Ezol (Oral)

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

Butalbital is part of a group of medicines known as barbiturates. Barbiturates work in the central nervous system (CNS) to produce their effects.

Acetaminophen helps relieve pain and lower fever in patients. It does not cause dependence when taken for a long time. However, taking large doses of acetaminophen may lead to unwanted effects, including liver damage.

Using butalbital for a long time may lead to dependence, causing mental or physical reliance on the medication. However, people with ongoing pain should not avoid using narcotics for relief due to fear of dependence. Physical dependence may cause withdrawal side effects if treatment is stopped suddenly. Severe withdrawal side effects can usually be avoided by gradually lowering the dose over time before stopping completely.

Caffeine is a CNS stimulant used with pain relievers to enhance their effects. It has also been used for migraine headaches. However, caffeine can also lead to physical dependence when used for a long time, which may result in withdrawal (rebound) headaches when you stop taking it.

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

It is very important for your doctor to monitor your progress while you or your child are taking this medicine. This will help your doctor determine if the medicine is effective and if you should keep using it.

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

Contact your doctor immediately if you or your child experience pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellowing of the eyes or skin. These could be signs of a serious liver issue.

Serious skin reactions can happen with this medicine. Immediately inform your doctor 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 using this medicine.

This medicine can cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and needs urgent medical help. Call your doctor right away if you or your child experience a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling in your hands, face, or mouth while using this medicine.

This medicine may cause dizziness or drowsiness. Be aware of how you respond to this medicine before driving, operating machinery, or doing anything else that could be dangerous if you feel dizzy or are not alert.

This medicine will increase the effects of alcohol and other CNS depressants (medicines that can cause drowsiness or decreased alertness). Examples of CNS depressants include antihistamines or medications for allergies or colds, sedatives, tranquilizers, sleeping medicines, other prescription pain medicines or narcotics, medications for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Additionally, drinking three or more alcoholic beverages while taking acetaminophen may increase the risk of liver damage. Do not consume alcoholic beverages, and consult your doctor before taking any of these medicines while using this medicine.

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

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

In deciding to use a medicine, you and your doctor will need to consider the risks and benefits. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have allergies to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

There have been no appropriate studies on how butalbital, acetaminophen, and caffeine combination affects children younger than 12 years. Its safety and effectiveness in this age group have not been established.

Geriatric

So far, studies have not shown any age-related issues that would limit the use of butalbital, acetaminophen, and caffeine combination in older adults. However, older patients may have kidney problems related to aging, which could require caution and possibly a dose adjustment.

Breast Feeding

There are no sufficient studies in women to determine any risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be taken together, while others may be used together, even if interactions could happen. If you are taking this medicine, it is very important for your healthcare professional to know if you are using any of the medicines listed below. The interactions listed here are significant but not 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 necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use for one or both 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 increase the risk of certain side effects, but taking both may be necessary for your treatment. If both are prescribed together, your doctor may change the dose or frequency of use for one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around meal times or with certain foods because interactions may happen. Using alcohol or tobacco with some medicines may also lead to interactions. The following interactions have been selected based on their potential significance and are not 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 adjust the dose or frequency of use for this medicine, or provide special instructions regarding food, alcohol, or tobacco.

• Ethanol
• Tobacco

Using this medicine with any of the following may increase the risk of certain side effects, but this may be unavoidable in some cases. If used together, your doctor may adjust the dose or frequency of use for this medicine, or provide special instructions regarding food, alcohol, or tobacco.

• Cabbage

Other Medical Problems

Other medical issues may affect how this medicine works. Be sure to inform your doctor if you have any other medical conditions, especially:

• History of alcohol abuse
• History of drug dependence
• 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 stronger because the body may take longer to remove the medicine.

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

• Stomach problems—Use with caution. May worsen these conditions.

Along with its necessary effects, a medicine can cause some unwanted effects. Although not all of these side effects may happen, if they do occur, they may require 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 inform 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.

In the U.S.

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

Available Dosage Forms:

• Tablet
• Capsule
• Solution

Therapeutic Class: Butalbital/Acetaminophen Combination

Pharmacologic Class: Barbiturate

Chemical Class: Methylxanthine

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.