Drug Information: Tramadol (Systemic)
Description
Tramadol ( TRA-ma-dole) is used to relieve pain, including pain after
surgery. The effects of tramadol are similar to those of narcotic analgesics.
Although tramadol is not classified as a narcotic, it may become habit-forming,
causing mental or physical dependence.
Tramadol is available only with your doctor's prescription, in the following
dosage form:
Before Using This Medicine
In 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 tramadol, the following should be considered:
Allergies—Tell your doctor if you have ever had any unusual
or allergic reaction to tramadol or narcotic analgesics. Also tell your health
care professional if you are allergic to any other substances, such as foods,
preservatives, or dyes.
Pregnancy—Although studies on birth defects have not been
done in pregnant women, tramadol has not been reported to cause birth defects.
In animal studies, there were drug-related birth defects observed. Studies done
in animals given very high (toxic) doses resulted in lower than normal birth
weights and some deaths in the fetuses and birth defects in some of the
newborns.
Breast-feeding—Tramadol passes into breast milk and may
cause unwanted effects in nursing babies. It may be necessary for you to take
another medicine or to stop breast-feeding during treatment. Be sure you have
discussed the risks and benefits of the medicine with your doctor.
Children—There is no specific information on the
relationship of age to the effects of tramadol in patients less than 16 years of
age.
Older adults—Studies in older adults show that tramadol
stays in the body a little longer than it does in younger adults. Your doctor
will consider this when deciding on your doses.
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 tramadol, it is especially important that your health care provider know
if you are taking any of the following:
- Carbamazepine (e.g., Tegretol)—May decrease the effects of tramadol by
decreasing the amount of medicine in the body
- Central nervous system (CNS) depressants (medicines that cause
drowsiness)—Using these medicines with tramadol may increase the chance of
serious side effects or increase the risk of convulsions (seizures)
- Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan],
phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g.,
Eldepryl], tranylcypromine [e.g., Parnate])—The chance of convulsions (seizures)
may be increased
Other medical problems—The presence of
other medical problems may affect the use of tramadol. Make sure you tell your
doctor if you have any other medical problems, especially:
- Abdominal or stomach conditions (severe)—Tramadol may hide signs of other
medical conditions
- Alcohol or drug abuse, or history of—May increase the serious side effects
of tramadol
- Head injury—Tramadol can hide signs of other medical conditions
- Kidney disease or
- Liver disease—The chance of side effects may be increased. Your doctor will
consider this when deciding on your doses.
- Seizures—The chance of convulsions (seizures) may be increased
Proper Use of Tramadol
If you think that this medicine is not working as well after you have been
taking it for a few weeks, do not increase the dose. Instead, check
with your medical doctor or dentist.
Dosing—
The dose of tramadol 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 tramadol. If your dose is
different, do not change it unless your doctor tells you to do so.
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 taking tramadol.
Take this medicine only as directed. 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. Using
too much of this medicine increases the chance of unwanted effects.
- For pain:
- For oral dosage form (tablets):
- Adults—One-half to two 50-milligram (mg) tablets every four to six hours as
needed, no more than 8 tablets in a day. Your healthcare professional may want you
to break the tablets in half for the first dose and increase your dose by
half-tablets, up to a maximum of 2 full tablets per dose. By starting at a lower
dose and slowly increasing the amount of medicine you take, this will help you
get used to the medicine gradually. Your healthcare professional may want you to
take 2 tablets for the first dose if you are having severe pain. This helps the
medicine start working a little faster.
- Children up to 16 years of age—Use and dose must be determined by your
doctor.
Missed dose—
If your medical doctor or dentist has directed you to take this medicine
according to a regular schedule and 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.
Storage—
To store this medicine:
- Keep out of the reach of children.
- Store away from heat and direct light.
- Do not store tramadol tablets in the bathroom, near the kitchen sink, or in
other damp places. Heat or moisture may cause the medicine to break down.
- Do not keep outdated medicine or medicine no longer needed. Be sure that any
discarded medicine is out of the reach of children.
Precautions While Using Tramadol
This medicine will add to the effects of alcohol and other CNS depressants
(medicine that causes drowsiness). Some examples of CNS depressants are
antihistamines or medicine for hay fever, other allergies, or colds; sedatives,
tranquilizers, or sleeping medicine; prescription pain medicine or narcotics;
barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including
some dental anesthetics. Do not drink alcoholic beverages, and check with
your medical doctor or dentist 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.
Dizziness, lightheadedness, or fainting may occur, especially when
you get up suddenly from a lying or sitting position. Getting up slowly may help
lessen this problem.
Nausea or vomiting may occur, especially after the first couple of doses.
This effect may go away if you lie down for awhile. However, if nausea or
vomiting continues, check with your medical doctor or dentist. Lying down for a
while may also help relieve some other side effects, such as dizziness or
lightheadedness, that may occur.
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. Taking tramadol together with medicines that are used during surgery
or dental or emergency treatments may cause increased side effects.
If you think you or someone else may have taken an overdose of tramadol,
get emergency help at once. Signs of an overdose include convulsions
(seizures) and pinpoint pupils of the eyes.
Side Effects of This Medicine
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.
Get emergency help immediately if any of the following symptoms of
overdose occur:
- Convulsions (seizures); difficulty in breathing; pinpointed pupils of the
eyes
Also, check with your doctor as soon as possible if any of the following side
effects occur:
- Less common or rare
- Blisters under the skin; blurred vision ; change in walking and balance;
convulsions (seizures); difficult urination; dizziness or lightheadedness when
getting up from a lying or sitting position; fainting; fast heartbeat;
frequent urge to urinate; loss of memory; numbness, tingling, pain, or
weakness in hands or feet; seeing, hearing, or feeling things that are not
there; severe redness, swelling, and itching of the skin; shortness of breath
; trembling and shaking of hands or feet; trouble performing routine tasks
Other 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. However, check with your doctor if any of the following side effects
continue or are bothersome:
- More common
- Abdominal or stomach pain; agitation ; anxiety; constipation ;
diarrhea; dizziness; drowsiness; dry mouth; headache; heartburn; itching
of the skin; loss of appetite; loss of strength or weakness; nausea ;
nervousness; skin rash ; sweating; unusual feeling of excitement; vomiting
- Less common
- Confusion; depression; excessive gas; flushing or redness of the skin;
general feeling of bodily discomfort; hot flashes; trouble in sleeping
After you stop using this medicine, your body may need time to adjust. The
length of time this takes depends on the amount of medicine you were using and
how long you used it. During this period of time check with your doctor if you
notice any of the following side effects:
- Anxiety; body aches; diarrhea; fast heartbeat; fever, runny nose, or
sneezing; gooseflesh; high blood pressure; increased sweating ; increased
yawning; loss of appetite; nausea or vomiting; nervousness, restlessness or
irritability; shivering or trembling; stomach cramps; trouble in sleeping;
unusually large pupils; weakness
Other side effects not listed above may also occur in some patients. If you
notice any other effects, check with your doctor.
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