Pronunciation:

bue-TAL-bi-tal, a-seet-a-MIN-oh-fen, KAF-een

Brand Names:

• Anolor 300
• Dolgic LQ
• Esgic
• Esgic-Plus
• Ezol
• Fioricet
• Geone
• Margesic
• Medigesic
• Nonbac
• Pacaps
• Repan

Dosage Forms:

• Tablet
• Capsule
• Solution

Warnings:

Liver failure, sometimes associated with liver transplant or fatalities, has occurred with acetaminophen use. These cases of liver injury were often associated with the use of more than 1 acetaminophen-based product and with total daily acetaminophen doses exceeding 4000 mg .

Classifications:

Therapeutic—

Butalbital/Acetaminophen Combination

Pharmacologic—

Barbiturate

Chemical—

Methylxanthine

Uses of This Medicine:

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.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

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.

Children—

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.

Older adults—

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.

Breast-feeding—

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.

Other medicines—

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
• Viloxazine

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
• Barbital
• Butabarbital
• Calcium Oxybate
• Capmatinib
• Carisoprodol
• Chloral Hydrate
• Chlordiazepoxide
• Chlorzoxazone
• Clarithromycin
• Clonazepam
• Clorazepate
• Dantrolene
• Darunavir
• Diazepam
• Dicumarol
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Drospirenone
• Esketamine
• Estazolam
• Eterobarb
• Ethchlorvynol
• Ethinyl Estradiol
• Etonogestrel
• Flunitrazepam
• Flurazepam
• Givosiran
• Halazepam
• Heptabarbital
• Hexobarbital
• Imatinib
• Iobenguane I 131
• Isocarboxazid
• Isoniazid
• Ketazolam
• Linezolid
• Lorazepam
• Lormetazepam
• Magnesium Oxybate
• Medazepam
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methocarbamol
• Methohexital
• Methylene Blue
• Midazolam
• Nifedipine
• Nitrazepam
• Norethindrone
• Norgestimate
• Norgestrel
• Oxazepam
• Ozanimod
• Peginterferon Alfa-2b
• Pentobarbital
• Phenelzine
• Phenindione
• Phenobarbital
• Phenprocoumon
• Piperaquine
• Pixantrone
• Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate
• Potassium Oxybate
• Prazepam
• Primidone
• Procarbazine
• Quazepam
• Rasagiline
• Ritlecitinib
• Safinamide
• Secobarbital
• Selegiline
• Sodium Oxybate
• Temazepam
• Thiopental
• Tocilizumab
• Tranylcypromine
• Trazodone
• Triazolam
• Ulipristal
• Zotepine

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
• Carbamazepine
• Fosphenytoin
• Lixisenatide
• Ospemifene
• Phenytoin
• Prednisone
• St John's Wort
• 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

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or
• Drug dependence, or history of or
• Weakened physical condition—Use with caution. May increase risk for more serious side effects.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Porphyria (an enzyme problem)—Should not be used in patients with this condition.

• Stomach problems—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken for a long time, it may become habit-forming and cause mental or physical dependence. Also, large amounts of acetaminophen may cause liver damage if taken for a long time.

Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).

Dosing—

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.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you or your child are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine may be habit-forming. If you or your child feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may make you dizzy or drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.

Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Lightheadedness

shortness of breath

Incidence not known

Abdominal or stomach pain

black, tarry stools

bleeding gums

blistering, peeling, or loosening of the skin

blood in the urine or stools

blurred vision

change in the frequency of urination or amount of urine

chills

cough

diarrhea

difficulty with breathing

difficulty with swallowing

dizziness

drowsiness

dry mouth

fainting

fast, pounding, or irregular heartbeat or pulse

flushed or dry skin

fruit-like breath odor

hives, itching, or skin rash

increased hunger

increased thirst

increased urination

joint or muscle pain

loss of appetite

nausea or vomiting

pinpoint red spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

red, irritated eyes

seizures

shakiness in the legs, arms, hands, or feet

sore throat

sores, ulcers, or white spots in the mouth or on the lips

sweating

swelling of the feet or lower legs

tightness in the chest

trembling or shaking of the hands or feet

troubled breathing

unexplained weight loss

unusual bleeding or bruising

unusual tiredness or weakness

weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Confusion as to time, place, or person

dark urine

difficult or painful urination

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fever

general feeling of discomfort or illness

hallucinations

headache

holding false beliefs that cannot be changed by fact

increased sweating

irregular, fast or slow, or shallow breathing

light-colored stools

loss of appetite

pale or blue lips, fingernails, or skin

restlessness

sudden decrease in the amount of urine

sweating

trouble sleeping

unpleasant breath odor

unusual excitement, nervousness, or restlessness

vomiting of blood

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Relaxed and calm

sleepiness

Incidence not known

Anxiety

bloated

constipation

continuing ringing or buzzing or other unexplained noise in the ears

depression

earache

excess air or gas in the stomach or intestines

false or unusual sense of well-being

full feeling

hearing loss

heartburn

heavy eyelids

high energy

hot spells

hyperventilation

irritability

numbness

pain in the leg

passing gas

sluggishness

stuffy nose

tingling sensation

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.