BACLOFEN (Systemic)

Some commonly used brand names are:

In the U.S.?

• Lioresal

In Canada?

• Lioresal
• Apo-Baclofen
• Novo-Baclofen
• Nu-Baclofen
• PMS-Baclofen

Generic name product may be available in the U.S.

Category

• Antispastic analgesic (in trigeminal neuralgia)

Description

Baclofen (BAK-loe-fen) is used to helprelax certain muscles in your body. It relieves the spasms, cramping, andtightness of muscles caused by medical problems such as multiple sclerosisor certain injuries to the spine. Baclofen does not cure these problems, butit may allow other treatment, such as physical therapy, to be more helpfulin improving your condition.

Baclofen acts on the central nervous system (CNS) to produce its musclerelaxant effects. Its actions on the CNS may also cause some of the medicine'sside effects. Baclofen may also be used to relieve other conditions as determinedby your doctor.

This medicine is available only with your doctor's prescription, in thefollowing dosage form:

Oral
• Tablets (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For baclofen, the followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to baclofen. Also tell your health care professional ifyou are allergic to any other substances, such as foods, preservatives, ordyes.

Pregnancy?Studies on birth defects with baclofen have not beendone in humans. However, studies in animals have shown that baclofen, whengiven in doses several times the human dose, increases the chance of herniasand incomplete or slow development of bones in the fetus, and of lower birthweight.

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 adultpatients, and there is no specific information comparing use of baclofen inchildren with use in other age groups.

Older adults?Side effects such as hallucinations, confusion ormental depression, other mood or mental changes, and severe drowsiness maybe especially likely to occur in elderly patients, who are usually more sensitivethan younger adults to the effects of baclofen.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingbaclofen, it is especially important that your health care professional knowif 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) depressants (medicines that causes drowsiness)?Thechance of side effects may be increased

Other medical problems?The presence of other medicalproblems may affect the use of baclofen. Make sure you tell your doctor ifyou have any other medical problems, especially:

• Type 2 diabetes mellitus ?Baclofen may raise bloodsugar levels

• Epilepsy or
• Kidney disease or
• Mental or emotional problems or
• Stroke or other brain disease?The chance of side effects maybe increased

Proper Use of This Medicine

Dosing?The dose of baclofen will be different for different patients. Follow your doctor's orders or the directions on thelabel. The following information includes only the average doses ofbaclofen. 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:
    • Adults and teenagers?At first, the dose is 5 milligrams (mg)three times a day. Then, each dose may be increased by 5 mg every three daysuntil the desired response is reached. No more than 80 mg should be takenwithin a twenty-four-hour period.
    • Children?Use and dose must be determined by your doctor.

Missed dose?If you miss a dose of this medicine, and you rememberwithin 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 backto 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 in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Do not suddenly stop taking this medicine. Unwanted effectsmay occur if the medicine is stopped suddenly. Check with your doctor forthe best way to reduce gradually the amount you are taking before stoppingcompletely.

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 abovewhile you are using baclofen.

This medicine may cause drowsiness, dizziness, vision problems, or clumsinessor unsteadiness in some people. Make sure you know howyou react to this medicine before you drive, use machines, or do anythingelse that could be dangerous if you are not alert, well-coordinated, and ableto see well.

For diabetic patients:

• This medicine may cause your blood sugar levels to rise. If you noticea change in the results of your blood or urine sugar test or if you have anyquestions 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 mayneed medical attention.

Check with your doctor as soon as possible if any of the following sideeffects occur:

Less common or rare

Bloody or dark urine; chest pain; fainting; hallucinations (seeing orhearing things that are not there); mental depressionor other mood changes; ringing or buzzing in theears; 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 medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects 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 amountof urine; false sense of well-being; frequent urge to urinate or uncontrolled urination; headache; loss of appetite; low blood pressure; muscle or jointpain; numbness or tingling in hands or feet; pounding heartbeat; sexual problemsin males; slurred speech or other speech problems; stuffy nose; swellingof ankles; trouble in sleeping; unexplained muscle stiffness; unusual excitement; unusual tiredness; weightgain

Some side effects may occur after you have stopped taking this medicine,especially if you stop taking it suddenly. Check withyour doctor immediately if any of the following effects occur:

Convulsions (seizures); hallucinations(seeing or hearing things that are not there); increasein muscle spasm, cramping, or tightness; mood ormental changes; unusual nervousness or restlessness

Other side effects not listed above mayalso occur in some patients. If you notice any other effects, check with yourdoctor.

Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although this use is not included in product labeling,baclofen is used in certain patients with trigeminal neuralgia (severe burningor 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.