Carbidopa/levodopa ODT 25-250mg Tab

Manufacturer SUN 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's Agent
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Pharmacologic Class
Dopamine Precursor and 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?

This medicine is used to treat Parkinson's disease. It helps to reduce symptoms like stiffness, tremors, and difficulty moving. Levodopa turns into a natural chemical in your brain called dopamine, which is low in Parkinson's disease. Carbidopa helps more levodopa get to your brain and reduces side effects like nausea.
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How to Use This Medicine

Taking Your Medication Correctly

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 Administration

Before handling 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 drink water with it. Do not swallow the medication whole, and avoid chewing, breaking, or crushing it.

Interactions with Other Substances

If you take an iron supplement or a multivitamin that contains iron, consult your doctor or pharmacist about 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.

Continuing Your Medication

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

Storage and Disposal

Store your medication at room temperature, protected from light, and in a dry place. Do not store 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 disposal, consult your pharmacist. You may also have access to 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 exactly as prescribed by your doctor. Do not stop taking it suddenly without consulting your doctor, as this can lead to serious side effects.
  • Do not crush, chew, or split the orally disintegrating tablet. Allow it to dissolve completely on your tongue and then swallow with saliva.
  • Take on an empty stomach at least 30 minutes before or 1 hour after a meal, especially high-protein meals, to improve absorption. If stomach upset occurs, take with a small, low-protein snack.
  • Be aware of potential dizziness or lightheadedness, especially when standing up quickly (orthostatic hypotension). Rise slowly from a sitting or lying position.
  • Avoid driving or operating machinery until you know how this medication affects you, as it can cause drowsiness or sudden sleep onset.
  • Report any new or worsening involuntary movements (dyskinesias) or mental changes (e.g., hallucinations, confusion, unusual urges) to your doctor.
  • Maintain good hydration.

Dosing & Administration

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Adult Dosing

Standard Dose: Individualized. Initial: 25 mg carbidopa/100 mg levodopa orally 3 times daily. Adjust dosage gradually based on response and tolerability.
Dose Range: 25 - 250 mg

Condition-Specific Dosing:

Parkinson's Disease: Initial: 25 mg carbidopa/100 mg levodopa orally 3 times daily. May increase by 25 mg carbidopa/100 mg levodopa every 1-2 days as needed, up to a maximum of 200 mg carbidopa/2000 mg levodopa per day. Doses should be divided and given 4-8 times per day. For patients converting from immediate-release carbidopa/levodopa, the daily dose of carbidopa/levodopa ODT should be approximately the same as the previous immediate-release product.
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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, but use with caution.
Moderate: No specific dose adjustment recommended, but use with caution.
Severe: No specific dose adjustment recommended, but use with caution. Monitor for adverse effects.
Dialysis: Not well studied. Use with caution and monitor closely.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Levodopa, a 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 decarboxylation of levodopa, thereby increasing the amount of levodopa available for transport to the brain and reducing peripheral side effects (e.g., nausea, vomiting) associated with dopamine formation outside the CNS.
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Pharmacokinetics

Absorption:

Bioavailability: Levodopa: Approximately 30% (variable, increased by carbidopa). Carbidopa: Approximately 50%.
Tmax: Levodopa: 0.5-2 hours (ODT may be faster than conventional tablets). Carbidopa: 0.5-2 hours.
FoodEffect: High-protein meals can significantly reduce levodopa absorption and peak plasma concentrations due to competition for transport across the gut wall.

Distribution:

Vd: Levodopa: 0.9-1.6 L/kg. Carbidopa: Not well characterized.
ProteinBinding: Levodopa: Approximately 10-30%. Carbidopa: Approximately 36%.
CnssPenetration: Levodopa: Yes (actively transported). Carbidopa: No (does not cross intact blood-brain barrier).

Elimination:

HalfLife: Levodopa: Approximately 1-2 hours (extended to 1.5 hours with carbidopa). Carbidopa: Approximately 2-3 hours.
Clearance: Not readily available for combination product.
ExcretionRoute: Primarily renal (urine) as metabolites.
Unchanged: Levodopa: <1% (in urine). Carbidopa: Approximately 30% (in urine).
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Pharmacodynamics

OnsetOfAction: Within 30-60 minutes (ODT may be slightly faster than conventional tablets).
PeakEffect: 1-2 hours.
DurationOfAction: 3-6 hours, highly variable depending on dose, disease severity, and individual patient factors ('wearing-off' phenomenon).

