Butalbital Meds Rebound: Breaking the Cycle.

Rebound from Butalbital Compounds Presents Even More Problems

Medications containing butalbital with either acetaminophen or aspirin, usually with caffeine, are some of the most commonly prescribed medications for the relief of many types of headache and pain relief during Migraine attacks. These medications include Fiorinal®, Fioricet®, Esgic®, Medigesic®, Phrenilin®, and others.

(Note: Ironically, because of the topic of this article, some of the ads near this comment and at the bottom of the page will be for online pharmacies selling butalbital compounds such as Fiorinal and Fioricet with no prior prescription required. Please note that I neither choose nor endorse any advertisement on this site.)

Unfortunately, when used more than two or three days a week, these medications quite often lead to rebound headaches, also referred to as medication overuse headaches.

Rebound headaches present us with additional problems:
As rebound progresses, we need more of the medications to achieve the same results.
The rebound headaches will occur until our systems are clear of the medications that caused them.
To stop rebound, we not only have to stop the specific medications that caused it, but also other medications of the same class of drugs.
When we're experiencing rebound, preventive medications can't work effectively.
Some people who withdraw too quickly from butalbital compounds can experience seizures.¹

Dr. Elizabeth Loder and Dr. David Biondi, both noted headache and Migraine specialists, have seen butalbital compound rebound in many patients, and have been looking at ways to withdraw patients from these medications. When patients are taking butalbital compounds daily, it's been a common practice to taper their dose down by one tablet every two to three days. However, if the patient's exact intake isn't reliable established, this method can be ineffective and not entirely safe.

Loder and Biondi undertook a review of 18 cases in which patients were hospitalized for withdrawal from overuse of butalbital medications using a pheonobarbital-loading protocol.

Study Objective:
Their objective was "to evaluate the safety and effectiveness of an oral phenobartibal-loading (loading to the patient's level of tolerance) protocol for withdrawal from short-acting, butalbital-combination medications." Phenobarbital has a long half-lifeaveraging 90 hours. This natural slow elimination allows phenobarbital loading, which minimizes the risk of withdrawal seizures from the absence of the butalbital medications. The oral administration is preferred over the intravenous administration that most of us think of in such situations because it allows patients to be more comfortable and reduces opportunities for infection. This method also eliminates the need to account for possibly unknown variable of exactly how much butalbital medications the patient had been taking. In addition to the phenobarbital, the study included a structured program of behavior modification.

Study Patients and Methods:
The 18 patients with headache were inpatients in the Pain Management Program of the Spaulding Rehabilitation Hospital in Boston, Massachusetts. The average length of hospitalization was 23 days, emphasizing withdrawal of the butalbital medications, formulation of both acute and preventive medication regimens, and educating patients about alternative pain-control strategies including ice, heat, biofeedback, hypnosis, meditation, and aerobic exercise. The previously described phenobarbital-loading protocol was used to withdraw the patients from the use of butalbital medications.

Cochrane Review Finds Acetaminophen Effective for Pain Relief After Wisdom Tooth Extraction

Cochrane Review Finds Acetaminophen Effective for Pain Relief After Wisdom Tooth Extraction

Overview
Additional Resources
Read More "Science in the News"

Overview

In a new systematic review from the Cochrane Collaboration ,1 acetaminophen is shown to be a safe and effective analgesic for relieving postoperative pain after third molar extraction, and most effective at an optimal dosage of 1000 milligrams. The Cochrane review findings drew news coverage from United Press International ,2 Reuters Health 3 and other outlets.

The Cochrane Collaboration, an international nonprofit organization, develops evidence-based systematic reviews on the relative effectiveness of health care interventions. The reviewers examined data from 21 randomized controlled trials, involving over 1,900 patients, to determine the optimal dose of acetaminophen and the optimal time for drug administration for pain relief after wisdom tooth extraction. Patients in the included studies received intravenous sedation or anesthesia (local or general), were not taking analgesics at the time of surgery, and were required to report a post-operative pain intensity of at least moderate to severe pain prior to administration of the study medications.

