Istradefylline

Istradefylline is used along with levodopa and carbidopa to treat "wearing-off" episodes (muscle stiffness, loss of muscle control) in individuals with Parkinson's disease.

Istradefylline may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Istradefylline is usually taken once per day. Follow your doctor's dosing instructions very carefully.

You may take istradefylline with or without food.

Store at room temperature away from moisture and heat.

Follow all instructions on your medicine label and package. Inform each of your healthcare providers about all your medical conditions, allergies, and all medicines you are using.

Tell your doctor if you have ever had:

• abnormal muscle movements;
• mental illness or psychosis;
• liver disease; or
• if you smoke.

Tell your doctor if you are pregnant or breastfeeding.

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

Istradefylline may cause serious side effects. Call your doctor right away if you have:

• uncontrolled or involuntary muscle movements;
• unusual thoughts or behavior;
• confusion, hallucinations; or
• risk-taking behavior, being impulsive.

You may experience increased sexual urges, unusual urges to gamble, or other strong urges while taking istradefylline. Talk with your doctor if this happens.

Common side effects of istradefylline may include:

• involuntary muscle movements;
• hallucinations;
• dizziness;
• nausea, constipation; or
• sleep problems (insomnia).

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 Parkinson's Disease:

Initial dose: 20 mg orally once a day -Dose may be increased based on individual need and tolerability Maintenance dose: 20 to 40 mg orally once a day Maximum dose: 40 mg/day Use: As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing OFF episodes.

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 the same time.

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

Follow your doctor's instructions about any restrictions on food, drinks, or activities.

Sometimes, it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medications less effective.

Other drugs may affect istradefylline, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.