Safety & Warnings

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Side Effects

Urgent 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 suicidal thoughts
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 mole color or size
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
Sudden, unexplained sleepiness, especially during activities like driving, eating, or talking (this can occur up to 1 year after starting the medication)

If you experience sudden sleepiness, do not drive or engage in activities that require alertness. Contact your doctor immediately.

Other Possible Side Effects

Most medications can cause side effects, but many people experience none or only mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor:

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

This is not an exhaustive list of possible side effects. If you have concerns or questions, 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 nausea or vomiting
  • Uncontrolled, involuntary movements (dyskinesias)
  • Hallucinations, delusions, or severe confusion
  • Sudden onset of sleep during daily activities
  • Severe dizziness or fainting spells
  • Worsening of Parkinson's symptoms (e.g., rigidity, tremor, difficulty walking) if medication is stopped suddenly
  • Unusual urges or behaviors (e.g., gambling, hypersexuality, compulsive shopping)
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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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Glaucoma
+ Skin lumps or growths
+ A history of skin cancer
Current or recent use of specific medications, including:
+ Reserpine or tetrabenazine
+ Linezolid or methylene blue
+ Certain antidepressants or Parkinson's disease medications taken in the last 14 days, such as:
- Isocarboxazid
- Phenelzine
- Tranylcypromine
- Selegiline
- Rasagiline (note: taking these medications with this drug can lead to very high blood pressure)
Use of any other medications that contain the same active ingredient as this drug

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.
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Precautions & Cautions

Important Information to Share with Your Healthcare Team

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 potential interactions with other treatments.

Precautions to Take While on This Medication

To avoid accidents, do not drive or perform tasks that require alertness until you know how this medication affects you. When getting up from a sitting or lying down position, rise slowly to reduce the risk of dizziness or fainting. Be cautious when climbing stairs.

Lab Tests and Monitoring

This medication may interfere with certain laboratory tests. Inform all your healthcare providers and lab personnel that you are taking this medication. Follow your doctor's instructions for regular blood work and eye exams to monitor your condition.

Special Considerations for People with Diabetes

If you have high blood sugar (diabetes), consult with your doctor about the best glucose tests to use while taking this medication.

Managing Your Medication Schedule

As the time approaches for your next dose, you may experience a decrease in the medication's effects. If this occurs and bothers you, discuss it with your doctor.

Interactions with Other Substances

Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor.

Skin Cancer Risk

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

Phenylketonuria (PKU) Considerations

If you have PKU, consult with your doctor, as some products contain phenylalanine.

Stopping or Adjusting Your Medication

Do not suddenly stop taking this medication or reduce your dose without consulting your doctor. Abruptly stopping or changing your dosage can 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.

Pregnancy and Breastfeeding

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

Overdose Symptoms:

  • Severe dyskinesias
  • Orthostatic hypotension
  • Palpitations, arrhythmias
  • Confusion, agitation, psychosis
  • Nausea, vomiting

What to Do:

Seek immediate medical attention. Call 911 or 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.

Drug Interactions

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Contraindicated Interactions

  • Nonselective monoamine oxidase (MAO) inhibitors (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, risperidone, olanzapine) - may antagonize the effects of levodopa due to dopamine receptor blockade, worsening Parkinson's symptoms.
  • Iron salts (ferrous sulfate, gluconate) - may chelate levodopa, reducing its absorption and bioavailability.
  • Metoclopramide - may antagonize the effects of levodopa and increase risk of dyskinesia.
  • Phenytoin - may reduce the therapeutic effect of levodopa.
  • Papaverine - may reduce the therapeutic effect of levodopa.
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Moderate Interactions

  • Antihypertensives - increased risk of orthostatic hypotension.
  • Tricyclic antidepressants (TCAs) - may increase the risk of orthostatic hypotension and dyskinesia.
  • Dopamine D2 receptor antagonists (e.g., domperidone) - may reduce the efficacy of levodopa.
  • Pyridoxine (Vitamin B6) - large doses may reverse the effects of levodopa if carbidopa is not present in sufficient amounts (less relevant with fixed-dose combination).
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Minor Interactions

  • High-protein diet - may reduce levodopa absorption.

Monitoring

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Baseline Monitoring

Neurological assessment (motor symptoms, dyskinesia)

Rationale: To establish baseline severity of Parkinson's disease symptoms and identify existing dyskinesias before initiating therapy.

Timing: Prior to initiation of therapy.

Blood pressure (sitting and standing)

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

Timing: Prior to initiation of therapy.

