Generic Name: butalbital and aspirin combination (Oral route)
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Butalbital and aspirin combination is a pain reliever and relaxant. It is used to treat tension headaches. Butalbital belongs to the group of medicines called barbiturates. Barbiturates act in the central nervous system (CNS) to produce their effects.
When you use 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 of these medicines also contain caffeine. 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 aspirin combination is sometimes also used for other kinds of headaches or other kinds of pain, as determined by your doctor.
These medicines are available only with your doctor's prescription.
Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Although this combination medicine has not been reported to cause problems, the chance always exists, especially if the medicine is taken for a long time or in large amounts.
Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.
Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain butalbital and aspirin combination. It may not be specific to Fiorinal. Please read with care.
Take this medicine with food or a full glass (8 ounces) of water to lessen stomach irritation.
Do not take this medicine if it has a strong vinegar-like odor. This odor means the aspirin in it is breaking down. If you have any questions about this, check with your health care professional.
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 aspirin combination is taken regularly (for example, every day), it may become habit-forming (causing mental or physical dependence). The caffeine in some butalbital and aspirin combinations can also increase the chance of dependence. Dependence is especially likely to occur in patients who take this medicine to relieve frequent headaches. Taking too much of this combination medicine can also lead to stomach problems or to 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.
The dose medicines in this class 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 amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. 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.
Keep out of the reach of children.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Do not keep outdated medicine or medicine no longer needed.
Check with your doctor:
Check the labels of all nonprescription (over-the-counter [OTC]) and prescription medicines you now take. If any contain a barbiturate, aspirin, or other salicylates, including diflunisal, 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 or narcotics; other barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Also, stomach problems may be more likely to occur if you drink alcoholic beverages while you are taking aspirin. 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 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 may occur if your medical doctor or dentist gives you certain other medicines without knowing that you have taken butalbital.
Do not take this medicine for 5 days before any planned surgery, including dental surgery, unless otherwise directed by your medical doctor or dentist. Taking aspirin during this time may cause bleeding problems.
Before you have any medical tests, tell the person in charge that you are taking this medicine. Caffeine (present in some butalbital and aspirin 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 some other tests may also be affected by butalbital and aspirin combinations.
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 using it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely, 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 death. Symptoms of overdose of this medicine include convulsions (seizures); hearing loss; confusion; ringing or buzzing in the ears; severe excitement, nervousness, or restlessness; severe dizziness; severe drowsiness; shortness of breath or troubled breathing; and severe weakness.
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:Less common or rare - may mean that a serious allergic reaction is occurring
Check with your doctor as soon as possible if any of the following side effects occur:Less common or rare
Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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