Butalbital, acetaminophen, and caffeine combination is used to relieve symptoms of tension (or muscle contraction) headaches.
Fioricet is supplied in hard-gelatin capsule form for oral administration.
Each capsule contains the following active ingredients:
Butalbital, USP……………………50 mg
Acetaminophen, USP…………….300 mg
Caffeine, USP……………………..40 mg
Inactive Ingredients: sodium lauryl sulfate, talc, microcrystalline cellulose, stearic acid, FD&C red # 40, titanium dioxide, FD&C blue # 1,FD&C yellow # 6, gelatin.
Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula:
Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula:
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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.
One ingredient in this product is acetaminophen. Taking too much acetaminophen may cause serious (possibly fatal) liver disease. Adults should not take more than 4000 milligrams (4 grams) of acetaminophen a day. If you have liver problems, consult your doctor or pharmacist for a safe dosage of this medication. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Avoid alcohol. Check with your doctor or pharmacist for more information. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting, stomach/abdominal pain, extreme tiredness, or yellowing eyes/skin.
Acetaminophen is an ingredient found in many nonprescription products and in some combination prescription medications (such as pain/fever drugs or cough-and-cold products). Carefully check the labels on all your medicines because they may also contain acetaminophen. Ask your pharmacist about using those products safely. Get medical help right away if you have taken more than 4000 milligrams of acetaminophen a day, even if you feel well.
This combination medication Butalbital APAP Caffeine is used to treat tension headaches. Acetaminophen helps to decrease the pain from the headache. Caffeine helps increase the effects of acetaminophen. Butalbital is a sedative that helps to decrease anxiety and cause sleepiness and relaxation. OTHER This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.This medication may also be used to treat migraine headaches
Fioricet is the brand name of a combination drug that’s used for the treatment of headaches that can include tension headaches, headaches from muscle contractions and post-dural puncture headaches. While not an official indication, Fioricet is also often given to treat migraines and other causes of pain.The three components of Fioricet do the following:
Some Fioricet may also contain codeine, so it contains both butalbital and another potentially addictive narcotic.
There are certain people who are advised against taking Fioricet. These people include anyone who has a history of liver disease or cirrhosis, people who drink more than three alcoholic beverages a day, and people with a history of substance abuse. It’s also not intended for use in people with kidney disease, breathing disorders, or a history of suicidal thoughts or mental illness.
Some of the potential side effects of Fioricet include:
The more severe side effects that can occur with Fioricet include confusion, seizures, shortness of breath, nausea, upper stomach pain, or jaundice.
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.
Fioricet is an older medication that used to frequently be prescribed to treat migraine symptoms. However, there is not enough evidence that shows it’s effective for migraine attacks, especially when compared to safer products.
Although Fioricet has been used for many years for migraine, it’s not approved for this use, and there are greater risks than benefits with this medication.
Fioricet may be an option if other migraine treatment options have not worked. Your doctor will just want to monitor you closely to avoid side effects.
It’s prescribed to help relieve immediate headache symptoms, but not to prevent migraine attacks.
Fioricet is not safe for anyone with porphyria, a skin and nervous system condition.
Taking Fioricet can make you sleepy, dizzy, or tired, and these effects can last several hours. Avoid driving or doing any tasks that require mental focus or alertness. Talk with your doctor about the risks of Fioricet and how it may affect your daily activities.
Drinking alcohol with Fioricet can increase sedating side effects. Too much alcohol with Fioricet can also increase the risk of liver damage and toxicity.
Fioricet may not be right for you if you have certain health or medical conditions.
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.
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
Like any medication, Fioricet can cause side-effects. People who misuse Fioricet or use it compulsively are at greater risk for experiencing the worst side-effects of the medication.
The possible side-effects of Fioricet are:
In some cases, a person who takes Fioricet may develop an allergic reaction to the drug. The symptoms of an allergic reaction are trouble breathing, itching, rashes, intense dizziness, and swelling in the face, throat, and tongue.
