HomeNDC LookupIngredientsCarbidopa And Levodopa › 71610-0664-80
Carbidopa and levodopa 25 mg; 100 mg Tablet, 180-count — NDC 71610-0664-80 package photo

Carbidopa and levodopa 25 mg; 100 mg Tablet, 180-count

by Aphena Pharma Solutions - Tennessee, LLC · 180 TABLET in 1 BOTTLE (71610-664-80)
NDC 71610-0664-80
🏷️ FDA NDC (as labeled) 71610-664-80 billing pads the product segment with a zero
This package
Contains180-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.1325/unit — full pricing hub ↓
Also comes in: 90 tablets 71610-0664-60
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 71610-664-80
Product NDC 71610-664
11-digit billing NDC 71610066480
NCPDP billing unit EA — each (per item)
RxCUI 197444
UNII MNX7R8C5VO, 46627O600J
Application # ANDA074260
SPL Set ID 64254508-dbe7-4512-902d-f4a6ef2bfdf8
Established class (EPC) Aromatic Amino Acid Decarboxylation Inhibitor; Aromatic Amino Acid
Mechanism of action DOPA Decarboxylase Inhibitors
Chemical class Amino Acids, Aromatic
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-03-15
Route ORAL
Dosage form TABLET
Substance CARBIDOPA; LEVODOPA
GCN Seq No 002538
GCN 62741
HICL code 013894
Ingredient (HICL) Carbidopa/Levodopa
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6A
Therapeutic class — specific (HIC3) Antiparkinsonism Drugs,Other
AHFS code 28:36.16.00
AHFS class Dopamine Precursors
FDB label name CARBIDOPA-LEVODOPA 25-100 TAB
FDB brand name Carbidopa-Levodopa
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 71610-664-80 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 71610-0664-80. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Aromatic Amino Acid Decarboxylation Inhibitor class.

Pharmacologic class Aromatic Amino Acid Decarboxylation Inhibitor
How it works DOPA Decarboxylase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAphena Pharma Solutions - Tennessee, LLC
Application holderACTAVIS ELIZABETH LLC
FDA applicationANDA074260 (ANDA)
Labeler code71610
First marketedMar 2022
Product typeHuman Prescription Drug
Portfolio795 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name CARBIDOPA-LEVODOPA 25-100 TAB Ingredient Carbidopa/Levodopa
📖 What it is MedlinePlus · NLM

