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.

• 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 days until the desired response is reached. No more than 80 mg should be taken within 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 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:

• 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• Do not keep outdated medicine or medicine no longer needed.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.

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:

• 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) The chance of side effects may be increased

• Diabetes mellitus (sugar diabetes) Baclofen may raise blood sugar levels

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