The Cochrane reviewers found that acetaminophen showed “a statistically significant benefit when compared with placebo at both 4 and 6 hours" for pain relief, and that the drug could be taken at six-hour intervals without compromising patient safety. Based on the published evidence to date, the reviewers state that using acetaminophen after third molar surgery is “extremely safe” and has a low incidence of adverse effects.

Importantly, the Cochrane review did not analyze the effectiveness of ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs) in relieving pain following third molar extraction, a common oral surgical procedure with demanding pain-control situations. To fill this evidence gap, the Cochrane reviewers are conducting an additional systematic review to compare the relative efficacy of ibuprofen and acetaminophen for the relief of postoperative pain after third molar surgery.

Acute pain management is integral to the provision of optimal dental care and supporting the well-being of patients. While the Cochrane review supports the use of acetaminophen as an effective reliever of postoperative dental pain, randomized trials dating back to the early 1980s have shown that acetaminophen provides significantly greater pain relief than placebo after third molar extraction. For years, acetaminophen has been widely accepted for the treatment of mild to moderate pain.

Oral analgesics are commonly prescribed for a few days following oral surgery or other procedures, after which patients are typically pain-free or can switch to over-the-counter medications (i.e., either lower doses of the same analgesics or different OTC drugs). Dentists should also be aware that an extensive body of pain research supports conventional NSAIDs (e.g., ibuprofen, aspirin) as effective analgesic treatments, including a 2004 systematic review from the University of Oxford .4

Dentists who perform invasive or surgical procedures should take a comprehensive medical history and consult with the patient’s physician as appropriate. In assessing a patient’s health history, conditions that may affect the patient’s ability to metabolize medications are important to consider. For acetaminophen, existing liver damage is one such consideration since it is the primary site of the drug’s metabolism.

Patients should always be reminded to use acetaminophen and other oral analgesics as directed. While 1,000 mg of acetaminophen every six hours approaches the customary maximum recommended daily dose (4,000 mg/day), patients typically exhibit significant reduction in pain after the first post-operative day, suggesting that short-term use may benefit many patients.

For additional information, dentists are encouraged to consult the Oxford League Table of Analgesic Efficacy , the ADA/PDR® Guide to Dental Therapeutics, Fourth Edition , and the ADA.org list of systematic reviews on pain management .

Footnotes

1Weil K, Hooper L, Afzal Z, Esposito M, Worthington HV, van Wijk AJ, Coulthard P. Paracetamol for pain relief after surgical removal of lower wisdom teeth. Cochrane Database of Systematic Reviews 2007, Issue 3. Abstract available at: “http://www.cochrane.org/reviews/en/ab004487.html ”.
Accessed July 25, 2007.

2 Acetaminophen good for wisdom teeth removal. United Press International, July 19, 2007. Available at: “www.upi.com/Consumer_Health_Daily/Briefing/2007/07/19/acetaminophen_
good_for_wisdom_teeth_removal/2593/ ”.
Accessed July 26, 2007.

3 Acetaminophen eases post-wisdom tooth removal pain. Reuters Health, July 30, 2007. Available at: “http://www.reuters.com/article/healthNews/ idUSHAR06617720070730 ”.
Accessed July 30, 2007.

4Barden J, Edwards JE, McQuay HJ, Wiffen PJ, Moore RA. Relative efficacy of oral analgesics after third molar extraction. British Dental Journal 2004; 197, 407-411. Available at: “http://www.nature.com/bdj/journal/v197/n7/full/4811721a.html ”.
Accessed July 30, 2007.

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Additional Resources
A-Z Public Topic: Anesthesia & Sedation
A-Z Public Topic: Wisdom Teeth
Journal of the American Dental Association: Selecting new drugs for pain control: evidence-based decisions or clinical impressions? (August 2002)
Journal of the American Dental Association: The efficacy of combination analgesic therapy in relieving dental pain (July 2002)
American Heart Association: Use of nonsteroidal antiinflammatory drugs—an update for clinicians: a scientific statement from the American Heart Association (March 2007)

Acetaminophen Safe, Effective After Wisdom Tooth Removal

The commonly used and inexpensive analgesic acetaminophen (Tylenol or paracetamol) is an effective pain reliever after surgical removal of lower wisdom teeth, according to a new systematic review of 21 studies. The most effective dose appears to be 1,000 milligrams taken at six-hour intervals, the review concludes.

