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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).
Butalbital, acetaminophen, and caffeine combination is used to relieve symptoms of tension (or muscle contraction) headaches.
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.
You should not use Fioricet if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.
Do not use Fioricet if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.
Do not take more Fioricet than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).
In rare cases, acetaminophen may cause a severe skin reaction. Stop taking Fioricet and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.
Before taking this medicine
Do not use Fioricet if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.
You should not use Fioricet if you are allergic to it, if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other opioids.
To make sure Fioricet is safe for you, tell your doctor if you have ever had:
- liver disease, cirrhosis, a history of alcoholism or drug addiction, or if you drink more than 3 alcoholic beverages per day;
- kidney disease;
- stomach ulcer or bleeding;
- a history of skin rash caused by any medication; or
- a history of mental illness or suicidal thoughts.
It is not known whether Fioricet will harm an unborn baby. If you use butalbital while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.
Acetaminophen, butalbital, and caffeine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breastfeeding a baby.
Key Points to Understanding Fioricet
Fioricet is a combination prescription medication used to treat migraines and tension headaches. Keep the following key points in mind regarding Fioricet:
- Fioricet includes butalbital, acetaminophen and caffeine
- Fioricet is a controlled substance and should be taken exactly as prescribed
- As a depressant, Fioricet can have side effects like feeling sluggish or drowsiness as the body adjusts to the medication. In rare cases, side effects can be more severe.
- Fioricet can interact with other drugs and health conditions and you should speak to a doctor if you are taking other medications, have any other health conditions or are pregnant
- Fioricet has some addictive qualities
- Misusing Fioricet can be dangerous or deadly
As with many medications, when taken over a long period of time or in high doses, the body can come to depend on the drug to function normally. Misusing Fioricet can result in dependence and addiction and can pose serious risks to health. Signs of a Fioricet addiction can include drug-seeking behavior, doctor-shopping or pretending to lose Fioricet prescriptions to get access to more.
Fioricet has addictive qualities, and it’s important to watch for signs of addiction when using this medication. If you are misusing or addicted to Fioricet, getting off the drug is the first step of recovery. There are different types of treatments available that can address Fioricet addiction. Treatment can also include therapy and skill building, which can address the underlying reasons for abusing Fioricet.
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What you should know before you take Fioricet ?
- Do not overuse Fioricet because you may become addicted to it and have difficulty stopping it.
- Over-use of Fioricet can also result in a medication-overuse headache (also known as a rebound headache) which occurs when analgesics are taken too frequently to relieve a headache.
- Never share your Fioricet with anybody else.
- May be administered without regards to food; although food may decrease any reported stomach upset.
- If you have been taking Fioricet regularly, or if you think you have become addicted to it, talk to your doctor about slowly withdrawing it, as sudden withdrawal may precipitate a withdrawal syndrome (symptoms include anxiety, dizziness, hallucinations, muscle twitching, nausea, seizures, sleeplessness, or tremor).
- Fioricet can cause sedation and affect your ability to drive or operate machinery.
- Do not drink more than two alcoholic drinks a day if you are a man or one alcoholic drink per day if you are women and taking Fioricet.
- Talk to your doctor if you have any side effects of concern. Seek urgent medical advice if you develop an allergic-type reaction (difficulty breathing or swallowing, rash, or facial swelling) soon after taking Fioricet.
- Not recommended for women who are pregnant or breastfeeding.
- Fioricet contains acetaminophen which may be “hidden” in other cough/cold medicines. The total dose of acetaminophen from any source should not exceed 4000mg per day (24 hours).
- Talk to your doctor or pharmacist before taking any other medications or natural products with Fioricet as it can interact with a large number of drugs.
How Fioricet works
Fioricet is a combination of three medications that help relieve pain caused by tension headaches (headaches that are generally related to stress and cause muscle tightness and pain around your forehead and neck).
- Butalbital is a barbiturate that works in your brain to help you relax.
- Acetaminophen is a pain reliever. It stops the production of certain chemicals in the brain that cause pain.
- Caffeine is an adenosine antagonist. It blocks a natural chemical in your body called adenosine. It’s unclear exactly how caffeine works to treat headaches, but it’s thought to boost the pain-relieving activity of acetaminophen.
What is Fioricet used for?
- Tension headaches
Fioricet dosage forms
Typical dosing for Fioricet
Oral tablets: Each tablet contains 50 mg of butalbital, 325 mg of acetaminophen, and 40 mg of caffeine.
- Adults and children 12 years and older: The typical dose is 1 to 2 tablets by mouth every 4 hours as needed for pain. Don’t take more than 6 tablets in a 24-hour period.
Oral capsules: Each capsule contains 50 mg of butalbital, 300 mg of acetaminophen, and 40 mg of caffeine.
- Adults and children 12 years and older: The typical dose is 1 to 2 capsules by mouth every 4 hours as needed for pain. Don’t take more than 6 capsules in a 24-hour period.
