Acetaminophen and butalbital

Name: Acetaminophen and butalbital

What happens if I miss a dose?

Since this medicine is used for pain, you are not likely to miss a dose. Skip any 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?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen and butalbital 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 extreme drowsiness, confusion, fainting, shallow breathing, or no breathing.

What should I avoid while taking acetaminophen and butalbital?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

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.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Dose Adjustments

Use with caution

Precautions

US BOXED WARNING: Hepatotoxicity
-Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most cases of liver injury are associated with acetaminophen use at doses that exceed 4000 mg per day, and often involve more than 1 acetaminophen-containing product.

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Upsides

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

Downsides

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

  • Dizziness, drowsiness, lightheadedness, sedation, shortness of breath, nausea, vomiting, abdominal pain, or an intoxicated feeling are the most commonly reported side effects.
  • Other side effects, such as constipation, excessive sweating, itch, and mental confusion and uncommon.
  • Butalbital is habit-forming and there is a high risk of dependence with extended and repeated use of butalbital/acetaminophen.
  • May cause medication-overuse headache with repeated use and a withdrawal syndrome on discontinuation.
  • The potential for liver damage with the acetaminophen component exists, even at recommended dosages. The risk is increased with higher dosages, with chronic alcohol use, with some medications, and in patients with significant liver disease.
  • May not be suitable for some people, including the elderly and people with kidney or liver disease.
  • Although butalbital/acetaminophen may be prescribed for migraine headaches, it is not FDA approved for this use and evidence does not support its use for migraine.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.

Acetaminophen / butalbital 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 studies with this combination product in pregnant patients. 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.

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