Butalbital and acetaminophen (byoo-TAL-bi-tal and a-seat-a-MIN-oh-fen) combination is a pain reliever and relaxant. It is used to treat tension headaches. Butalbital belongs to the group of medicines called barbiturates (bar-BI-tyoo-rates) . Barbiturates act in the central nervous system (CNS) to produce their effects.

When you take butalbital for a long time, your body may get used to it so that larger amounts are needed to produce the same effects. This is called tolerance to the medicine. Also, butalbital may become habit-forming (causing mental or physical dependence) when it is used for a long time or in large doses. Physical dependence may lead to withdrawal side effects when you stop taking the medicine. In patients who get headaches, the first symptom of withdrawal may be new (rebound) headaches.

Some butalbital and acetaminophen combinations also contain caffeine (KAF-een) . Caffeine may help to relieve headaches. However, caffeine can also cause physical dependence when it is used for a long time. This may lead to withdrawal (rebound) headaches when you stop taking it.

Butalbital and acetaminophen combination may also be used for other kinds of headaches or other kinds of pain as determined by your doctor.

Butalbital and acetaminophen combinations are available only with your doctor's prescription in the following dosage forms:

Oral
• Butalbital and Acetaminophen
  • Capsules (U.S.)
  • Tablets (U.S.)
• Butalbital, Acetaminophen, and Caffeine
  • Capsules (U.S.)
  • Tablets (U.S.)

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If butalbital and acetaminophen combination is taken regularly (for example, every day), it may become habit-forming (causing mental or physical dependence). The caffeine in some butalbital and acetaminophen combinations can also increase the chance of dependence. Dependence is especially likely to occur in patients who take these medicines to relieve frequent headaches. Taking too much of this medicine may also lead to liver damage or other medical problems.

This medicine will relieve a headache best if you take it as soon as the headache begins. If you get warning signs of a migraine, take this medicine as soon as you are sure that the migraine is coming. This may even stop the headache pain from occurring. Lying down in a quiet, dark room for a while after taking the medicine also helps to relieve headaches.

People who get a lot of headaches may need to take a different medicine to help prevent headaches. It is important that you follow your doctor's directions about taking the other medicine, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve than before. This will reduce the amount of headache relievers that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.

Dosing—

The dose of butalbital and acetaminophen combination medicines will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules or tablets that you take depends on the strength of the medicine.

• For oral dosage forms (capsules or tablets):
  • For tension headaches:
    • Adults—One or 2 capsules or tablets every four hours as needed. If your medicine contains 325 or 500 milligrams (mg) of acetaminophen in each capsule or tablet, you should not take more than six capsules or tablets a day. If your medicine contains 650 mg of acetaminophen in each capsule or tablet, you should not take more than four capsules or tablets a day.
    • Children—Dose must be determined by your doctor.

Missed dose—

If your doctor has ordered you to take this medicine according to a regular schedule and you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children. Overdose is especially dangerous in young children.
• Store away from heat and direct light.
• Do not store this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Check with your doctor:

• If the medicine stops working as well as it did when you first started using it. This may mean that you are in danger of becoming dependent on the medicine. Do not try to get better pain relief by increasing the dose.
• If you are having headaches more often than you did before you started taking this medicine. This is especially important if a new headache occurs within 1 day after you took your last dose of this medicine, headaches begin to occur every day, or a headache continues for several days in a row. This may mean that you are dependent on the medicine. Continuing to take this medicine will cause even more headaches later on. Your doctor can give you advice on how to relieve the headaches.

Check the labels of all nonprescription (over-the-counter [OTC]) or prescription medicines you now take. If any contain a barbiturate or acetaminophen, check with your health care professional. Taking them together with this medicine may cause an overdose.

The butalbital in this medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine; narcotics; other barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Also, drinking large amounts of alcoholic beverages regularly while taking this medicine may increase the chance of liver damage, especially if you take more of this medicine than your doctor ordered or if you take it regularly for a long time. Therefore, do not drink alcoholic beverages, and check with your doctor before taking any of the medicines listed above, while you are using this medicine.

This medicine may cause some people to become drowsy, dizzy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded.

Before you have any medical tests, tell the person in charge that you are taking this medicine. Caffeine (present in some butalbital and acetaminophen combinations) interferes with the results of certain tests that use dipyridamole (e.g., Persantine) to help show how well blood is flowing to your heart. Caffeine should not be taken for 8 to 12 hours before the test. The results of other tests may also be affected by butalbital and acetaminophen combinations.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine. Serious side effects can occur if your medical doctor or dentist gives you certain medicines without knowing that you have taken butalbital.

If you have been taking large amounts of this medicine, or if you have been taking it regularly for several weeks or more, do not suddenly stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely in order to lessen the chance of withdrawal side effects.