Levodopa and carbidopa is used to treat the symptoms of Parkinson's disease and Parkinson's-like symptoms that may develop after encephalitis (swelling of the brain) or injury to the nervous system caused by carbon monoxide poisoning or manganese poisoning. Levodopa is in a class of medications called central nervous system agents. It works by being converted to dopamine in the brain (the natural substance that is low in Parkinson's and causes the symptoms of tremor, stiffness, and slowness of movement). Carbidopa is in a class of medications called decarboxylase inhibitors. It works by preven...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Levodopa is the medicine that actually works in your brain — it crosses into the brain and gets converted into dopamine, the chemical that Parkinson's disease depletes. The problem...
  • What exactly does levodopa and carbidopa do, and why do I need both?
  • Generally yes, but the timing and content of your meals can matter. High-protein foods — like large servings of meat, eggs, or dairy — can compete with levodopa for absorption in y...
  • Can I eat normally while taking this medication?
📖 Read our full Levodopa and Carbidopa guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color yellow
ShapeRound
ImprintTV;9702
Size9 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII CQ3XH3DET6
    D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1325 $23.85 / 180 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Carbidopa and levodopa 25 mg/1; 100 mg 00093-9702-01 Teva 100 tablets $0.077 AB Availability likely
Carbidopa and Levodopa 25 mg/1; 100 mg 00904-7501-61 Major 100 tablets $0.077 AB Availability likely
Carbidopa And Levodopa 25 mg/1; 100 mg 31722-0382-01 Camber 100 tablets $0.077 AB Availability likely
Carbidopa and Levodopa 25 mg/1; 100 mg 50228-0458-01 ScieGen 100 tablets $0.077 AB Availability likely
Carbidopa-levodopa 25 mg/1; 100 mg 52817-0391-00 TruPharma, 1000 tablets $0.077 AB Availability likely
Carbidopa and Levodopa 25 mg/1; 100 mg 59651-0457-01 Aurobindo 100 tablets $0.077 AB Availability likely
Carbidopa and Levodopa 25 mg/1; 100 mg 60687-0661-01 American 100 tablets $0.077 AB Availability likely
Carbidopa and Levodopa 25 mg/1; 100 mg 69367-0339-01 Westminster 100 tablets $0.077 AB Availability likely
Carbidopa-levodopa 25 mg/1; 100 mg 72888-0107-00 Advagen 1000 tablets $0.077 AB Availability likely
Carbidopa and Levodopa 25 mg/1; 100 mg 75907-0020-01 Dr. 100 tablets $0.077 AB Availability likely
Sinemet 25 mg/1; 100 mg 78206-0168-01 Organon 100 tablets $1.424 AB Discontinued
Sinemet 25 mg/1; 100 mg 78206-0190-01 Organon 100 tablets $1.424 AB Availability likely
Dhivy 25 mg/1; 100 mg 75854-0701-01 Avion 100 tablets $3.614 Availability likely
Carbidopa and Levodopa 25 mg/1; 100 mg 00615-8536-05 NCS 15 tablets AB FDA listed
Carbidopa and levodopa 25 mg/1; 100 mg 42291-0472-01 AvKARE 100 tablets AB FDA listed
Carbidopa and Levodopa 25 mg/1; 100 mg 50090-5969-01 A-S 90 tablets AB FDA listed
Carbidopa and Levodopa 25 mg/1; 100 mg 50090-6580-01 A-S 90 tablets AB FDA listed
Carbidopa and Levodopa 25 mg/1; 100 mg 50090-6725-00 A-S 90 tablets AB FDA listed
Carbidopa and levodopa 25 mg/1; 100 mg 50090-6727-00 A-S 90 tablets AB FDA listed
Carbidopa and Levodopa 25 mg/1; 100 mg 50090-7498-01 A-S 90 tablets AB FDA listed
Carbidopa and Levodopa 25 mg/1; 100 mg 50090-7499-00 A-S 90 tablets AB FDA listed
Carbidopa and Levodopa 25 mg/1; 100 mg 50268-0202-15 AvPAK 50 tablets AB FDA listed
Carbidopa and Levodopa 25 mg/1; 100 mg 55154-2643-00 Cardinal 10 tablets AB FDA listed
Carbidopa And Levodopa 25 mg/1; 100 mg 62756-0518-08 Sun 100 tablets AB FDA listed
Carbidopa And Levodopa 25 mg/1; 100 mg 63629-2356-01 Bryant 500 tablets AB Discontinued
Carbidopa And Levodopa 25 mg/1; 100 mg 63629-2357-01 Bryant 100 tablets AB Discontinued
Carbidopa-levodopa 25 mg/1; 100 mg 67046-1507-03 Coupler 30 tablets AB FDA listed
Carbidopa And Levodopa 25 mg/1; 100 mg 68071-2240-01 NuCare 100 tablets AB FDA listed
Carbidopa and Levodopa 25 mg/1; 100 mg 71205-0878-00 Proficient 100 tablets AB FDA listed
Carbidopa-levodopa 25 mg/1; 100 mg 71335-2588-01 Bryant 90 tablets AB FDA listed
Carbidopa and Levodopa 25 mg/1; 100 mg 71610-0647-60 Aphena 90 tablets AB FDA listed
Carbidopa and levodopa 25 mg/1; 100 mgthis 71610-0664-80 Aphena 180 tablets AB FDA listed
Carbidopa And Levodopa 25 mg/1; 100 mg 72865-0362-01 XLCare 100 tablets AB FDA listed
Carbidopa And Levodopa 25 mg/1; 100 mg 53401-0020-60 Aphena 90 tablets AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
On the market since
Mar 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Carbidopa and Levodopa — the ingredient across all brands.

Top reported reactions

Fall4,472
Hallucination3,935
Tremor3,311
Dyskinesia3,020
Death2,907
Parkinson^s Disease2,539
Dizziness2,523

