Tag: acetaminophen

Are There any Negative Side Effects of the Pain Killer Fioricet (Butalbital APAP Caffeine)?

Fioricet is a medication commonly prescribed for the treatment of tension headaches.

Fioricet Side Effects
Fioricet Side Effects

It contains three active ingredients: acetaminophen (a pain reliever and fever reducer), butalbital (a barbiturate that relaxes muscle contractions), and caffeine (which enhances the effects of acetaminophen and butalbital). While Fioricet can be effective for managing headaches, it also carries the risk of side effects. Common side effects of Fioricet may include:

      1. Dizziness: Feeling lightheaded or unsteady.
      2. Drowsiness: Feeling sleepy or tired.
      3. Nausea: Feeling sick to your stomach.
      4. Vomiting: Throwing up.
      5. Stomach upset: Indigestion or discomfort in the stomach.
      6. Constipation: Difficulty passing stools.
      7. Shaking or tremors: Involuntary shaking movements.
      8. Shortness of breath: Difficulty breathing.
      9. Increased heart rate: Feeling your heart beating faster than usual.
      10. Feeling anxious or nervous: Experiencing restlessness or worry.

In rare cases, Fioricet can also cause more serious side effects, such as allergic reactions, liver problems, or dependence if used for an extended period. It’s essential to take Fioricet exactly as prescribed by your doctor and to be aware of potential side effects.

What is Fioricet and Why it can Relieve Headaches ?

Fioricet (Butalbital, Acetaminophen, and Caffeine Tablets, USP) is supplied in tablet form for oral administration.

Each tablet contains the following active ingredients:
butalbital USP . . . . . . . . . .50 mg
acetaminophen USP . . . . 325 mg
caffeine USP . . . . . . . . . . .40 mg

Fioricet contains Butalbital, Acetaminophen, and Caffeine. 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

Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most tissues in the body. Barbiturates in general may appear in breast milk and readily cross the placental barrier. They are bound to plasma and tissue proteins to a varying degree and binding increases directly as a function of lipid solubility.

Elimination of butalbital is primarily via the kidney (59% to 88% of the dose) as unchanged drug or metabolites. The plasma half-life is about 35 hours. Urinary excretion products include parent drug (about 3.6% of the dose), 5-isobutyl-5-(2, 3-dihydroxypropyl) barbituric acid (about 24% of the dose), 5-allyl-5(3-hydroxy-2-methyl-1-propyl) barbituric acid (about 4.8% of the dose), products with the barbituric acid ring hydrolyzed with excretion of urea (about 14% of the dose), as well as unidentified materials. Of the material excreted in the urine, 32% is conjugated.

The in vitro plasma protein binding of butalbital is 45% over the concentration range of 0.5-20 mcg/mL. This falls within the range of plasma protein binding (20%-45%) reported with other barbiturates such as phenobarbital, pentobarbital, and secobarbital sodium. The plasma-to-blood concentration ratio was almost unity, indicating that there is no preferential distribution of butalbital into either plasma or blood cells.

Acetaminophen

Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug.

Caffeine

Like most xanthines, caffeine is rapidly absorbed and distributed in all body tissues and fluids, including the CNS, fetal tissues, and breast milk.

Caffeine is cleared through metabolism and excretion in the urine. The plasma half-life is about 3 hours. Hepatic biotransformation prior to excretion results in about equal amounts of 1-methylxanthine and 1-methyluric acid. Of the 70% of the dose that is recovered in the urine, only 3% is unchanged drug.

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.

Each tablet contains the following active ingredients:

      • butalbital USP . . . . . . . . . .50 mg
      • acetaminophen USP . . . . 325 mg
      • caffeine USP . . . . . . . . . . .40 mg

Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. Butalbital belongs to the group of medicines called barbiturates.

Barbiturates act in the central nervous system (CNS) to produce their effects. 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. It has the following structural formula:

Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. 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.

It has the following structural formula:Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant.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.

How to treat Fioricet overdose

The treatment of Fioricet overdose is complicated by the presence of two substances which are highly toxic when taken in excessive amounts. Fioricet overdoses generally result in toxic amounts of both acetaminophen and butalbital being consumed at once, requiring both overdoses to be treated at once.

Fioricet overdose by anyone and/or any consumption by persons to whom it is not prescribed (particularly children) is always a medical emergency and medical attention must be sought immediately if an overdose or consumption by other persons is suspected.fioricet

Fioricet overdose is often fatal and symptoms may not present for hours following consumption, once initial overdose symptoms present they can progress rapidly and there may not be time to reach appropriate medical care after this point.

