Brand Name

Sinemet CR {Merck}

Generic Name

levodopa and carbidopa pronounced LEE voe DOE pa and KAR bi DOE pa

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Drug Guide

The information contained in the following drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.

What is Sinemet CR?

Sinemet CR is a controlled release tablet that is used to control the symptoms of Parkinson’s disease. These may include muscle stiffness, spasms, tremors and poor muscle control. This controlled release medication may also be used to treat Parkinson’s-like symptoms which may be caused by carbon monoxide poisoning or manganese intoxication.

Sinemet CR may be used for purposes not indicated in this medication guide.

Key Facts About Sinemet CR

Sinemet CR is comprised of two medications, Levodopa and Carbidopa. Levodopa is helpful as it is converted to a chemical called dopamine in your brain. Patients with Parkinson’s disease have low levels of dopamine in their brain. The Carbidopa in Sinemet CR helps to prevent the breakdown of levodopa before it can reach your brain and take effect.

You should wait at least 12 hours after taking levodopa (Larodopa, Dopar) before you take Sinemet CR.

Sinemet CR may affect impulse control. Sinemet CR can cause behavioral changes in patients resulting in increased sexual urges, unusual urges to gamble or other intense urges. While it is not definite that Sinemet CR may be responsible for these urges you should tell your doctor immediately if you believe that you have any intense or unusual urges while taking this medication.

Taking Sinemet CR may make you unusually drowsy or cause you to have issues with normal daytime activities like working, talking, eating or driving. You should take care when doing anything that requires you to be alert, especially when you first start taking Sinemet CR.

Tell your doctor if you are pregnant or plan to become pregnant. Sinemet CR is in FDA pregnancy category C. Sinemet CR is not known to harm an unborn baby. If you are breast-feeding you should ask your doctor about taking Sinemet CR. Sinemet CR may affect a breast-feeding baby as it is known to pass into breast milk.

Some patients who take Sinemet CR and other medications for Parkinson’s disease have developed skin cancer of the melanoma type. However, it is not determined if people with Parkinson’s disease have a higher risk than most people for developing melanoma, or if the medications relate to this finding. You should talk to your doctor about your individual risks for melanoma, as well as what skin symptoms to watch for. You should continue having regular skin exams while taking Sinemet CR.

Before You Take Sinemet CR

If you are allergic tocarbidopa (Lodosyn) or levodopa (Larodopa) you should not take Sinemet CR.

Do not take Sinemet CR if you have used an MAO inhibitor like isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) within the past 14 days. You may experience life-threatening side effects if you take Sinemet CR before the MAO inhibitor has been cleared from your body.

You should wait at least 12 hours after taking levodopa (Larodopa, Dopar) before you take Sinemet CR.

You should not take Sinemet CR if you have narrow-angle glaucoma, unusual skin lesions that have not been checked by your doctor or a history of malignant melanoma, which is a type of skin cancer.

If you have high or low blood pressure, heart disease, a heart rhythm disorder, kidney disease or liver disease you should tell your doctor before taking Sinemet CR.

If you have a history of a heart attack, asthma, chronic obstructive pulmonary disease (COPD), or another breathing disorder tell your doctor before starting treatment with Sinemet CR.

If you have an endocrine or hormonal disorder, stomach or intestinal ulcer, wide-angle glaucoma, depression or another mental illness you should inform your doctor before taking Sinemet CR.

You should not stop taking Sinemet CR without talking to your doctor. It may take a few weeks before you notice a substantial improvement in your symptoms. Talk to your doctor if you do not notice any improvements after a few weeks of treatment with Sinemet CR.

Sinemet CR Drug Interactions

You should inform your doctor if you are taking any of the following:

• Non selective MAO inhibitors are contraindicated with Sinemet CR IE isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), Linezolid (Zyvox, Zyvoxid)
• antidepressants like amitriptyline (Elavil, Vanatrip), doxepin (Sinequan) and nortriptyline (Pamelor) may increase risk of high blood pressure and impairment of voluntary movements (dyskinesia)
• blood pressure medications may result in increased hypotension risks monitoring of blood pressure medications is recommended
• isoniazid (Nydrazid)
• metoclopramide (Reglan)
• papaverine (Pavabid, Papacon, Pavagen, Pavacot)
• Parkinson’s disease medications ie Selegeline may be associated with severe orthostatic hypotension.
• phenytoin (Dilantin)
• psychiatric disorder medications like chlorpromazine (Thorazine), haloperidol (Haldol), prochlorperazine (Compazine) and risperidone (Risperdal)

Other drugs you take that are not listed may interact with Sinemet CR. You should tell your doctor about all of the medications you use. This includes prescription drugs, vitamins, supplements and herbal products, and over the counter medications. You should not begin taking a new medication without telling your doctor first.