Age at onset

Neonate1
Infant1
Child12
Adolescent3
Adult553
Elderly1,778

Reporter sex

0 reports
Male · 57%
Female · 43%
Unknown · 0%

Serious outcomes

Death5,934
Disabling759
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,898 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71610-0664-60 90 TABLET in 1 BOTTLE (71610-664-60) 2022-10-04 Active
71610-0664-80 You're viewing this 180 TABLET in 1 BOTTLE (71610-664-80) 2022-10-17 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71610-0664-80?
NDC 71610-0664-80 is a 180-count package — 180 tablet in 1 bottle.
What is the difference between NDC 71610-0664-80 and NDC 71610-0664-60?
Both are Carbidopa and levodopa 25 mg; 100 mg Tablet — the drug itself is identical. NDC 71610-0664-80 is the 180-count package, while NDC 71610-0664-60 is the 90 tablets package.
What NDC number is used to bill for this package of Carbidopa and levodopa 25 mg; 100 mg Tablet?
Bill NDC 71610-0664-80 — the 11-digit billing format is 71610066480. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 71610-664-80, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71610-0664-80, written without dashes as 71610066480. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71610-0664-80, the first segment (71610) is the labeler code FDA assigned to Aphena Pharma Solutions - Tennessee, LLC; the middle segment (0664) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (80) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Aphena Pharma Solutions - Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 90 tablets (71610-0664-60). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Aphena Pharma Solutions - Tennessee, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 110 words

INDICATIONS AND USAGE Carbidopa and levodopa tablets 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.

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.

⏱️ Dosage and Administration ~3 min read

DOSAGE AND ADMINISTRATION The optimum daily dosage of carbidopa and levodopa must be determined by careful titration in each patient. Carbidopa and levodopa tablets are available in a 1:4 ratio of carbidopa to levodopa (25 mg/100 mg) as well as 1:10 ratio (25 mg/250 mg and 10 mg/100 mg). Tablets of the two ratios may be given separately or combined as needed to provide the optimum dosage.

Studies show that peripheral dopa decarboxylase is saturated by carbidopa at approximately 70 to 100 mg a day. Patients receiving less than this amount of carbidopa are more likely to experience nausea and vomiting. Usual Initial Dosage Dosage is best initiated with one tablet of carbidopa and levodopa 25 mg/100 mg three times a day.

This dosage schedule provides 75 mg of carbidopa per day. Dosage may be increased by one tablet every day or every other day, as necessary, until a dosage of eight tablets of carbidopa and levodopa 25 mg/100 mg a day is reached. If carbidopa and levodopa 10 mg/100 mg is used, dosage may be initiated with one tablet three or four times a day.

However, this will not provide an adequate amount of carbidopa for many patients. Dosage may be increased by one tablet every day or every other day until a total of eight tablets (2 tablets four times a day) is reached. How to Transfer Patients from Levodopa Levodopa must be discontinued at least twelve hours before starting this combination product.

A daily dosage of carbidopa and levodopa should be chosen that will provide approximately 25% of the previous levodopa dosage. Patients who are taking less than 1,500 mg of levodopa a day should be started on one tablet of carbidopa and levodopa 25 mg/100 mg three or four times a day. The suggested starting dosage for most patients taking more than 1,500 mg of levodopa is one tablet of carbidopa and levodopa 25 mg/250 mg three or four times a day.

Maintenance Therapy should be individualized and adjusted according to the desired therapeutic response. At least 70 to 100 mg of carbidopa per day should be provided. When a greater proportion of carbidopa is required, one 25 mg/100 mg tablet may be substituted for each 10 mg/100 mg tablet.

When more levodopa is required, each 25 mg/250 mg tablet should be substituted for a 25 mg/100 mg tablet or a 10 mg/100 mg tablet. If necessary, the dosage of carbidopa and levodopa 25 mg/250 mg may be increased by one-half or one tablet every day or every other day to a maximum of eight tablets a day. Experience with total daily dosages of carbidopa greater than 200 mg is limited.

Because both therapeutic and adverse responses occur more rapidly with this combination product than with levodopa alone, patients should be monitored closely during the dose adjustment period. Specifically, involuntary movements will occur more rapidly with carbidopa and levodopa than with levodopa. The occurrence of involuntary movements may require dosage reduction.

Blepharospasm may be a useful early sign of excess dosage in some patients. Addition of Other Antiparkinsonian Medications Standard drugs for Parkinson's disease, other than levodopa without a decarboxylase inhibitor, may be used concomitantly while carbidopa and levodopa is being administered, although dosage adjustments may be required. Interruption of Therapy Sporadic cases of hyperpyrexia and confusion have been associated with dose reductions and withdrawal of carbidopa and levodopa.

Patients should be observed carefully if abrupt reduction or discontinuation of carbidopa and levodopa is required, especially if the patient is receiving neuroleptics (see WARNINGS ). If general anesthesia is required, carbidopa and levodopa may be continued as long as the patient is permitted to take fluids and medication by mouth. If therapy is interrupted temporarily, the patient should be observed for symptoms resembling NMS, and the usual daily dosage may be administered as soon as the patient is able to take oral medication.

