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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.
Fioricet (butalbital / acetaminophen / caffeine) is a combination of three medications. Butalbital is a barbiturate that relaxes you. Acetaminophen relieves pain, and caffeine narrows the blood vessels that contribute to headaches.
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.
Fioricet is a brand-name analgesic, and it’s used to treat tension headaches. The active ingredients are acetaminophen (pain reliever), caffeine (enhances effects of acetaminophen), and butalbital (sedative). You might have a tension headache if you have a dull pain, tightness, or pressure across your forehead or in the back of your head and neck. They can last as long as 30 minutes to several days. A chronic case could result in headaches lasting for 60 to 90 days. Although tension headaches are common in adults, only 3% have chronic tension headaches on a daily basis.
Your healthcare provider will determine the best medication and dosage for your tension headaches based on the severity and duration of your headaches, your medical history, and current list of medications.
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.
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?
- Fioricet (butalbital / acetaminophen / caffeine) works better and faster in treating tension headaches than the combination of acetaminophen and codeine.
- Fioricet (butalbital / acetaminophen / caffeine) has a cheaper, generic version.
- Fioricet (butalbital / acetaminophen / caffeine) does not require dosage adjustments if you have kidney and liver problems.
- Fioricet (butalbital / acetaminophen / caffeine) isn’t the first choice medication for treating tension headaches.
- Fioricet (butalbital / acetaminophen / caffeine) is not a good medication for long-term use.
- Overuse of Fioricet (butalbital / acetaminophen / caffeine) can lead to chronic tension headaches.
- Fioricet (butalbital / acetaminophen / caffeine) can cause dangerous withdrawal symptoms, intoxication, and dependence.
- Taking Fioricet (butalbital / acetaminophen / caffeine) can decrease your ability to drive a car, or operate machinery.
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?
Side effect rates for Fioricet (butalbital / acetaminophen / caffeine)
If you experience any of the following symptoms, call your doctor immediately:
- skin rash
- 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).
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.
Fioricet (butalbital / acetaminophen / caffeine) contains acetaminophen, also known as Tylenol or APAP. Taking too much acetaminophen causes liver damage that can be permanent and life-threatening. Using more than 4000 mg of the acetaminophen can cause serious harm to your liver, so be sure not to take more than the recommended dose of Fioricet (butalbital / acetaminophen / caffeine) or other medications that contain acetaminophen.
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
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.
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 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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Fioricet drug abuse and dependence
abuse and dependence
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.
Following an acute overdosage of butalbital, acetaminophen and caffeine, toxicity may result from the barbiturate or the acetaminophen. Toxicity due to caffeine is less likely, due to the relatively small amounts in this formulation.
signs and symptoms
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.
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.
dosage and administration
One or 2 tablets every 4 hours as needed. Total daily dosage should not exceed 6 tablets.
Extended and repeated use of this product is not recommended because of the potential for physical dependence.
Butalbital, Acetaminophen and Caffeine Tablets, USP
Containing 50 mg butalbital, 325 mg acetaminophen and 40 mg caffeine. Available as white, round shaped tablets, debossed “2355” on one side, and debossed “V” on the reverse side.
- Bottles of 60: NDC 0603-2544-20
- Bottles of 90: NDC 0603-2544-02
- Bottles of 100: NDC 0603-2544-21
- Bottles of 500: NDC 0603-2544-28
- Bottles of 1000: NDC 0603-2544-32
store and dispense
Store at 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]; dispense in a tight, light-resistant container as defined in the USP.
Chestnut Ridge, NY 10977
|BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
butalbital, acetaminophen, and caffeine tablet
|Labeler – Par Pharmaceutical (011103059)|
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