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Butalbital / APAP / caffeine tablets are a combination product containing 50 mg butalbital, 325 mg acetaminophen and 40 mg caffeine indicated for the relief of the symptom of tension (or muscle contraction) headaches. This combination medication 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.

A lot of American suffer from all kinds of headaches.  Fioricet contains a combination of acetaminophen, butalbital, and caffeine.  Butalbital is habit-forming and potentially abusable. Consequently, the extended use of Fioricet is not recommended. Acetaminophen is a pain reliever and fever reducer. Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache. Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow. 

Butalbital / APAP / caffeine is a prescription drug which is used in treatment of headaches. The combination of three ingredients can provide a more effective relief of headache pain in tensions headaches, muscle contraction headaches, migraine, and even neck pain caused by muscle tension. Fioricet is prescribed for tension headache. But a lot of patients take fioricet for migraine headache and cluster headache.

 

Butalbital / APAP / caffeine generic is not controlled substance by DEA. Some patients are wondering why fioricet is not controlled but fiorinal is controlled. The reasons is that Fiorinal contains aspirin but fioricet only contains non-aspirin pain killer and barbiturate butalbital.  The potential for abuse is decreased if a sufficient amount of a non-controlled substance (e.g., aspirin or acetaminophen) is added.

Usual Adult Dose of Fioricet for Headache: Acetaminophen 325 mg, butalbital 50 mg, and caffeine 40 mg:1 or 2 tablet(s), capsule(s), or tablespoonful(s) orally every 4 hours. Maximum daily dose: 6 doses. Please never exceed your max dosage. If you overdose your fioricet pills, you will hurt your liver, kidney, and heart. Hurting is caused by acetaminophen (Tylenol).

 The safe acetaminophen dosage is 3000mg per day.  Healthy adults taking regular doses of up to 4,000 mg a day show little evidence of toxicity (although some researchers disagree). In 2011 the U.S. Food and Drug Administration launched a public education program to help consumers avoid overdose, warning: “Acetaminophen can cause serious liver damage if more than directed is used. Some doctors even suggest acetaminophen be controlled or become prescription.

Butalbital is one kind of barbiturate. The average daily dose for the barbiturate addict is usually about 1500 mg. You cannot be addictive on butalbital (totally 240mg per day taken ) in fioricet. But you may depend on butalbital in fioricet.  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.

Warning

Before taking this medication, tell your doctor or pharmacist if you are allergic to acetaminophen, caffeine, or butalbital; or to other barbiturates (such as phenobarbital) or xanthine derivatives (such as theophylline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe breathing problems (such as bronchopneumonia), a certain enzyme disorder (porphyria), liver disease, kidney disease, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), mental/mood disorders, abdominal/stomach problems (such as stomach ulcer).

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Liquid products may contain alcohol, sugar and/or aspartame. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

Before having surgery or certain medical procedures (such as a heart stress test or a procedure to restore a normal heart rhythm if you have an unusually fast heartbeat), tell your doctor or dentist that you use this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially drowsiness and trouble falling asleep. These side effects can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have used this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, seizures, or diarrhea. Tell your doctor right away if you notice any of these symptoms in your newborn.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Information For Patients /Caregivers

• • Do not take Fioricet®  if you are allergic to any of its ingredients.
  • If you develop signs of allergy such as a rash or difficulty breathing, stop taking Esgic® Capsules and contact your healthcare provider immediately.
  • Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.
  • This product may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product.
  • Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.
  • Butalbital may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

Fioricet Mechanism of Action

Fioricet is a brand name consisting of a combination of butalbital (a barbiturate), APAP and caffeine which is indicated for the treatment of tension headaches, muscle contraction headaches and post-dural puncture headaches. Acetaminophen is a pain reliever and fever reducer. Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache. Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

Butalbital has generalized depressant effect on central nervous system and, in very high doses, has peripheral effects. Acetaminophen has analgesic and antipyretic effects mediated by a metabolite which acts atcannabinoid receptors, contrary to popular belief it is not an anti-inflammatory at safe levels (it becomes toxic at doses above 1,000mg per dose and/or 3,000mg per day). Caffeine is thought to produce constriction ofcerebral blood vessels and serves to counteract the sedative effect of butalbital.