Contraindications 84 words

CONTRAINDICATIONS Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with carbidopa and levodopa. These inhibitors must be discontinued at least two weeks prior to initiating therapy with this combination product. Carbidopa and levodopa may be administered concomitantly with the manufacturer's recommended dose of an MAO inhibitor with selectivity for MAO type B (e.g., selegiline HCl) (see PRECAUTIONS , Drug Interactions ).

Carbidopa and levodopa is contraindicated in patients with known hypersensitivity to any component of this drug, and in patients with narrow-angle glaucoma.

⚠️ Warnings ~3 min read

WARNINGS When carbidopa and levodopa tablets are to be given to patients who are being treated with levodopa, levodopa must be discontinued at least twelve hours before therapy with the combination product is started. In order to reduce adverse reactions, it is necessary to individualize therapy. See DOSAGE AND ADMINISTRATION section before initiating therapy.

The addition of carbidopa with levodopa in the form of this combination product reduces the peripheral effects (nausea, vomiting) due to decarboxylation of levodopa; however, carbidopa does not decrease the adverse reactions due to the central effects of levodopa. Because carbidopa permits more levodopa to reach the brain and more dopamine to be formed, certain adverse central nervous system (CNS) effects, e.g., dyskinesias (involuntary movements), may occur at lower dosages and sooner with carbidopa and levodopa than with levodopa alone.

All patients should be observed carefully for the development of depression with concomitant suicidal tendencies. Carbidopa and levodopa should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease. As with levodopa, care should be exercised in administering the combination product, to patients with a history of myocardial infarction who have residual atrial, nodal, or ventricular arrhythmias.

In such patients, cardiac function should be monitored with particular care during the period of initial dosage adjustment, in a facility with provisions for intensive cardiac care. As with levodopa, treatment with the combination product may increase the possibility of upper gastrointestinal hemorrhage in patients with a history of peptic ulcer. Falling Asleep During Activities of Daily Living and Somnolence Patients taking carbidopa and levodopa alone or with other dopaminergic drugs have reported suddenly falling asleep without prior warning of sleepiness while engaged in activities of daily living (includes operation of motor vehicles).

Road traffic accidents attributed to sudden sleep onset have been reported. Although many patients reported somnolence while on dopaminergic medications, there have been reports of road traffic accidents attributed to sudden onset of sleep in which the patient did not perceive any warning signs, such as excessive drowsiness, and believed that they were alert immediately prior to the event. Sudden onset of sleep has been reported to occur as long as one year after the initiation of treatment.

Falling asleep while engaged in activities of daily living usually occurs in patients experiencing preexisting somnolence, although some patients may not give such a history. For this reason, prescribers should reassess patients for drowsiness or sleepiness especially since some of the events occur well after the start of treatment. Prescribers should be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities.

Patients should be advised to exercise caution while driving or operating machines during treatment with carbidopa and levodopa. Patients who have already experienced somnolence or an episode of sudden sleep onset should not participate in these activities during treatment with carbidopa and levodopa. Before initiating treatment with carbidopa and levodopa, advise patients about the potential to develop drowsiness and ask specifically about factors that may increase the risk for somnolence with carbidopa and levodopa such as the use of concomitant sedating medications and the presence of sleep disorders.

Consider discontinuing carbidopa and levodopa in patients who report significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating, etc.). If treatment with carbidopa and levodopa continues, patients should be advised not to drive and to avoid other potentially…

🤒 Adverse Reactions ~2 min read

ADVERSE REACTIONS The most common adverse reactions reported with carbidopa and levodopa have included dyskinesias, such as choreiform, dystonic, and other involuntary movements, and nausea. The following other adverse reactions have been reported with carbidopa and levodopa: Body as a Whole Chest pain, asthenia. Cardiovascular Cardiac irregularities, hypotension, orthostatic effects including orthostatic hypotension, hypertension, syncope, phlebitis, palpitation.

Gastrointestinal Dark saliva, gastrointestinal bleeding, development of duodenal ulcer, anorexia, vomiting, diarrhea, constipation, dyspepsia, dry mouth, taste alterations. Hematologic Agranulocytosis, hemolytic and non-hemolytic anemia, thrombocytopenia, leukopenia. Hypersensitivity Angioedema, urticaria, pruritus, Henoch-Schönlein purpura, bullous lesions (including pemphigus-like reactions).

