Carbidopa/levodopa ODT 25-100mg 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 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
Mar 2010
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Carbidopa/levodopa ODT is a medication used to treat Parkinson's disease. It helps to reduce symptoms like stiffness, tremors, and difficulty moving. The ODT (Orally Disintegrating Tablet) dissolves quickly in your mouth without water, making it easier to take.
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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.

Before handling the 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.

If you take iron supplements or multivitamins that contain iron, consult your doctor or pharmacist about how to take them with this medication, as iron may reduce the absorption of this drug. Diets high in protein, fat, or calories, as well as consuming acidic foods, may also decrease the absorption of this medication. Discuss your diet with your doctor, especially if you plan to make any changes.

Continue taking this medication even when you're not experiencing symptoms. Keeping a diary of your symptoms can be helpful. 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. Do not store it in a bathroom. Keep all medications in a safe location, 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.

What to Do If You Miss 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 continue with your regular schedule. Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take the tablet on an empty stomach, at least 30 minutes before or 1 hour after meals, especially high-protein meals, to maximize absorption. If stomach upset occurs, take with a small, low-protein snack.
  • Do not crush, chew, or split the orally disintegrating tablet. Allow it to dissolve completely on the tongue.
  • Maintain a consistent dosing schedule to help manage symptoms and reduce 'off' periods.
  • Avoid sudden changes in body position to minimize dizziness from orthostatic hypotension.
  • Report any new or worsening side effects, especially involuntary movements (dyskinesias), hallucinations, or unusual urges/behaviors (e.g., gambling, hypersexuality).

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 25 mg carbidopa/100 mg levodopa orally disintegrating tablet three times daily. Titrate as needed.
Dose Range: 25 - 200 mg

Condition-Specific Dosing:

initial_therapy: 25 mg carbidopa/100 mg levodopa three times daily. May increase by 25 mg carbidopa/100 mg levodopa daily or every other day until optimal response is achieved.
conversion_from_immediate_release: Patients currently treated with conventional carbidopa/levodopa tablets may be switched to the orally disintegrating tablets at an equivalent daily dose. Dosing should be individualized and may require titration.
maximum_daily_dose: Typically 200 mg carbidopa/2000 mg levodopa per day, divided into 4-8 doses. Carbidopa dose should be at least 70-100 mg/day to inhibit peripheral decarboxylation.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (Safety and efficacy not established in pediatric patients)
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, but monitor for adverse effects.
Moderate: No specific dose adjustment recommended, but monitor for adverse effects.
Severe: No specific dose adjustment recommended, but monitor for adverse effects. Use with caution due to potential for accumulation of levodopa metabolites.
Dialysis: Not well studied. Levodopa is dialyzable, but carbidopa is not. Use with caution and monitor closely.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended. Use with caution due to potential for altered metabolism.

Pharmacology

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Mechanism of Action

Carbidopa inhibits DOPA decarboxylase, an enzyme responsible for the peripheral metabolism of levodopa to dopamine. This allows more levodopa to cross the blood-brain barrier for conversion to dopamine in the central nervous system, reducing peripheral side effects of levodopa. Levodopa is a metabolic precursor of dopamine, which replenishes dopamine levels in the brain, alleviating symptoms of Parkinson's disease.
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Pharmacokinetics

Absorption:

Bioavailability: Levodopa: Approximately 30% (when given with carbidopa, it increases significantly compared to levodopa alone). Carbidopa: Approximately 40-70%.
Tmax: Levodopa: 0.5-2 hours (with carbidopa). Carbidopa: 1.5-5 hours.
FoodEffect: High-protein meals can significantly reduce the absorption of levodopa due to competition for transport across the intestinal wall. Taking with food may delay Tmax and decrease Cmax. ODT formulation may have slightly faster absorption than conventional tablets.

Distribution:

Vd: Levodopa: 0.9-1.6 L/kg. Carbidopa: Not extensively distributed.
ProteinBinding: Levodopa: Approximately 10-30%. Carbidopa: Approximately 36%.
CnssPenetration: Levodopa: Yes (actively transported across the blood-brain barrier). Carbidopa: Limited (does not cross the blood-brain barrier in significant amounts).