Butalbital has a half-life of about 35 hours. Acetaminophen has a half-life of about 1.25 to 3 hours, but may be increased by liver damage and after an overdose. Caffeine has a half-life of about 5 to 7 hours.

Butalbital has generalized depressant effect on CNS and, in very high doses, has peripheral effects. Acetaminophen has analgesic and antipyretic effects; its analgesic effects may be mediated through inhibition of prostaglandin synthetase enzyme complex. Caffeine is thought to produce constriction of cerebral blood vessels.

Butalbital has generalized depressant effect on central nervous system and, in very high doses, has peripheral effects. Acetaminophen has analgesic and antipyretic effects mediated by a metabolite which acts atcannabinoid receptors, contrary to popular belief it is not an antiinflammatory at safe levels (it becomes toxic at doses above 1,000mg per dose and/or 3,000mg per day). Caffeine is thought to produce constriction ofcerebral blood vessels and serves to counteract the sedative effect of butalbital.

Butalbital has a half-life of about 35 hours. Acetaminophen has a half-life of about 1.25 to 3 hours, but may be increased by liver damage and after an overdose. Caffeine has a half-life of about 5 to 7 hours

Fioricet is well established, proven brand that was introduced in the US in the mid 1980s. Watson Pharmaceuticals, Inc. acquired the United States rights to the Fioricet® and Fiorinal® lines for $178 million from Novartis Pharmaceuticals Corporation in 2003. Fioricet® and Fiorinal® are based on combinations of popular pain relief compounds and are used for tension headaches:

• • • Fioricet ® (butalbital, acetaminophen, and caffeine)
    • Fioricet ® with Codeine CIII (butalbital, acetaminophen, caffeine, codeine phosphate)
    • Fiorinal ® (butalbital, aspirin, and caffeine)
    • Fiorinal ® with Codeine (butalbital, aspirin, caffeine and codeine phosphate)

Actually more patients take fioricet for migraine headache than for tension headache. More than 90% patients think fioricet is good and effective for tension headache and more than 80% patients think fioricet is good and effective for Migraine Headache. some customers even take fioricet for neck tension pain.

Fioricet Product Information and shapes:

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Fioricet can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include insomnia, restlessness, tremor, diarrhea, increased shallow breathing, uneven heartbeats, seizure (convulsions), or fainting.

What should I do if I overdose?

It is relatively easy to overdose on Fioricet. An overdose can cause caffeine toxicity, which seldom happens due to the normal consumption of food and caffeinated beverages. Overdosing can cause seizures, weakness, confusion, trouble breathing, and severe liver damage.

Other symptoms might include ringing in the ears, unusual heartbeat, trouble walking or sleeping, and slurred speech.

If you have taken too much of this medicine, call the poison control center at 800-222-1222. You may need to go to the emergency room. Fioricet overdose can be serious, and there have been instances of people intentionally overdosing.

Fioricet should be stored out of the reach of children and pets.

What should I avoid while taking Fioricet?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

While you are taking this medication, avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice.

For more Fioricet information, please check:

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Risks of Taking Fioricet

Butalbital-containing medications can be habit-forming and may lead to addiction and other problems. Risks of taking Fioricet and Fiorinal include:

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

Medication overuse headaches, a type of headache disorder that occurs when a person takes medication too frequently to treat their headaches, are common in patients who take butalbital medications. With Fioricet or Fiorinal, a medication overuse headache or rebound headache can occur from taking it three times a week or 10 or more days a month. 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.

Withdrawal

When taking butalbital, you may experience withdrawal symptoms 8 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.

What if I have an allergic reaction?

Allergy symptoms include itching, skin rash, and difficulty breathing. You should call your doctor immediately if you experience these symptoms. Rarely, acetaminophen can cause Stevens-Johnson Syndrome,² a serious allergic reaction that causes inflammation of the skin and detachment of the upper surface. 

Because of this, any skin reaction to Fioricet needs to be taken seriously. Do not take any more of the medication and call your doctor right away. This reaction can happen even if you have taken acetaminophen before.