"Acetaminophen has been around a long time. It has a good safety record and is widely available without prescription. Our findings suggest it is a good choice for dental pain," said review co-author Kiaran Weil.

The review appears in the latest issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.

Researchers from the University of Manchester School of Dentistry in England and the University of Amsterdam in the Netherlands analyzed the studies.

The review examined data from 1,968 patients enrolled in studies that compared the effectiveness of acetaminophen versus placebo to decrease pain after surgical extraction of the third molars, or lower wisdom teeth. The review included patients who received local anesthesia, intravenous sedation or general anesthesia; however, it excluded patients who took pain relievers at the time of surgery.

All patients reported moderate to severe pain just after surgery. Researchers tallied the number of patients who reported 50 percent pain relief at four and six hours after surgery.

Patients who received any dose of acetaminophen after surgery were at least three times more likely to report 50 percent pain relief than patients who took a placebo. However, patients given the higher dose of 1,000 milligrams were four to five times more likely to report that their pain was cut in half. Study participants who took less than 1,000 milligrams were about twice as likely to report 50 percent pain relief.

Patients treated with acetaminophen reported a similar number of side effects as patients who received a placebo. However, researchers monitored patients taking acetaminophen, and Weil cautions that side effects are less likely to occur under controlled circumstances.

The maximum recommended dose of acetaminophen is 4,000 milligrams per day for adults.

Acetaminophen can cause liver toxicity when an individual exceeds the maximum daily dose. Heavy drinkers, malnourished patients and people with AIDS or anorexia nervosa also have an increased risk for liver toxicity.

While the review shows acetaminophen is effective for pain relief, oral surgeon Morton Rosenberg said many dentists prescribe analgesics plus narcotic pain relievers after surgical removal of wisdom teeth.

"This is a procedure where the dentist is working on bone and cutting oral tissue. These are some of the strongest stimuli for pain that we know of," said Rosenberg, professor of oral and maxillofacial surgery at Tufts University School of Dental Medicine in Boston.

In his practice, Rosenberg treats pain after wisdom tooth removal on a case-by-case basis.

"It varies so much from patient to patient that it is hard to generalize. I do often give a prescription for something like Tylenol with codeine and advise the patient to fill the prescription if needed," he said. Many patients expect to receive something stronger than an over-the-counter medication, he added.

Future reviews of studies will compare acetaminophen directly to other pain relievers such as ibuprofen.

Weil K, et al. Paracetamol for pain relief after surgical removal of lower wisdom teeth. (Review) Cochrane Database of Systematic Reviews 2007, Issue 3.

The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. Visit http://www.cochrane.org for more information.

What should I avoid while taking acetaminophen, butalbital, caffeine?

how should I avoid while taking acetaminophen, butalbital, caffeine?

Use caution when driving, operating machinery, or performing other hazardous activities. Butalbital will cause drowsiness or dizziness. If you experience drowsiness or dizziness, avoid these activities.

Avoid sleeping pills, antihistamines, sedatives, and tranquilizers except under the supervision of your doctor. These may also make you drowsy.

Avoid alcohol. Alcohol taken during therapy with acetaminophen and butalbital can be very damaging to your liver and can increase drowsiness and dizziness.

Check the acetaminophen content of other over-the-counter and prescription products while taking this medication. You should not exceed 4 grams (4000 mg) of acetaminophen per day.

Avoid taking too much caffeine. Check the caffeine content of other over-the-counter and prescription products as well as beverages (coffee, tea, and colas) while taking this medication.

How well does acetaminophen work and compare to anti-inflammatories to treat osteoarthritis and is it safe?
Fifteen studies of moderate to high quality were reviewed and provide the best evidence we have today. The studies tested almost 6000 people with osteoarthritis of the hip or knee. The studies compared people who took 4000 mg of acetaminophen (Tylenol, Paracetamol) a day to people who took a placebo (fake pill) or non-steroidal anti-inflammatory drugs (NSAIDs). Most studies lasted on average about 6 weeks.

