Baclofen (Oral Route)

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.

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.``

This product is available in the following dosage forms:

• Tablet

Before Using

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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.

Geriatric

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.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Type 2 diabetes mellitusa€”Baclofen may raise blood sugar levels

• Epilepsy or


• Kidney disease or


• Mental or emotional problems or


• Stroke or other brain diseasea€”The chance of side effects may be increased

Proper Use

Dosing

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, 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 using the medicine.

• For oral dosage form (tablets):
  
  
  
  • For muscle relaxation:
    
    
    
    • Adults and teenagersa€”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 .
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Missed Dose

If 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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions

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 .

Side Effects

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:

Less common or 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

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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

After you stop using this medicine, it may still produce some side effects that need attention . During this period of time, check with your doctor immediately if you notice the following side effects:

• 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 may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.