Zebutal

Acetaminophen + butalbital + caffeine

CMI, dosage, igredients, description, price, photo

What is Zebutal?

Acetaminophen is a pain reliever and fever reducer.

Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache.

Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

Acetaminophen, butalbital, and caffeine is a combination medicine used to treat tension headaches that are caused by muscle contractions.

Acetaminophen, butalbital, and caffeine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Zebutal?

You should not use this medicine if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

In rare cases, acetaminophen may cause a severe skin 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.

What should I discuss with my healthcare provider before taking Zebutal?

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

You should not use acetaminophen, butalbital, and caffeine if you are allergic to it, if you have porphyria, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

To make sure acetaminophen, butalbital, and caffeine is safe for you, tell your doctor if you have:

  • liver disease, cirrhosis, a history of alcoholism or drug addiction, or if you drink more than 3 alcoholic beverages per day;

  • kidney disease;

  • asthma, sleep apnea, or other breathing disorder;

  • stomach ulcer or bleeding;

  • a history of skin rash caused by any medication;

  • a history of mental illness or suicidal thoughts; or

  • if you use medicine to prevent blood clots.

It is not known whether this medicine will harm an unborn baby. If you use butalbital while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

This medicine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take Zebutal?

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 happens if I miss a dose of Zebutal?

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose Zebutal?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen, butalbital, and caffeine can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include insomnia, restlessness, tremor, diarrhea, increased shallow breathing, uneven heartbeats, seizure (convulsions), or fainting.

What should I avoid while taking Zebutal?

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.

Zebutal 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.

 

What other drugs will affect Zebutal?

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking acetaminophen, butalbital, and caffeine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with acetaminophen, butalbital, and caffeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Zebutal side effects

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

As well as its needed effects, acetaminophen / butalbital / caffeine may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking acetaminophen / butalbital / caffeine, check with your doctor immediately:

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

If any of the following symptoms of overdose occur while taking acetaminophen / butalbital / caffeine, get emergency help immediately:

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 acetaminophen / butalbital / caffeine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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

Dosage of Zebutal

One or two capsules every four hours. Total daily dosage should not exceed 6 capsules.

Extended and repeated use of this product is not recommended because of the potential for physical dependence.

Zebutal pregnancy warnings

Acetaminophen-butalbital-caffeine has been assigned to pregnancy category C by the FDA. Animal reproduction studies have not been conducted on this combination product. There are no controlled data in human pregnancy. Acetaminophen-butalbital-caffeine is only recommended for use during pregnancy when benefit outweighs risk.

Note: This information may not be actual at the time of reading. Always look for actual instructions in the package with the medication.
It is forbidden to use these materials without the advice of healthcare professional.

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