Musculoskeletal Back pain, shoulder pain, muscle cramps. Nervous System/Psychiatric Psychotic episodes including delusions, hallucinations, and paranoid ideation, bradykinetic episodes ("on-off" phenomenon), confusion, agitation, dizziness, somnolence, dream abnormalities including nightmares, insomnia, paresthesia, headache, depression with or without development of suicidal tendencies, dementia, pathological gambling, increased libido including hypersexuality, impulse control symptoms. Convulsions also have occurred; however, a causal relationship with carbidopa and levodopa has not been established.

Respiratory Dyspnea, upper respiratory infection. Skin Rash, increased sweating, alopecia, dark sweat. Urogenital Urinary tract infection, urinary frequency, dark urine.

Laboratory Tests Decreased hemoglobin and hematocrit; abnormalities in alkaline phosphatase, SGOT (AST), SGPT (ALT), LDH, bilirubin, BUN, Coombs test; elevated serum glucose; white blood cells, bacteria, and blood in the urine. Other adverse reactions that have been reported with levodopa alone and with various carbidopa and levodopa formulations, and may occur with this combination product are: Body as a Whole Abdominal pain and distress, fatigue. Cardiovascular Myocardial infarction.

Gastrointestinal Gastrointestinal pain, dysphagia, sialorrhea, flatulence, bruxism, burning sensation of the tongue, heartburn, hiccups. Metabolic Edema, weight gain, weight loss. Musculoskeletal Leg pain.

Nervous System/Psychiatric Ataxia, extrapyramidal disorder, falling, anxiety, gait abnormalities, nervousness, decreased mental acuity, memory impairment, disorientation, euphoria, blepharospasm (which may be taken as an early sign of excess dosage; consideration of dosage reduction may be made at this time), trismus, increased tremor, numbness, muscle twitching, activation of latent Horner's syndrome, peripheral neuropathy. Respiratory Pharyngeal pain, cough. Skin Malignant melanoma, flushing.

Special Senses Oculogyric crises, diplopia, blurred vision, dilated pupils. Urogenital Urinary retention, urinary incontinence, priapism. Miscellaneous Bizarre breathing patterns, faintness, hoarseness, malaise, hot flashes, sense of stimulation.

Laboratory Tests Decreased white blood cell count and serum potassium; increased serum creatinine and uric acid; protein and glucose in urine. To report SUSPECTED ADVERSE EVENTS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch for voluntary reporting of adverse reactions.

🆘 Overdosage 212 words

OVERDOSAGE Management of acute overdosage with carbidopa and levodopa is the same as management of acute overdosage with levodopa. Pyridoxine is not effective in reversing the actions of this product. General supportive measures should be employed, along with immediate gastric lavage.

Intravenous fluids should be administered judiciously and an adequate airway maintained. Electrocardiographic monitoring should be instituted and the patient carefully observed for the development of arrhythmias; if required, appropriate antiarrhythmic therapy should be given. The possibility that the patient may have taken other drugs as well as carbidopa and levodopa tablets should be taken into consideration.

To date, no experience has been reported with dialysis; hence, its value in overdosage is not known. Based on studies in which high doses of levodopa and/or carbidopa were administered, a significant proportion of rats and mice given single oral doses of levodopa of approximately 1,500 to 2,000 mg/kg are expected to die. A significant proportion of infant rats of both sexes are expected to die at a dose of 800 mg/kg.

A significant proportion of rats are expected to die after treatment with similar doses of carbidopa. The addition of carbidopa in a 1:10 ratio with levodopa increases the dose at which a significant proportion of mice are expected to die to 3,360 mg/kg.

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY Mechanism of Action Parkinson's disease is a progressive, neurodegenerative disorder of the extrapyramidal nervous system affecting the mobility and control of the skeletal muscular system. Its characteristic features include resting tremor, rigidity, and bradykinetic movements. Symptomatic treatments, such as levodopa therapies, may permit the patient better mobility.

Current evidence indicates that symptoms of Parkinson's disease are related to depletion of dopamine in the corpus striatum. Administration of dopamine is ineffective in the treatment of Parkinson's disease apparently because it does not cross the blood-brain barrier. However, levodopa, the metabolic precursor of dopamine, does cross the blood-brain barrier, and presumably is converted to dopamine in the brain.

