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Butalbital-acetaminophen-caffeine 50 Mg-325 Mg-40 Mg Tablet Brand Name

Before Taking Acetaminophen Butalbital Caffeine

  • tell your doctor and pharmacist if you are allergic to acetaminophen, butalbital, caffeine, or any other drugs.
  • tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially anticoagulants such as warfarin , antidepressants, antihistamines, pain medications, sedatives, sleeping pills, tranquilizers, and vitamins. Many nonprescription pain relievers contain acetaminophen. Too much of this drug can be harmful.
  • tell your doctor if you have or have ever had liver disease, porphyria, or depression.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking this medication, call your doctor.
  • you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
  • remember that alcohol can add to the drowsiness caused by this drug.

Acetaminophen Butalbital And Caffeine

Pronunciation: a SEET a MIN oh fen, bue TAL bi tal, and KAF een

Brand: Esgic, Fioricet, Zebutal

325 mg-50 mg-40 mg, round, blue, imprinted with WESTWARD 787

325 mg-50 mg-40 mg, round, blue, imprinted with LCI, 1695

300 mg-50 mg-40 mg, capsule, blue, imprinted with FIORICET, LOGO

325 mg-50 mg-40 mg, round, white, imprinted with WATSON, 3369

325 mg-50 mg-40 mg, round, white, imprinted with 2355, V

325 mg-50 mg-40 mg, oblong, white, imprinted with MIA 110

325 mg-50 mg-40 mg, capsule, white, imprinted with 59743, 004

325 mg-50 mg-40 mg, oblong, white, imprinted with MIA 110

325 mg-50 mg-40 mg, round, white, imprinted with M, 970

325 mg-50 mg-40 mg, oblong, white, imprinted with 3416, WPI

325 mg-50 mg-40 mg, capsule, white, imprinted with 59743, 004

325 mg-50 mg-40 mg, capsule, white, imprinted with MIA 110

325 mg-50 mg-40 mg, capsule, green/white, imprinted with LOGO, 535-12

325 mg-50 mg-40 mg, round, blue, imprinted with FIORICET S, LOGO

325 mg-50 mg-40 mg, round, blue, imprinted with CP, 275

What Happens If I Overdose On Fioricet

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 , or fainting.

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Risks From Concomitant Use With Benzodiazepines Or Other Cns Depressants

Profound sedation, respiratory depression, coma, and death may result from the concomitant use of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules with benzodiazepines or other CNS depressants . Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone. Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics .

If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response. If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response. Follow patients closely for signs and symptoms of respiratory depression and sedation.

Risks Of Use In Patients With Increased Intracranial Pressure Brain Tumors Head Injury Or Impaired Consciousness

Butalbital/Apap/Caffeine, 50/325/40, 100 Tablets/Bottle

In patients who may be susceptible to the intracranial effects of CO2 retention , Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules.

Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules in patients with impaired consciousness or coma.

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What Should I Discuss With My Healthcare Provider Before Taking This Medicine

You should not use this medicine if you are allergic to acetaminophen, butalbital, caffeine, or codeine, or if you have:

  • severe asthma or breathing problems
  • a blockage in your stomach or intestines
  • if you have taken an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

This medicine is not approved for use by anyone younger than 12 years old.

Do not give this medicine to anyone younger than 18 years old who recently had surgery to remove the tonsils or adenoids.

Tell your doctor if you have ever had:

  • breathing problems, sleep apnea
  • a head injury, or seizures
  • liver or kidney disease
  • problems with your gallbladder, thyroid, or adrenal gland or
  • alcoholism or drug addiction.

If you use opioid medicine 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 opioids may need medical treatment for several weeks.

Do not breastfeed. Codeine can pass into breast milk and may cause drowsiness, breathing problems, or death in a nursing baby.

How To Use Fioricet

Take this medication by mouth with or without food as directed by your doctor, usually every 4 hours as needed.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your medical condition, age, and response to treatment. This medication works best if it is used as the first signs of a headache occur. If you wait until the headache has worsened, the medication may not work as well.

If you suddenly stop using this medication, you may have withdrawal symptoms . To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used this medication for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder . Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

Tell your doctor if you notice increased use of this medication, a worsening of headaches, an increase in the number of headaches, the medication not working as well, or use of this medication for more than 2 headache episodes a week. Do not take more than recommended. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches.

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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:

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.

Fioricet is not approved for use by anyone younger than 12 years old.

Patient Access To Naloxone For The Emergency Treatment Of Opioid Overdose

Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules .

Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines .

Consider prescribing naloxone, based on the patients risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose. The presence of risk factors for overdose should not prevent the proper management of pain in any given patient .

