What is the primary use of the acetaminophen, butalbital, and caffeine combination. How should this medication be taken. What are the potential side effects and precautions associated with this drug combination. How should this medication be stored and disposed of properly.

Understanding the Acetaminophen, Butalbital, and Caffeine Combination

The combination of acetaminophen, butalbital, and caffeine is a potent medication primarily prescribed for the relief of tension headaches. This drug combination leverages the pain-relieving properties of acetaminophen, the muscle-relaxing effects of butalbital, and the stimulating action of caffeine to provide comprehensive headache relief.

Pronunciation Guide

• Acetaminophen: a-set-a-mee’-noe-fen
• Butalbital: byoo-tal’-bi-tal
• Caffeine: kaf’-een

Proper Usage and Dosage Instructions

This medication is available in both capsule and tablet forms, designed for oral administration. The typical dosing schedule involves taking the medication every 4 hours as needed for headache relief. However, it’s crucial to adhere to the prescribed dosage and not exceed six tablets or capsules within a 24-hour period.

Can this medication be habit-forming? Yes, the combination of acetaminophen, butalbital, and caffeine can be habit-forming. It’s essential to take the medication exactly as directed by your healthcare provider and not to increase the dose, frequency, or duration of use without medical consultation.

Key Dosage Guidelines

1. Follow prescription label instructions carefully
2. Take every 4 hours as needed
3. Do not exceed six tablets or capsules per day
4. Consult your doctor if you feel you need more for symptom relief

Important Precautions and Considerations

Before starting this medication, it’s crucial to inform your healthcare provider about any allergies, current medications, and medical history. This information helps prevent potential drug interactions and adverse effects.

Medical Conditions to Disclose

• Liver disease
• Porphyria
• Depression
• Pregnancy or breastfeeding status

Is it safe to drive while taking this medication? The combination of acetaminophen, butalbital, and caffeine may cause drowsiness. It’s advisable to avoid driving or operating machinery until you understand how the medication affects you personally.

Potential Side Effects and Adverse Reactions

While this medication is effective for tension headache relief, it may cause various side effects. It’s important to be aware of these potential reactions and to report severe or persistent symptoms to your healthcare provider.

Common Side Effects

• Drowsiness
• Upset stomach
• Vomiting
• Stomach pain
• Depression
• Lightheadedness
• Confusion

Severe Side Effects Requiring Immediate Medical Attention

• Skin rash
• Itching
• Difficulty breathing

How should severe side effects be reported? If you experience serious side effects, you or your doctor can report them to the FDA’s MedWatch Adverse Event Reporting program. This can be done online at http://www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088.

Proper Storage and Disposal Guidelines

Proper storage and disposal of this medication are crucial for maintaining its effectiveness and ensuring safety, especially in households with children or pets.

Storage Instructions

• Keep in original container, tightly closed
• Store at room temperature
• Avoid excess heat and moisture
• Keep out of reach of children

Safe Disposal Methods

How should unused medication be disposed of? The safest way to dispose of unused medication is through a medicine take-back program. If this option is unavailable, check with your pharmacist or local garbage/recycling department for proper disposal methods. Do not flush this medication down the toilet.

For more information on safe medication disposal, visit the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p.

Emergency Procedures and Overdose Information

In case of suspected overdose, immediate action is crucial. Recognizing the signs of overdose and knowing how to respond can be life-saving.

Overdose Symptoms

• Difficulty breathing
• Seizures
• Loss of consciousness

What should you do in case of an overdose? If an overdose is suspected, immediately call the poison control helpline at 1-800-222-1222 or visit https://www.poisonhelp.org/help for online assistance. In severe cases where the victim has collapsed, had a seizure, is having trouble breathing, or can’t be awakened, call emergency services immediately.

Drug Interactions and Special Considerations

The combination of acetaminophen, butalbital, and caffeine can interact with various medications and substances, potentially altering its effectiveness or increasing the risk of side effects.

