Carbidopa/levodopa 10-100mg Tabs

Manufacturer AUROBINDO PHARMA Active Ingredient Carbidopa and Levodopa 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; aromatic L-amino acid decarboxylase inhibitor
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Pregnancy Category
Category C
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FDA Approved
Jun 1975
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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. It works by increasing the levels of a natural substance called dopamine in your brain, which helps to improve movement, reduce stiffness, and control tremors.
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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 prescription and follow the instructions closely. You can take this medication with or without food.

Some tablets may have a score line, which allows you to split them if needed. However, only split the tablets on the score line. 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, as iron may reduce the absorption of this drug.

Your diet can also affect how well your body absorbs this medication. Diets high in protein, fat, or calories, as well as eating acidic foods, may reduce absorption. Discuss your diet with your doctor, especially if you plan to make any changes.

It's essential to continue taking this medication even when you're not experiencing symptoms. Keeping a diary of your symptoms can help you 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 in a safe place, out of the reach of children and pets.

When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore 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 resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take this medication exactly as prescribed by your doctor. Do not stop taking it suddenly without consulting your doctor, as this can lead to serious withdrawal symptoms.
  • Take with food if you experience nausea, but avoid high-protein meals (e.g., large amounts of meat, dairy) around the time of your dose, as protein can interfere with absorption. Discuss timing of meals with your doctor.
  • Stay hydrated to help prevent constipation and orthostatic hypotension.
  • Be aware of potential dizziness or lightheadedness, especially when standing up quickly. Change positions slowly.
  • Do not crush or chew extended-release tablets; swallow them whole.
  • Report any new or worsening side effects to your doctor promptly.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 25 mg carbidopa/100 mg levodopa orally 3 times daily. Titrate gradually.
Dose Range: 25 - 200 mg

Condition-Specific Dosing:

Parkinson's Disease (initial): 25 mg carbidopa/100 mg levodopa orally 3 times daily. May increase by 1 tablet every 1-2 days as tolerated, up to 8 tablets per day. Max daily dose of levodopa is 800 mg (for 10/100 formulation).
Parkinson's Disease (maintenance): Individualized, typically 300-800 mg levodopa daily in divided doses. Max daily dose of carbidopa is 200 mg.
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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 adjustment recommended, use with caution.
Moderate: No specific adjustment recommended, use with caution.
Severe: No specific adjustment recommended, use with caution. Monitor for adverse effects.
Dialysis: Not well studied; levodopa is dialyzable. Consider dose adjustment based on clinical response and tolerability.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Carbidopa inhibits the peripheral decarboxylation of levodopa, increasing the amount of levodopa available to cross the blood-brain barrier. Levodopa is then converted to dopamine in the brain, replenishing dopamine levels in the striatum, which are deficient in Parkinson's disease.
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Pharmacokinetics

Absorption:

Bioavailability: Levodopa: Approximately 30% (variable); Carbidopa: Approximately 40-70%
Tmax: Levodopa: 0.5-2 hours; Carbidopa: 1-2 hours
FoodEffect: High-protein meals can significantly reduce levodopa absorption and peak plasma concentrations due to competition for transport across the gut wall and blood-brain barrier. Food generally delays Tmax and decreases Cmax.

Distribution:

Vd: Levodopa: 0.9-1.6 L/kg; Carbidopa: Not widely distributed to CNS
ProteinBinding: Levodopa: Approximately 10-30%; Carbidopa: Approximately 36%
CnssPenetration: Levodopa: Yes (after decarboxylation inhibition); Carbidopa: Limited

Elimination:

HalfLife: Levodopa: 1-2 hours (when co-administered with carbidopa); Carbidopa: 2-3 hours
Clearance: Levodopa: Approximately 0.3 L/kg/hr
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: Levodopa: <1% (when co-administered with carbidopa); Carbidopa: Approximately 30% (unchanged in urine)
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Pharmacodynamics

OnsetOfAction: Within 30 minutes to 1 hour (for initial dose, full therapeutic effect may take weeks of titration)
PeakEffect: 1-2 hours after dose
DurationOfAction: Variable, typically 4-6 hours, but can shorten with disease progression (wearing-off phenomena)

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 medical attention:

