BUTALBITAL
Fioricet and Butalbital are brand name drugs made from a combination of acetaminophen (325 mg), butalbital (a barbiturate, 50 mg), and caffeine (40 mg). They are usually used to treat tension headaches and migraine headaches.
Take Butalbital 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 Butalbital with food or milk if it upsets your stomach. Never take more Butalbital than is prescribed for you. If your pain is not being adequately treated, talk to your doctor. Store Butalbital at room temperature away from moisture and heat. Acetaminophen is a pain reliever and fever reducer. Butalbital is in a class of drugs called barbiturates that slow down your central nervous system (brain and nerve impulses) causing relaxation. Caffeine is believed to constrict dilated blood vessels that may contribute to tension headaches. Together, acetaminophen, butalbital, and caffeine are used to relieve complex tension (muscle contraction) headaches although precisely how it works is unknown. Butalbital may also be used for purposes other than those listed in this medication guide.  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 Butalbital can be very damaging to your liver and can increase drowsiness and dizziness. |
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Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication. If you experience any of the following serious side effects, stop taking acetaminophen / Butalbital / caffeine and seek emergency medical attention: an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives); slow, weak breathing; liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue); blood problems (easy or unusual bleeding or bruising); or low blood sugar (fatigue, increased hunger or thirst, dizziness, or fainting). These side effects are very rare and are not likely to occur during proper treatment with acetaminophen and caffeine. If you experience any unusual reactions, stop taking this medicine and seek the advice of your doctor. Other, less serious side effects may be more likely to occur. Continue to take acetaminophen / Butalbital / caffeine and talk to your doctor if you experience drowsiness; dizziness,, confusion or lightheadedness; shortness of breath; dry mouth; nausea, vomiting, abdominal pain, or decreased appetite; tiredness, leg pain, or muscle weakness; agitation, irritability, nervousness, anxiety or excitability; rash or itching; feeling of intoxication; headache; or constipation. This medication is habit forming and should only be used under close supervision. Take this drug only for as long as it is prescribed , in the amounts it is prescribed, and no more frequently than prescribed. Do not take Butalbital without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease. You may not be able to take Butalbital, or you may require a lower dose. Do not take Butalbital if you have porphyria. Before taking this medication, tell your doctor if you have: kidney disease, liver disease. You may not be able to take Butalbital, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above. This drug combination is in the FDA pregnancy category C. This means that its effects on an unborn baby are not known. Do not take this medication without first talking to your doctor if you are pregnant. This drug combination passes into breast milk and may harm a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. Butalbital has not been approved for use in children younger than 12 years of age. Keep Butalbital in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication. Do not take Butalbital if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. Dangerous side effects could result. Butalbital may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), other pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine unless your doctor approves. Many other medicines contain acetaminophen, especially over-the-counter pain, fever, cold, and allergy medications. Too much acetaminophen can be very dangerous.
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