Medications to Watch Out For

• Anticoagulants (blood thinners) like warfarin
• Antidepressants
• Antihistamines
• Other pain medications
• Sedatives
• Sleeping pills
• Tranquilizers

Is it safe to take other acetaminophen-containing products while on this medication? Many over-the-counter pain relievers contain acetaminophen. It’s crucial to avoid taking additional acetaminophen-containing products while using this combination medication, as excessive acetaminophen intake can be harmful to the liver.

Alcohol Consumption

Can alcohol be consumed while taking this medication? Alcohol can enhance the drowsiness caused by this drug combination. It’s advisable to avoid alcohol consumption while taking acetaminophen, butalbital, and caffeine to prevent excessive sedation and potential liver damage.

Pregnancy and Breastfeeding Considerations

The use of acetaminophen, butalbital, and caffeine during pregnancy and breastfeeding requires careful consideration and medical supervision.

Pregnancy

Is this medication safe during pregnancy? If you are pregnant or planning to become pregnant, inform your healthcare provider before taking this medication. The potential risks to the fetus must be weighed against the benefits of treatment.

Breastfeeding

Can this medication be taken while breastfeeding? If you are breastfeeding, consult your doctor before using this medication. Some components of the drug may pass into breast milk and affect the nursing infant.

What should you do if you become pregnant while taking this medication? If you become pregnant while taking acetaminophen, butalbital, and caffeine, contact your healthcare provider immediately for guidance on whether to continue or discontinue the medication.

The combination of acetaminophen, butalbital, and caffeine offers effective relief for tension headaches when used as prescribed. However, it’s crucial to be aware of the potential for habit formation, side effects, and drug interactions. Always follow your healthcare provider’s instructions, report any concerns or severe side effects, and store the medication safely out of reach of children and pets. By understanding the proper use, precautions, and potential risks associated with this medication, patients can maximize its benefits while minimizing potential harm.

Acetaminophen, Butalbital, and Caffeine: MedlinePlus Drug Information

pronounced as (a set a mee’ noe fen) (byoo tal’ bi tal) (kaf’ een)

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This combination of drugs is used to relieve tension headaches.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

The combination of acetaminophen, Butalbital, Caffeine comes as a capsule and tablet to take by mouth. It usually is taken every 4 hours as needed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take acetaminophen, Butalbital, Caffeine exactly as directed. Do not take more than six tablets or capsules in 1 day. If you think that you need more to relieve your symptoms, call your doctor.

This medication can be habit-forming. Do not take a larger dose, take it more often, or for a longer period than your doctor tells you to.

Before taking acetaminophen, Butalbital, Caffeine,

• tell your doctor and pharmacist if you are allergic to acetaminophen, butalbital, caffeine, or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially anticoagulants (‘blood thinners’) such as warfarin (Coumadin), antidepressants, antihistamines, pain medications, sedatives, sleeping pills, tranquilizers, and vitamins. Many nonprescription pain relievers contain acetaminophen. Too much of this drug can be harmful.
• tell your doctor if you have or have ever had liver disease, porphyria, or depression.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking this medication, call your doctor.
• you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
• remember that alcohol can add to the drowsiness caused by this drug.

Acetaminophen, Butalbital, Caffeine may cause an upset stomach. Take this medicine with food or milk.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Acetaminophen, Butalbital, Caffeine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
• upset stomach
• vomiting
• stomach pain
• depression
• lightheadedness
• confusion

If you experience any of the following symptoms, call your doctor immediately:

• skin rash
• itching
• difficulty breathing

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www. fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

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• Esgic^® Plus (containing Acetaminophen, Butalbital, Caffeine, Codeine)
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• Phrenilin^® with Caffeine and Codeine (containing Acetaminophen, Butalbital, Caffeine, Codeine)

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Last Revised – 05/15/2019

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Butalbital-Acetaminophen-Caffeine: Uses and Side Effects

Headaches are common sources of pain that affect nearly every person on the planet at some point. There are several types of headaches, and they have different causes and treatments.

A tension headache is the most common type of headache. Chances are that you’ve experienced its characteristic pain in your neck, head, or behind your eyes. It can also feel like someone put a band around your head and is pulling it tight.

