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Acetaminophen/butalbital Patient Tips

Written by C. Fookes, BPharm on Mar 1, 2017.

How it works

  • Butalbital/acetaminophen is a combination pain-reliever (analgesic) containing butalbital and acetaminophen.
  • Butalbital belongs to the class of medicines called barbiturates. When used for pain due to tension headaches experts believe it works by relaxing muscle contractions and causing sedation via an enhancement of the inhibitory effects of GABA (a neurotransmitter that regulates communication between brain cells).
  • Experts aren't sure exactly how acetaminophen works, but suspect it blocks a specific type of cyclo-oxygenase (COX) enzyme, located mainly in the brain.
  • Butalbital/acetaminophen belongs to the class of medicines known as barbiturates because it contains butalbital. It may also be called a combination analgesic.

Upsides

  • May be used short-term to relieve episodic tension-type headaches.
  • Generic butalbital/acetaminophen is available.

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 are less common.
  • Butalbital is habit-forming and there is a high risk of dependence with extended and repeated use of butalbital/acetaminophen. Therefore it is not considered a first-choice medicine for headaches.
  • May cause medication-overuse headache with repeated use and a withdrawal syndrome upon 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 a migraine.
  • Should not be used during pregnancy or breastfeeding.
  • May interact with a number of other medications including those that also cause sedation such as opioids, benzodiazepines, and sedating antihistamines. Alcohol should be avoided.

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.

Bottom Line

Butalbital/acetaminophen may be used for the short-term treatment of tension-type headaches; however, it is not a first-choice medicine because it is potentially habit-forming and causes sedation. Simpler and safer analgesics or analgesic combinations should be tried first.

Tips

  • May be administered without regards to food; although food may decrease any reported stomach upset.
  • Do not overuse butalbital/acetaminophen because you may become addicted to it and have difficulty stopping it.
  • Over-use of butalbital/acetaminophen can also result in a medication-overuse headache (also known as a rebound headache) which occurs when analgesics are taken too frequently to relieve a headache. Only use butalbital/acetaminophen at the minimum effective dose and for s short period of time.
  • Never share your butalbital/acetaminophen with anybody else.
  • If you have been taking butalbital/acetaminophen regularly, or if you think you have become addicted to it, talk to your doctor about slowly withdrawing it, as sudden withdrawal may precipitate a withdrawal syndrome (symptoms include anxiety, dizziness, hallucinations, muscle twitching, nausea, seizures, sleeplessness, or tremor).
  • Butalbital/acetaminophen can cause sedation and affect your ability to drive or operate machinery.
  • Do not drink more than two alcoholic drinks a day if you are a man or one alcoholic drink per day if you are women and taking butalbital/acetaminophen.
  • Talk to your doctor or pharmacist before taking any other medications including those bought over-the-counter because they may not be compatible with butalbital/acetaminophen.
  • Talk to your doctor if you have any side effects of concern. Seek urgent medical advice if you develop an allergic-type reaction (difficulty breathing or swallowing, rash, or facial swelling) soon after taking butalbital/acetaminophen.
  • Not recommended for women who are pregnant or breastfeeding.
  • Butalbital/acetaminophen contains acetaminophen which may be "hidden" in other cough/cold medicines. The total dose of acetaminophen from any source should not exceed 4000mg per day (24 hours).

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 an analgesic effect 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.

References

Butalbital and Acetaminophen [Package Insert]. Revised 06/2017. Alvogen Inc. https://www.drugs.com/pro/butalbital-and-acetaminophen.html

  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use acetaminophen/butalbital only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that this information is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This drug information does not endorse drugs, diagnose patients or recommend therapy. It is an informational resource designed as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of this information. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2017 Drugs.com. Revision Date: 2017-11-13 20:41:59

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