Elimination:

HalfLife: Levodopa: Approximately 1-2 hours (when given with carbidopa). Carbidopa: Approximately 2-3 hours.
Clearance: Levodopa: 0.3 L/kg/hr. Carbidopa: Not well quantified.
ExcretionRoute: Mainly renal (urine).
Unchanged: Levodopa: Approximately 5-10% (when given with carbidopa). Carbidopa: Approximately 50% excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Variable, typically within 30 minutes to 2 hours for symptomatic relief.
PeakEffect: 1-2 hours after dose.
DurationOfAction: Variable, typically 3-6 hours, depending on disease severity and individual response. May shorten over time (wearing-off phenomenon).

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately

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

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
New or worsening behavioral or mood changes, such as:
+ Depression
+ Thoughts of suicide
Hallucinations (seeing or hearing things that are not there)
Feeling confused
Strong, uncontrollable urges (e.g., eating, gambling, sex, or spending money)
A skin lump or growth
Changes in the color or size of a mole
New or worsening trouble controlling body movements
Eyelid twitching
Muscle twitching
Stomach pain
Black, tarry, or bloody stools
Vomiting blood or material that looks like coffee grounds
Chest pain or pressure
Fast or abnormal heartbeat
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Dark urine or yellow skin and eyes
Changes in eyesight, eye pain, or severe eye irritation
Shortness of breath
Sudden 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

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:

Bad dreams
Constipation
Dizziness or sleepiness
Dry mouth
Headache
Trouble sleeping
Some products may cause a dark red, brown, or black color to appear in your saliva, urine, or sweat (this is harmless but may discolor your clothes)
* Upset stomach or vomiting

This is not a comprehensive list of all possible side effects. 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, involuntary movements (dyskinesias)
  • Hallucinations, delusions, confusion, or unusual thoughts
  • Excessive daytime sleepiness or sudden onset of sleep
  • Unusual urges or behaviors (e.g., gambling, hypersexuality, compulsive shopping)
  • Severe nausea or vomiting
  • Darkening of urine, sweat, or saliva (harmless, but report to doctor)
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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. Describe the allergic reaction you experienced, including the symptoms that occurred.
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 within 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 medication that contains the same active ingredient as this drug
* All your prescription and over-the-counter medications, natural products, vitamins, and health problems, as this is not an exhaustive list of potential interactions

To ensure your safety, it is crucial to consult with your doctor and pharmacist about all your medications and health conditions before taking this medication. Do not initiate, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

Important Information to Share with Your Healthcare Providers

Inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure that you receive the best possible care.

Precautions to Take While Using 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 Medical Exams

This medication may interfere with certain laboratory tests. Be sure to inform all of your healthcare providers and laboratory personnel that you are taking this medication. Follow your doctor's instructions for regular blood tests and eye exams.

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 effectiveness. 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. It is unclear if this medication also increases this risk. To be safe, undergo regular skin exams while taking this medication and discuss any concerns with your doctor.

Phenylketonuria (PKU) Considerations

If you have phenylketonuria (PKU), consult with your doctor before taking this medication, as some products may 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 may lead to severe or life-threatening 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 and your doctor 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
  • Cardiac arrhythmias
  • Orthostatic hypotension
  • Confusion, agitation, hallucinations
  • Insomnia
  • Nausea, vomiting

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management is supportive, including gastric lavage, IV fluids, and antiarrhythmics if needed. Monitor cardiac function and vital signs.

Drug Interactions

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Contraindicated Interactions

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

  • Selective MAO-B inhibitors (e.g., selegiline, rasagiline) - may potentiate levodopa effects, requiring dose reduction of carbidopa/levodopa.
  • Antipsychotics (e.g., phenothiazines, butyrophenones, risperidone, olanzapine) - may antagonize the effects of levodopa due to dopamine receptor blockade.
  • Metoclopramide - may antagonize the effects of levodopa and increase risk of extrapyramidal symptoms.
  • Iron salts (ferrous sulfate, ferrous gluconate) - may reduce levodopa absorption.
  • 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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Moderate Interactions

  • Antihypertensives - additive hypotensive effects, especially orthostatic hypotension.
  • Tricyclic antidepressants (TCAs) - rare reports of hypertension and dyskinesia.
  • Sympathomimetics (e.g., epinephrine, norepinephrine, dopamine) - increased risk of cardiac arrhythmias.
  • High-protein diet - may reduce levodopa absorption and efficacy.
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Minor Interactions

  • Antacids - may slightly increase levodopa absorption.

