Medigesic (Oral)

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

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

Acetaminophen is used to relieve pain and lower fever in patients. It does not become habit-forming when taken for a long time. However, taking large doses of acetaminophen may cause other unwanted effects, including liver damage.

When butalbital is used for a long time, it may become habit-forming, leading to mental or physical dependence. However, people who have ongoing pain should not let the fear of dependence stop them from using narcotics to relieve their pain. Physical dependence may result in withdrawal side effects if treatment is stopped suddenly. Nevertheless, severe withdrawal side effects can usually be avoided by gradually reducing the dose over time before stopping treatment completely.

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

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

It is very important for your doctor to monitor your progress while you or your child are taking this medicine. This helps 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. Contact 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 may be signs of a serious liver issue.

Serious skin reactions can happen with this medicine. Contact your doctor immediately if you have blistering, peeling, or loose skin, red skin lesions, severe acne or rash, sores or ulcers on the skin, or fever or chills while using this medicine.

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

This medicine may make you dizzy or drowsy. Make sure you know how this medicine affects you before driving, operating machinery, or doing anything else that could be dangerous if you are dizzy or not alert.

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

Before any medical tests, inform the medical professional 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 medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, it's important to consider the risks against the benefits. This is a decision you and your doctor will make together. For this medicine, please consider the following:

Allergies

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

Pediatric

There have not been appropriate studies on how butalbital, acetaminophen, and caffeine combination affects children younger than 12 years. Safety and effectiveness have not been established.

Geriatric

So far, studies have not shown specific problems in elderly patients that would limit the usefulness of butalbital, acetaminophen, and caffeine combination. However, older adults are more likely to have age-related kidney issues, which may require caution and a dose adjustment for those taking butalbital, acetaminophen, and caffeine combination.

Breast Feeding

There are no adequate studies on women to determine the risk to infants using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction is possible. In these situations, your doctor may want to adjust the dose or take other precautions. It's especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on their potential significance and are not necessarily a complete list.

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 cases. If both medicines are prescribed together, your doctor may change the dose or frequency of 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 using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or frequency of 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 the time of eating certain foods, as interactions may occur. Using alcohol or tobacco with some medicines may also cause interactions. The following interactions are based on their potential significance and are not necessarily a complete list.

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 frequency of 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 may be unavoidable in some cases. If used together, your doctor may change the dose or frequency of this medicine, or provide special instructions regarding food, alcohol, or tobacco.

• Cabbage

Other Medical Problems

Other medical problems may affect how this medicine works. Be sure to tell your doctor about any other medical issues you have, 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 stronger because the medicine is removed from the body more slowly.

• 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 may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away 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 overdose symptoms 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. Your health care professional may also 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.

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.