Butalbital/Acetaminophen/CaffeineButalbital, Acetaminophen and Caffeine

About Butalbital/Acetaminophen/Caffeine

The combination joins butalbital, a short to intermediate-acting barbiturate, with acetaminophen, a pain and fever reliever, and caffeine, a stimulant; how each part contributes is not fully understood. The label approves it for the symptoms of tension (or muscle contraction) headache and says evidence for its safety and effectiveness in multiple recurrent headaches is unavailable. The dose is one or two tablets or capsules every 4 hours as needed, no more than six a day, or 15 or 30 mL of the oral solution every 4 hours, no more than 90 mL a day. Safety and effectiveness below age 12 have not been established; older adults usually start at the low end of the dose range, and because butalbital is cleared largely by the kidneys, poor kidney function may raise the risk of toxic reactions.

The boxed warning says acetaminophen has been associated with cases of acute liver failure, at times leading to a liver transplant or death, mostly at more than 4,000 mg a day and often when more than one acetaminophen product was taken, and the warnings add that the risk is high with liver disease or with drinking alcohol. Rare but serious skin reactions (AGEP, Stevens-Johnson syndrome and toxic epidermal necrolysis) and severe allergic reactions mean stopping it at the first rash or other sign of allergy, and getting medical care right away for swelling or trouble breathing. It is not taken by people with porphyria or an allergy or intolerance to any ingredient. Drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain and an intoxicated feeling are the most common side effects, and it can impair driving.

Butalbital can be habit-forming: tolerance and physical dependence can develop, so the label advises against extended and repeated use, and in someone who has become dependent, stopping suddenly can bring on withdrawal with seizures and delirium, so the drug is withdrawn gradually. Federal status depends on the exact product. The DEA’s table of exempted prescription products lists Fioricet and many generic tablets, capsules and oral solutions, which are exempt, for administrative purposes, from federal controlled-substance requirements that include the prescription rules; the Fioricet label lists no DEA schedule. Butalbital products not on that table are Schedule III, and some generic capsules and oral solutions are listed as CIII; a Schedule III prescription can carry up to five refills within six months of the date written. A newborn whose mother took a butalbital product late in pregnancy had withdrawal seizures. Butalbital products with aspirin or with codeine are different medicines with their own rules.

Taking Butalbital/Acetaminophen/Caffeine

How to take it

One or two tablets or capsules every 4 hours as needed, no more than six in a day; the oral solution is 15 or 30 mL every 4 hours, no more than 90 mL a day, measured with a dosing cup or spoon made for medicine, not a household spoon. Follow the prescription label, and do not take more than prescribed.

If you miss a dose

It is usually taken only as needed. If your prescriber has you take it on a schedule, take a missed dose when you remember unless the next is almost due, and never take extra to catch up.

Storage

In the original container, tightly closed, at room temperature away from excess heat and moisture (not in the bathroom), out of reach of children. Do not flush unused medicine; use a medicine take-back program.

Interactions to know about

Check other medicine labels for acetaminophen or APAP, and do not use more than one product that contains acetaminophen. Alcohol adds to the liver risk, and alcohol, opioids, sleep medicines, tranquilizers and other sedatives add to its depressant effect on the nervous system; MAO inhibitors can strengthen the effects of butalbital.

This summarizes the official prescribing information. Your prescriber’s and pharmacist’s instructions, and the leaflet that comes with your medicine, take priority.

Why the cash price for Butalbital/Acetaminophen/Caffeine differs from pharmacy to pharmacy

Generic tablets and capsules have many makers and cost pharmacies little, so quotes differ mainly by markup and dispensing fee, and because it is taken only as needed, fills are often small and the fee is a large share of the price. A prescription that names Fioricet and blocks substitution is priced as a brand, and the oral solution, with few makers, may have to be ordered.

Schedule III versions fall under federal limits on refills and refill transfers, while exempt versions do not, so it is worth asking which version a pharmacy stocks before the first fill.

Ways to pay less for Butalbital/Acetaminophen/Caffeine without insurance

• Ask for a generic, and make sure the prescription allows substitution rather than naming Fioricet only.
• Ask whether the tablets or capsules are on the pharmacy’s flat-price generic list, and compare more than one pharmacy.
• If the oral solution is prescribed, ask the prescriber whether tablets or capsules would suit you.
• Ask which version the pharmacy stocks and whether it is handled as a controlled substance in your state, since that affects refills and transfers.
• Upload the prescription to Script Unlock so licensed pharmacies can quote their cash price. You pay the pharmacy directly.

Questions to ask your pharmacist about Butalbital/Acetaminophen/Caffeine

1. 1.How much acetaminophen am I taking a day at this dose?
2. 2.Which of my other medicines contain acetaminophen or APAP?
3. 3.Is the version you stock handled as a controlled substance here, and how many refills can I have?
4. 4.How often can I take it without risking dependence?

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