Monitoring

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Baseline Monitoring

Neurological examination (motor function, gait, balance)

Rationale: To establish baseline Parkinson's symptoms and severity.

Timing: Prior to initiation of therapy.

Blood pressure (supine and standing)

Rationale: To assess for baseline orthostatic hypotension risk.

Timing: Prior to initiation of therapy.

Mental status assessment (cognitive function, mood)

Rationale: To establish baseline for potential psychiatric side effects.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Motor function (e.g., UPDRS scores, 'on-off' periods, dyskinesias)

Frequency: Regularly, especially during dose titration and at follow-up visits (e.g., every 3-6 months or as clinically indicated).

Target: Optimal symptom control with minimal side effects.

Action Threshold: Worsening motor symptoms, increased 'off' time, or troublesome dyskinesias warrant dose adjustment or addition of adjunctive therapy.

Blood pressure (supine and standing)

Frequency: Regularly, especially during dose titration and if symptoms of orthostatic hypotension occur.

Target: Maintain normotension, minimize orthostatic drop.

Action Threshold: Symptomatic orthostatic hypotension (e.g., dizziness, syncope) warrants dose reduction or management strategies.

Psychiatric symptoms (e.g., hallucinations, delusions, confusion, depression)

Frequency: Regularly, at each follow-up visit.

Target: Absence or control of psychiatric symptoms.

Action Threshold: Emergence or worsening of psychiatric symptoms warrants dose reduction or specific management.

Gastrointestinal symptoms (e.g., nausea, vomiting)

Frequency: Regularly, especially during initial therapy.

Target: Absence or control of GI symptoms.

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

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Symptom Monitoring

  • Dyskinesias (involuntary movements)
  • Motor fluctuations ('on-off' phenomena, wearing-off)
  • Orthostatic hypotension (dizziness, lightheadedness upon standing)
  • Nausea, vomiting
  • Hallucinations, delusions, confusion
  • Sleep disturbances (insomnia, somnolence)
  • Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)

Special Patient Groups

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Pregnancy

Use only if the potential benefit justifies the potential risk to the fetus. Levodopa has shown developmental toxicity in animal studies.

Trimester-Specific Risks:

First Trimester: Potential for developmental toxicity based on animal studies. Limited human data.
Second Trimester: Limited human data. Continue to monitor for fetal development.
Third Trimester: Limited human data. Consider potential for neonatal withdrawal symptoms if used close to term.
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Lactation

Levodopa is excreted in breast milk and may inhibit lactation. Avoid breastfeeding or discontinue the drug, considering the importance of the drug to the mother.

Infant Risk: L3 (Moderate risk). Potential for effects on infant CNS (e.g., drowsiness, irritability) and inhibition of lactation. Monitor infant for adverse effects.
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Pediatric Use

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

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Geriatric Use

No specific dose adjustments are generally required based on age alone. However, elderly patients may be more sensitive to the central nervous system (e.g., hallucinations, confusion) and cardiovascular (e.g., orthostatic hypotension) side effects. Initiate with lower doses and titrate slowly, monitoring closely for adverse effects.

Clinical Information

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Clinical Pearls

  • The ODT formulation is beneficial for patients with dysphagia or those who need to take medication without water.
  • Consistent timing of doses is crucial to minimize 'off' periods and motor fluctuations.
  • Advise patients to avoid high-protein meals close to dosing, as protein can interfere with levodopa absorption.
  • Educate patients about the potential for impulse control disorders and other psychiatric side effects.
  • Orthostatic hypotension is a common side effect; advise patients to rise slowly from sitting or lying positions.
  • The effectiveness of carbidopa/levodopa may decrease over time, leading to motor complications such as dyskinesias and 'wearing-off' phenomena.
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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, opicapone, tolcapone)
  • Amantadine
  • Istradefylline
  • Pimavanserin (for Parkinson's disease psychosis)
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Cost & Coverage

Average Cost: $50 - $300+ per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.