What is Butalbital APAP Caffeine ?

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.

This product is available in the following dosage forms:

      • Tablet
      • Capsule
      • Solution

This combination medication is used to treat tension headaches. Aspirin helps to decrease the pain from the headache. Caffeine helps increase the effects of aspirin. Butalbital is a sedative that helps to decrease anxiety and cause sleepiness and relaxation.

How to use Butalbital-APAP-Caffeine 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 (8 ounces or 240 milliliters) 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 (such as nausea/vomiting, mental/mood changes, seizures). 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 (such as overuse of or addiction to drugs/alcohol). 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.

Side Effects of Butalbital APAP Caffeine

Nausea, vomiting, stomach upset, gas, shaking (tremor), lightheadedness, dizziness, or drowsiness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood changes, fainting, fast/irregular heartbeat, increased thirst/urination, hearing changes (e.g., ringing in the ears), easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat), heartburn, discomfort when swallowing, dark urine, yellowing eyes/skin, signs of kidney problems (such as change in the amount of urine), unusual tiredness.

Seek immediate medical attention if any of these rare but very serious side effects occur: black stools, severe stomach/abdominal pain, vomit that looks like coffee grounds, trouble speaking, weakness on one side of the body.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions of Butalbital APAP Caffeine

Before taking this medication, tell your doctor or pharmacist if you are allergic to aspirin, caffeine, or butalbital; or to other barbiturates (e.g., phenobarbital), salicylates (e.g., salsalate), nonsteroidal anti-inflammatory drugs (e.g., ibuprofen), or xanthine derivatives (e.g., theophylline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., bronchopneumonia), a certain enzyme disorder (porphyria), aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), severe stomach/bowel problems (e.g., stomach/intestinal ulcers), bleeding/blood clotting disorders (e.g., hemophilia, von Willebrand’s disease, thrombocytopenia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, asthma, heartburn, gout, growths in the nose (nasal polyps), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), certain enzyme deficiencies (pyruvate kinase or G6-PD deficiency), mental/mood disorders, heart disease (e.g., irregular heartbeat, recent heart attack).

Before having surgery or certain medical procedures (such as a heart stress test or a procedure to restore a normal heart rhythm if you have an unusually fast heartbeat), tell your doctor or dentist that you use this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

This medication contains aspirin. Children and teenagers less than 18 years old should not take aspirin if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine, without first consulting a doctor about Reye’s syndrome, a rare but serious illness.

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, stomach/intestinal bleeding and ulcers, and trouble falling asleep. Drowsiness and trouble falling asleep can increase the risk of falling.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks. Tell your doctor if you are pregnant or if you plan to become pregnant. This medication may harm an unborn baby and cause problems with normal labor/delivery. It is not recommended for use in pregnancy from 20 weeks until delivery. If your doctor decides that you need to use this medication between 20 and 30 weeks of pregnancy, you should use the lowest effective dose for the shortest possible time. You should not use this medication after 30 weeks of pregnancy.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Leave a Reply