Butalbital/acetaminophen/caffeine (Esgic, Floricet) is an inexpensive drug used to treat tension headaches. It is more popular than comparable drugs. it is available in multiple generic and brand versions.

Pharmacologic Classifications: Barbiturate

What is Fioricet ?

Butalbital, acetaminophen, and caffeine combination is used to relieve symptoms of tension (or muscle contraction) headaches.

Butalbital belongs to the group of medicines called barbiturates. Barbiturates act in the central nervous system (CNS) to produce their effects.

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.

Fioricet is available only with your doctor’s prescription.

Fioricet Dosing Information

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage forms (capsules or tablets):
- For tension headaches:
  - Adults and children 12 years of age and older—One or two capsules or tablets every 4 hours as needed. However, the dose is usually not more than 6 capsules or tablets per day. Do not exceed 4 grams (4000 milligrams) of acetaminophen (Tylenol®) per day.
  - Children younger than 12 years of age—Use and dose must be determined by your doctor.

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 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 several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Fioricet can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines.

Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of butalbital, acetaminophen, and caffeine combination in children younger than 12 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of butalbital, acetaminophen, and caffeine combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving butalbital, acetaminophen, and caffeine combination.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

- - Riociguat

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

- - Alfentanil
  - Alprazolam
  - Amobarbital
  - Anisindione
  - Aprobarbital
  - Butabarbital
  - Carisoprodol
  - Chloral Hydrate
  - Chlordiazepoxide
  - Chlorzoxazone
  - Clarithromycin
  - Clonazepam
  - Clorazepate
  - Dantrolene
  - Darunavir
  - Diazepam
  - Dicumarol
  - Doxorubicin
  - Doxorubicin Hydrochloride Liposome
  - Esketamine
  - Estazolam
  - Ethchlorvynol
  - Etonogestrel
  - Flunitrazepam
  - Flurazepam
  - Halazepam
  - Imatinib
  - Iobenguane I 131
  - Isoniazid
  - Ketazolam
  - Lorazepam
  - Lormetazepam
  - Medazepam
  - Mephenesin
  - Mephobarbital
  - Meprobamate
  - Metaxalone
  - Methocarbamol
  - Methohexital
  - Midazolam
  - Nifedipine
  - Nitrazepam
  - Oxazepam
  - Peginterferon Alfa-2b
  - Pentobarbital
  - Phenindione
  - Phenobarbital
  - Phenprocoumon
  - Piperaquine
  - Pixantrone
  - Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate
  - Prazepam
  - Primidone
  - Quazepam
  - Secobarbital
  - Sodium Oxybate
  - Temazepam
  - Thiopental
  - Trazodone
  - Triazolam
  - Ulipristal

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

- - Acenocoumarol
  - Cannabis
  - Carbamazepine
  - Fosphenytoin
  - Lixisenatide
  - Ospemifene
  - Phenytoin
  - Prednisone
  - Warfarin
  - Zidovudine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

- - Ethanol
  - Tobacco

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

- - Cabbage
  - Ethanol

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.

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