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Fioricet

acetaminophen/butalbital/caffeine (oral) (a seet a MIN oh fen and boo TAL bi tall and CAFF een)

What is the most important information I should know about Fioricet?

Use caution when driving, operating machinery, or performing other hazardous activities. Butalbital will cause drowsiness. If you experience drowsiness or dizziness, avoid these activities.
Avoid sleeping pills, sedatives, and tranquilizers except under the supervision of your doctor. These may also make you drowsy.
Avoid alcohol. Alcohol taken during therapy with Fioricet 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.
Never take more Fioricet than is prescribed for you. If your pain is not being adequately treated, talk to your doctor.

What is Fioricet?

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.
Fioricet may also be used for purposes other than those listed in this medication guide.


What should I discuss with my healthcare provider before taking Fioricet?

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 Fioricet 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 Fioricet, or you may require a lower dose.
Do not take Fioricet if you have porphyria.
Before taking this medication, tell your doctor if you have
      kidney disease, or
      liver disease.
You may not be able to take Fioricet, 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.
Fioricet has not been approved for use in children younger than 12 years of age.


How should I take Fioricet?

Take Fioricet 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 Fioricet with food or milk if it upsets your stomach.
Never take more Fioricet than is prescribed for you. If your pain is not being adequately treated, talk to your doctor.
Store Fioricet at room temperature away from moisture and heat.


What happens if I miss a dose?

Take the missed dose as soon as you remember. Do not take a double dose of this medication. Wait the prescribed amount of time before taking your next dose.


What happens if I overdose?

Seek emergency medical attention.
Symptoms of an Fioricet overdose include insomnia, restlessness, tremor, nausea, vomiting, diarrhea, abdominal pain, sweating, seizures, drowsiness, decreased breathing, dizziness or fainting, confusion, an irregular heartbeat, and coma.


What should I avoid while taking Fioricet?

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 Fioricet 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


What are the possible side effects of Fioricet?

If you experience any of the following serious side effects, stop taking Fioricet 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 Fioricet 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.
Butalbital may be habit forming.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.


What other drugs will affect Fioricet?

Do not take Fioricet 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.
Fioricet 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.
Drugs other than those listed here may also interact with Fioricet. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.


Where can I get more information?

Your pharmacist has additional information about Fioricet written for health professionals that you may read.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

 

Tension-type Headaches in Children and Adolescents

What are tension-type headaches?
Tension-type headaches are the most common type of headache in adolescents. They are commonly referred to as muscle contraction headaches, stress headaches, daily headaches, or chronic non-progressive headaches.

A tension-type headache might occur periodically (episodic, less than 15 days per month) or chronically (daily or > 15 days per month). The headache is described as a mild to moderate, constant band-like pain or pressure that lasts from 30 minutes to all day in duration. Tension-type headaches usually begin gradually, and often occur in the middle of the day.

The "severity" of a tension-type headache might increase significantly with its frequency. Severe tension-type headaches occur daily or almost daily, and the pain is usually described as a throbbing pain affecting the front, top, or sides of the head. Although the intensity of the pain might vary throughout the day, the pain is almost always present. It is important to realize that although tension-type headaches come and go over a prolonged period of time and might impair your day-to-day function, they do not cause neurological symptoms, or affect vision, balance, or strength.

What causes tension-type headaches?
There is no single cause for tension-type headaches. This type of headache syndrome is not usually an inherited trait that runs in families. In some people, tension-type headaches are thought to be caused by or result in tightened muscles in the back of the neck and scalp. This muscle tension might be caused by (1) inadequate rest, (2) poor posture, or (3) emotional or mental stress, including depression. This stress might be known (overt) or unknown (covert) to the patient and his or her parents. The most common sources of stress in children and adolescents include school, family, and friends or peers. Examples of stressors (not in any particular order) include:

  • Not getting enough sleep
  • Being on the honor role or a straight-A student
  • Having problems at home/difficult family life
  • Going to a new school
  • Having overly permissive or overly strict parents
  • Having a substitute or strict teacher
  • Having a new brother or sister
  • Being a "teacher's pet"
  • Having no close friends
  • Preparing for school tests or exams
  • Learning to drive
  • Joining too many extra-curricular activities
  • Starting a new part-time job
  • Going on a field trip or vacation
  • Being overweight
  • Having other children make fun of you
  • Competing in sports or other activities
  • Learning difficulties

Having the adolescent seen by a headache specialist might be helpful, particularly when the cause of tension-type headaches is difficult to identify. Once the evaluation is completed, it is important to reassure the patient that the headache pain they are experiencing is NOT likely to be a brain tumor.

What are the symptoms of tension-type headaches?
Patients with tension-type headaches commonly report these symptoms:

  • Constant or episodic, mild-to-moderate head pain
  • Headache upon awakening
  • General muscle aches
  • Difficulty falling asleep and staying asleep
  • Chronic fatigue
  • Irritability
  • Disturbed concentration
  • Mild sensitivity to light or noise
  • Occasional dizziness
  • Occasional nausea

The presence of an aura (physical warning sign), significant sensitivity to light or noise, nausea, and vomiting are not symptoms associated with this type of headache syndrome. Often, the pain associated with a tension-type headache is difficult for the patient to describe. There are no associated neurological symptoms (for example, balance or visual disturbances) in patients with tension-type headaches.

How common are tension-type headaches?
Tension-type headaches affect 15 percent to 20 percent of adolescents and a lower percentage of younger children. The percent of adults who suffer with occasional tension-type headaches ranges from 30 percent to about 80 percent. Women are twice as likely to suffer from tension-type headaches as are men.

Most people with episodic tension-type headaches have them no more than once or twice a month, but the headaches can occur more frequently.

Chronic tension-type headaches tend to be more common in females and in students who are "high achievers." Many patients with chronic tension-type headaches have already had the headaches for more than 60 to 90 days when evaluated, and many have missed an excessive amount of school.

Nearly 60 percent of people with tension-type headaches report that their daily activities are impaired because of the headaches.

Chronic tension-type headaches might co-exist in adolescents and children who already have a history of migraines. These are called mixed headaches.

How are tension-type headaches diagnosed?
The correct headache diagnosis is needed to develop an effective treatment plan. The most important aspect of the headache evaluation is the headache history, which should be obtained from both the child and his or her parents.

The history includes asking patients to describe how they feel with the headache, what happens when a headache occurs, the frequency and duration of the headaches, and any associated symptoms experienced. A description of previous and current medicines taken to treat the headaches is also an important part of the headache evaluation. The results of any previously conducted studies or tests should be brought with you to the headache evaluation.

After completing the medical history part of the evaluation, your doctor will perform physical and neurological examinations. Usually, the results of these examinations are normal for people with tension-type headaches.

An interview with a psychologist is commonly a part of the headache evaluation. The psychologist usually meets with the child and the parents together, and then with them separately for structured interviews. The parents are typically asked to complete computerized questionnaires in order to provide more in-depth information. Usually, no severe problems are discovered, but stress factors are often identified.

After evaluating the results of the headache history, physical examination, neurological and psychological examinations, your doctor should be able to determine what type of headache you have, whether or not a serious problem is present, and if additional tests are needed. Often, no additional blood tests or X-rays are needed.

How are tension-type headaches treated?
Tension-type headaches are treated using several drug and non-drug strategies. Among the non-drug strategies are lifestyle changes (sleep, dietary changes), physical therapy, stress management/relaxation training, and counseling. Regardless of the treatment, tension-type headaches are best treated before the headaches become more frequent and painful ? that is, when the symptoms first begin and are mild.

Stress management/relaxation training and counseling
Both episodic and chronic tension-type headaches can be improved using stress management and relaxation training. This is an essential part of managing these types of headaches.

Recognizing and treating the underlying stress and tension that are causing the headaches is very helpful. Often, however, patients forget what stressful events initiated their headaches. Counseling helps patients identify their headache triggers and learn useful coping methods.