Tension headaches can be due to stress or tension in your neck or other causes. They’re more common in women, and they often start in your 20s and peak in your 40s. They can happen once in a while or many times over several months.

If your headache pain is especially bad or continues to occur over a long period, healthcare professionals may sometimes prescribe a medication that contains acetaminophen, caffeine, and butalbital.

Butalbital is a barbiturate, which is a controlled substance that has a sedating effect on your brain. It’s better at relieving psychological tension and anxiety than the other two ingredients alone.

But butalbital can lead to addiction in some people. That’s why butalbital-acetaminophen-caffeine (BAC) is prescription-only and usually comes with limited refills.

BAC is available under many brand names, of which Fioricet is the most common. Fioricet has:

• 50 milligrams (mg) of butalbital
• 300 mg of acetaminophen
• 40 mg of caffeine

Some combinations may also include codeine, an opiate used for pain. Codeine also carries a risk of addiction.

Different medications have different amounts of acetaminophen but generally the same amount of butalbital and caffeine.

Some BAC-containing medications include:

• Anolor 300
• Cephadyn
• Esgic
• Esgic-Plus, which has more acetaminophen than Esgic
• Fiorinal, which contains aspirin in place of acetaminophen
• Fioricet
• Fioricet with codeine
• Orbivan CF
• Phrenilin Forte

What does each component do?

BAC is a combination of three medications that enhance each other’s effects. That’s to say, they work better together than they do alone.

• Butalbital is a barbiturate that helps relieve anxiety and stress. It causes a depressant and relaxing effect on your brain and central nervous system.
• Acetaminophen is a common over-the-counter pain reliever. It’s the generic name for Tylenol.
• Caffeine enhances the effectiveness of analgesics such as aspirin and acetaminophen. It’s especially effective for tension headaches.

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A doctor may prescribe BAC to help relieve symptoms of tension headaches. They may also prescribe the combination to treat migraine, though it’s not Food and Drug Administration (FDA)-approved for this use.

You should use BAC sparingly to prevent medication overuse headaches. Taking more medication than prescribed and for longer than prescribed can lead to these types of headaches, also called rebound headaches.

Side effects of BAC can include:

• drowsiness
• upset stomach
• vomiting
• stomach pain
• depression
• lightheadedness
• confusion
• medication overuse headaches

When to contact a doctor

The National Library of Medicine recommends calling your doctor right away if you’re taking this medication and experience:

• skin rash
• itching
• difficulty breathing

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If a doctor prescribes BAC to you, here are some things to keep in mind:

• It can make you drowsy. Use caution while driving and operating heavy machinery.
• Alcohol can add to the drowsiness.
• It can cause an upset stomach. Try taking it with food or milk.
• If you miss a dose, don’t take a double dose. Take a missed dose as soon as you remember. If you’re close to the next dose, take it then.
• Keep out of the reach of children to prevent accidental poisoning.
• It can cross into your breast milk if you’re nursing.
• It carries a risk of addiction if used more frequently or for longer than prescribed.

In pregnant people

An older study from 2014 found that women who used butalbital around the time of conception were more likely to deliver babies with some congenital heart defects. More research is needed before butalbital can be considered safe for pregnant people.

Often, headaches improve by the second or third trimester of pregnancy. If they don’t, talk with your healthcare team. They may suggest other interventions such as:

• lifestyle changes
• stress reduction
• ibuprofen
• acetaminophen

Small amounts of barbiturates and caffeine can make it into breast milk. Talk with a healthcare professional if you plan to breastfeed or chestfeed.

BAC is available in capsules, tablets, or a liquid. The number of capsules or tablets you take varies by medication.

In capsule form, the recommended dosage is usually one to two pills every 4 hours as needed.

In liquid form, it’s usually 15 milliliters (mL) or 30 mL of oral suspension every 4 hours, up to a certain amount per day.

Be sure to read the prescription directions.