Acetaminophen over-exerts its toxicity through the production of a toxic metabolite which produces liver damage in doses of 3,000mg or more per day and acute liver failure in doses above that. The specific antidote to acetaminophen overdose is N-acetyl-cysteine. Kidney failure and stomach bleeding may also occur.

Butalbital overdoses exerts its toxicity through excessive sedation resulting in respiratory depression and ultimately death via hypoxia. Nonlethal overdoses may also result in coma and death. There is no specific antidote to butalbital overdose and treatment is supportive, common treatment regimens generally include the administration of intravenous administration of saline, naloxone, thiamine, glucose, NaHCO3 to alkalize the urine to increase rate of excretion, and activated charcoal via nasogastric tube. It is not uncommon for doctor to recommend observation of the patient in the Emergency Department for a number of hours or admission to the hospital for several days of observation if symptoms are severe and to counsel the patient on drug abuse and/or refer them for psychiatric evaluation.

What is the max dosage of acetaminophen ?

Acetaminophen, which is also known as paracetamol, is a commonly used OTC (over-the-counter) pain reliever (analgesic) and fever reducer (antipyretic). People use it for headaches, and minor aches and pain. Liver injury from acetaminophen overdose remains a serious public health problem despite ongoing regulatory and educational efforts over the past several years to improve the safe use of medicines that contain acetaminophen.

Fioricet contains acetaminophen 325 mg per tablet. The max dosage of an adult for acetaminophen goes down from 4000mg to 3000mg per day (http://www.medicalnewstoday.com/articles/231915.php). So only acetaminophen, you should not take more than eight tablet fioricet per day. IF you take more than eight fioricet tablet per day, you will hurt your liver.

acetaminophen

From tylenol website, they lowered the maximum daily dose for single-ingredient Extra Strength TYLENOL® (acetaminophen) products sold in the U.S. from 8 pills per day (4,000 mg) to 6 pills per day (3,000 mg). The dosing interval has also changed from 2 pills every 4 – 6 hours to 2 pills every 6 hours.

What is Fioricet and What is Fioricet Side Effects ?

Fioricet and Esgic are brand names of a combination of butalbital (a barbiturate), acetaminophen and caffeine which is indicated for the treatment of tension headaches, muscle contraction headaches and post-dural puncture headaches. Although not indicated, they are commonly used to treat migraines and other pain related ailments.

Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets USP) is supplied in tablet form for oral administration.

Each tablet contains the following active ingredients:
butalbital USP . . . . . . . . . . . .50 mg
acetaminophen USP . . . . . . 325 mg
caffeine USP . . . . . . . . . . . . .40 mg

Inactive Ingredients: crospovidone, FD&C Blue #1, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.

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.

Before taking Fioricet

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 acetaminophen, butalbital, or caffeine, if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

To make sure Fioricet is safe for you, tell your doctor if you have:

  • liver disease, cirrhosis, a history of alcoholism or drug addiction, or if you drink more than 3 alcoholic beverages per day;
  • kidney disease;
  • asthma, sleep apnea, or other breathing disorder;
  • stomach ulcer or bleeding;
  • a history of skin rash caused by any medication;
  • a history of mental illness or suicidal thoughts; or
  • if you use medicine to prevent blood clots.

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 sever

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 Fioricet 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 Fioricet is against the law.

Take Fioricet with food or milk if it upsets your stomach.

Store Fioricet 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.

Fioricet dosing information

Usual Adult Dose of Fioricet for Headache:

Acetaminophen 300 mg, butalbital 50 mg, and caffeine 40 mg:
1 or 2 capsule(s) orally every 4 hours as needed. Maximum daily dose: 6 doses.

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

Acetaminophen 500 mg, butalbital 50 mg, and caffeine 40 mg:
1 tablet or capsule orally every 4 hours.
Maximum daily dose: 6 doses

Acetaminophen 750 mg, butalbital 50 mg, and caffeine 40 mg:
1 tablet orally every 4 hours.
Maximum daily dose: 5 tablets

Usual Pediatric Dose of Fioricet for Headache:

12 years and older:
Acetaminophen 300 mg, butalbital 50 mg, and caffeine 40 mg:
1 or 2 capsule(s) orally every 4 hours as needed. Maximum daily dose: 6 doses.

