Clinical Information:Generic Code And Description: 52885 Carbidopa/Levodopa/Entacapone Oral Tablet 12.5-50 Mg Strength: 12.5 Mg-50 Mg-200 MgDose Form: Tablet Product Category: Rx Pharmaceuticals Fine Line Class: 850085008510 All Rx Products DEA Class: None Omp Family:Drug Class: 28361600 Dopamine Precursors28361200 Catechol-O-Methyltransferase(Comt)Inhib.Active Ingredients: 1085 Carbidopa 388214971639 Levodopa 599277684 Entacapone 130929576 Inactive Ingredients: 2272 Mannitol 696582598 Sucrose 57501
These highlights do not include all the information needed to use CARBIDOPA, LEVODOPA AND ENTACAPONE safely and effectively. See full prescribing information for CARBIDOPA, LEVODOPA AND ENTACAPONE.
CARBIDOPA, LEVODOPA AND ENTACAPONE tablets, for oral use
Initial U.S. Approval: 2003
INDICATIONS AND USAGE
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) are indicated for the treatment of Parkinson's disease. Carbidopa, levodopa and entacapone tablets are to be used:
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To substitute (with equivalent strengths of each of the three components) for carbidopa/levodopa and entacapone previously administered as individual products (1)
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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 (1)
DOSAGE AND ADMINISTRATION
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The optimum daily dosage of carbidopa, levodopa and entacapone tablets must be determined by careful titration in each patient (2.1)
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Individual tablets should not be split or fractionated. Administer only one tablet at each dosing interval (2.6)
DOSAGE FORMS AND STRENGTHS
Each carbidopa, levodopa and entacapone tablet contains a 1:4 ratio of carbidopa to levodopa and 200 mg of entacapone (mg of carbidopa per mg of levodopa per mg of entacapone) (3)
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Carbidopa, levodopa and entacapone tablets 12.5 mg per 50 mg per 200 mg
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Carbidopa, levodopa and entacapone tablets 18.75 mg per 75 mg per 200 mg
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Carbidopa, levodopa and entacapone tablets 25 mg per 100 mg per 200 mg
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Carbidopa, levodopa and entacapone tablets 31.25 mg per 125 mg per 200 mg
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Carbidopa, levodopa and entacapone tablets 37.5 mg per 150 mg per 200 mg
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Carbidopa, levodopa and entacapone tablets 50 mg per 200 mg per 200 mg
CONTRAINDICATIONS
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Concomitant use of nonselective monoamine oxidase (MAO) inhibitors (4)
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Narrow-angle glaucoma (4)
WARNINGS AND PRECAUTIONS
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May cause falling asleep during activities of daily living without apparent warning, and daytime drowsiness and somnolence (5.1)
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May cause syncope and hypotension/orthostatic hypotension (5.2)
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May cause or exacerbate dyskinesia (5.3)
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May cause depression and suicidality (5.4)
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May cause hallucinations and/or other psychotic-like behavior (5.5)
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May cause problems with impulse control and compulsive behaviors (5.6)
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Abrupt discontinuation may cause hyperpyrexia and confusion (5.7)
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May cause diarrhea and/or drug-induced colitis (5.8)
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May cause rhabdomyolysis (5.9)
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Increased risk of melanoma (5.10)
ADVERSE REACTIONS
The most common adverse reactions (incidence 3% or higher than placebo incidence) are dyskinesias, urine discoloration, diarrhea, nausea, abdominal pain, vomiting, and dry mouth (6)
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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Drugs metabolized by COMT: use with caution (5.11,7.2)
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Anti-hypertensive agents: dose adjustment may be required (7.3)
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Tricyclic antidepressants: risk of hypertension and dyskinesia reported during concomitant use with carbidopa/levodopa (7.4)
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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)
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Drugs that interfere with biliary excretion, glucuronidation and intestinal beta-glucuronidase: dose adjustment of carbidopa, levodopa and entacapone tablets may be required (7.10)
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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)
USE IN SPECIFIC POPULATIONS
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Pregnancy: based on animal data, may cause fetal harm (8.1)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 2/2016
