Carbidopa/levodopa ODT 10-100mg Tab

Manufacturer SUN PHARMACEUTICALS Active Ingredient Carbidopa and Levodopa Orally Disintegrating Tablets(kar bi DOE pa & lee voe DOE pa) Pronunciation kar bi DOE pa & lee voe DOE pa
It is used to treat Parkinson's disease.It is used to treat signs like Parkinson's disease caused by other health problems.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Anti-Parkinson Agent
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Pharmacologic Class
Dopamine Precursor; DOPA Decarboxylase Inhibitor
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Pregnancy Category
Category C
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FDA Approved
Sep 2004
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Carbidopa/levodopa is a medication used to treat Parkinson's disease. Levodopa helps replace a natural substance in your brain called dopamine, which is low in Parkinson's. Carbidopa helps levodopa work better by preventing it from breaking down too quickly in your body, allowing more of it to reach your brain and reducing side effects.
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How to Use This Medicine

Taking Your Medication

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food.

Handling and Administering Your Medication

Before touching your medication, make sure your hands are dry. Remove the medication from the bottle immediately before taking it. Place the medication on your tongue and let it dissolve. You don't need to take it with water, and be sure not to swallow it whole or chew, break, or crush it.

Interactions with Other Substances

If you take an iron product or a multivitamin that contains iron, ask your doctor or pharmacist for guidance on how to take it with this medication. Iron may reduce the absorption of this medication. Additionally, diets high in protein, fat, or calories, as well as acidic foods, may also affect absorption. Discuss your diet with your doctor, especially if you plan to make any changes.

Maintaining Your Medication Routine

Continue taking this medication even when you're not experiencing symptoms. Keep a record of your symptoms to track your progress. Take this medication at the same time every day, as directed by your doctor or healthcare provider, even if you're feeling well.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take the orally disintegrating tablet by placing it on your tongue, allowing it to dissolve completely, and then swallowing with or without water. Do not chew or crush the tablet.
  • Take this medication on an empty stomach or with a low-protein meal to maximize absorption. High-protein meals can reduce its effectiveness.
  • Do not stop taking this medication suddenly without consulting your doctor, as this can lead to serious withdrawal symptoms.
  • Be aware of potential dizziness or lightheadedness, especially when standing up quickly. Rise slowly from a sitting or lying position.
  • Report any new or worsening involuntary movements (dyskinesia) or changes in mood/behavior (e.g., hallucinations, confusion, unusual urges) to your doctor.
  • Maintain adequate hydration.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 25 mg carbidopa/100 mg levodopa three times daily or 10 mg carbidopa/100 mg levodopa three to four times daily. Titrate gradually.
Dose Range: 30 - 2000 mg

Condition-Specific Dosing:

Parkinson's Disease: Initial: 25 mg carbidopa/100 mg levodopa three times daily or 10 mg carbidopa/100 mg levodopa three to four times daily. Increase by 10-25 mg carbidopa/100 mg levodopa every 1-2 days as tolerated. Max: 200 mg carbidopa/2000 mg levodopa per day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution; monitor for adverse effects.
Dialysis: Not well studied; monitor for adverse effects.

Hepatic Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution; monitor for adverse effects.

Pharmacology

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Mechanism of Action

Levodopa, a metabolic precursor of dopamine, crosses the blood-brain barrier and is converted to dopamine in the brain. Carbidopa, an aromatic amino acid decarboxylase inhibitor, does not cross the blood-brain barrier and inhibits the peripheral conversion of levodopa to dopamine, thereby increasing the amount of levodopa available for transport to the brain and reducing peripheral side effects.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 30% (levodopa with carbidopa)
Tmax: 0.5-2 hours (levodopa)
FoodEffect: High-protein meals can significantly decrease levodopa absorption and peak plasma concentrations.

Distribution:

Vd: 0.9-1.6 L/kg (levodopa)
ProteinBinding: 10-30% (levodopa)
CnssPenetration: Yes (levodopa)

Elimination:

HalfLife: 1-2 hours (levodopa with carbidopa)
Clearance: Not available
ExcretionRoute: Primarily renal (as metabolites)
Unchanged: Small percentage
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Pharmacodynamics

OnsetOfAction: 30-60 minutes
PeakEffect: 1-2 hours
DurationOfAction: 4-6 hours (variable, depends on dose and patient response)