Relaxation techniques include deep breathing exercises, progressive muscle relaxation, mental imagery relaxation, or relaxation to music. Ask your doctor for more information about these techniques.

Biofeedback is another method of learning how to manage stress. During biofeedback, a series of sensors are connected to your body. The sensors detect changes in physical functions, such as muscle tension, blood pressure, heart rate, and skin temperature, and provide immediate feedback through a tone displayed on a computer screen. Biofeedback helps you recognize that your body is tense, identify the things that make it tense, and learn ways to reduce the tension. Biofeedback usually requires several sessions with a skilled biofeedback therapist.

If you miss more than five days of school per term, your counselor will need to work with you and your parents to develop a plan so that you can make up missed school work and ensure a smooth transition back to school. Continued excessive school absence is an impediment to recovery.

Medicines
For occasional symptomatic relief of infrequent tension-type headaches, over-the-counter (non-prescription) medicines are recommended. Ask the advice of your doctor or pharmacist about the use of acetaminophen (Tylenol), ibuprofen (Advil or Motrin), or naproxen sodium (Aleve). The use of aspirin in children under age 14 is not recommended because of aspirin's link with Reye's syndrome. Also, avoid compounds that contain caffeine.

For relief of chronic tension-type headaches, daily preventive medicines might be prescribed. These medicines which are aimed at reducing both the frequency and severity of the headaches might include antidepressants, such as amitriptyline hydrochloride (Elavil), and non-steroidal anti-inflammatory medicines (NSAIDs), such as naproxen sodium (Aleve). These medicines are not habit-forming.

Benzodiazepines, butalbital combinations, and narcotics (Codeine) should be avoided because these medicines could become habit-forming or addictive. Overuse of these medicines or the daily use of pain-relieving medicines can cause analgesic rebound headaches, described below.

Medicine overuse can increase headaches
An extremely important factor contributing to the development of chronic daily headaches is the overuse of pain medicines. Medicine overuse is most likely to occur in patients with chronic tension-type headaches.

Medicines associated with analgesic rebound headaches include acetaminophen, ibuprofen, NSAIDs, triptans, ergotamine preparations, butalbital combination analgesics, opiates, and combination analgesics containing caffeine. Effective treatment of headaches associated with medicine overuse requires withdrawal from the medicines causing the rebound headaches. Rebound headaches might not go away for weeks after the medicines are discontinued.

Treating tension-type headaches without medicines
Although medicines are helpful, it is important to learn other headache treatment methods. Here are some suggestions:

  • Apply an ice pack to the painful area of your head. Firmly position it on your forehead, temples, or the back of your neck. (For example, first place a thin cloth on your forehead, followed by the ice pack, then finally secure it in place with a headband.)
  • Take a warm bath or shower; take a nap; or take a walk.
  • Ask someone to rub your neck and back, or treat yourself to a massage.
  • Apply gentle, steady rotating pressure to the painful area of your head with your index finger and/or thumb. Maintain pressure for seven to 15 seconds, then release. Repeat as needed.
  • Rest, sit, or lie quietly in a low-lit room. Close your eyes and try to release the tension in your back, neck, and shoulders.
  • For patients who have excessive muscle contractions in the neck, physical therapy exercises performed daily are often helpful.

How can I help reduce or prevent headaches?

  • Follow your treatment plan Avoid taking medicines that have not been ordered by your doctor. Do not overuse over-the-counter medicines.
  • Reduce emotional stress Take time to relax and take time away from stressful situations. Learn relaxation skills, such as deep breathing and progressive muscle relaxation.
  • Reduce physical stress Proper rest and sleep will allow you to deeply relax so you can face the stressors of the new day. When sitting for prolonged periods, get up and stretch periodically. Relax your jaw, neck, and shoulders.
  • Exercise regularly Get at least 20 minutes of exercise three times a week.
  • Talk to a friend, family member, religious professional, or health care professional This can help if  your problems are getting to you.

 

 

 


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