Mental status/Psychiatric evaluation

Rationale: To assess for baseline cognitive function, mood disorders, or psychotic symptoms, which can be exacerbated by levodopa.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Effectiveness (reduction in bradykinesia, rigidity, tremor)

Frequency: Regularly during dose titration and periodically thereafter (e.g., every 3-6 months or as clinically indicated).

Target: Optimal symptom control with minimal side effects.

Action Threshold: Inadequate symptom control or emergence of 'wearing-off' or 'on-off' fluctuations may require dose adjustment or addition of adjunctive therapy.

Dyskinesia (involuntary movements)

Frequency: Regularly during dose titration and periodically thereafter.

Target: Absence or minimal, tolerable dyskinesia.

Action Threshold: Troublesome or disabling dyskinesia may require dose reduction or adjustment of dosing frequency.

Orthostatic hypotension (blood pressure)

Frequency: Regularly during dose titration and periodically thereafter (e.g., at each visit).

Target: Stable blood pressure without symptomatic drops.

Action Threshold: Symptomatic orthostatic hypotension may require dose reduction, fluid intake increase, or other interventions.

Psychiatric symptoms (hallucinations, delusions, confusion, agitation)

Frequency: Regularly during dose titration and periodically thereafter.

Target: Absence of new or worsening psychiatric symptoms.

Action Threshold: Emergence or worsening of psychiatric symptoms may require dose reduction or discontinuation.

Gastrointestinal symptoms (nausea, vomiting)

Frequency: Regularly during dose titration and periodically thereafter.

Target: Absence or minimal, tolerable GI symptoms.

Action Threshold: Persistent or severe GI symptoms may require dose adjustment or antiemetic therapy.

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Symptom Monitoring

  • Motor fluctuations ('wearing-off', 'on-off' phenomena)
  • Dyskinesias (chorea, dystonia)
  • Nausea and vomiting
  • Orthostatic dizziness or lightheadedness
  • Hallucinations, delusions, confusion
  • Sleep disturbances (insomnia, somnolence, sudden sleep onset)
  • Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
  • Depression or anxiety

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on fetal development.

Trimester-Specific Risks:

First Trimester: Potential for developmental toxicity observed in animal studies.
Second Trimester: Potential for developmental toxicity observed in animal studies.
Third Trimester: Potential for developmental toxicity observed in animal studies.
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Lactation

L3 (Moderate Risk). Levodopa is excreted into breast milk and may inhibit lactation. Due to the potential for serious adverse reactions in breastfed infants, 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: Potential for central nervous system effects (e.g., drowsiness, irritability) and interference with infant's dopamine regulation. May also suppress lactation.
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Pediatric Use

Safety and effectiveness have not been established in pediatric patients. Not recommended for use in children under 18 years of age.

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Geriatric Use

Elderly patients may be more sensitive to the adverse effects of carbidopa/levodopa, particularly dyskinesias, orthostatic hypotension, and psychiatric disturbances (e.g., hallucinations, confusion). Initiate therapy with lower doses and titrate slowly, monitoring closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Dosing is highly individualized; careful titration is essential to balance symptom control and side effects.
  • Patients may experience 'wearing-off' (return of symptoms before next dose) or 'on-off' phenomena (unpredictable fluctuations between good and poor motor control). These may require dose adjustments, more frequent dosing, or addition of adjunctive therapies.
  • High-protein meals can interfere with levodopa absorption; advise patients to take medication on an empty stomach or with low-protein food.
  • Orthostatic hypotension is a common side effect; advise patients to rise slowly and stay hydrated.
  • Impulse control disorders (e.g., pathological gambling, hypersexuality) can occur; screen patients for these behaviors.
  • ODT formulation is useful for patients with dysphagia or those who need rapid onset of action, but it should not be chewed or crushed.
  • Sudden discontinuation can lead to a neuroleptic malignant syndrome-like syndrome (fever, rigidity, altered mental status, autonomic instability).
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Alternative Therapies

  • Dopamine agonists (e.g., pramipexole, ropinirole, rotigotine)
  • COMT inhibitors (e.g., entacapone, opicapone)
  • MAO-B inhibitors (e.g., selegiline, rasagiline, safinamide)
  • Amantadine
  • Anticholinergics (e.g., benztropine, trihexyphenidyl - for tremor)
  • Deep Brain Stimulation (DBS) for advanced disease
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Cost & Coverage

Average Cost: Varies widely, typically $50 - $500+ per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (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 come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate 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.