Rytary contains a combination of carbidopa and levodopa.

Rytary extended release capsules are 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 (DOE pa meen) in the brain.

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

You should not use Rytary if you have narrow-angle glaucoma.

Do not use Rytary if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.

Take Rytary 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.

If you already take levodopa, you must stop taking it at least 12 hours before you start taking Rytary.

Rytary can be taken with or without food. Take your doses at regular intervals to keep a steady amount of the drug in your body at all times.

Swallow the capsule whole and do not crush, chew, break, or open it.

It may take up to several weeks of using Rytary before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after a few weeks of treatment. Also tell your doctor if the effects of this medication seem to wear off quickly in between doses.

If you use Rytary long-term, you may need frequent medical tests.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Rytary.

Do not stop using Rytary suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Parkinson's Disease:

Optimum dosage is determined by careful individual titration: All doses expressed as CARBIDOPA-LEVODOPA

Rytary extended-release capsules:
-Initial dose (levodopa-naive): 23.75 mg-95 mg orally 3 times a day for 3 days; on the fourth day, may increase to 36.25 mg-145 mg 3 times a day
-Dosing interval may be increased up to a maximum of 5 times a day, if tolerated
-Maximum daily dose: 612.5 mg-2450 mg
Conversion from IMMEDIATE-RELEASE carbidopa-levodopa to Rytary: These recommended starting doses should be divided and given three times a day:
-For patients receiving levodopa 400 to 549 mg/day: total daily dose of levodopa in Rytary - 855 mg/day
-For patients receiving levodopa 550 to 749 mg/day: total daily dose of levodopa in Rytary - 1140 mg/day
-For patients receiving levodopa 750 to 949 mg/day: total daily dose of levodopa in Rytary - 1305 mg/day
-For patients receiving levodopa 950 to 1249 mg/day: total daily dose of levodopa in Rytary - 1755 mg/day
-For patients receiving levodopa equal or greater than 1250 mg/day: Rytary levodopa dose should be 2205 or 2340 mg/day

Comments:
-Peripheral dopa decarboxylase is saturated by carbidopa at approximately 70 to 100 mg/day; patient's receiving less than this amount of carbidopa are more likely to experience nausea and vomiting; experience with carbidopa doses greater than 200 mg/day is limited.
-Rytary products are not interchangeable with other carbidopa-levodopa products; for patients receiving carbidopa-levodopa plus catechol-O-methyl transferase (COMT) inhibitors, the initial recommended total daily dose of levodopa may need to be increased.

Use: For the treatment of the symptoms of idiopathic Parkinson's disease, postencephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication.

You should not use Rytary if you are allergic to carbidopa or levodopa, or if you have:

• narrow-angle glaucoma.

Do not use Rytary 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, tranylcypromine, and others.

To make sure Rytary is safe for you, tell your doctor if you have:

• heart disease, high blood pressure, or 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

• 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.

Tell your doctor if you are pregnant or breastfeeding.

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.

Get your prescription refilled before you run out of medicine completely.

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

Avoid driving or hazardous activity until you know how Rytary will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid taking iron supplements or eating a diet that is high in protein (protein sources include meat, eggs, and cheese). These things can make it harder for your body to digest and absorb carbidopa and levodopa. Talk with your doctor or dietitian about the best foods to eat while you are taking this medicine.

Get emergency medical help if you have signs of an allergic reaction to Rytary: 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 Rytary 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 Rytary side effects may include:

• jerky or twisting muscle movements;

• headache, dizziness;

• low blood pressure (feeling light-headed);

• sleep problems, strange dreams;

• dry mouth;

• muscle contractions; or

• nausea, vomiting, constipation.

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.

Other drugs may interact with carbidopa and levodopa, 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.