BAC can become habit-forming. To lower risk, doctors recommend that you do not:

• take a larger dose
• take it more often than a doctor prescribes
• take it for a longer period than a doctor prescribes

Use it exactly as directed and for a limited time. If you think you need more than the prescribed amount for your symptoms or need to take it for longer, contact your healthcare team to discuss.

Support for substance use disorder

Substance use disorder is a condition in which you keep using a substance despite adverse consequences and your desire to stop. It can result in failure to meet family, social, or work obligations. It can have financial, legal, and health consequences.

Substance use disorder is a complex but treatable health condition. If you feel that you’re becoming addicted, talk with a healthcare professional or trusted family and friends. You may also consider reaching out to one of these resources:

• The Substance Abuse and Mental Health Services Administration (SAMHSA) offers free resources and referrals to treatment. If you have questions or need help, call the 24/7 helpline at 800-662-HELP (4357).
• Narcotics Anonymous (NA) offers meetings and support groups for people in recovery from narcotic addiction or misuse.

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BAC is not for everyone. Your doctor may not prescribe BAC if:

• You’re allergic to acetaminophen, butalbital, or caffeine.
• You’re taking certain other medications, especially:
  • blood thinners such as warfarin (Coumadin)
  • some antidepressants
  • antihistamines
  • pain medications
  • sedatives, sleeping pills, or tranquilizers
  • certain vitamins
• You’re already taking medication that includes acetaminophen. Too much of this drug can damage your liver.
• You have or had liver disease, porphyria, or depression.
• You’re pregnant, plan to become pregnant, or are nursing.
• You drink alcohol, which adds to the drowsiness that BAC can cause.
• You’re a child. Experts don’t yet know the effects of this medication on developing brains.

If you’re not able to take BAC, a healthcare professional may suggest one or more of the following interventions:

• lifestyle changes, including staying hydrated, getting adequate sleep, and reducing stress
• over-the-counter medications such as aspirin, acetaminophen, or ibuprofen, with or without caffeine
• other prescription medications, depending on the underlying cause of your headache, such as:
  • ketorolac
  • naproxen
  • antidepressants
  • beta-blockers

Is butalbital-acetaminophen-caffeine available over the counter?

No, BAC is only available by prescription. Your number of refills will also be limited.

Is butalbital-acetaminophen-caffeine available as a generic drug?

Yes, several of the prescriptions on the market are generics.

Is butalbital-acetaminophen-caffeine a controlled substance?

BAC on its own is not a federally controlled substance. Although it contains butalbital, it’s on the Drug Enforcement Agency (DEA)’s list of exempted prescription products. But some states do classify BAC as a controlled substance.

Other combinations that contain BAC or are similar to BAC may be controlled substances. The DEA classifies Fiorinal, which contains butalbital, aspirin, and caffeine, as a Schedule III drug. That means that there’s a low to moderate risk of dependence or overuse.

In April 2022, the DEA proposed removing the exemption for BAC. The proposed rule change would add all products that contain butalbital to its list of Schedule III controlled substances.

Do I need to take butalbital-acetaminophen-caffeine with food?

You don’t have to take BAC with food. Still, it can irritate your stomach. Taking BAC with food may lessen this side effect.

Can I take Fioricet with Tylenol?

Fioricet contains 300 mg of acetaminophen, the active ingredient in Tylenol. Taking Fioricet or any BAC product with Tylenol can have serious side effects. It can cause damage to your liver and other organs.

Also, be sure not to take more Fioricet than your doctor prescribed. This can also lead to acetaminophen overdose.

Key takeaways

• Butalbital-acetaminophen-caffeine (BAC) is an effective pain relieving combination for moderately to severely painful tension headaches.
• BAC contains butalbital, a barbiturate that poses some risk of developing dependence or misuse.
• The three components of BAC work together for an enhanced, pain-relieving effect.
• BAC is available in several prescription brand names and generic medications.
• If you use BAC, don’t take more than a doctor recommends or for longer than recommended. This will reduce your risk of substance use disorder and acetaminophen overdose.
• If you’re pregnant or nursing, ask your healthcare team for other options.

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KAISA

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