If you think you or anyone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of this medicine or taking alcohol or CNS depressants with this medicine may lead to unconsciousness or possibly death. Signs of butalbital overdose include severe drowsiness, confusion, severe weakness, shortness of breath or unusually slow or troubled breathing, slurred speech, staggering, and unusually slow heartbeat. Signs of severe acetaminophen poisoning may not occur until 2 to 4 days after the overdose is taken, but treatment to prevent liver damage or death must be started within 24 hours or less after the overdose is taken.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur, especially if several of them occur together:

• Rare
  • Bleeding or crusting sores on lips;  chest pain;  fever with or without chills;  hive-like swellings (large) on eyelids, face, lips, and/or tongue ;  muscle cramps or pain;  red, thickened, or scaly skin;  shortness of breath, troubled breathing, tightness in chest, or wheezing;  skin rash, itching, or hives;  sores, ulcers, or white spots in mouth (painful);  sore throat 
  
  

• Symptoms of overdose
  • Anxiety, confusion, excitement, irritability, nervousness, restlessness, or trouble in sleeping (severe, especially with products containing caffeine) ;  convulsions (seizures) (for products containing caffeine);  diarrhea, especially if occurring together with increased sweating, loss of appetite, and stomach cramps or pain;  dizziness, lightheadedness, drowsiness, or weakness, (severe) ;  frequent urination (for products containing caffeine) ;  hallucinations (seeing, hearing, or feeling things that are not there);  increased sensitivity to touch or pain (for products containing caffeine);  muscle trembling or twitching (for products containing caffeine);  nausea or vomiting, sometimes with blood;  ringing or other sounds in ears (for products containing caffeine);  seeing flashes of ``zig-zag'' lights (for products containing caffeine);  shortness of breath or unusually slow or troubled breathing;  slow, fast, or irregular heartbeat;  slurred speech;  staggering;  swelling, pain, or tenderness in the upper abdomen or stomach area;  unusual movements of the eyes 
  
  

Also, check with your doctor as soon as possible if any of the following side effects occur:

• Less common
  • Confusion (mild);  mental depression ;  unusual excitement (mild) 
  
  

• Rare
  • Bloody or black, tarry stools;  bloody urine;  pinpoint red spots on skin;  swollen or painful glands;  unusual bleeding or bruising ;  unusual tiredness or weakness (mild) 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Bloated or ``gassy'' feeling;  dizziness or lightheadedness (mild);  drowsiness (mild);  nausea, vomiting, or stomach pain (occurring without other symptoms of overdose) 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Information
Butalbital (Fiorinal) has been around since the 1920's when someone put together aspirin, caffeine, and a short acting sedative, butalbital.  Butalbital is related to the longer acting phenobarbital.  These are reasonably good for migraine and tension headache, but can cause rebound headaches (when used daily) and they are habit forming.  10% of the world is at risk for becoming addicted because in those 10% of people they find that these meds relieve anxiety/depression, give them a 'high or euphoric' feeling for several hours, or give them more energy.  90% of people feel either tired or no beneficial psychic feelings, and only take these for the intended purpose, headaches.

These meds are relatively cheap and well tolerated.  They are not as effective for migraine as the newer triptans (Imitrex, Zomig) or Migranal nasal spray.  The generic of the butalbital meds notoriously does not seem to work quite as well;  we try and order the 'Creighton' generic, as I believe it is manufactured by the same house as the regular fiorinal.  Butalbital meds should not, in general (although there are certainly exceptions) be utilized for daily headaches;  limits need to be place on them.  While they are technically sedatives they can also, in addition to sedation, cause increased energy or even insomnia.

These meds come in a variety of forms, each designed for a different time and purpose;  if someone has very much stomach upset, we use the type without aspirin.... for those with insomnia and  a sensitivity to caffeine, the ones without caffeine are best.  Aspirin and caffeine enhance the efficacy of these meds, but there is a place for the ones without these ingredients.  Many patients have several types of the butalbital meds around, and utilize different ones in certain circumstances.

The following shows the differences in the makeup between similar variations of this medication:

Fiorinal= aspirin + caffeine + butalbital
Fioricet & Esgic= acetaminophen + caffeine + butalbital (Esgic Plus is the same, with a bit more acetaminophen)
Phrenilin= acetaminophen + butalbital (Phrenilin Forte just adds a bit more acetaminophen) 

While Fiorinal is more effective than the others, you can see that each has a role to play.  Unless overused, these are very useful meds, even in younger people and, in tiny doses (1/2 tablet) in children over age 9 or so; not as a first line choice in kids, but as a second line medication.

Fiorinal with codeine adds 30mg of codeine to Fiorinal;  Fioricet with codeine adds 30mg of codeine to the Fioricet.  These not only add effectiveness with the narcotic addition, but also all of the side effects of codeine.  These meds are, of course, more addicting because of the codeine.  Again, in judicious amounts they can be very beneficial.  And occasionally, as a last resort, we do tolerate these on a daily basis if people are dependent, NOT addicted (see previous section in What's New, October, on addiction vs. dependence).  As I tell doctors all the time in my lectures, if you give a patient 30 Fiorinal, and they call 3 days later and say "those were great, doc, can I have some more", you have a problem!

HOWEVER, despite the misconceptions, the overwhelming majority of people do NOT overuse these, or any, drugs.

