WHAT IS RYTARY?

Carbidopa and levodopa is a combination medicine used to treat symptoms of Parkinson’s disease, such as muscle stiffness, tremors, spasms, and poor muscle control. Parkinson’s disease may be caused by low levels of a chemical called dopamine in the brain.

Levodopa is converted to dopamine in the brain. Carbidopa helps prevent the breakdown of levodopa before it can reach the brain and take effect.

Carbidopa and levodopa is also used to treat Parkinson symptoms caused by carbon monoxide poisoning or manganese intoxication.

Carbidopa and levodopa may also be used for purposes not listed in this medication guide.

You should not use carbidopa and levodopa if you have narrow-angle glaucoma.

Do not use carbidopa and levodopa if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You should not use carbidopa and levodopa if you are allergic to it, or if you have narrow-angle glaucoma.

To make sure carbidopa and levodopa is safe for you, tell your doctor if you have:

• Heart disease, high blood pressure, history of heart attack;
• liver or kidney disease;
• an endocrine (hormonal) disorder;
• asthma, chronic obstructive pulmonary disease (COPD), or other breathing disorder;
• a stomach or intestinal ulcer;
• open-angle glaucoma; or
• a history of depression, mental illness, or psychosis.

People with Parkinson’s disease may have a higher risk of skin cancer (melanoma). Talk to your doctor about this risk and what skin symptoms to watch for.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Carbidopa and levodopa can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

The carbidopa and levodopa disintegrating tablet may contain phenylalanine. Talk to your doctor before using this form of carbidopa and levodopa if you have phenylketonuria (PKU).

RYTARY SIDE EFFECTS

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

Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• worsening of tremors (uncontrolled shaking);
• severe or ongoing vomiting or diarrhea;
• confusion, hallucinations, unusual changes in mood or behavior;
• depression or suicidal thoughts; or
• severe nervous system reaction–very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Some people taking carbidopa and levodopa have fallen asleep during normal daytime activities such as working, talking, eating, or driving. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

You may notice that your sweat, urine, or saliva appears dark in color, such as red, brown, or black. This is not a harmful side effect, but it may cause staining of your clothes or bed sheets. Common side effects may include:

• jerky or twisting muscle movements;
• muscle contractions; or
• nausea.

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.