I started on it sometime when I was first in ICU (8 years ago) and don't
know if I had any adverse reaction at first. I don't have any now, possibly
drowsiness is because of the baclefin.
Here's the information I have:
Drug Reference
Baclofen (Systemic)
It is very important that you read and understand the following
information. If
any of it causes you special concern, check with your doctor. Also, if you
have
any questions or if you want more information about this medicine or your
medical problem, ask your doctor, nurse, or pharmacist.
Consumer Reports Complete Drug Reference as Compiled by the U.S. Pharmacopeia.
Copyright (c) 1993, The United States Pharmacopeial Convention.
Overview: BACLOFEN (Systemic)
-----------------------------
It is very important that you read and understand the following
information. If
any of it causes you special concern, check with your doctor. Also, if you
have
any questions or if you want more information about this medicine or your
medical problem, ask your doctor, nurse, or pharmacist.
Brand and Common Names
----------------------
A commonly used brand name in the U.S. and Canada is Lioresal.
Generic name product may also be available in the U.S.
Description
-----------
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
o Tablets (U.S. and Canada)
Before Using This Medicine
--------------------------
Before you begin using any new medicine (prescription or nonprescription)
or if
you develop any new medical problem while you are using this medicine, check
with your doctor, nurse, or pharmacist.
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:
ALLERGIES: Tell your doctor if you have ever had any unusual or allergic
reaction to baclofen. Also tell your doctor and pharmacist if you are
allergic
to any other substances, such as foods, preservatives, or dyes.
PREGNANCY: 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.
BREAST-FEEDING: Baclofen passes into the breast milk. However, this medicine
has not been reported to cause problems in nursing babies.
CHILDREN: 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.
OLDER ADULTS: 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.
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 baclofen, it
is especially important that your doctor and pharmacist know if you are
taking
any of the following:
o 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
o Central nervous system (CNS) depressants: The chance of
side effects may be increased
OTHER MEDICAL PROBLEMS: 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:
o Diabetes mellitus (sugar diabetes): Baclofen may raise
blood sugar levels
o Epilepsy or
o Kidney disease or
o Mental or emotional problems or
o Stroke or other brain disease: The chance of side effects
may be increased
Proper Use of This Medicine
---------------------------
MISSED DOSE: 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.
STORAGE To store this medicine:
o Keep out of the reach of children.
o Store away from heat and direct light.
o 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.
o 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
-------------------------------------
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:
o 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.
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.
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
restlessnessOther side effects not listed above may also occur in some
patients. If you notice any other effects, check with your doctor.
Additional Information
----------------------
Once a medicine has been approved for marketing for a certain use, experience
may show that it is also useful for other medical problems. Although this
use is
not included in product labeling, baclofen is used in certain patients with
trigeminal neuralgia (severe burning or stabbing pain along the nerves in the
face); also called "tic douloureux."
There is no additional information relating to proper use, precautions, or
side
effects for this use of baclofen.
Jim Lubin
jlubin(AT)eskimo.com
http://www.eskimo.com/~jlubin
----
A searchable archive and more TM information is available at:
Transverse Myelitis Internet Club
http://www.eskimo.com/~jlubin/disabled/tmic