Oral solution: Each tablespoonful (15 mL) contains 50 mg of butalbital, 325 mg of acetaminophen, and 40 mg of caffeine.
- Adults and children 12 years and older: The typical dose is 15 mL (1 tablespoon) to 30 mL (2 tablespoons) by mouth every 4 hours. Don’t take more than 90 mL (6 tablespoons) in a 24-hour period.
How should I take Fioricet?
Take Fioricet exactly as prescribed. Follow all directions on your prescription label. Do not take more of this medication than recommended. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
Butalbital may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.
Store at room temperature away from moisture and heat.
Keep track of the amount of medicine used from each new bottle. Butalbital is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Usual Adult Dose for Headache:
Butalbital 50 mg/acetaminophen 300 mg/caffeine 40 mg: 1 or 2 capsules orally every 4 hours as needed not to exceed 6 capsules per day
Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.
Usual Pediatric Dose for Headache:
12 years or older: Butalbital 50 mg/acetaminophen 300 mg/caffeine 40 mg: 1 or 2 capsules orally every 4 hours as needed not to exceed 6 capsules per day
-Due to high rate of physical dependence, the extended use of this drug is not recommended.
-The safety and efficacy of treating multiple recurrent headaches with this product is not known.
Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.
Pros and cons of Fioricet
- Available as a lower-cost, generic medication
- Conveniently combines three different medications
- Available in a liquid form as a fruit-punch flavored syrup
- Can be used in people as young as 12 years old
- Can become habit-forming if taken for a long time
- Not a first-choice medication for treating tension headaches
- Can cause liver damage
- Is a controlled medication in some states, so it might have special requirements to getting your prescription filled
Pharmacist tips for Fioricet
- Fioricet can cause excessive sleepiness, dizziness, and lightheadedness. Don’t drive or use any heavy machinery until you know how the medication affects you.
- Since Fioricet contains some caffeine, be sure to limit how much caffeine you use per day. Too much caffeine can lead to nervousness, shakiness, restlessness, trouble sleeping, and a fast heart rate.
- Avoid drinking alcohol while taking Fioricet, since it can cause you to be more drowsy and less alert, and raise your risk of accidental injuries and liver damage.
- Many over-the-counter and prescription medications contain acetaminophen. Don’t take more than 3 to 4 grams of acetaminophen per day to avoid liver damage. Ask your provider what your maximum daily amount of acetaminophen is, since this depends on your provider’s instructions.
- Use caution if you currently take medications called monoamine oxidase inhibitors (MAOIs), such as phenelzine (Nardil), tranylcypromine (Parnate), or selegiline (Eldepryl). Taking a MAOI with Fioricet can lead to sleepiness, dizziness, and slowed breathing.
- If you’re using the oral syrup form of Fioricet, use the dosing cup or syringe provided by your pharmacist to measure out your dose. Don’t use kitchen spoons or cups since they might not give you the most accurate dose.
- Store Fioricet at room temperature in a place out of reach from children due to the life-threatening risk of accidental overdose, misuse, and abuse. If you or someone you know accidentally overdoses on Fioricet, get emergency medical help or call your local poison control center at 1-800-222-1222 right away.
Fioricet Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
- Bleeding or crusting sores on lips
- chest pain
- fever with or without chills
- hive-like swellings (large) on eyelids, face, lips, and/or tongue
- muscle cramps or pain
- red, thickened, or scaly skin
- shortness of breath, troubled breathing, tightness in chest, or wheezing
- skin rash, itching, or hives
- sores, ulcers, or white spots in mouth (painful)
Symptoms of overdose
- Anxiety, confusion, excitement, irritability, nervousness, restlessness, or trouble in sleeping (severe, especially with products containing caffeine)
- convulsions (seizures) (for products containing caffeine)
- diarrhea, especially if occurring together with increased sweating, loss of appetite, and stomach cramps or pain
- dizziness, lightheadedness, drowsiness, or weakness, (severe)
- frequent urination (for products containing caffeine)
- hallucinations (seeing, hearing, or feeling things that are not there)
- increased sensitivity to touch or pain (for products containing caffeine)
- muscle trembling or twitching (for products containing caffeine)
- nausea or vomiting, sometimes with blood
- ringing or other sounds in ears (for products containing caffeine)
- seeing flashes of “zig-zag” lights (for products containing caffeine)
- shortness of breath or unusually slow or troubled breathing
- slow, fast, or irregular heartbeat
- slurred speech
- swelling, pain, or tenderness in the upper abdomen or stomach area
- unusual movements of the eyes
Check with your doctor as soon as possible if any of the following side effects occur:
- Confusion (mild)
- mental depression
- unusual excitement (mild)
- Bloody or black, tarry stools
- bloody urine
- pinpoint red spots on skin
- swollen or painful glands
- unusual bleeding or bruising
- unusual tiredness or weakness (mild
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Bloated or “gassy” feeling
- dizziness or lightheadedness (mild)
- drowsiness (mild)
- nausea, vomiting, or stomach pain (occurring without other symptoms of overdose)
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.