Carbidopa and Levodopa
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]
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Overview
Carbidopa and Levodopa is an immunologic adjuvant that is FDA approved for the treatment of parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism. Common adverse reactions include nausea, confusion, dizziness, headache.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Parkinson's disease
- Carbidopa and levodopa tablets, USP are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
- Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets.. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa.
- Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.
- Dosing information
- Dosage:(single-agent carbidopa; inadequate reduction in nausea and vomiting when carbidopa dose is less than 70 mg/day) carbidopa 25 mg ORALLY given with first carbidopa/levodopa dose of the day; additional carbidopa 12.5 to 25 mg may be given during the day with each dose of carbidopa/levodopa; MAX total carbidopa dose, 200 mg/day
- (single-agent carbidopa; patients requiring individual titration of carbidopa and levodopa), carbidopa 25 mg ORALLY 3 or 4 times daily given concomitantly with levodopa; give the 2 drugs at same time and initiate with 20% to 25% of the previous or recommended daily dose of levodopa when given without carbidopa; initiate carbidopa therapy at least 12 hours after the last dose of levodopa
- (immediate-release; initial dose and titration; levodopa-naive) carbidopa 25 mg/levodopa 100 mg tablet (preferred); initial, 1 tablet ORALLY 3 times a day; increase by 1 tablet daily or every other day, as necessary, to 8 tablets daily
- (immediate-release; initial dose and titration; levodopa-naive) carbidopa 10 mg/levodopa 100 mg tablet; initial, 1 tablet ORALLY 3 or 4 times daily; increase by 1 tablet daily or every other day, as necessary, to 2 tablets ORALLY 4 times daily
- (immediate-release; initial dose; currently receiving less than levodopa 1500 mg/day) carbidopa 25 mg/levodopa 100 mg tablet; 1 tablet ORALLY 3 or 4 times a day
- (immediate-release; initial dose; currently receiving more than levodopa 1500 mg/day) carbidopa 25 mg/levodopa 250 mg tablet; 1 tablet ORALLY 3 or 4 times a day
- (immediate-release; titration and maintenance) carbidopa 25 mg/levodopa 250 mg tablet: may increase by one-half or 1 tablet every day or every other day, as necessary, to MAX 8 tablets/day
- (sustained-release; initial dose; levodopa-naive, mild to moderate disease) carbidopa 50 mg/levodopa 200 mg CR tablet; 1 tablet ORALLY twice daily at an interval not less than 6 hours
- (sustained-release; initial dose; currently receiving levodopa, mild to moderate disease) carbidopa 50 mg/levodopa 200 mg CR tablet; 1 tablet ORALLY twice daily; discontinue levodopa at least 12 hours before starting carbidopa/levodopa therapy
- (sustained-release, titration and maintenance) allow at least 3 days between dose changes; doses and dosing intervals may be increased or decreased depending upon therapeutic response; most patients are adequately treated with doses that provide levodopa 400 to 1600 mg/day, administered in divided doses at intervals of 4 to 8 hours during the waking day
- (sustained-release, maintenance, advanced disease) either one-half tablet or a whole tablet of immediate-release carbidopa 25 mg/levodopa 100 mg or carbidopa 10 mg/levodopa 100 mg may be added to sustained-release regimen for a brief time during daytime hours
- conversion from immediate-release to sustained-release carbidopa/levodopa, begin with a carbidopa/levodopa daily dose that provides approximately 10% more levodopa; some patients may require up to 30% more of the previous daily levodopa dose, based on clinical response; maintain a dosing interval of 4 to 8 hours during waking hours
- if dosage is reduced abruptly or treatment is temporarily interrupted, monitor the patient for signs of neuroleptic malignant syndrome, and reinitiate therapy as soon as oral administration is possible
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Carbidopa and Levodopa in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Carbidopa and Levodopa in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Carbidopa and Levodopa FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Carbidopa and Levodopa in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Carbidopa and Levodopa in pediatric patients.
Contraindications
There is limited information regarding Carbidopa and Levodopa Contraindications in the drug label.
Warnings
There is limited information regarding Carbidopa and Levodopa Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Carbidopa and Levodopa Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Carbidopa and Levodopa Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Carbidopa and Levodopa Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Carbidopa and Levodopa in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Carbidopa and Levodopa in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Carbidopa and Levodopa during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Carbidopa and Levodopa in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Carbidopa and Levodopa in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Carbidopa and Levodopa in geriatric settings.
Gender
There is no FDA guidance on the use of Carbidopa and Levodopa with respect to specific gender populations.
Race
There is no FDA guidance on the use of Carbidopa and Levodopa with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Carbidopa and Levodopa in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Carbidopa and Levodopa in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Carbidopa and Levodopa in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Carbidopa and Levodopa in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Carbidopa and Levodopa Administration in the drug label.
Monitoring
There is limited information regarding Carbidopa and Levodopa Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Carbidopa and Levodopa and IV administrations.
Overdosage
There is limited information regarding Carbidopa and Levodopa overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Carbidopa and Levodopa Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Carbidopa and Levodopa Mechanism of Action in the drug label.
Structure
- Carbidopa and levodopa tablets, USP are a combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome.
- Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white to yellowish white, crystalline compound or creamy white powder, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C10H14N2O4•H20, and its structural formula is:
Pharmacodynamics
There is limited information regarding Carbidopa and Levodopa Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Carbidopa and Levodopa Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Carbidopa and Levodopa Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Carbidopa and Levodopa Clinical Studies in the drug label.
How Supplied
There is limited information regarding Carbidopa and Levodopa How Supplied in the drug label.
Storage
There is limited information regarding Carbidopa and Levodopa Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Carbidopa and Levodopa Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Carbidopa and Levodopa interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Carbidopa and Levodopa Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Carbidopa and Levodopa Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.