What happens if I miss a dose?

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

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 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.

Fioricet side effects

Get emergency medical help if you have signs of an allergic reaction to Fioricet: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using this medicine and call your doctor at once if you have:

  • confusion, seizure (convulsions);
  • shortness of breath;
  • a light-headed feeling, like you might pass out; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Fioricet side effects may include:

  • drowsiness, dizziness;
  • feeling anxious or restless;
  • drunk feeling; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Fioricet?

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking Fioricet with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with acetaminophen, butalbital, and caffeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Fioricet only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Fioricet Drug Interaction

Fioricet contains Butalbital, Acetaminophen, and caffeine.  A lot of other pain relievers contain Butalbital, Acetaminophen, and caffeine too.

I can only list some common over the counter medicines that contain Acetaminophen:  Actifed, Alka-Seltzer, Plus Liquid Gels, Anacin, Cepacol, Contac, Coricidin, Dayquil, Dimetapp, Dristan, Excedrin, Feverall …

Some prescriptions that contain acetaminophen are: Ultrace, Fioricet, Oxycodone, Endocet, Tylox …

You also must know what drugs contain Butalbital:  Bupap, Phrenilin, Tencon, Cephadyn; Fioricet, Esgic, Esgic-Plus; Fioricet with Codeine, Floricet with Codeine, Phrenilin with Caffeine and Codeine; Axotal; Fiorinal, Butalbital Compound, Farbital, Idenal; Fiorinal with Codeine, Fiorinal with Codeine III, Ascomp with Codeine, Fiortal with Codeine.

When you take more than one pain killer, you must read very carefully about their components.  Never exceed the max dosage of acetaminophen and butalbital of all the medicines you are taking.   Normally All the packages sent to you have the drug introduction and doctor names and phone number.  Read the drug introduction very carefully and never share the medicines with your sisters, your brothers,  your parents, or any friends. Always do not let the children touch the medicines.

Please donot drink any alcohol (Ethanol) with your Fioricet Because Ethanol together with acetaminophen will cause serious side effects that affect your liver, and Ethanol together with Butalbital will cause side effects of dizziness, drowsiness.

Please don’t take herb while you are taking Fioricet. Even Vitamins will have some interaction with Fioricet.

Be honest to place the current medicines you are taking in the health questionnaire  form. The doctor will check whether you are OK to take Fioricet.  If they think your current drugs or herbs have some interaction with Fioricet, they will phone you to discuss the situation with you. So please always leave us the correct phone number. We will never call you to promote you anything.

Most frequently checked interactions

View interaction reports for Fioricet (acetaminophen / butalbital / caffeine) and the medicines listed below.

  • Adderall (amphetamine / dextroamphetamine)
  • Advil (ibuprofen)
  • Ambien (zolpidem)
  • aspirin
  • Ativan (lorazepam)
  • baclofen
  • caffeine
  • clonazepam
  • codeine
  • Cymbalta (duloxetine)
  • Excedrin (acetaminophen / aspirin / caffeine)
  • Flexeril (cyclobenzaprine)
  • gabapentin
  • hydrocodone
  • ibuprofen
  • ibuprofen
  • Imitrex (sumatriptan)
  • Klonopin (clonazepam)
  • levothyroxine
  • Lexapro (escitalopram)
  • lisinopril
  • Lyrica (pregabalin)
  • meloxicam
  • naproxen
  • Norco (acetaminophen / hydrocodone)
  • omeprazole
  • oxycodone
  • Percocet (acetaminophen / oxycodone)
  • prednisone
  • Suboxone (buprenorphine / naloxone)
  • Topamax (topiramate)
  • tramadol
  • trazodone
  • Tylenol (acetaminophen)
  • Vitamin D3 (cholecalciferol)
  • Xanax (alprazolam)
  • Zofran (ondansetron)

Fioricet (acetaminophen / butalbital / caffeine) disease interactions

There are 25 disease interactions with Fioricet (acetaminophen / butalbital / caffeine) which include:

What is Fioricet?

Fioricet contains a combination of acetaminophen, butalbital, and caffeine.

Each tablet contains the following active ingredients:
butalbital USP . . . . . . . . . . . .50 mg
acetaminophen USP . . . . . . 325 mg
caffeine USP . . . . . . . . . . . . .40 mg

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.

Fioricet is used to treat tension headaches that are caused by muscle contractions.