INDICATIONS

Lioresal (Baclofen) is a muscle relaxer and an antispastic agent.

Baclofen is used to treat muscle symptoms caused by multiple sclerosis, including spasm, pain, and stiffness.

Baclofen may also be used for purposes not listed in this medication guide.

INSTRUCTIONS

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.
Call your doctor if your muscle symptoms do not improve after 2 weeks of taking this medication. Do not stop taking this medication without first talking to your doctor. You may have withdrawal symptoms such as seizures or hallucinations, when you stop using baclofen after using it over a long period of time. You may need to use less and less before you stop the medication completely.

DOSAGE

Take the medicine as directed by your doctor.

Adult Patients with Spasticity of Spinal Cord Origin: After the first 24 hours, for adult patients, the daily dosage should be increased slowly by 10- 30% increments and only once every 24 hours, until the desired clinical effect is achieved.

Adult Patients with Spasticity of Cerebral Origin: After the first 24 hours, the daily dose should be increased slowly by 5- 15% only once every 24 hours, until the desired clinical effect is achieved.

Pediatric Patients: After the first 24 hours, the daily dose should be increased slowly by 5-15% only once every 24 hours, until the desired clinical effect is achieved. If there is not a substantive clinical response to increases in the daily dose, check for proper pump function and catheter patency. Patients must be monitored closely in a fully equipped and staffed environment during the screening phase and dose- titration period immediately following implant. Resuscitative equipment should be immediately available for use in case of life- threatening or intolerable side effects.

STORAGE

Does not require refrigeration.

Do not store above 86°F (30°C).

Do not freeze.

Do not heat sterilize.

MORE INFO:

Active ingredient: Baclofen

Lioresal is a muscle relaxant. It reduces the frequency and severity of muscle spasms that occur as a result of neurological disorders such as multiple sclerosis.

SAFETY INFORMATION

You should not use baclofen if you are allergic to it.

To make sure you can safely take baclofen, tell your doctor if you have any of these other conditions:

kidney disease;

epilepsy or other seizure disorder; or

a history of stroke or blood clots.

Using baclofen may increase your risk of developing an ovarian cyst. Talk with your doctor about your specific risk. FDA pregnancy category C. It is not known whether baclofen will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether baclofen passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using baclofen. Do not give this medication to a child younger than 12 years old. Older adults may be more sensitive to the effects of this medicine.

Important safety information

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of baclofen. Do not use baclofen at a time when muscle tone is needed to assure safe balance and movement for certain activities. In some situations, it may endanger your physical safety to be in a state of reduced muscle tone.

SIDE EFFECTS

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

seizure (convulsions);

confusion, hallucinations; or

an uneven heartbeat.

Less serious side effects may include:

drowsiness, dizziness, weakness, tired feeling;

headache;

sleep problems (insomnia);

nausea, constipation; or

urinating more often than usual.

This is not a complete list of side effects and others may occur.

Call your doctor for medical advice about side effects.