Baclofen (BAK-loe-fen) is used to
help relax certain muscles in your body. It relieves the spasms, cramping, and
tightness of muscles caused by medical problems such as multiple sclerosis or
certain injuries to the spine. Baclofen does not cure these problems, but it
may allow other treatment, such as physical therapy, to be more helpful in
improving your condition.
Baclofen acts on the central nervous
system (CNS) to produce its muscle relaxant effects. Its actions on the CNS may
also cause some of the medicine's side effects. Baclofen may also be used to
relieve other conditions as determined by your doctor.
This medicine is available only with
your doctor's prescription, in the following dosage form:
Oral
Tablets (U.S. and Canada)
Before/Having/Using/Receiving this
Medicine/Testó 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 baclofen, the following should be
considered:
Tell your doctor if you have ever had
any unusual or allergic reaction to baclofen. Also tell your health care
professional if you are allergic to any other substances, such as foods,
preservatives, or dyes.
Studies on birth defects with
baclofen have not been done in humans. However, studies in animals have shown
that baclofen, when given in doses several times the human dose, increases the
chance of hernias and incomplete or slow development of bones in the fetus, and
of lower birth weight.
Baclofen passes into the breast milk.
However, this medicine has not been reported to cause problems in nursing
babies.
Studies on this medicine have been
done only in adult patients, and there is no specific information comparing use
of baclofen in children with use in other age groups.
Side effects such as hallucinations,
confusion or mental depression, other mood or mental changes, and severe
drowsiness may be especially likely to occur in elderly patients, who are
usually more sensitive than younger adults to the effects of baclofen.
The presence of other medical
problems may affect the use of baclofen. Make sure you tell your doctor if you
have any other medical problems, especially:
Diabetes mellitus (sugar diabetes)
Baclofen may raise blood sugar levels
Epilepsy or Kidney disease or Mental
or emotional problems or Stroke or other brain diseaseóThe chance of side
effects may be increased
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 baclofen, it is especially important that your health care professional
know if you are taking any of the following:
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)
depressantsóThe chance of side effects may be increased
To store this medicine:
Keep out of the reach of children.
Store away from heat and direct light. Do not store 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.
The dose of baclofen 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 baclofen.
If your dose is different, do not change it unless your doctor tells you to do
so.
For oral dosage form (tablets):
For muscle relaxation:
At first, the dose is 5 milligrams
(mg) three times a day. Then, each dose may be increased by 5 mg every three
days until the desired response is reached. No more than 80 mg should be taken
within a twenty-four hour period.
Use and dose must be determined by
your doctor.
If you miss a dose of this medicine,
and you remember within an hour or so of the missed dose, take it as soon as
you remember. However, if you do not remember until later, skip the missed dose
and go back to your regular dosing schedule. Do not double doses.
Precautions While/After Using
Receiving this Medicineó
Do not suddenly stop taking this
medicine. Unwanted effects may occur if the medicine is stopped suddenly. Check
with your doctor for the best way to reduce gradually the amount you are taking
before stopping completely.
This medicine will add to the effects
of alcohol and other CNS depressants (medicines that slow down the nervous
system, possibly causing 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; other muscle relaxants; or anesthetics,
including some dental anesthetics. Check with your doctor before taking any of
the above while you are using baclofen.
This medicine may cause drowsiness,
dizziness, vision problems, or clumsiness or unsteadiness in some people. 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 not alert, well-coordinated,
and able to see well.
For diabetic patients:
This medicine may cause your blood
sugar levels to rise. If you notice a change in the results of your blood or
urine sugar test or if you have any questions about this, check with your
doctor.
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.
Check with your doctor as soon as
possible if any of the following side effects occur:
Rare Bloody or dark urine; chest
pain; fainting; hallucinations (seeing or hearing things that are not there);
mental depression or other mood changes; ringing or buzzing in the ears; skin
rash or itching
Symptoms of overdose Blurred or
double vision; convulsions (seizures); muscle weakness (severe); shortness of
breath or unusually slow or troubled breathing; vomiting
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 Confusion; dizziness or
lightheadedness; drowsiness; nausea; unusual weakness, especially muscle
weakness
Less common or rare Abdominal or
stomach pain or discomfort; clumsiness, unsteadiness, trembling, or other
problems with muscle control; constipation; diarrhea; difficult or painful
urination or decrease in amount of urine; false sense of well-being; frequent
urge to urinate or uncontrolled urination; headache; loss of appetite; low
blood pressure; muscle or joint pain; numbness or tingling in hands or feet;
pounding heartbeat; sexual problems in males; slurred speech or other speech
problems; stuffy nose; swelling of ankles; trouble in sleeping; unexplained
muscle stiffness; unusual excitement; unusual tiredness; weight gain
Some side effects may occur after you
have stopped taking this medicine, especially if you stop taking it suddenly. Check
with your doctor immediately if any of the following effects occur:
Convulsions (seizures);
hallucinations (seeing or hearing things that are not there); increase in
muscle spasm, cramping, or tightness; mood or mental changes; unusual
nervousness or restlessness
Other side effects not listed above
may also occur in some patients. If you notice any other effects, check with
your doctor.
NOTICE:
The information about drugs contained
in this website is general in nature and is intended for use as an educational
aid. It does not cover all possible uses, actions, precautions, side effects,
or interactions of these medicines, nor is the information intended as medical
advice for individual problems or for making an evaluation as to the risks and
benefits of taking a particular drug. Side effects contained herein, although possible,
may be extremely rare. Always consult your physician to assess your particular
risks.
Once a medicine has been approved for marketing for a
certain use, experience may show that it is also useful for other medical
problems. In certain cases this would mean that the medication may not have FDA
approval for a certain use, for which your physician may know it to be appropriate.
FDA approval for a specific indication is usually given to those drugs for
which the parent pharmaceutical company has decided to invest money in conducting
efficacy and safety studies, for the use of the medicine on that particular
indication. Occasionally, the condition may be rare and the investment to
profit ratio for the pharmaceutical may not warrant their interest in pursuing
that indication.