What is osteoarthritis and what drugs are used to treat it?
Osteoarthritis (OA) is the most common form of arthritis that can affect the hands, hips, shoulders and knees. In OA, the cartilage that protects the ends of the bones breaks down and causes pain and swelling. There are two main types of drug treatments in OA: acetaminophen which is used to relieve pain but does not affect swelling; and NSAIDs, such as ibuprofen, diclofenac and cox IIs (celecoxib), which are used to decrease pain and swelling. It is not clear which type is best to use or which causes more side effects: high doses of acetaminophen may cause stomach problems, such as ulcers, and NSAIDs may cause stomach, kidney or heart problems.

What did the studies show?
Acetaminophen compared to placebo
The studies show that people who took acetaminophen has less pain (when resting, moving, sleeping and overall) and felt better overall than people who took a placebo. Pain (when measured on a different scale), physical function and stiffness were about the same.
? Pain decreased by 4 more points on a scale of 0-100 for people who took acetaminophen instead of a placebo.

Acetaminophen compared to NSAIDs
The studies show that people who took NSAIDs had less pain and stiffness and had greater physical function than people who took acetaminophen.
? Pain decreased by 6 more points on a scale of 0-100 in people who took NSAIDs instead of acetaminophen.

How safe is acetaminophen and NSAIDs?
When comparing people who took acetaminophen or a placebo, or people who took acetaminophen or an NSAID, the type and amount of side effects were about the same.
This was also true when comparing cox-II NSAIDs to acetaminophen. However, people taking traditional NSAIDs, such as ibuprofen or naproxen, were more likely to have a stomach problems (diarrhoea, nausea, heartburn or stomach pain) than people taking acetaminophen.

? 19 out of 100 had side effects with traditional NSAIDs
? 13 out of 100 had side effects with acetaminophen

What is the bottom line?
The level of quality of the evidence is 'platinum'. In people with osteoarthritis of the hip or knee, acetaminophen improves pain more than no treatment. Non-steroidal anti-inflammatory drugs improve pain, function and stiffness more than acetaminophen, especially in people with moderate to severe pain. There does not appear to be a major difference in side effects between acetaminophen and NSAIDs, although people taking traditional NSAIDs were more likely to have stomach problems.
The benefits between the drugs are modest and the studies were only about 6 weeks long. Therefore, it is important to consider preferences, risks, costs, availability of the drugs and the doctors' judgement when making a decision.

How should I take acetaminophen, butalbital, caffeine?

How should I take acetaminophen, butalbital, caffeine?

Take acetaminophen/butalbital/caffeine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Take acetaminophen/butalbital/caffeine with food or milk if it upsets your stomach.

Never take more acetaminophen/butalbital/caffeine than is prescribed for you. If your pain is not being adequately treated, talk to your doctor.

Store acetaminophen/butalbital/caffeine at room temperature away from moisture and heat.

Side effects

Side effects

Side effects for any drug are difficult to predict, but commonly reported side effects for Fioricet include:

* Abdominal pain
* Dizziness
* Drowsiness
* Intoxicated feeling
* Light-headedness
* Nausea
* Vomiting
* Sedation
* Addiction
* Shortness of breath
* Abdominal pain

Fioricet

Generic name: Butalbital, Acetaminophen, Caffeine
Brand names: Esgic-Plus, Esgic, Anolor 300, Fioricet
Why is Fioricet prescribed?

Fioricet, a strong, non-narcotic pain reliever and relaxant, is prescribed for the relief of tension headache symptoms caused by muscle contractions in the head, neck, and shoulder area. It combines a sedative barbiturate (butalbital), a non-aspirin pain reliever (acetaminophen), and caffeine.
Most important fact about Fioricet

Mental and physical dependence can occur with the use of barbiturates such as butalbital when these drugs are taken in higher than recommended doses over long periods of time.
How should you take Fioricet?

Take Fioricet exactly as prescribed. Do not increase the amount you take without your doctor's approval.

--If you miss a dose...

Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Never take 2 doses at the same time.

--Storage instructions...

Store at room temperature in a tight, light-resistant container.
What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Fioricet.
More common side effects may include:
Abdominal pain, dizziness, drowsiness, intoxicated feeling, light-headedness, nausea, sedation, shortness of breath, vomiting
Why should Fioricet not be prescribed?