Directions for Taking Sinemet CR

You should not take iron supplements or eat a diet that is high in protein as it may make it harder for your body to digest and absorb Sinemet CR. Talk with your doctor about the best foods to eat while you are taking this medication.

You should take Sinemet CR exactly your doctor has told you to. It is important that you do not take Sinemet CR in larger or smaller amounts, or for longer or shorter than recommended. Follow the directions on your prescription label and follow any dose changes carefully if your doctor instructs you to change your dose.

You can take Sinemet CR with or without food, but it is important to take your doses at regular intervals to keep a steady amount of this drug in your body at all times.

You should wait at least 12 hours after taking levodopa (Larodopa, Dopar) before you take Sinemet CR.

Your doctor may have your blood tested regularly while you are taking Sinemet CR. This medication may cause abnormal results on certain blood tests, so be sure to tell all doctors that treat you that you are taking Sinemet CR.

You should store Sinemet CR at room temperature away from moisture and heat.

If you miss a dose of Sinemet CR you should attempt to take the missed dose as soon as you remember. However, if it is almost time for your next scheduled dose, or if your next dose is less than 12 hours away you should skip the dose you missed.

Sinemet CR Side Effects

If you experience any of the following adverse effects you should stop taking Sinemet CR and seek emergency medical help immediately:

• allergic reaction symptoms like breathing difficulties, hives, and swelling of your face, lips, throat or tongue
• faint feeling
• fast or uneven heartbeats, fluttering of your heart
• fever
• hallucinations, agitation, anxiety, depressed mood or thoughts of suicide
• nausea, vomiting or diarrhea that is severe
• seizures or convulsions
• stiff muscles
• sweating and confusion
• tightness in your chest and trouble breathing, with pain that may spread to your arm
• tremors that are worsening
• urination that is difficult or painful

More common side effects of Sinemet CR may include

Sudden onset of Sleep: Sinemet CR has been associated with sudden and unexpected incidents of falling asleep. This has occurred while engaged in activities of daily life, including driving and cooking. This has resulted in severe accidents. Some patients do not feel sleepy before they suddenly fall asleep. It is very important to be aware of the risks of operating hazardous machinery, driving motor vehicles or participating in activities requiring alertness for safety.

• Jerky involuntary muscle movement
• Impaired or ablnormal voluntary movements.
• appetite loss
• blurry vision
• constipation
• cough and cold symptoms, like a stuffy or runny nose
• diarrhea
• dizziness
• drowsiness
• dry mouth
• headache
• heartburn
• insomnia or strange dreams
• muscle pain with numbness and tingling
• nausea
• skin rash and itching, mild

It should be noted that this is not a complete list of possible side effects of Sinemet CR. You should contact your physician for a complete list and medical advice regarding these effects.

Sinemet CR Description and Dosing

Sinemet CR is available as sustained-release tablets containing either 200 mg of levodopa and 50mg of carbidopa, or 100 mg of levodopa and 25mg of carbidopa. The 200/50 tablet is an oval, compressed tablet that is dappled-purple in color and is coded “521” on one side and is plain on the other side. The 100/25 tablet is supplied as an oval, compressed tablet that is dappled-purple in color and is coded “601” on one side and is plain on the other side.

If you suspect that you have overdosed with Sinemet CR you should seek emergency help immediately.

Ingredients in Sinemet CR

The active ingredients in Sinemet CR are carbidopa and levodopa. Inactive ingredients are hydroxypropyl cellulose, magnesium stearate, and hypromellose. Sinemet CR 100/25 and Sinemet CR 200/50 also contain FD&C Blue #2/Indigo Carmine AL and FD&C Red #40/Allura Red AC AL.

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The information contained in this drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.