Sinemet

DRUG DESCRIPTION

SINEMET® (carbidopa-levodopa) is a combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome.

Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (—)-L-?-hydrazino-?-methyl-?-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4•H2O, and its structural formula is:

Carbidopa Structural Formula Illustration

Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.3.

Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (—)-L-?-amino-?-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is:

SINEMET (carbidopa-levodopa) is supplied as tablets in three strengths:

SINEMET (carbidopa-levodopa) 25-100, containing 25 mg of carbidopa and 100 mg of levodopa.

SINEMET (carbidopa-levodopa) 10-100, containing 10 mg of carbidopa and 100 mg of levodopa.

SINEMET (carbidopa-levodopa) 25-250, containing 25 mg of carbidopa and 250 mg of levodopa.

Inactive ingredients are hydroxypropyl cellulose, pregelatinized starch, crospovidone, microcrystalline cellulose, and magnesium stearate. SINEMET (carbidopa-levodopa) 10-100 and 25-250 Tablets also contain FD&C Blue #2/lndigo Carmine AL. SINEMET (carbidopa-levodopa) 25-100 Tablets also contain D&C Yellow #10 Lake.

What are the possible side effects of carbidopa and levodopa (Atamet, Parcopa, Sinemet, Sinemet CR)?

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.

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

Call your doctor at once if you have any of these serious side effects:

  • restless muscle movements in your eyes, tongue, jaw, or...

Read All Potential Side Effects and See Pictures of Sinemet »

What are the precautions when taking carbidopa-levodopa (Sinemet)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to carbidopa or levodopa; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain eye problem (narrow-angle glaucoma).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders, breathing problems (e.g., asthma, emphysema), certain eye problem (wide-angle glaucoma), heart or blood vessel problems (e.g., arrhythmias, heart attack, angina), kidney disease,...

Read All Potential Precautions of Sinemet »


Sinemet Consumer (continued)

SIDE EFFECTS: Dizziness, nausea, vomiting, trouble sleeping, and headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may cause your urine, sweat or saliva to turn red, brown, or black. This is harmless, but your clothes may become discolored.

Tell your doctor immediately if any of these unlikely but serious side effects occur: greatly increased eye blinking/twitching, irregular heartbeat, fainting, mental/mood changes (e.g., confusion, depression, hallucinations, thoughts of suicide), worsening of involuntary movements/spasms.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, signs of infection (e.g., fever, persistent sore throat), tingling of the hands/feet, vision changes (e.g., blurred/double vision).

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, seizures, vomit that looks like coffee grounds, black/tarry stools.

Abruptly stopping or reducing the dose of this medication may rarely cause a serious (sometimes fatal) condition (neuroleptic malignant syndrome). Seek immediate medical attention if any of these rare but very serious side effects occur: fast/shallow breathing, confusion, severe dizziness/fainting, high fever, unusual muscle stiffness, unusual sweating.

For males, in the very unlikely event you have a painful or prolonged erection (lasting more than 4 hours), stop using this drug and seek immediate medical attention or permanent problems could occur.

A very serious allergic reaction is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to carbidopa or levodopa; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain eye problem (narrow-angle glaucoma).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders, breathing problems (e.g., asthma, emphysema), certain eye problem (wide-angle glaucoma), heart or blood vessel problems (e.g., arrhythmias, heart attack, angina), kidney disease, liver disease, mental/mood disorders (e.g., depression, schizophrenia), peptic ulcer, seizure.

This drug may make you dizzy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To minimize lightheadedness, get up slowly when rising from a sitting or lying position.

Before having surgery, tell your doctor or dentist that you are taking this medication.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

Levodopa may pass into breast milk and affect milk production. Consult your doctor before breast-feeding.


Sinemet Patient Information Including Side Effects

Brand Names: Atamet, Parcopa, Sinemet, Sinemet CR

Generic Name: carbidopa and levodopa (Pronunciation: KAR bi DOE pa and LEE voe DOE pa)

  • What is carbidopa and levodopa (Sinemet)?
  • What are the possible side effects of carbidopa and levodopa (Sinemet)?
  • What is the most important information I should know about carbidopa and levodopa (Sinemet)?
  • What should I discuss with my healthcare provider before taking carbidopa and levodopa (Sinemet)?
  • How should I take carbidopa and levodopa (Sinemet)?
  • What happens if I miss a dose (Sinemet)?
  • What happens if I overdose (Sinemet)?
  • What should I avoid while taking carbidopa and levodopa (Sinemet)?
  • What other drugs will affect carbidopa and levodopa (Sinemet)?
  • Where can I get more information?

What is carbidopa and levodopa (Sinemet)?

Levodopa is converted to a chemical called dopamine (DOE pa meen) in the brain. Symptoms of Parkinson's disease may be caused by low levels dopamine in the brain.

Carbidopa helps prevent the breakdown of levodopa before it can reach the brain and take effect.

The combination of carbidopa and levodopa is used to treat Parkinson symptoms such as muscle stiffness, tremors, spasms, and poor muscle control. This medication is also used to treat Parkinson symptoms caused by carbon monoxide poisoning or manganese intoxication.

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

What are the possible side effects of carbidopa and levodopa (Sinemet)?

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.

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

Call your doctor at once if you have any of these serious side effects:

  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • worsening of tremors (uncontrolled shaking);
  • high fever, stiff muscles, sweating, fast or uneven heartbeats, rapid breathing, feeling like you might pass out;
  • seizure (convulsions);
  • painful or difficult urination;
  • severe nausea, vomiting, or diarrhea;
  • uneven heart rate or fluttering in your chest;
  • confusion, hallucinations, anxiety, agitation, depressed mood, thoughts of suicide or hurting yourself;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder.

Less serious side effects may include:

  • mild nausea, dry mouth, loss of appetite, heartburn, diarrhea, constipation;
  • headache, dizziness, drowsiness, blurred vision;
  • sneezing, stuffy nose, cough, or other cold symptoms;
  • sleep problems (insomnia), strange dreams;
  • muscle pain, numbness or tingly feeling; or
  • skin rash or itching.

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.

What is the most important information I should know about carbidopa and levodopa (Sinemet)?

If you are already taking levodopa (Larodopa, Dopar), you must stop taking it at least 12 hours before you start taking carbidopa and levodopa.

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.

Do not crush, chew, or break an extended-release tablet (Sinemet CR). Swallow the pill whole.

This medication may cause you to fall asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. 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 medication. Talk with your doctor if you believe you have any intense or unusual urges while taking carbidopa and levodopa.

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