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Acetaminophen/butalbital/caffeine is used in the treatment of headache and belongs to the drug class analgesic combinations. Risk cannot be ruled out during pregnancy. Acetaminophen/butalbital/caffeine 325 mg / 50 mg / 40 mg is not a controlled substance under the Controlled Substances Act (CSA).

People who suffer from tension-type headaches that do not respond to over-the-counter (OTC) medications may find relief with combination drugs that include butalbital. Commonly prescribed as Fioricet (butalbital/acetaminophen/caffeine) or Fiorinal (butalbital/aspirin/caffeine), butalbital is a sedative in the barbiturate class of medicines. Although the drug causes intense relaxation and eases the pain of a tension headache, it is not without risks.

Butalbital, acetaminophen, and caffeine combination is used to relieve symptoms of tension (or muscle contraction) headaches.

Butalbital belongs to the group of medicines called barbiturates. Barbiturates act in the central nervous system (CNS) to produce their effects.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.

When butalbital is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

Caffeine is a CNS stimulant that is used with pain relievers to increase their effect. It has also been used for migraine headaches. However, caffeine can also cause physical dependence when it is used for a long time. This may lead to withdrawal (rebound) headaches when you stop taking it.

This medicine is available only with your doctor’s prescription.

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.

Tension Headaches and Butalbital 

The most common type of headache disorder, a tension headache occurs when neck and scalp muscles become tense, or contract, meaning they squeeze down. This causes pain, often described as a rubber-band-around-the-head feeling or a pressure sensation, on both sides of the head. Tension headaches can be triggered by a number of factors including stress, hunger, lack of sleep, anxiety, and temperature changes. They may occur at any age but are most common in adults and older teens. Some people are more prone or vulnerable to developing tension headaches than others, although the reason behind this is not very clear.

Most tension headaches are mild in pain and can be easily alleviated with rest, fluids, removal of the trigger, and/or an over-the-counter medication like Motrin (ibuprofen) or Tylenol (acetaminophen). Behavioral therapies too can be effective like physical therapy or cognitive-behavioral therapy.

Butalbital

When recurring tension headaches do not respond to other treatments, your doctor may prescribe Fiorinal or Fioricet. Codeine may also be added to this combination of medicine. While this medication is very effective in the short-term, there are some things to watch out for.

  • Are allergic to any ingredients in the medication, such as acetaminophen or aspirin.
  • Are currently taking blood thinners, antidepressants, antihistamines, or other sedatives such as sleeping pills or tranquilizers
  • Have or previously had liver disease, porphyria, or depression
  • Are pregnant, plan to become pregnant, or are currently breastfeeding

How should this medicine be used?

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.

What special precautions should I follow?

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.

What special dietary instructions should I follow?

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

What should I do if I forget a dose?

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.

What side effects can this medication cause?

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).

Intoxication

Butalbital slows the central nervous system, leading to lack of coordination, problems with thinking and memory, slowness of speech, disinhibition, and emotional disturbances. Do not drive or operate heavy machinery while taking medicines containing butalbital.

Medication Overuse Headache

A medication-overuse headache (MOH), once known as a rebound headache, drug-induced headache, or medication-misuse headache, is a chronic headache that develops as a result of prolonged and frequent use of certain medications for acute headaches. Such headaches are a common side effect of a number of classes of medications used to treat headaches.

According to the International Classification of Headache Disorders, MOH is diagnosed when a person has a headache 15 or more times a day and, in the case of combination pain relievers like Fioricet and Fiorinal, has been taking the drug for 10 days a month for more than three months.

In addition, medication overuse headaches are often not responsive to preventive headache medications. This lack of response to other medications is often a clue to doctors that a medication overuse headache has developed.

Medications containing butalbital should be limited to two days per week to avoid this rebound effect.7

Withdrawal

When taking butalbital, you may experience withdrawal symptoms within eight to 36 hours after the last dose. Withdrawal symptoms may include anxiety, muscle twitching, tremor, weakness, dizziness, nausea and vomiting, insomnia, weight loss, and even seizures when the medication is discontinued.

Due to the risk of seizures with a withdrawal from butalbital, medical treatment in a monitored setting under the care of a physician is indicated.

Tolerance and Addiction

Tolerance and addiction may also occur with butalbital. Tolerance means that a person needs more of the medication to achieve headache relief. Addiction to butalbital is characterized by persistent behaviors, like compulsions, to take a butalbital-containing medication.

These behaviors impair their life in some way, negatively impacting relationships and/or everyday functioning.

Acetaminophen Overdose

Do not take Fioricet along with other medications that contain acetaminophen as it can be toxic to the liver.

What should I know about storage and disposal of this medication?

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 emergency/overdose

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.

What other information should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. This medication is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

 

Brand names

  • Alagesic®
  • Americet®
  • Anolor®
  • Anoquan®
  • Arcet®
  • Dolgic®
  • Dolmar®
  • Endolor®
  • Esgic®
  • Ezol®
  • Femcet®
  • Fioricet®
  • Fiorpap®
  • G-1®
  • Ide-cet®
  • Isocet®
  • Margesic®
  • Medigesic®
  • Minotal®
  • Mygracet®
  • Nonbac®
  • Pacaps®
  • Pharmagesic®
  • Quala Cet®
  • Repan®
  • Tenake®
  • Tencet®
  • Triad®
  • Two-Dyne®
  • Zebutal®

Brand names of combination products

  • Esgic® Plus (containing Acetaminophen, Butalbital, Caffeine, Codeine)
  • Geone® (containing Acetaminophen, Butalbital, Caffeine)
  • Orbivan® (containing Acetaminophen, Butalbital, Caffeine)
  • Fioricet® with Codeine (containing Acetaminophen, Butalbital, Caffeine, Codeine)
  • Phrenilin® with Caffeine and Codeine (containing Acetaminophen, Butalbital, Caffeine, Codeine)

This branded product is no longer on the market. Generic alternatives may be available.

Last Revised – 05/15/2019

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