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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 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.

How to Treat Fioricet Overdosage ?

Treating Fioricet overdosage requires prompt medical attention and intervention to prevent serious complications. Fioricet contains three active ingredients: butalbital, acetaminophen, and caffeine. Overdosing on Fioricet can lead to toxicity from any of these components, with acetaminophen overdose being particularly concerning due to its potential to cause liver damage. Here are some steps for treating Fioricet overdosage:

Seek Emergency Medical Assistance: If you suspect that you or someone else has overdosed on Fioricet, call emergency services immediately or go to the nearest emergency room. Time is critical in cases of overdose, and prompt medical intervention can help prevent serious complications.
Provide Information: Provide healthcare providers with as much information as possible about the amount of Fioricet ingested, the time of ingestion, and any other medications or substances taken concurrently.
Gastric Decontamination: In cases of recent ingestion, healthcare providers may perform gastric decontamination to remove the remaining medication from the stomach. This may involve inducing vomiting or administering activated charcoal to absorb the medication and prevent further absorption into the bloodstream.
Acetaminophen Antidote: If the overdose involves a significant amount of acetaminophen, healthcare providers may administer N-acetylcysteine (NAC), an antidote that helps protect the liver from acetaminophen toxicity. NAC is most effective when administered within 8-10 hours of acetaminophen ingestion but can still provide benefit if given later.
Monitoring and Supportive Care: Patients who have overdosed on Fioricet may require close monitoring of vital signs, liver function tests, and other laboratory parameters. Supportive care may include intravenous fluids, oxygen therapy, and medications to manage symptoms such as nausea, vomiting, and pain.
Treatment of Complications: Depending on the severity of the overdose and associated complications, additional treatments may be necessary. For example, patients with liver damage may require further medical interventions, such as liver transplantation in severe cases.
Psychological Support: Overdosing on medication can be distressing and may indicate underlying mental health issues. Patients who overdose on Fioricet should receive psychological support and counseling to address any underlying issues and prevent future occurrences.

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 Pharmacokinetics

The behavior of the individual components is described below.

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 Ingredient

Fioricet contains a combination of acetaminophen, butalbital, 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.

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

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

Acetaminophen

Caffeine

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

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.

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1. You have porphyria;
2. You have recently used alcohol;
3. You have recently used sedatives, tranquilizers, or other narcotic medications;
4. You have taken a MAO inhibitor in the past 14 days because A dangerous drug interaction could occur;
5. You have liver , heart disease, kidney disease;
6. You have a history of alcoholism or drug addiction;
7. You have asthma, sleep apnea, or other breathing disorder;
8. You have stomach ulcer or bleeding;
9. You have a history of skin rash caused by any medication;
10. You have a history of mental illness or suicidal thoughts;
11. You use medicine to prevent blood clots;
12. You are pregnant because your baby could become dependent on the drug;
13. You are now breast feeding because Fioricet can pass into breast milk and may harm a nursing baby.

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Fioricet Overdose Signs, Symptoms and Treatment

Fioricet Signs and Symptoms

Toxicity from barbiturate poisoning include 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 thrombocytopenia 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. In adults hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams, or fatalities with less than 15 grams.

Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia and extrasystoles.

Fioricet overdose Treatment

A single or multiple 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. Vomiting should be induced mechanically, or with syrup of ipecac, if the patient is alert (adequate pharyngeal and laryngeal reflexes). Oral activated charcoal (1 g/kg) should follow gastric emptying. The first dose should be accompanied by an appropriate cathartic. If repeated doses are used, the cathartic might be included with alternate doses as required. Hypotension is usually hypovolemic and should respond to fluids. Pressors should be avoided. A cuffed endotracheal tube should be inserted before gastric lavage of the unconscious patient and when necessary, to provide assisted respiration. If renal function is normal, forced diuresis may aid in the elimination of the barbiturate. Alkalinization of the urine increases renal excretion of some barbiturates, especially phenobarbital.

Meticulous attention should be given to maintaining adequate pulmonary ventilation. In severe cases of intoxication, peritoneal dialysis, or preferably hemodialysis may be considered. If hypoprothrombinemia occurs due to acetaminophen overdose, vitamin K should be administered intravenously.

If the dose of acetaminophen may have exceeded 140 mg/kg, acetylcysteine should be administered as early as possible. Serum acetaminophen levels should be obtained, since levels four or more hours following ingestion help predict acetaminophen toxicity. Do not await acetaminophen assay results before initiating treatment. Hepatic enzymes should be obtained initially, and repeated at 24-hour intervals.

Methemoglobinemia over 30% should be treated with methylene blue by slow intravenous administration.

Toxic Doses (for adults)

Butalbital:	toxic dose	1 g	(20 tablets)
Acetaminophen:	toxic dose	10 g	(30 tablets)
Caffeine:	toxic dose	1 g	(25 tablets)

In all cases of suspected overdosage, call your Regional Poison Control Center to obtain the most up-to-date information about the treatment of overdosage. Telephone numbers of certified Regional Poison Control Centers are listed in the Physicians’ Desk Reference®*.

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.

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