If you are sensitive to or have ever had an allergic reaction to barbiturates, acetaminophen, or caffeine, you should not take Fioricet. Make sure that your doctor is aware of any drug reactions that you have experienced.

Unless you are directed to do so by your doctor, do not take Fioricet if you have porphyria (an inherited metabolic disorder affecting the liver or bone marrow).
Special warnings about Fioricet

Fioricet may cause you to become drowsy or less alert; therefore, driving or operating dangerous machinery or participating in any hazardous activity that requires full mental alertness is not recommended until you know your response to Fioricet.

If you are being treated for severe depression or have a history of severe depression or drug abuse, consult with your doctor before taking Fioricet.

Use Fioricet with caution if you are elderly or in a weakened condition, if you have liver or kidney problems, or if you have severe abdominal trouble.
Possible food and drug interactions when taking Fioricet

Butalbital slows the central nervous system (CNS) and intensifies the effects of alcohol and other CNS depressants. Use of alcohol with Fioricet may also cause overdose symptoms. Avoid alcoholic beverages while taking Fioricet.

If Fioricet is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Fioricet with the following:

Antihistamines such as Benadryl
Drugs known as monoamine oxidase inhibitors, including the antidepressants Nardil and Parnate
Drugs to treat depression such as Elavil
Major tranquilizers such as Haldol and Thorazine
Muscle relaxants such as Flexeril
Narcotic pain relievers such as Darvon
Sleep aids such as Halcion
Tranquilizers such as Xanax and Valium
Special information if you are pregnant or breastfeeding

If you are pregnant or plan to become pregnant, inform your doctor immediately. Fioricet can affect a developing baby. It also appears in breast milk. If Fioricet is essential to your health, your doctor may advise you to discontinue breastfeeding your baby until your treatment is finished.
Recommended dosage

ADULTS

The usual dose of Fioricet is 1 or 2 tablets taken every 4 hours as needed. Do not exceed a total dose of 6 tablets per day.

The usual dose of Esgic-Plus is 1 tablet every 4 hours as needed. Do not take more than 6 tablets a day.

CHILDREN

The safety and effectiveness of Fioricet have not been established in children under 12 years of age.

OLDER ADULTS

Fioricet may cause excitement, depression, and confusion in older people. Therefore, your doctor will prescribe a dose individualized to suit your needs.
Overdosage

Symptoms of Fioricet overdose can be due to its barbiturate or its acetaminophen component.
Symptoms of barbiturate poisoning may include:
Coma, confusion, drowsiness, low blood pressure, shock, slow or troubled breathing

Overdose due to the acetaminophen component of Fioricet may cause kidney and liver damage, blood disorders, or coma due to low blood sugar. Massive doses may cause liver failure.
Symptoms of liver damage include:
Excess perspiration, feeling of bodily discomfort, nausea, vomiting

If you suspect an overdose, seek emergency medical treatment immediately.

Mechanism of action

Butalbital has generalized depressant effect on central nervous system and, in very high doses, has peripheral effects. Acetaminophen has analgesic and antipyretic effects; its analgesic effects may be mediated through inhibition of prostaglandin synthetase enzyme complex. Caffeine is thought to produce constriction of cerebral blood vessels.

Butalbital has half-life of about 35 hours. Acetaminophen half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Caffeine half-life is about 3 hours.

What is Fioricet?