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 and all other forms of liver failure cause jaundice, the yellowing of the skin and eyes. Other symptoms of an overdose include:
Some formulas for Fioricet contain codeine, a potent and addictive opioid. Codeine enhances the pain-relieving effects of Fioricet, but it also poses additional risks for overdose and addiction. Fioricet is the property of the pharmaceutical firm Actavis, one of three generic drug companies which contributed substantially to the Opioid Epidemic, according to DEA data.
Patients who receive prescriptions for Fioricet should know whether their prescription contains codeine. If codeine is an ingredient in your Fioricet prescription, consider asking for opioid-free medication. If a person misuses Fioricet with codeine, either accidentally or intentionally, they might suffer lethal respiratory depression. Shallow breathing, a slow heart rate, extreme drowsiness, chest pain, and intense confusion are some of the symptoms of overdose on Fioricet with codeine.
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.
Fioricet can also interact with different medications, including:
This is not a full list of all the side effects and interactions of Fioricet. Ask your pharmacist for a complete list.
Fioricet has several risks and may not be suitable for everyone.
The active ingredient butalbital in Fioricet may be habit-forming. Using higher doses for a long time may lead to dependence on Fioricet. Suddenly stopping the medication after regular use may also cause withdrawal symptoms.
Drinking alcohol or taking other sedative medications with Fioricet may be harmful and cause dangerous side effects. Butalbital takes a long time to clear from your body.
Do not take Fioricet with other products that have the same active ingredients. Taking too much of these ingredients together can increase the risk of overdose, cause liver or kidney damage, and may be life-threatening.
Talk with your doctor about any medications and over-the-counter products you’re taking, including vitamins, herbs, and natural supplements.
Some examples include:
Taking Fioricet regularly can increase your risk for rebound headaches or medication overuse headaches. The American Migraine Prevalence and Prevention Study found use of butalbital for 5 days per month would increase the risk of acute migraine becoming chronic migraine.
Fioricet can raise blood pressure and heart rate, if you have a history of high blood pressure or heart related conditions, ask your doctor about the risks of Fioricet.
While it seems like opioids get the bulk of the attention right now regarding prescription medication addiction, Fioricet is addictive. When people take Fioricet, they should be warned of the potential for Fioricet abuse and Fioricet addiction. It’s the butalbital that may be habit-forming in Fioricet, and if it contains codeine, that element may also be.Butalbital is a central nervous system depressant, and it can sedate how a person feels pain. This is combined with the pain-relieving effects of acetaminophen, which works differently than the butalbital.
So how do Fioricet abuse and Fioricet addiction occur?
When someone is addictive to Fioricet, it usually begins as tolerance. With a drug tolerance someone takes the substance for a period of time, and then their body becomes used to it, so they need continuously higher doses to get the same effects.
A tolerance can be developed for butalbital as well as codeine if it’s contained in Fioricet. There is research that shows the average barbiturate addict may need to take 1500 mg of the drug to feel the effects they want. Unfortunately, people who are addicted to Fioricet also often take other opioids and narcotics either to amplify the effects of the Fioricet or when they run out of it to achieve the same effect.
What are the signs of Fioricet addiction?
While all addictions to prescription drugs are worrisome, with Fioricet, there is not only the concern of being addicted to the butalbital, but there are the risks of the acetaminophen component of the drug. Acetaminophen can cause liver damage or failure when high amounts are taken, and it can be an acute situation where it happens very suddenly. It’s important for people who take Fioricet to be aware of this.
Acute liver failure can occur in doses of more than 4,000 mg in a day.
In addition to the dangers of acetaminophen, with Fioricet abuse, there is the risk of overdosing on butalbital as well. Butalbital can cause respiratory depression and excessive sedation, so Fioricet addiction is dangerous in multiple ways.
If you or someone you know may have a Fioricet abuse problem, it’s important to seek professional help, because it’s an addiction that can very easily be dangerous or deadly.
Keep all appointments with your doctor.
Do not let anyone else take your medication. Fioricet is not 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.
¶ This branded product is no longer on the market. Generic alternatives may be available.
Last Revised – 05/15/2019
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