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 or 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 coffee ground-like material
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

Some people have experienced sudden sleepiness during activities like driving, eating, or talking, even if they didn't feel tired beforehand. 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 if you experience sudden sleepiness or excessive sleepiness.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or 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 (harmless but may discolor clothing)
Upset stomach or vomiting

This is not an exhaustive list of 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:

  • New or worsening involuntary movements (dyskinesia)
  • Hallucinations, delusions, or confusion
  • Sudden onset of sleep during daily activities
  • Severe dizziness or fainting (orthostatic hypotension)
  • Unusual urges or behaviors (e.g., gambling, hypersexuality, compulsive shopping)
  • Severe nausea or vomiting that persists
  • 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. Be sure to describe the allergic reaction you experienced.
Certain health conditions, including:
+ Glaucoma
+ Skin lumps or growths
+ A history of skin cancer
Medications you are currently taking, such as:
+ Reserpine or tetrabenazine
+ Linezolid or methylene blue
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking this medication with these drugs can lead to very high blood pressure)
* If you are taking another medication that contains the same active ingredient as this drug

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
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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 they are aware of any potential interactions or effects.

To minimize the risk of accidents, avoid driving and other activities that require alertness until you understand how this medication affects you. Additionally, to reduce the likelihood of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when navigating stairs.

This medication may influence the results of certain laboratory tests. Therefore, it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this medication. Adhere to your doctor's recommendations regarding blood tests and eye exams to monitor your condition.

If you have diabetes (high blood sugar), consult with your doctor to determine the most suitable glucose tests to use. You may experience a decrease in the medication's effectiveness as the time for your next dose approaches, a phenomenon known as "wearing off." If this occurs and bothers you, discuss it with your doctor.

Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may impair your reactions, consult with your doctor. Individuals with Parkinson's disease may have an increased risk of developing a type of skin cancer called melanoma, although it is unclear if this medication contributes to this risk. To monitor your skin health, undergo regular skin exams while taking this medication and discuss any concerns with your doctor.

Do not abruptly discontinue or reduce your dosage of this medication without consulting your doctor, as this may lead to severe or potentially life-threatening side effects. These symptoms may include fever, muscle cramps or stiffness, dizziness, severe headache, confusion, altered thinking, irregular or rapid 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 both you and your baby.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Management is supportive, including gastric lavage, IV fluids, and careful monitoring of cardiac and respiratory function. Antiarrhythmics may be needed for cardiac dysrhythmias.

Drug Interactions

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Contraindicated Interactions

  • Nonselective 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

  • Antipsychotics (e.g., haloperidol, chlorpromazine, risperidone, olanzapine) - 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 - can reduce levodopa absorption and transport across the blood-brain barrier.
  • Metoclopramide - may antagonize the effects of levodopa and increase risk of extrapyramidal symptoms.
  • Phenytoin - may reduce the therapeutic effect of levodopa.
  • Papaverine - may reduce the therapeutic effect of levodopa.
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Moderate Interactions

  • Antihypertensives - additive hypotensive effects, especially orthostatic hypotension.
  • Tricyclic antidepressants (TCAs) - may increase the risk of orthostatic hypotension and hypertension.
  • Sympathomimetics (e.g., epinephrine, norepinephrine, dopamine) - increased risk of arrhythmias.
  • Pyridoxine (Vitamin B6) - large doses (e.g., >10-25 mg) can reverse the effects of levodopa if carbidopa is not present in sufficient amounts (less relevant with carbidopa/levodopa combination).
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Minor Interactions

  • Not typically classified as minor, most interactions are moderate to major due to the narrow therapeutic index and critical nature of Parkinson's treatment.

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 (supine and standing)

Rationale: To assess for baseline orthostatic hypotension risk.

Timing: Prior to initiation of therapy

Renal and hepatic function tests (BUN, creatinine, LFTs)

Rationale: To assess baseline organ function, although dose adjustments are not typically required, caution is advised in severe impairment.

Timing: Prior to initiation of therapy

Complete Blood Count (CBC)

Rationale: To establish baseline, as rare cases of hemolytic anemia have been reported.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (motor symptoms, ADLs)

Frequency: Regularly during titration, then every 3-6 months or as clinically indicated

Target: Improved motor function, reduced rigidity, tremor, bradykinesia, improved quality of life.