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Fainting or changes in vision
New or worsening behavioral or mood changes, such as:
+ Depression or thoughts of suicide
Hallucinations (seeing or hearing things that are not there)
Confusion
Strong, uncontrollable urges (e.g., eating, gambling, sex, or spending money)
Skin lumps or growths
Changes in the color or size of a mole
New or worsening trouble controlling body movements
Eyelid twitching or muscle twitching
Stomach pain, black, tarry, or bloody stools, vomiting blood, or coffee ground-like vomit
Chest pain or pressure, rapid or irregular heartbeat
Fever, chills, sore throat, unexplained bruising or bleeding, or feeling extremely tired or weak
Dark urine, yellow skin or eyes
Changes in vision, eye pain, or severe eye irritation
Shortness of breath

Some people have experienced sudden, uncontrollable sleepiness while taking this medication, even during activities like driving, eating, or talking. If this happens to you, do not drive or engage in tasks that require alertness. Contact your doctor immediately if you experience excessive sleepiness or fall asleep during activities.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Bad dreams
Constipation
Dizziness or drowsiness
Dry mouth
Headache
Sleep disturbances
Some products may cause a harmless but potentially clothing-staining discoloration of saliva, urine, or sweat
Upset stomach or vomiting

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting (orthostatic hypotension)
  • New or worsening uncontrolled movements (dyskinesia)
  • Hallucinations (seeing or hearing things that are not there)
  • Unusual urges or behaviors (e.g., gambling, hypersexuality, compulsive shopping)
  • Severe nausea or vomiting
  • Darkening of urine, sweat, or saliva (harmless but can stain clothes)
  • Chest pain or irregular heartbeat
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
Certain health conditions, including:
+ Glaucoma
+ Skin lumps or growths
+ A history of skin cancer
Current or recent use of specific medications, such as:
+ Reserpine or tetrabenazine
+ Linezolid or methylene blue
+ Certain antidepressants or Parkinson's disease medications taken in the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (as this may increase the risk of very high blood pressure)
Use of any other medications that contain the same active ingredient as this drug
* All your prescription and over-the-counter medications, natural products, vitamins, and health problems. This is not an exhaustive list, and it is crucial to discuss all your medications and health conditions with your doctor and pharmacist to ensure safe use.

Remember, do not start, stop, or change the dose of any medication without consulting your doctor first. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent any potential interactions with other treatments.

To minimize the risk of accidents, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. When changing positions, such as standing up from a sitting or lying down position, do so slowly to reduce the likelihood of dizziness or fainting. Be cautious when navigating stairs to prevent falls.

This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug. Adhere to your doctor's recommendations for regular blood tests and eye exams to monitor your condition.

If you have diabetes, consult with your doctor to determine the most suitable glucose tests to use, as this medication may affect the accuracy of some tests. Additionally, be aware that the effectiveness of this medication may decrease as the time approaches for your next dose. If you experience a decrease in effectiveness, discuss this with your doctor to determine the best course of action.

Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor to discuss potential risks and interactions.

People with Parkinson's disease may have an increased risk of developing a type of skin cancer called melanoma. Although it is unclear whether this medication contributes to this risk, it is essential to undergo regular skin exams while taking this medication. Discuss any concerns with your doctor.

If you have phenylketonuria (PKU), a condition where the body cannot break down the amino acid phenylalanine, consult with your doctor before taking this medication, as some products may contain phenylalanine.

Do not abruptly stop taking this medication or reduce your dosage without consulting your doctor, as this may lead to severe side effects, including fever, muscle cramps or stiffness, dizziness, severe headache, confusion, changes in thinking, abnormal heartbeat, or excessive sweating. If you experience any of these symptoms, contact your doctor immediately.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe involuntary movements (dyskinesia)
  • Agitation, confusion, disorientation
  • Insomnia
  • Palpitations, irregular heartbeat
  • Orthostatic hypotension
  • Nausea, vomiting

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive, including gastric lavage, IV fluids, and careful monitoring of cardiac and respiratory function. Antiarrhythmics may be needed for cardiac arrhythmias.

Drug Interactions

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Contraindicated Interactions

  • Non-selective monoamine oxidase inhibitors (MAOIs) (e.g., phenelzine, tranylcypromine) - risk of hypertensive crisis. Discontinue MAOIs at least 2 weeks prior to initiating carbidopa/levodopa.
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Major Interactions

  • Antipsychotics (e.g., haloperidol, chlorpromazine) - may antagonize the effects of levodopa due to dopamine receptor blockade.
  • Iron salts (ferrous sulfate, gluconate) - can chelate levodopa, reducing its absorption.
  • High-protein diet - competition for absorption across the gut and blood-brain barrier.
  • Metoclopramide - may antagonize the effects of levodopa and increase risk of extrapyramidal symptoms.
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Moderate Interactions

  • Antihypertensives - additive hypotensive effects, especially orthostatic hypotension.
  • Phenytoin - may reduce levodopa efficacy.
  • Papaverine - may reduce levodopa efficacy.
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Minor Interactions

  • Antacids - may slightly increase levodopa absorption.

