Acetaminophen and butalbital

Follow all directions on your prescription label. Do not take more than your recommended dose. An acetaminophen 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.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using acetaminophen and butalbital.

If you need surgery, tell the surgeon ahead of time that you are using this medicine. You may need to stop using the medicine for a short time.

Do not stop using acetaminophen and butalbital suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

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.

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

Other drugs may interact with acetaminophen and butalbital, 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.

Applies to acetaminophen / butalbital: oral capsule, oral tablet

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling sleepy.
• Belly pain.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to acetaminophen / butalbital: oral capsule, oral tablet

General

The most frequently reported adverse events have included drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.[Ref]

Hepatic

Acetaminophen:
Frequency not reported: Liver failure[Ref]

Acute liver failure has been reported with acetaminophen use; many case have been associated with use at doses in excess of 4 g/day, and often involving more than 1 acetaminophen-containing product.[Ref]

Hypersensitivity

Butalbital-Acetaminophen:
Uncommon (0.1% to 1%): Allergic reactions
Postmarketing reports: Anaphylaxis

Acetaminophen:
Postmarketing reports: Anaphylaxis[Ref]

Dermatologic

Butalbital-Acetaminophen:
Uncommon (0.1% to 1%): Hyperhidrosis, pruritus
Frequency not reported: Toxic epidermal necrolysis, erythema multiforme

Acetaminophen:
Rare (less than 0.1%): Serious skin reactions such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis
Frequency not reported: Rash[Ref]

Several cases of dermatologic reactions including toxic epidermal necrolysis and erythema multiforme have been reported.[Ref]

Psychiatric

Uncommon (0.1% to 1%): Agitation, euphoria[Ref]

Nervous system

Common (1% to 10%): Drowsiness, lightheadedness, dizziness, sedation
Uncommon (0.1% to 1%): Headache, shaky feeling, tingly, fainting, numbness, seizures, mental confusion, excitement or depression due to intolerance[Ref]

Respiratory

Common (1% to 10%): Shortness of breath
Uncommon (0.1% to 1%): Nasal congestion[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting, abdominal pain
Uncommon (0.1% to 1%): Dry mouth, difficulty swallowing, heartburn, flatulence, constipation[Ref]

Hematologic

Acetaminophen:
Frequency not reported: Thrombocytopenia, agranulocytosis[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Tachycardia[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Leg pain, muscle fatigue[Ref]

Other

Common (1% to 10%): Intoxicated feeling
Uncommon (0.1% to 1%): Fatigue, high energy, heavy eyelids, sluggishness, hot spells, fever, earache, tinnitus[Ref]

Renal

Uncommon (0.1% to 1%): Diuresis,[Ref]

Some side effects of acetaminophen / butalbital may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Butalbital 50 mg/acetaminophen 300 or 325 mg:
1 or 2 tablets orally every 4 hours as needed not to exceed 6 tablets per day

Butalbital 25 mg/acetaminophen 325 mg:
2 tablets orally every 4 hours as needed not to exceed 12 tablets per day

Comments:
-Due to high rate of physical dependence, the extended use of this drug is not recommended.
-The safety and efficacy of treating multiple recurrent headaches with this product is not known.

Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.

Butalbital/acetaminophen is a combination tablet containing two different ingredients: butalbital and acetaminophen.

Butalbital belongs to the class of medicines called barbiturates. When used for tension headaches it relaxes muscle contractions and causes 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.

Both acetaminophen and butalbital are excreted into human milk in small concentrations. The significance of the effects on nursing infants has not been reported, but due to the potential for serious adverse reactions in nursing infants, other agents may be preferred.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes (barbiturates); Yes (acetaminophen)