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Tramadol
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About Tramadol
Tramadol ( TRA-ma-dole) is used to relieve pain,
including pain after surgery. The long-acting tablets
are used for chronic ongoing pain. 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.
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.
Before taking this medicine, make sure your doctor knows
if you are pregnant or if you may become pregnant.
- 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
tablets in patients less than 16 years of age and
tramadol extended-release tablets in patients less than
18 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.
Neuroleptic drugs (antipsychotic drugs)
(chlorpromazine [e.g., Thorazine], clozapine [e.g.,
Clozaril], haloperidol [e.g., Haldol], loxapine [e.g.,
Loxitane]) or Other drugs that lower seizure threshold
(epilepsy drugs)-May increase chances of seizures so
caution is recommended
- 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.
- Addiction problems or Suicidal - Tramadol
should not be used.
- Alcohol or drug abuse, or history of - May
increase the serious side effects of tramadol
- Epilepsy or History of seizures - Increased
risk for seizures caused by alcohol and drug
withdrawal, brain or spinal cord infections, or head
trauma-Risk of seizures may be increased.
- 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.
Proper Use of This Medicine
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 chronic pain:
For oral dosage form
(long-acting tablets):
- Adults-100 mg once a day. Your doctor may increase
your dose as needed. You should not take more than 300
mg per day.
- Children up to 18 years of age-Use and dose must
be determined by your doctor.
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 dayYour 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 This Medicine
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:
- Change in consciousness; chest pain or discomfort;
convulsions (seizures); decreased awareness or
responsiveness; difficulty in breathing; dizziness or
fainting; lack of muscle tone; lightheadedness ; loss
of consciousness; pinpointed pupils of the eyes;
severe sleepiness ; shortness of breath; slow or
irregular heartbeat; unusual
tiredness
Also, check with your doctor
as soon as possible if any of the following side effects
occur:
Less common or rare
- Abdominal fullness; abnormal or decreased touch
sensation; blisters under the skin; bloating; blood in
urine; blood pressure increased; blurred vision ;
chest pain or discomfort; change in walking and
balance; chills; convulsions (seizures); darkened
urine ; difficult urination; dizziness or
lightheadedness when getting up from a lying or
sitting position ; fainting; fast heartbeat ; frequent
urge to urinate; gaseous abdominal pain; heart rate
increased; indigestion; irregular heartbeat; loss of
memory; numbness and tingling of face, fingers, or
toes; numbness, tingling, pain, or weakness in hands
or feet; pain in arms, legs, or lower back, especially
pain in calves and/or heels upon exertion; pain or
discomfort in arms, jaw, back or neck; pains in
stomach, side, or abdomen, possibly radiating to the
back; pale bluish-colored or cold hands or feet;
recurrent fever; seeing, hearing, or feeling things
that are not there; severe cramping; severe nausea;
severe redness, swelling, and itching of the skin;
shortness of breath; sweats; trembling and shaking of
hands or feet; trouble performing routine tasks; weak
or absent pulses in legs; yellow eyes or
skin
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 ; cough; diarrhea; discouragement;
dizziness; drowsiness; dry mouth; feeling of warmth;
feeling sad or empty ; feeling unusually cold; fever;
general feeling of discomfort or illness; headache;
heartburn; itching of the skin; irritability; joint
pain; loss of appetite; loss of interest or pleasure;
loss of strength or weakness; muscle aches and pains;
nausea; nervousness; redness of the face, neck, arms
and occasionally, upper chest; restlessness; runny
nose; shivering; skin rash; sleepiness or unusual
drowsiness; sore throat; stuffy nose; sweating;
tiredness; trouble concentrating; unusual feeling of
excitement; unusual tiredness or weakness; vomiting;
weakness
Less common or rare
- Abnormal dreams; appetite decreased ; back pain;
bladder pain ; blistering, crusting, irritation,
itching, or reddening of skin; bloody or cloudy urine;
body aches or pain; change in hearing; clamminess;
cold flu-like symptoms; confusion; cough producing
mucus; cracked, dry, scaly skin; decreased interest in
sexual intercourse; difficult, burning, or painful
urination; difficulty breathing ; difficulty in
moving; disturbance in attention; ear congestion; ear
drainage; earache or pain in ear ; excessive gas;
fall; false or unusual sense of well-being; feeling
hot; feeling jittery; flushing or redness of the skin;
general feeling of bodily discomfort; goosebumps;
headache, severe and throbbing; hoarseness; hot
flashes; inability to have or keep an erection;
itching, pain, redness, swelling, tenderness, warmth
on skin; joint sprain; joint stiffness; joint
swelling; loss in sexual ability, desire, drive, or
performance; loss of voice; lower back or side pain;
muscle aching or cramping; muscle injury ; muscle pain
or stiffness; muscle spasms or twitching; nasal
congestion; neck pain; night sweats; pain; pain in
limb; pain or tenderness around eyes and cheekbones;
pain, swelling, or redness in joints; skin
discoloration ; swelling; swelling of hands, ankles,
feet, or lower legs; tightness of chest; trouble in
holding or releasing urine; troubled breathing;
trouble in sleeping ; weight increased or decreased
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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