Sinemet

Name: Sinemet

Manufacturer

  • Merck Sharp & Dohme Corp.

What should I discuss with my healthcare provider before taking Sinemet (carbidopa and levodopa)?

You should not use carbidopa and levodopa if you are allergic to it, or 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.

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).

What happens if I overdose?

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

Warnings

When Sinemet is to be given to patients who are being treated with levodopa, levodopa must be discontinued at least twelve hours before therapy with Sinemet is started. In order to reduce adverse reactions, it is necessary to individualize therapy. See DOSAGE AND ADMINISTRATION section before initiating therapy.

The addition of carbidopa with levodopa in the form of Sinemet reduces the peripheral effects (nausea, vomiting) due to decarboxylation of levodopa; however, carbidopa does not decrease the adverse reactions due to the central effects of levodopa. Because carbidopa permits more levodopa to reach the brain and more dopamine to be formed, certain adverse central nervous system (CNS) effects, e.g., dyskinesias (involuntary movements), may occur at lower dosages and sooner with Sinemet than with levodopa alone.

All patients should be observed carefully for the development of depression with concomitant suicidal tendencies.

Sinemet should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease.

As with levodopa, care should be exercised in administering Sinemet to patients with a history of myocardial infarction who have residual atrial, nodal, or ventricular arrhythmias. In such patients, cardiac function should be monitored with particular care during the period of initial dosage adjustment, in a facility with provisions for intensive cardiac care.

As with levodopa, treatment with Sinemet may increase the possibility of upper gastrointestinal hemorrhage in patients with a history of peptic ulcer.

Falling Asleep During Activities of Daily Living and Somnolence

Patients taking Sinemet alone or with other dopaminergic drugs have reported suddenly falling asleep without prior warning of sleepiness while engaged in activities of daily living (includes operation of motor vehicles). Road traffic accidents attributed to sudden sleep onset have been reported. Although many patients reported somnolence while on dopaminergic medications, there have been reports of road traffic accidents attributed to sudden onset of sleep in which the patient did not perceive any warning signs, such as excessive drowsiness, and believed that they were alert immediately prior to the event. Sudden onset of sleep has been reported to occur as long as one year after the initiation of treatment.

Falling asleep while engaged in activities of daily living usually occurs in patients experiencing pre-existing somnolence, although some patients may not give such a history. For this reason, prescribers should reassess patients for drowsiness or sleepiness especially since some of the events occur well after the start of treatment. Prescribers should be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities. Patients should be advised to exercise caution while driving or operating machines during treatment with Sinemet. Patients who have already experienced somnolence or an episode of sudden sleep onset should not participate in these activities during treatment with Sinemet.

Before initiating treatment with Sinemet, advise patients about the potential to develop drowsiness and ask specifically about factors that may increase the risk for somnolence with Sinemet such as the use of concomitant sedating medications and the presence of sleep disorders. Consider discontinuing Sinemet in patients who report significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating, etc.). If treatment with Sinemet continues, patients should be advised not to drive and to avoid other potentially dangerous activities that might result in harm if the patients become somnolent. There is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living.

Hyperpyrexia and Confusion

Sporadic cases of a symptom complex resembling neuroleptic malignant syndrome (NMS) have been reported in association with dose reductions or withdrawal of certain antiparkinsonian agents such as levodopa, carbidopa levodopa, or carbidopa levodopa extended release. Therefore, patients should be observed carefully when the dosage of levodopa is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics.

NMS is an uncommon but life-threatening syndrome characterized by fever or hyperthermia. Neurological findings, including muscle rigidity, involuntary movements, altered consciousness, mental status changes; other disturbances, such as autonomic dysfunction, tachycardia, tachypnea, sweating, hyper- or hypotension; laboratory findings, such as creatine phosphokinase elevation, leukocytosis, myoglobinuria, and increased serum myoglobin have been reported.

The early diagnosis of this condition is important for the appropriate management of these patients. Considering NMS as a possible diagnosis and ruling out other acute illnesses (e.g., pneumonia, systemic infection, etc.) is essential. This may be especially complex if the clinical presentation includes both serious medical illness and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system (CNS) pathology.

The management of NMS should include: 1) intensive symptomatic treatment and medical monitoring and 2) treatment of any concomitant serious medical problems for which specific treatments are available. Dopamine agonists, such as bromocriptine, and muscle relaxants, such as dantrolene, are often used in the treatment of NMS; however, their effectiveness has not been demonstrated in controlled studies.

PRINCIPAL DISPLAY PANEL - Bottle Label 10 mg/100 mg

Sinemet®
(carbidopa-levodopa) Tablets

10 mg/100 mg

Rx only

100 Tablets

NDC 0006-3915-68

Each tablet contains 10 mg carbidopa (anhydrous equivalent) and 100 mg levodopa.

USUAL ADULT DOSAGE: See Package Insert.

Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Store in a tightly closed container, protected from light and moisture.

Dispense in a tightly closed, light-resistant container. This is a bulk package and not intended for dispensing. Package not child resistant.

Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC.
Whitehouse Station, NJ 08889, USA

By: Mylan Pharmaceuticals, Inc.
Morgantown, WV 26505, USA

7001127201
100 | No. 3915

For the Consumer

Applies to carbidopa / levodopa: oral capsule extended release, oral tablet, oral tablet disintegrating, oral tablet extended release

Other dosage forms:

  • route not applicable suspension

Along with its needed effects, carbidopa / levodopa may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking carbidopa / levodopa:

More common
  • Twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
Less common
  • Bladder pain
  • bloody or cloudy urine
  • chest pain
  • confusion
  • difficult, burning, or painful urination
  • discouragement
  • feeling sad or empty
  • frequent urge to urinate
  • inability to move the eyes
  • increased blinking or spasms of the eyelid
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • lower back or side pain
  • seeing, hearing, or feeling things that are not there
  • sticking out of tongue
  • tiredness
  • trouble concentrating
  • trouble in breathing, speaking, or swallowing
  • trouble sleeping
  • uncontrolled twisting movements of the neck, trunk, arms, or legs
  • unusual facial expressions
Incidence not known
  • Anxiety
  • black, tarry stools
  • bluish color
  • blurred vision
  • changes in skin color
  • chest discomfort
  • chills
  • convulsions
  • cough or hoarseness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • false beliefs that cannot be changed by facts
  • fast, irregular, pounding, or racing heartbeat or pulse
  • feelings about hurting oneself or others
  • fever with or without chills
  • general feeling of tiredness or weakness
  • high fever
  • hyperventilation
  • increased in sexual ability, desire, drive, or performance
  • increased interest in sexual intercourse
  • increased sweating
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of bladder control
  • lower back or side pain
  • nausea
  • pain
  • pain or discomfort in the arms, jaw, back, or neck
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • severe muscle stiffness
  • shaking
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swelling of the foot or leg
  • swollen glands
  • tenderness
  • tiredness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusually pale skin
  • vomiting

Some side effects of carbidopa / levodopa may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Acid or sour stomach
  • back or shoulder pain
  • belching
  • body aches or pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • diarrhea
  • difficulty having a bowel movement (stool)
  • ear congestion
  • headache
  • heartburn
  • indigestion
  • loss of voice
  • muscle cramps
  • nasal congestion
  • runny nose
  • sneezing
  • stomach discomfort, upset, or pain
  • unusual dreams
  • weight loss
Incidence not known
  • Abdominal or stomach distress
  • bad, unusual, or unpleasant (after) taste
  • belching
  • change in taste
  • dark sweat
  • double vision
  • enlarged pupils
  • feeling of warmth
  • hair loss or thinning of the hair
  • lack or loss of strength
  • redness of the face, neck, arms, and occasionally, upper chest
  • seeing double
  • skin rash, hives or welts, itching

Highlights for Sinemet

Sinemet is used to treat the symptoms of Parkinson’s disease. Symptoms include shaking, stiffness, and slow movement. Sinemet is also used to treat parkinsonism (Parkinson’s-like symptoms) from encephalitis (swelling of the brain). This drug is also used to treat symptomatic parkinsonism due to injury of the nervous system from carbon monoxide or manganese intoxication.

Sinemet comes in the form of an immediate-release tablet. It’s also available as an extended-release tablet called Sinemet CR.

Sinemet is the brand name for the drug carbidopa/levodopa. It is also available as a generic drug.

The more common side effects of this drug can include nausea, dizziness, headache, and insomnia. They can also include strange dreams, dry mouth, and involuntary body movements.

In some cases, this drug can cause serious side effects. These include an increased risk for drowsiness and falling asleep suddenly. You shouldn’t drive, use machinery, or do other activities that require alertness until you know how this drug affects you. 

IMPORTANT INFORMATION
  • Drowsiness and falling asleep suddenly See Details

  • Neuroleptic malignant syndrome See Details

  • Phenylketonuria See Details

  • Suicidal thoughts or actions See Details

What is Sinemet?

This drug is a prescription drug. It’s available as an immediate-release or extended-release oral tablet.

Sinemet is the brand name for the drug carbidopa/levodopa. This drug is available as a generic drug. Generic drugs usually cost less. In some cases, they may not be available in every strength or form as the brand-name version.

This drug is a combination drug. It contains two drugs: carbidopa and levodopa. It’s important to know about all the drugs in the combination because each drug may affect you in a different way.

This drug may be used as part of combination therapy. This means you may have to take it with other medications for Parkinson’s disease.

Why it's used

This drug is used to treat the symptoms of Parkinson’s disease. It’s also used to treat parkinsonism (Parkinson’s-like symptoms) that develops after encephalitis (swelling of the brain). This drug is also used to treat parkinsonism due to injury of the nervous system from carbon monoxide and/or manganese intoxication. This is called symptomatic parkinsonism. Symptoms of these conditions include shaking, stiffness, and slow movement.