A migraine is a very painful type of headache. People who get migraines often describe the pain as pulsing or throbbing in one area of the head. During migraines, people are very sensitive to light and sound. They may also become nauseated and vomit.

Migraine is three times more common in women than in men. Some people can tell when they are about to have a migraine because they see flashing lights or zigzag lines or they temporarily lose their vision.

Many things can trigger a migraine. These include

• Anxiety
• Stress
• Lack of food or sleep
• Exposure to light
• Hormonal changes (in women)

Doctors used to believe migraines were linked to the opening and narrowing of blood vessels in the head. Now they believe the cause is related to genes that control the activity of some brain cells. Medicines can help prevent migraine attacks or help relieve symptoms of attacks when they happen. For many people, treatments to relieve stress can also help.

What Kind of Research Is Being Done?

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is currently supporting a number of studies to better understand and treat back pain. Goals of current research include the following:

To compare the effectiveness of surgery versus nonsurgical treatment for low back pain. Although the percentage of people having spinal surgery in the United States has increased sharply over time, there is not much information on whether back surgery is better than nonoperative treatments. One study is comparing the most commonly used surgical treatments to the most commonly used nonoperative treatments for three common back problems: herniated discs of the lumbar spine, spinal stenosis, and spinal stenosis from spondylolisthesis. The study, being conducted at 12 medical centers, will follow patients for at least 24 months after treatment to determine the medical- and cost-effectiveness of treatments.

To identify the best treatments for certain low back pain patients. Just as certain treatments are effective for some back problems and not others, the same treatment may be effective for some people and not others – even if those people have the same medical problem. Researchers at several centers will study more than 3,000 patients who have one of three common causes of back pain – herniated discs, spinal stenosis, and spondylolisthesis – and who respond well to specific treatments. Extensive testing and surveys will allow doctors to identify the best treatments for these patients.

To test the effectiveness of lumbar fusion and other treatments for disc-derived pain. Discogenic pain is low back pain due to the wearing away of a disc between the vertebrae. While treatment for this condition is often lumbar spinal fusion, its effectiveness, as well as that of other treatments, has not been established. A new study will compare the results of spinal fusion with those of nonsurgical care for patients with similar disc degeneration. Researchers will also try to find out 1) what distinguishes people who choose surgery from those who do not; 2) the consequences of common complications of spinal fusion surgery and how often they occur; 3) what predicts a good response to surgical therapy but not to other treatments; and 4) what are the characteristics and outcomes of patients who have repeat back surgery for this condition.

To measure the frequency of complications in lumbar fusion surgery. Lumbar spinal fusion is a commonly performed procedure for several back problems, including disc degeneration, spondylolisthesis, spinal stenosis, and scoliosis, but the procedure can have complications. A new study will follow 1,000 people who have spinal fusion for one of these diagnoses to find out 1) how often complications occur after surgery, 2) how the rates of specific serious complications vary with different types of lumbar fusion, 3) the consequences of specific types of complications, and 4) the characteristics of treatments or patients that predict particularly severe complications. The information will help doctors better assess the benefits versus the risks of the procedure.

To better understand the relationship between the loss of motor control and low back pain. Compared to people without back problems, those with low back pain show losses in motor control, including problems with trunk muscle response and posture. Some researchers believe that losses in motor control may predispose people to falls that result in back pain. Other researchers think losses in motor control may result from damage sustained by tissue during a fall. To explore the relationship between motor control loss and back pain, scientists will study varsity athletes to determine whether poor motor control of the lumbar spine increases the risk of low back injury. They will also study changes in the lumbar spine motor control of people with low back pain after they complete rehabilitation programs that emphasize motor control training.

To develop and evaluate a psychosocial program for people with acute low back pain. Acute low back pain is a common problem that affects people抯 abilities to work and function, and it contributes to high health care costs. There are few studies, however, that prove whether or not a treatment truly reduces limitation and prevents the recurrence of pain. One new project will develop a program to enhance the social support and self-efficacy of people with acute low back pain. After developing and testing the program, researchers will evaluate its effectiveness by comparing the results of 160 participants with those of 160 people receiving usual care.

To evaluate the nervous system mechanisms of low back pain. Scientists think that when a disc ruptures, material leaking from its jelly-like filling leads to inflammation and the release of chemicals that irritate cells within the spinal canal. Scientists believe that the effects of these chemicals on the nerve endings in discs and adjacent tissue lead to low back pain, while the effects on dorsal nerve roots lead to sciatica. One study will test these ideas using a variety of techniques. A better understanding of pain mechanisms related to herniated discs will allow researchers to develop better treatments.

To evaluate an Internet-based patient education program. Patient education can play an important role in managing back pain. Yet taking part in an educational program can be difficult and time-consuming for some people, particularly if they live far from an area where such a program is offered. This study, conducted with patients recruited from Silicon Valley employers and the Internet, will test the effectiveness of an Internet-based education program. Participants will receive a book and videotape, and they will interact with other program participants through a moderated Internet discussion group. Patient assessments will also be conducted through the Internet.