Acetaminophen, butalbital, and caffeine

Name: Acetaminophen, butalbital, and caffeine

Do I need a prescription for narcotic analgesic-apap-caffeine-butalbital-oral?

Yes

From

Migraines and Headaches Resources
  • What's Triggering Your Migraines?
  • Personalized Tips for Managing Migraine
  • A Visual Guide to Migraines
Featured Centers
  • 13 Best Quit-Smoking Tips Ever
  • What Stress Does to Your Mouth
  • Healthy Home: To Buy or Not to Buy Organic?
Health Solutions From Our Sponsors
  • Frequent Constipation?
  • Greater Food Accessibility
Reviewed on 6/23/2014 References REFERENCES:

MedlinePlus. Acetaminophen, Butalbital, and Caffeine.

Medscape. butalbital/acetaminophen/caffeine (Rx).

How should I take acetaminophen, butalbital, and caffeine?

Follow all directions on your prescription label. Do not take more of this medication than recommended. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Butalbital may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Take the medicine with food or milk if it upsets your stomach.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Butalbital is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What should I avoid while taking acetaminophen, butalbital, and caffeine?

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.

Acetaminophen, butalbital, and caffeine side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using this medicine and call your doctor at once if you have:

  • confusion, seizure (convulsions);

  • shortness of breath;

  • a light-headed feeling, like you might pass out; or

  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • drowsiness, dizziness;

  • feeling anxious or restless;

  • drunk feeling; or

  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For the Consumer

Applies to acetaminophen / butalbital / caffeine: oral capsule, oral solution, oral tablet

Along with its needed effects, acetaminophen / butalbital / caffeine 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 while taking acetaminophen / butalbital / caffeine:

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 while taking acetaminophen / butalbital / caffeine:

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 of acetaminophen / butalbital / caffeine 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

Upsides

  • Effective for the short-term treatment of episodic tension-type headaches.

Bottom Line

Acetaminophen/butalbital/caffeine is an effective pain reliever for the short-term treatment of tension-type headaches. However, it is sedating and potentially habit forming and should not be used repeatedly. Simpler and safer analgesics or analgesic combinations are preferred.

Response and Effectiveness

  • The pain-relieving effects of acetaminophen are reached within 30-60 minutes of administration.
  • Butalbital is well absorbed from the gastrointestinal tract and produces a muscle relaxing effect and sedation within one to two hours. Butalbital is metabolized in the liver by the CYP450 enzyme system which means it has the potential to interact with a large number of other drugs. Butalbital has an average half-life of around 35 hours, which means it lasts for a long time in the body and repeated doses may have a cumulative effect, increasing the risk of side effects.
  • Caffeine is metabolized in the liver to other active substances, and has a short half-life (3 to 7 hours).

View as a slideshow

Acetaminophen / butalbital / caffeine Pregnancy Warnings

Use is not recommended unless clearly needed US FDA pregnancy category: C Comment: Monitor for barbiturate withdrawal in neonates

Animal reproduction studies have not been conducted on this combination product. Epidemiologic data for acetaminophen, including a population based case-control study from the National Birth Defects Prevention Study (n= 11,610) and data from 26,424 live singleton births have shown no increased risk of major birth defects in children with first trimester prenatal exposure. In 2015, the US Food and Drug Administration released results of their evaluation on published research studies looking at mothers who took acetaminophen (either over the counter or as a prescription product) at any time during their pregnancy and the risk of attention deficit hyperactivity (ADHD) in their babies. They found all studies reviewed had potential limitations in their designs that prevented drawing reliable conclusions. Barbiturates have been reported to readily cross the placental barrier. A 2-day old infant whose mother had taken a butalbital-containing product during the last two months of pregnancy experienced withdrawal seizures; butalbital was found in the infant's serum. There are no controlled data in human pregnancy. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

(web3)