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Ingredient Name: BUTALBITAL (byoo-TAL-bi-tal) and ACETAMINOPHEN (a-seat-a-MIN-oh-fen)

Drug Manufacturer: QUALITEST PRODUCTS

Common Uses: This medicine is a barbiturate and analgesic combination used to treat tension headaches.

Before Using This Medicine: Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking anticoagulants, birth control pills, corticosteroids, doxycycline, isoniazid, metronidazole, quinidine, theophylline, or medicine for high blood pressure or heart conditions (beta blockers). Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.

How to Use This Medicine: Follow the directions for using this medicine provided by your doctor. STORE THIS MEDICINE at room temperature in a tightly-closed container, away from heat and light. IF YOU MISS A DOSE OF THIS MEDICINE and you are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Cautions: DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed without checking with your doctor. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit-forming. AVOID ALCOHOL while you are using this medicine. This medicine will add to the effects of alcohol and other depressants. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. THIS MEDICINE CONTAINS ACETAMINOPHEN. Do not take additional acetaminophen for pain or fever without checking with your doctor or pharmacist. Ask your pharmacist if you have questions about which medicines contain acetaminophen. Acetaminophen may cause liver damage. If you drink alcohol on a daily basis, do not take this medicine without first discussing it with your doctor. Alcohol use combined with acetaminophen may increase your risk for liver damage. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. FOR WOMEN TAKING BIRTH CONTROL PILLS: this medicine may decrease the effectiveness of your birth control pills. To prevent pregnancy, use an additional form of birth control while you are taking this medicine. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. THIS MEDICINE IS EXCRETED IN BREAST MILK. DO NOT BREAST-FEED while taking this medicine.

Possible Side Effects: SIDE EFFECTS, that may go away during treatment, include drowsiness, dizziness, lightheadedness, or nausea. If they continue or are bothersome, check with your doctor. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

Overdose: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include vomiting, excessive sweating, dark urine, stomach pain, extreme fatigue, unusual drowsiness or dizziness, lack of feeling alert, slow or shallow breathing, cold or clammy skin, and loss of consciousness.

Additional Information: IF YOUR HEADACHE SYMPTOMS do not improve or if they become worse, contact your doctor. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out

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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