Lyvispah Oral Granules

Lyvispah (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.

Lyvispah oral granules are used in adults and children at least 12 years old to treat muscle pain, spasms, and stiffness in people with multiple sclerosis or a spinal cord injury or disease.

Lyvispah relieves pain and improves muscle movement. Lyvispah should not be used to treat muscle spasms from inflammatory (rheumatic) disorders.

Take Lyvispah 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 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 withdrawal symptoms, such as severe muscle spasms, hallucinations, seizures, high fever, confusion, organ failure, and death, if you stop using Lyvispah suddenly. Ask your doctor before stopping the medicine.

Store the oral granules at room temperature, 68°F to 77°F (20°C to 25°C).

Do not use Lyvispah at a time when you need muscle tone for safe balance and movement during certain activities. Lyvispah 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, or you could have severe withdrawal symptoms, including severe muscle spasms, organ failure, and death.

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

You should not use Lyvispah if you are allergic to baclofen, or any of the ingredients in Lyvispah oral granules.

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

• mental illness or psychosis;
• epilepsy or other seizure disorder;
• problems with balance;
• high blood pressure, or fast heart rate;
• a stroke or blood clot; or
• kidney disease.

Using Lyvispah 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 Lyvispah while pregnant, withdrawal symptoms such as tremors, stiff muscles, or seizure may occur in the baby. This medicine can pass into breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby.

Get emergency medical help if you have signs of an allergic reaction to Lyvispah: 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 Lyvispah 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.

Initiate Lyvispah treatment using a low dosage, preferably in divided doses, administered orally. The following gradually increasing dosage regimen is suggested, but should be adjusted based on individual response and tolerance:

5 mg three times a day for three days 10 mg three times a day for three days 15 mg three times a day for three days 20 mg three times a day for three days

Additional increases may be necessary up to the maximum recommended dosage of 80 mg daily (20 mg four times a day). Multiple packets or multiple strengths can be used to achieve the prescribed dosage.

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 this medicine 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 Lyvispah 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 affect baclofen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Active ingredient: baclofen Inactive ingredients: amino methacrylate copolymer, calcium stearate, colloidal silicon dioxide, crospovidone, hypromellose, mannitol, saccharin sodium, strawberry flavor, talc, and xylitol.

Distributed by: Saol Therapeutics, Inc. Roswell, GA, USA.