Barbiturates can also cause potentially fatal skin reactions so, again, make sure that you get any kind of skin reaction checked by a healthcare professional immediately. Conditions such as Stevens-Johnson Syndrome and similar toxic epidermal necrolysis are associated with significant morbidity and mortality.

These conditions require early detection and care, so check your skin regularly if you are taking this medication and pay attention to any rash or lesions.

Other allergic symptoms should also warrant a call to your doctor. Most likely, you will have to discontinue the medication and switch to an alternative. You should not take Fioricet if you have previously had any reaction to acetaminophen or to caffeine.

Is Fioricet safe for pregnant women?

You should not take Fioricet if you are pregnant. Butalbital is potentially associated with certain congenital heart defects, namely:

1. Tetralogy of Fallot: This is a complex of four cardiac and pulmonary defects. Many infants with this condition require surgery soon after birth as it increases the risk of arrhythmia and endocarditis and causes developmental delays.

2. Pulmonary valve stenosis: This is a narrowing of the valve that controls blood flow to the lungs, causing the right ventricle to have to pump harder, which can cause damage to the heart over time. 

3. Secundum-type atrial septal defect (ASD): This is a hole in the wall between the two atriums of the heart, allowing blood to flow between the two atriums, which can affect blood oxygen levels. Small defects generally go untreated and often close on their own, but larger ones may need a procedure to lower the risk of abnormal heart rhythms, heart failure, heart infection, stroke, and pulmonary hypertension.

The connection has not been formally proven due to the small sample sizes in available studies. However, given it is statistically significant, Fioricet should be avoided while pregnant and breastfeeding, as it does pass into breast milk. 

If you get migraines and become pregnant, you should talk to your doctor. Other migraine medications can also carry risks during pregnancy and you may need your medications adjusted.

Is Fioricet addictive?

Both butalbital and caffeine can be physically addictive. It is very possible to become addicted to Fioricet, which is another reason it is not a front-line treatment. Because people with migraine get headaches fairly regularly, they have a higher risk of becoming addicted to Fioricet and/or its ingredients. 

Barbiturates, in particular, can be a drug of abuse. This is important to note as Fioricet is sometimes taken to help people sleep, reduce stress, or self-medicate anxiety or depression.

People with mental health issues or a history of substance use disorder are more likely to abuse Fioricet. In fact, these factors are considered potential contraindications for prescribing Fioricet. This includes alcoholism, especially as mixing alcohol and Fioricet can cause extreme drowsiness and impaired judgment. 

Fioricet Withdrawal Symptoms

Regular use can cause rebound headaches, which are highly unpleasant and may not always respond to normal treatments. You should not use Fioricet on a daily basis in order to avoid this. Rebound headaches are caused by physical dependence on the drug to control pain and/or by physical addiction to caffeine, which results in headaches as a withdrawal symptom. 

Caffeine withdrawal can also cause fatigue, low energy, depression, drowsiness, concentration issues, brain fog, and irritability. If you are prone to caffeine addiction, you need to be aware that Fioricet can cause or aggravate it due to a large amount of caffeine in the drug.

Barbiturates can cause a withdrawal state similar to alcohol, including seizures and delirium. Usually, people get addicted to Fioricet after ordering it online to self-medicate for chronic headaches, without realizing that it should not be taken daily. There are substantiated cases of people taking Fioricet for migraine and becoming addicted. 

Additionally, much like alcohol, the more of the drug you take, the more you need to get the same effect, which can cause an overdose. You should talk to your doctor if Fioricet is no longer working as well as when you first started taking it. This can be a sign of physical dependence and may mean you need to stop taking the drug before you become tempted to take excessively large doses. 

Common withdrawal symptoms of Fioricet include:

• Depression

• Anxiety

• Insomnia

• Hallucinations

• Increased heart rate

• Increased sweating

• Nausea

• Seizures

People who have become addicted to Fioricet may require detox and rehab to help them get through the withdrawal symptoms. It is very important not to take this medication other than when you truly need it. As you can get a little bit high from Fioricet, the temptation for recreational abuse is present.