Drugplain

carbidopa, levodopa and entacapone 25 mg/1

carbidopa, levodopa and entacapone · TABLET, FILM COATED · Alembic Pharmaceuticals Limited

1 Recall on Record
Plain English

carbidopa, levodopa and entacapone is a tablet, film coated containing carbidopa, levodopa and entacapone at 25 mg/1, taken oral. Manufactured by Alembic Pharmaceuticals Limited.

Key Facts

Brand Name
carbidopa, levodopa and entacapone
Generic Name
carbidopa, levodopa and entacapone
NDC Code (Product)
46708-797
Manufacturer
Alembic Pharmaceuticals Limited
Strength
25 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA218535
Drug Class
Aromatic Amino Acid [EPC]; Catechol-O-Methyltransferase Inhibitor [EPC]
Marketing Start
02/12/2026

Recall History

1 Recall on Record
Class II08/08/2013

Novartis Pharmaceuticals Corp.

Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fall69 reports
death54 reports
hallucination52 reports
drug ineffective45 reports
parkinson^s disease41 reports
dyskinesia28 reports
urinary tract infection27 reports
confusional state25 reports
product dose omission issue25 reports
device issue21 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Carbidopa, levodopa and entacapone tablets, are indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tablets can be used: To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products. To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. Carbidopa, levodopa and entacapone tablets, a combination drug consisting of levodopa (aromatic amino acid), carbidopa (aromatic amino acid decarboxylation inhibitor), and entacapone (catechol-O-methyltransferase (COMT) inhibitor) is indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tablets are to be used: To substitute (with equivalent strengths of each of the three components) for carbidopa/levodopa and entacapone previously administered as individual products ( 1 ) To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs …

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Carbidopa, levodopa and entacapone tablets should be used as a substitute for patients already stabilized on equivalent doses of carbidopa/levodopa and entacapone. However, some patients who have been stabilized on a given dose of carbidopa/levodopa may be treated with carbidopa, levodopa and entacapone tablets if a decision has been made to add entacapone (see below). Therapy should be individualized and adjusted according to the desired therapeutic response. Evaluate vitamin B6 levels prior to starting treatment with carbidopa/levodopa therapies. ( 2.1 ) The optimum daily dosage of carbidopa, levodopa and entacapone tablets must be determined by careful titration in each patient ( 2.2 ) Individual tablets should not be split or fractionated. Administer only one tablet at each dosing interval ( 2.6 ) 2.1 Management of Vitamin B6 Levels Evaluate vitamin B6 levels prior to initiating carbidopa/levodopa therapies, including carbidopa, levodopa, and entacapone tablets, periodically during treatment, and as clinically indicated [see Warnings and Precautions (5.10) ]. If vitamin B6 levels are low, supplement to sufficient levels per standard of care. Patients…

Contraindications

4 CONTRAINDICATIONS Carbidopa, levodopa and entacapone tablets are contraindicated in patients: Taking nonselective monoamine oxidase (MAO) inhibitors (e.g., phenelzine and tranylcypromine). These nonselective MAO inhibitors must be discontinued at least two weeks prior to initiating therapy with carbidopa, levodopa and entacapone tablets. With narrow-angle glaucoma. Concomitant use of nonselective monoamine oxidase (MAO) inhibitors ( 4 ) Narrow-angle glaucoma ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Drugs metabolized by COMT: use with caution ( 5.11 , 7.2 ) Anti-hypertensive agents: dose adjustment may be required ( 7.3 ) Tricyclic antidepressants: risk of hypertension and dyskinesia reported during concomitant use with carbidopa/levodopa ( 7.4 ) Dopamine D2 receptor antagonists, isoniazid, phenytoin, papaverine and iron salts: may reduce efficacy of carbidopa, levodopa and entacapone tablets ( 7.5 , 7.6 , 7.7 , 7.8 , 7.9 ) Drugs that interfere with biliary excretion, glucuronidation and intestinal beta-glucuronidase: dose adjustment of carbidopa, levodopa and entacapone tablets may be required ( 7.10 ) Drugs metabolized by CYP2C9 (e.g., coumadin): dose adjustment of carbidopa, levodopa and entacapone tablets may be required; monitor INR when initiating carbidopa, levodopa and entacapone tablets in patients on coumadin ( 7.11 ) 7.1 MAO Inhibitors Patients receiving nonselective MAO inhibitors and carbidopa, levodopa and entacapone may be at risk of increased adrenergic tone. Therefore, the use of carbidopa, levodopa and entacapone tablets is contraindicated in patients receiving nonselective MAO inhibitors [ see Contraindications (4) ]. 7.2 Drugs Metabolize…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in the Warnings and Precautions sections of labeling: Falling Asleep During Activities of Daily Living and Somnolence [ see Warnings and Precautions (5.1) ] Hypotension/Orthostatic Hypotension and Syncope [ see Warnings and Precautions (5.2) ] Dyskinesia [ see Warnings and Precautions (5.3) ] Depression and suicidality [ see Warnings and Precautions (5.4) ] Hallucinations/Psychotic-Like Behavior [ see Warnings and Precautions (5.5) ] Impulse Control and/or Compulsive Behaviors [ see Warnings and Precautions (5.6) ] Withdrawal-Emergent Hyperpyrexia and Confusion [ see Warnings and Precautions (5.7) ] Diarrhea and Colitis [ see Warnings and Precautions (5.8) ] Rhabdomyolysis [ see Warnings and Precautions (5.9) ] Vitamin B6 Deficiency and Seizures [ see Warnings and Precautions (5.10) ] Peptic Ulcer Disease [ see Warnings and Precautions (5.13) ] The most common adverse reactions (incidence 3% higher than placebo incidence) are dyskinesias, hyperkinesia, diarrhea, nausea, abdominal pain, vomiting, dry mouth, and urine discoloration ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Hold…

Frequently Asked Questions

What is carbidopa, levodopa and entacapone used for?

carbidopa, levodopa and entacapone contains carbidopa, levodopa and entacapone. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is carbidopa, levodopa and entacapone a controlled substance?

carbidopa, levodopa and entacapone is not classified as a controlled substance by the DEA.

What is the generic name for carbidopa, levodopa and entacapone?

The generic name for carbidopa, levodopa and entacapone is carbidopa, levodopa and entacapone. There are 7 other brand versions of carbidopa, levodopa and entacapone.

What is the NDC code for carbidopa, levodopa and entacapone 25 mg/1?

The NDC (National Drug Code) for carbidopa, levodopa and entacapone 25 mg/1 is 46708-797, listed by Alembic Pharmaceuticals Limited.

Product NDC

46708-797

Package NDC

46708-797-31

Other Carbidopa, Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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