Butalbital and Acetaminophen (Systemic)
Before Using This MedicineIn 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 disease - The 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
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