Baclofen

Baclofen belongs to a class of medications called skeletal muscle relaxants. Baclofen is an antispasmodic agent that acts on spinal cord nerves and decreases the number and severity of muscle spasms in patients with certain conditions affecting the spinal cord.

Baclofen is used in adults and children at least 4 years old to treat certain types of spasticity (muscle stiffness and tightness) and muscle pain in people with multiple sclerosis or a spinal cord injury or other spinal cord diseases.

Baclofen relieves pain and improves muscle movement.

Take baclofen exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Shake the oral suspension (liquid).

Measure a dose with the supplied measuring device (not a kitchen spoon).

Shake and pour the entire oral granules packet to dissolve in your mouth or swallow whole at once, with or without liquids.

You may also mix the granules with liquids (milk, or apple juice) or soft food (apple sauce, yogurt, or pudding).

The oral granules can also be given through a feeding tube. Ask your doctor or pharmacist if you do not understand these instructions.

Call your doctor if your symptoms do not improve, or if they get worse.

You may have severe or life-threatening withdrawal symptoms if you stop using baclofen suddenly. Ask your doctor before stopping the medicine.

If you receive baclofen through an implantable pump, it is very important to keep your scheduled refill visits and pay attention to pump alarms to prevent a sudden, life-threatening withdrawal.

Store the oral suspension (liquid) at room temperature away from moisture and heat. Throw away any unused portion 2 months after first opening.

Store Ozobax in the refrigerator, do not freeze.

Use caution when taking baclofen at a time when you need muscle tone for safe balance and movement during certain activities. Baclofen may make you drowsy. Do not drive or operate heavy machinery until you know how this medicine affects you.

Do not stop using this medicine suddenly. Stopping suddenly can cause severe withdrawal symptoms, including hallucinations, seizures, high fever, confusion, severe muscle stiffness, multiple organ-system failure, and death.

Ask your doctor about the safe use of alcoholic beverages while you are taking baclofen. Alcohol can make the side effects from baclofen worse.

You should not use this medicine if you are allergic to baclofen.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• mental illness or psychosis;
• epilepsy or other seizure disorder;
• problems with balance;
• cerebral palsy;
• Parkinson's disease;
• schizophrenia or a confused state;
• high blood pressure, a sudden increase in high blood pressure (autonomic dysreflexia), or fast heart rate;
• a rheumatic disease;
• a stroke or blood clot; or
• kidney disease.

Using baclofen may increase your risk of developing an ovarian cyst. Talk with your doctor about your own risk.

Tell your doctor if you are pregnant or plan to become pregnant, or breastfeeding or plan to breastfeed. If you take baclofen while pregnant or breastfeeding, withdrawal symptoms such as tremors, stiff muscles, or seizure may occur in the baby.

Get emergency medical help if you have signs of an allergic reaction to baclofen: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Baclofen may cause serious side effects. Call your doctor at once if you have:

• severe drowsiness, breathing problems;
• confusion, hallucinations;
• muscle weakness, itching, tingling, or twitching in your hands, arms, feet, or legs; or
• fever.

Common baclofen side effects may include:

• drowsiness, dizziness, weakness, or tiredness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Spasticity:

Oral: -Initial dose: The following gradually increasing dosage regimen is suggested, but should be adjusted to suit individual patient requirements: 5 mg orally 3 times a day for 3 days, then 10 mg orally 3 times a day for 3 days, then 15 mg orally 3 times a day for 3 days, then 20 mg orally 3 times a day for 3 days -Maintenance dose: Should be individualized. -Maximum dose: 80 mg/day (20 mg orally 4 times a day).

Usual Pediatric Dose for Spasticity:

12 years and older: Oral: -Initial dose: The following gradually increasing dosage regimen is suggested, but should be adjusted to suit individual patient requirements: 5 mg orally 3 times a day for 3 days, then 10 mg orally 3 times a day for 3 days, then 15 mg orally 3 times a day for 3 days, then 20 mg orally 3 times a day for 3 days -Maintenance dose: Should be individualized. -Maximum dose: 80 mg/day (20 mg orally 4 times a day) Comments: -The lowest dose compatible with an optimal response is recommended. -Slowly withdraw therapy if benefits are not evident after a reasonable period.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include increasing drowsiness, dizziness, sleepiness, trouble focusing on objects, shallow breathing, seizure, or muscle weakness leading to loss of consciousness.

Avoid drinking alcohol.

Avoid driving or hazardous activity until you know how baclofen will affect you. Your reactions could be impaired.

Do not share this medicine with another person, even if they have the same symptoms you have.

Using baclofen with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may interact with baclofen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.