How it works

This medication contains two drugs: carbidopa and levodopa. Carbidopa belongs to a class of drugs called decarboxylase inhibitors. Levodopa belongs to a class of drugs called dopamine precursors. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

More Details

Sinemet May Interact with Other Medications

Sinemet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Alcohol interaction

The use of drinks that contain alcohol can increase your risk of sedative side effects from this drug. You may have slowed reflexes, poor judgment, and sleepiness. This could be dangerous. If you drink alcohol, talk to your doctor.

Medications that might interact with this drug

Antipsychotic drugs

Certain antipsychotic drugs may reduce the effectiveness of levodopa. This interaction may cause your Parkinson’s disease symptoms to get worse.

These drugs include:

  • chlorpromazine
  • fluphenazine
  • haloperidol
  • risperidone
  • quetiapine
  • olanzapine
Nausea and vomiting drugs

Certain drugs used to treat nausea and vomiting may reduce the effectiveness of levodopa. This interaction may cause your Parkinson’s disease symptoms to get worse.

These drugs include:

  • promethazine
  • prochlorperazine
  • metoclopramide
Antibiotics

Certain antibiotics may reduce the effectiveness of levodopa. This interaction may cause your Parkinson’s disease symptoms to get worse.

These drugs include:

  • isoniazid
Iron

Iron and multivitamins that contain iron can cling to Sinemet. This means that your body may not be able to absorb the drug as well. This interaction may cause your Parkinson’s disease symptoms to get worse.

Depression drugs

Certain depression drugs may increase the levels of Sinemet in your body. This interaction increases your risk of side effects. It may cause your blood pressure to drop to very low levels. You shouldn’t take these depression drugs with Sinemet.

These drugs include:

  • monoamine oxidase inhibitors (MAOIs), such as:
    • selegiline
    • isocarboxazid
    • phenelzine
    • tranylcypromine

 

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking. Drug warnings

People with glaucoma

This drug can increase the pressure in your eyes. If you have glaucoma, this drug can make your vision worse. If you have narrow-angle glaucoma, this drug can lead to permanent vision loss.  People with narrow-angle glaucoma shouldn’t use the immediate-release, extended-release, or orally disintegrating tablets. Ask to your doctor whether the extended-release capsules or enteral suspension is safe for you.  If you have chronic, wide-angle glaucoma, ask your doctor whether this drug is safe for you.

People with severe heart disease

In rare cases, this drug has been linked to heart disease. Heart disease includes angina (chest pain), heart attack, and arrhythmias (irregular heart rhythms). If you have a history of heart disease, your risk for these events is higher. Talk to your doctor about whether this drug is safe for you.

People with severe lung disease or asthma

This drug can cause shortness of breath in some people. If you already have trouble breathing due to asthma or chronic obstructive pulmonary disease (COPD), talk to your doctor about whether this drug is safe for you.

People with kidney disease

Your kidneys help remove this drug from your body. If you have kidney problems, this drug may build up in your body. This buildup can increase your risk for side effects. Talk to your doctor about whether this drug is safe for you.

People with liver disease

Your liver helps remove this drug from your body. If you have liver problems, this drug may build up in your body. This buildup can increase your risk for side effects. Talk to your doctor about whether this drug is safe for you.

People with endocrine disease

This drug can interfere with a certain urine test that is used to diagnose endocrine disorders. Some people taking this drug have been falsely diagnosed with the endocrine disorder pheochromocytoma. Talk to your doctor about whether this drug is safe for you or ask if it may interfere with any lab tests.

People with a history of peptic ulcers

If you have a history of peptic ulcers, this drug can increase your risk of stomach or intestinal bleeding. Talk to your doctor about whether this drug is safe for you.

Pregnant women

This drug is a category C pregnancy drug. That means two things:

  1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
  2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

Tell your doctor if you’re pregnant or plan to become pregnant. This drug should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Women who are breast-feeding

This drug passes into breast milk and may cause side effects in a child who is breastfed.

Talk to your doctor if you breastfeed your baby. You may need to decide whether to stop breastfeeding or stop taking this medication.

For seniors

Older adults may process drugs more slowly. A typical adult dose may cause levels of the drug to be higher than normal in older adults. 

Seniors also have a higher risk for mental health changes from this drug. These changes can include hallucinations (seeing or hearing things that aren’t there), confusion, and agitation. If you’re a senior, you may need a lower dose or a different schedule. 

For children

This drug hasn’t been studied in children. It shouldn’t be used in children under 18 years of age.

Allergies

This drug can cause a severe allergic reaction. Symptoms can include:

  • swelling of your face, lips, tongue, or throat
  • trouble breathing
  • rash
  • hives

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

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