Action Threshold: Worsening symptoms, wearing-off, dyskinesia, or inadequate response may require dose adjustment or addition of adjunctive therapy.

Adverse effects (dyskinesia, dystonia, nausea, orthostatic hypotension, psychiatric symptoms)

Frequency: At each visit, especially during titration

Target: Minimize or manage side effects to maintain patient tolerability.

Action Threshold: Significant or bothersome side effects may require dose reduction, change in dosing schedule, or adjunctive treatment.

Blood pressure (supine and standing)

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

Target: Maintain stable blood pressure, minimize orthostatic drops.

Action Threshold: Symptomatic orthostatic hypotension (e.g., dizziness, syncope) requires intervention (e.g., dose reduction, non-pharmacological measures).

Mental status/Psychiatric assessment (hallucinations, delusions, confusion, impulse control disorders)

Frequency: At each visit

Target: Maintain cognitive function and mental well-being.

Action Threshold: Emergence or worsening of psychiatric symptoms requires dose adjustment or consideration of atypical antipsychotics.

CBC, LFTs, Renal function

Frequency: Periodically (e.g., annually) or as clinically indicated

Target: Within normal limits

Action Threshold: Significant abnormalities may warrant further investigation or dose adjustment.

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Symptom Monitoring

  • Motor fluctuations (wearing-off, on-off phenomena)
  • Dyskinesia (involuntary movements)
  • Dystonia (sustained muscle contractions)
  • Orthostatic hypotension (dizziness upon standing)
  • Nausea/vomiting
  • Hallucinations, delusions, confusion
  • Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
  • Sleep disturbances (insomnia, somnolence, sudden sleep attacks)
  • Depression, anxiety

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. Levodopa has been shown to cause visceral and skeletal malformations in rabbits at doses approximately 20 times the maximum recommended human dose.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity observed in animal studies. Human data are limited.
Second Trimester: Limited human data, generally continued if benefits outweigh risks.
Third Trimester: Limited human data, generally continued if benefits outweigh risks. Potential for premature labor or effects on fetal heart rate due to dopamine activity.
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Lactation

L3 (Moderate Risk). Levodopa is excreted into breast milk. Carbidopa is also likely excreted. Levodopa can inhibit lactation. Monitor breastfed infant for potential adverse effects such as drowsiness, poor feeding, or unusual movements. Weigh the benefits of breastfeeding against the potential risks to the infant.

Infant Risk: Potential for drowsiness, poor feeding, or effects on motor development due to dopamine activity. Inhibition of lactation is also a concern.
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established for Parkinson's disease. Use is generally not recommended.

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Geriatric Use

Elderly patients may be more sensitive to the central nervous system side effects (e.g., hallucinations, confusion, dyskinesia) and orthostatic hypotension. Initiate therapy with lower doses and titrate slowly, monitoring closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Carbidopa/levodopa is the most effective medication for motor symptoms of Parkinson's disease.
  • Patients may experience 'wearing-off' (symptoms return before next dose) or 'on-off' phenomena (unpredictable fluctuations between good and poor motor control) as the disease progresses. Dosing adjustments, extended-release formulations, or adjunctive therapies may be needed.
  • Sudden discontinuation can lead to a neuroleptic malignant syndrome-like syndrome (fever, rigidity, altered mental status, autonomic instability). Taper slowly if discontinuation is necessary.
  • Impulse control disorders (e.g., pathological gambling, hypersexuality) can occur; patients and caregivers should be counseled on this risk.
  • Some patients may experience a harmless darkening of urine, sweat, or saliva due to levodopa metabolites.
  • Avoid taking with iron supplements or high-protein meals, as these can reduce absorption. Separate doses by at least 2 hours.
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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 - always with carbidopa/levodopa)
  • Amantadine
  • Anticholinergics (e.g., benztropine, trihexyphenidyl - for tremor)
  • Adenosine A2A receptor antagonists (e.g., istradefylline - as adjunctive therapy)
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Cost & Coverage

Average Cost: $20 - $100+ per 30 tablets (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 or 4 (brand)
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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's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't 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 details about the medication taken, the amount, and the time it occurred.