Summary: Baclofen is a powerful injectible and oral drug that may occasionally be prescribed by a doctor for the relief of muscle spasticity, that includes many causes, one of which may be cerebral palsy. The text of this paper is adapted from the information given by USP DI. Last revised January 21, 2007

 

BACLOFEN (Systemic): Especially as applicable to CP

Description

Baclofen 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:

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 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 health care professional 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 health care professional know if you are taking any of the following:

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:

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 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.

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:

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 :

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:

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:

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.

Warning

BACLOFEN IS A PRESCRIPTION ONLY DRUG. THIS INFORMATION IS ONLY A GUIDELINE TO HELP YOU INFORM YOUR DOCTOR ABOUT PRE-EXISTING CONDITIONS / SIDE EFFECTS IF ANY, IN CASE IT IS GIVEN TO YOUR CHILD.
IT IS NOT MEANT AS A GUIDE FOR SELF MEDICATION.


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