Monitoring

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Baseline Monitoring

Neurological assessment (motor symptoms, cognitive function)

Rationale: To establish baseline disease severity and identify specific symptoms for treatment targeting.

Timing: Prior to initiation of therapy

Blood pressure (sitting and standing)

Rationale: To assess for baseline orthostatic hypotension, a common side effect.

Timing: Prior to initiation of therapy

Renal and hepatic function tests

Rationale: To assess organ function, especially in patients with pre-existing conditions, though dose adjustments are not typically required.

Timing: Prior to initiation of therapy (if clinically indicated)

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Routine Monitoring

Motor symptoms (tremor, rigidity, bradykinesia, gait)

Frequency: Regularly, at each follow-up visit (e.g., every 1-3 months during titration, then every 3-6 months)

Target: Optimal symptom control with minimal dyskinesia or 'off' periods

Action Threshold: Worsening symptoms, new or increased dyskinesia, or 'wearing off' phenomena indicate need for dose adjustment or adjunctive therapy.

Orthostatic blood pressure

Frequency: Regularly, especially during dose titration and if symptoms of dizziness or syncope occur.

Target: Stable blood pressure without significant orthostatic drop (>20 mmHg systolic or >10 mmHg diastolic)

Action Threshold: Symptomatic orthostatic hypotension or significant drops require intervention (e.g., dose reduction, non-pharmacological measures).

Psychiatric symptoms (hallucinations, delusions, confusion, impulse control disorders)

Frequency: Regularly, at each follow-up visit

Target: Absence of new or worsening psychiatric symptoms

Action Threshold: Emergence or worsening of psychiatric symptoms requires dose adjustment or consideration of adjunctive therapy.

Complete Blood Count (CBC)

Frequency: Periodically (e.g., annually), or if signs of anemia occur

Target: Normal ranges

Action Threshold: Significant changes (e.g., hemolytic anemia, leukopenia) are rare but require investigation.

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Symptom Monitoring

  • Dyskinesia (involuntary movements)
  • 'Wearing-off' phenomena (return of Parkinson's symptoms before next dose)
  • Orthostatic hypotension (dizziness, lightheadedness upon standing)
  • Hallucinations or delusions
  • Nausea, vomiting
  • Sleep disturbances (insomnia, somnolence)
  • Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects.

Trimester-Specific Risks:

First Trimester: Potential for developmental toxicity observed in animal studies.
Second Trimester: Not well-studied in humans; theoretical risks remain.
Third Trimester: Not well-studied in humans; theoretical risks remain.
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Lactation

Levodopa is excreted into breast milk and may inhibit lactation. Due to potential for serious adverse reactions in the infant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: Moderate risk. Potential for central nervous system effects (e.g., somnolence, irritability) and interference with infant's dopamine regulation. May also suppress lactation.
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Not indicated for use in children.

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Geriatric Use

Elderly patients may be more sensitive to the central nervous system (e.g., hallucinations, confusion) and cardiovascular (e.g., orthostatic hypotension) adverse effects of carbidopa/levodopa. Dosing should be initiated cautiously and titrated slowly.

Clinical Information

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Clinical Pearls

  • The orally disintegrating tablet (ODT) formulation is particularly useful for patients with dysphagia (difficulty swallowing) or for 'on-demand' dosing to manage sudden 'off' periods.
  • Advise patients to avoid high-protein meals close to dosing, as protein can interfere with levodopa absorption and transport to the brain.
  • Counsel patients on the importance of not abruptly discontinuing the medication due to the risk of neuroleptic malignant syndrome-like symptoms.
  • Monitor for impulse control disorders, which can be a side effect of dopaminergic therapies in Parkinson's disease.
  • Inform patients that urine, sweat, or saliva may become dark-colored (red, brown, or black), which is a harmless but common side effect.
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Alternative Therapies

  • Dopamine agonists (e.g., pramipexole, ropinirole, rotigotine)
  • MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide)
  • COMT inhibitors (e.g., entacapone, tolcapone, opicapone)
  • Amantadine (for dyskinesia or 'off' time)
  • Istradefylline (adenosine A2A receptor antagonist)
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Cost & Coverage

Average Cost: $50 - $300+ per 30 tablets (generic)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, we encourage you to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.