Consider prescribing naloxone if the patient has household members or other close contacts at risk for accidental ingestion or overdose.

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What Is The Most Important Information I Should Know About Fioricet

Do not use this medicine 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 acetaminophen, butalbital, and caffeine if you are allergic to it, if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other opioids.

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

What Should I Know About Storage And Disposal Of This Medication

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 .

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 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 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 â one that is up and away and out of their sight and reach.

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What Are Dosages Of Butalbital/acetaminophen/caffeine

Adult and pediatric dosage

  • 50mg/300-325mg/40mg: 2 tablets or capsules orally every 4 hours not to exceed 6 tablets or capsules/day
  • 50mg/500mg/40mg: 1 tablet/capsule orally every 4 hours not to exceed 6 tablets or capsules/day
  • 50mg/750mg/40mg: 1 tablet/capsule orally every 4 hours not to exceed 5 tablets or capsules/day
  • 15-30 mL solution orally every 4 hours not to exceed 180 mL solution/day
  • Not to exceed 4 g/day of acetaminophen for any dosage form or regimen

Pediatric dosage

  • Children younger than 12 years of age: Safety and efficacy not established
  • Children 12 years of age or older:
  • 50mg/300-325mg/40mg: 2 tablets or capsules orally every 4 hours not to exceed 6 tablets or capsules/day
  • 50mg/500mg/40mg: 1 tablet/capsule orally every 4 hours not to exceed 6 tablets or capsules/day
  • 50mg/750mg/40mg: 1 tablet/capsule orally every 4 hours not to exceed 5 tablets or capsules/day
  • 15-30 mL solution orally every 4 hours not to exceed 90 mL solution/day
  • Not to exceed 4 g/day of acetaminophen for any dosage form or regimen

Dosage Considerations Should be Given as Follows:

What Does Each Ingredient Do

BAC contains three compounds. Each has a different action to help manage pain:

  • Butalbital: This compound is a type of barbiturate. It reduces anxiety and causes drowsiness by relaxing your muscles and nervous system. As it can be habit-forming, medications with butalbital are tightly regulated.
  • Acetaminophen: This is a widely used medication to reduce pain and fevers. Its the generic form of Tylenol.
  • Caffeine:Caffeine causes the other two ingredients to work better. It also has some anti-inflammatory effects.

Some BAC medications contain additional active ingredients. For example, Fioricet is also available with codeine, an opioid pain reliever.

Is BAC a controlled substance?

As of August 2022, BAC is on the Drug Enforcement Agency s list of exempted prescription drugs. That means its not federally regulated even though it contains butalbital, a regulated substance. Some states still choose to classify BAC as a controlled substance.

In April 2022, the DEA proposed removing the exemption. No decision has been made yet.

BAC is FDA-approved to treat tension headaches. The FDA has not approved its use to treat migraine, but some doctors prescribe it for that purpose.

When doctors prescribe a drug for something other than its approved use, its called off-label use.

Some people do find it works for migraine. Still, theres not a lot of evidence to support its use.

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Risks Of Use In Patients With Gastrointestinal Conditions

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus.

The codeine in Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis for worsening symptoms.

What Should I Avoid While Taking This Medicine

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen . Taking too much acetaminophen can lead to a fatal overdose.

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What Is The Most Important Information I Should Know About Acetaminophen Butalbital And Caffeine

Do not use this medcine 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 of this medication 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 .

In rare cases, acetaminophen may cause a severe skin 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.

How To Take Fioricet

Use Fioricet exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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.

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.

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How To Use Butalbital Compound Tablet

Take this medication by mouth, usually every 4 hours as needed or as directed by your doctor. Do not take more than 6 capsules/tablets in a 24-hour period. Take with a full glass of water unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this medication. To help prevent stomach upset, take it with food or milk.

The dosage is based on your medical condition and response to therapy. This medication works best if it is used as the first signs of a headache occur. If you wait until the headache has worsened, the medication may not work as well.

If you suddenly stop using this medication, you may have withdrawal symptoms . To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used this medication for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder . Do not increase your dose, take it more often, or use it for a longer time than prescribed. Use the smallest effective dose. Properly stop the medication when so directed.

What Is This Acetaminophen Butalbital Caffeine And Codeine

Codeine is an opioid pain medication. Acetaminophen is a less potent pain reliever. Butalbital is a barbiturate. Caffeine is a stimulant.

Acetaminophen, butalbital, caffeine, and codeine is a combination medicine used to treat tension headaches.

Acetaminophen, butalbital, caffeine, and codeine may also be used for purposes not listed in this medication guide.

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