. Do not use it if you had an allergic reaction to acetaminophen, butalbital, or caffeine, or if you have porphyria.

Fioricet Warnings

  • Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
  • Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, or stomach problems. Tell your doctor if you have a history of alcohol or drug addiction.
  • This medicine may cause the following problems:Liver damageSerious skin reactions
  • This medicine contains acetaminophen. Read the labels of all other medicines you are using to see if they also contain acetaminophen, or ask your doctor or pharmacist. Do not use more than 4 grams (4,000 milligrams) total of acetaminophen in one day.
  • This medicine may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
  • This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Fioricet Interactions

  • Some medicines can affect how this medicine works. Tell your doctor if you are also using an MAO inhibitor (MAOI).
  • Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
  • Do not drink alcohol while you are using this medicine. Acetaminophen can damage your liver, and alcohol can increase this risk.
  • This medicine may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
  • This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
  • Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Fioricet Side Effects

Serious Side Effects

  • Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
  • Extreme dizziness or weakness, trouble breathing, slow heartbeat, seizures, and cold, clammy skin
  • Blistering, peeling, red skin rash
  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Lightheadedness, dizziness, fainting

Less Serious Side Effects

  • Mild nausea or vomiting
  • Sleepiness, tiredness