This is thought to be the mechanism whereby levodopa relieves symptoms of Parkinson's disease. Pharmacodynamics When levodopa is administered orally, it is rapidly decarboxylated to dopamine in extracerebral tissues so that only a small portion of a given dose is transported unchanged to the central nervous system. For this reason, large doses of levodopa are required for adequate therapeutic effect, and these may often be accompanied by nausea and other adverse reactions, some of which are attributable to dopamine formed in extracerebral tissues.

Since levodopa competes with certain amino acids for transport across the gut wall, the absorption of levodopa may be impaired in some patients on a high protein diet. Carbidopa inhibits decarboxylation of peripheral levodopa. It does not cross the blood-brain barrier and does not affect the metabolism of levodopa within the central nervous system.

The incidence of levodopa-induced nausea and vomiting is less with the combination product than with levodopa. In many patients, this reduction in nausea and vomiting will permit more rapid dosage titration. Since its decarboxylase inhibiting activity is limited to extracerebral tissues, administration of carbidopa with levodopa makes more levodopa available for transport to the brain.

Pharmacokinetics Carbidopa reduces the amount of levodopa required to produce a given response by about 75% and, when administered with levodopa, increases both plasma levels and the plasma half-life of levodopa, and decreases plasma and urinary dopamine and homovanillic acid. The plasma half-life of levodopa is about 50 minutes, without carbidopa. When carbidopa and levodopa are administered together, the half-life of levodopa is increased to about 1.5 hours.

At steady state, the bioavailability of carbidopa from carbidopa and levodopa tablets is approximately 99% relative to the concomitant administration of carbidopa and levodopa. In clinical pharmacologic studies, simultaneous administration of carbidopa and levodopa produced greater urinary excretion of levodopa in proportion to the excretion of dopamine than administration of the two drugs at separate times. Pyridoxine hydrochloride (vitamin B 6 ), in oral doses of 10 mg to 25 mg, may reverse the effects of levodopa by increasing the rate of aromatic amino acid decarboxylation.

Carbidopa inhibits this action of pyridoxine; therefore, carbidopa and levodopa can be given to patients receiving supplemental pyridoxine (vitamin B 6 ). Special Populations Geriatric: A study in eight young healthy subjects (21 to 22 yr) and eight elderly healthy subjects (69 to 76 yr) showed that the absolute bioavailability of levodopa was similar between young and elderly subjects following oral administration of levodopa and carbidopa. However, the systemic exposure (AUC) of levodopa was increased by 55% in elderly subjects compared to young subjects.

Based on another study in forty patients with Parkinson’s disease, there was a correlation between age of patients and the increase of AUC of levodopa following administration of levodopa and an inhibitor of peripheral dopa decarboxylase. AUC of levodopa was increased by 28% in elde…

📦 How Supplied / Storage and Handling 175 words

HOW SUPPLIED Carbidopa and Levodopa Tablets, USP are supplied as follows: 10 mg/100 mg — Each dark blue, mottled, round tablet imprinted with ‘TV’ on one side and ‘9701’on the other side contains 10 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/100 mg — Each yellow, mottled, round tablet imprinted with ‘TV’ on one side and ‘9702’on the other side contains 25 mg of carbidopa, USP and 100 mg of levodopa, USP and is supplied in bottles of 100 (NDC 42291-472-01) and 1000 (NDC 42291-472-10). 25 mg/250 mg — Each light blue, mottled, round tablet imprinted with ‘TV’ on one side and ‘9703’ on the other side contains 25 mg of carbidopa, USP and 250 mg of levodopa, USP .

Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Manufactured for: AvKARE Pulaski, TN 38478 Mfg. Rev. B 09/20 AV 03/21 (P)

📋 Description ~1 min read

DESCRIPTION Carbidopa and levodopa tablets, USP are a combination product for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, 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 C 10 H 14 N 2 O 4 •H 2 O, and its structural formula is: Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid.

Its molecular formula is C 9 H 11 NO 4 , and its structural formula is: Carbidopa and Levodopa Tablets, USP for oral administration, are supplied in three strengths: 10 mg/100 mg, containing 10 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/100 mg, containing 25 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/250 mg, containing 25 mg of carbidopa, USP and 250 mg of levodopa, USP.

In addition, each tablet contains the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize). In addition, the 25 mg/100 mg strength contain D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake (sunset yellow lake). The 10 mg/100 mg and 25 mg/250 mg strengths contain FD&C blue #2 aluminum lake.

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Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.