BRAND NAMES: In the U.S. Amaphen Anolor-300 Anoquan Arcet Bancap Bucet Butace Conten Dolmar Endolor Esgic Esgic-Plus Ezol Femcet Fioricet Isocet Medigesic Pacaps Pharmagesic Phrenilin Phrenilin Forte Repan Sedapap Tencet Tencon Triad Triaprin Two-Dyne Description 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.) Proper Use of This Medicine 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: AdultsOne 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. ChildrenDose 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. Before Using This Medicine In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For butalbital and acetaminophen combinations, the following should be considered: Allergies - Tell your doctor if you have ever had any unusual or allergic reaction to butalbital or other barbiturates, or to acetaminophen, aspirin, or caffeine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes. Pregnancy - For butalbital: Barbiturates such as butalbital have been shown to increase the chance of birth defects in humans. Also, one study in humans has suggested that barbiturates taken during pregnancy may increase the chance of brain tumors in the baby. Butalbital may cause breathing problems in the newborn baby if taken just before or during delivery. For acetaminophen: Although studies on birth defects with acetaminophen have not been done in pregnant women, it has not been reported to cause birth defects or other problems. For caffeine: Studies in humans have not shown that caffeine (contained in some of these combination medicines) causes birth defects. However, use of large amounts of caffeine during pregnancy may cause problems with the heart rhythm and the growth of the fetus. Also, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to those present in 12 to 24 cups of coffee a day). Breast-feeding - For butalbital: Barbiturates such as butalbital pass into the breast milk and may cause drowsiness, unusually slow heartbeat, shortness of breath, or troubled breathing in nursing babies. For acetaminophen: Although acetaminophen has not been shown to cause problems in nursing babies, it passes into the breast milk in small amounts. For caffeine: Caffeine (present in some butalbital and acetaminophen combinations) passes into the breast milk in small amounts. Taking caffeine in the amounts present in these medicines has not been shown to cause problems in nursing babies. However, studies have shown that nursing babies may appear jittery and have trouble in sleeping when their mothers drink large amounts of caffeine-containing beverages. Therefore, breast-feeding mothers who use caffeine-containing medicines should probably limit the amount of caffeine they take in from other medicines or from beverages. Children - For butalbital: Although barbiturates such as butalbital often cause drowsiness, some children become excited after taking them. For acetaminophen: Acetaminophen has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults. For caffeine: There is no specific information comparing use of caffeine in children up to 12 years of age with use in other age groups. However, caffeine is not expected to cause different side effects or problems in children than it does in adults. Older adults - For butalbital: Certain side effects, such as confusion, excitement, or mental depression, may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of the butalbital in this combination medicine. For acetaminophen: Acetaminophen has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. For caffeine: Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of caffeine in the elderly with use in other age groups. Other medicines - Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking a butalbital and acetaminophen combination, it is especially important that your health care professional know if you are taking any of the following: Anticoagulants (blood thinners), or Carbamazepine (e.g., Tegretol) or Contraceptives, oral (birth control pills) containing estrogen, or Corticosteroids (cortisone-like medicines) or Corticotropin (e.g., ACTH)Butalbital may make these medicines less effective Antidepressants, tricyclic (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil]) or Central nervous system (CNS) depressants (medicines that often cause drowsiness)These medicines may add to the effects of butalbital and increase the chance of drowsiness or other side effects Divalproex (e.g., Depakote) or Valproic acid (e.g., Depakene)The chance of side effects may be increased Other medical problems - The presence of other medical problems may affect the use of butalbital and acetaminophen combinations. Make sure you tell your doctor if you have any other medical problems, especially: Alcohol abuse (or history of) or Drug abuse or dependence (or history of)Dependence on butalbital may develop; also, acetaminophen may cause liver damage in people who abuse alcohol Asthma (or history of), emphysema, or other chronic lung disease or Hepatitis or other liver disease or Hyperactivity (in children) or Kidney diseaseThe chance of serious side effects may be increased Diabetes mellitus (sugar diabetes) or Mental depression or Overactive thyroid or Porphyria (or history of)Butalbital can make these conditions worse Heart disease (severe)The caffeine in some butalbital and acetaminophen combinations can make some kinds of heart disease worse Precautions While Using This Medicine 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. Side Effects of This Medicine 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.

Usage and Dosage

Usage and Dosage

Fioricet is indicated for the treatment of complex and muscle contraction headaches. It is also commonly prescribed for migraines although it is not FDA indicated for this use. The usual adult dose is 1-2 tablets every four hours as needed, not exceeding six tablets in a 24 hour period.

Fioricet

Fioricet and Esgic are brand name drugs made from a combination of acetaminophen (325 mg), butalbital (a barbiturate, 50 mg), and caffeine (40 mg). They are indicated for the treatment of tension headaches and muscle contraction headaches. Although not indicated, they are commonly used to treat migraines and other pain related ailments.