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Carbidopa Levodopa And Entacapone Prescribing Information

This information is not for clinical use. These highlights do not include all the information needed to use Carbidopa Levodopa And Entacapone safely and effectively. Before taking Carbidopa Levodopa And Entacapone please consult with your doctor. See full prescribing information for Carbidopa Levodopa And Entacapone.

Indications And Usage

To substitute (with equivalent strength of each of the three components) for immediate-release carbidopa/levodopa and entacapone previously administered as individual products. To replace immediate-release carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose "wearing-off" (only for patients taking a total daily dose of levodopa of 600 mg or less and not experiencing dyskinesias, see DOSAGE AND ADMINISTRATION).

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Contraindications

Carbidopa, levodopa and entacapone tablets are contraindicated in patients who have demonstrated hypersensitivity to any component (carbidopa, levodopa, or entacapone) of the drug or its excipients. Monoamine oxidase (MAO) and COMT are the two major enzyme systems involved in the metabolism of catecholamines. It is theoretically possible, therefore, that the combination of entacapone and a non-selective MAO inhibitor (e.g., phenelzine and tranylcypromine) would result in inhibition of the majority of the pathways responsible for normal catecholamine metabolism. As with carbidopa-levodopa, nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with carbidopa, levodopa and entacapone tablets. These inhibitors must be discontinued at least two weeks prior to initiating therapy with carbidopa, levodopa and entacapone tablets. Carbidopa, levodopa and entacapone tablets may be administered concomitantly with the manufacturer’s recommended dose of MAO inhibitors with selectivity for MAO type B (e.g., selegiline HCl). (See PRECAUTIONS, Drug Interactions.) Carbidopa, levodopa and entacapone tablets are contraindicated in patients with narrow-angle glaucoma. Because levodopa may activate malignant melanoma, carbidopa, levodopa and entacapone tablets should not be used in patients with suspicious, undiagnosed skin lesions or a history of melanoma.

Adverse Reactions

Carbidopa-levodopa The most common adverse reactions reported with carbidopa-levodopa have included dyskinesias, such as choreiform, dystonic, and other involuntary movements and nausea. The following other adverse reactions have been reported with carbidopa-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-Schonlein purpura, bullous lesions (including pemphigus-like reactions). Musculoskeletal: Back pain, shoulder pain, muscle cramps. Nervous System and Psychiatric: Psychotic episodes including delusions, hallucinations, and paranoid ideation, neuroleptic malignant syndrome (see WARNINGS), 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, increased libido. Convulsions also have occurred; however, a causal relationship with carbidopa-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), lactic dehydrogenase, bilirubin, blood urea nitrogen (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-levodopa formulations, and may occur with carbidopa, levodopa and entacapone tablets 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 and Psychiatric: Ataxia, extrapyramidal disorder, failing, 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 (see also CONTRAINDICATIONS), flushing. Special Senses: Oculogyric crisis, 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. Entacapone The most commonly observed adverse events (greater than 5%) in the double-blind, placebo-controlled trials of entacapone (N=1,003) associated with the use of entacapone alone and not seen at an equivalent frequency among the placebo-treated patients were: dyskinesia/hyperkinesia, nausea, urine discoloration, diarrhea, and abdominal pain. Approximately 14% of the 603 patients given entacapone in the double-blind, placebo-controlled trials discontinued treatment due to adverse events compared to 9% of the 400 patients who received placebo. The most frequent causes of discontinuation in decreasing order are: psychiatric reasons (2% versus 1%), diarrhea (2% versus 0%), dyskinesia/hyperkinesia (2% versus 1%), nausea (2% versus 1%), abdominal pain (1% versus 0%), and aggravation of Parkinson's disease symptoms (1% versus 1%). Adverse Event Incidence in Controlled Clinical Studies of Entacapone Table 5 lists treatment emergent adverse events that occurred in at least 1% of patients treated with entacapone participating in the double-blind, placebo-controlled studies and that were numerically more common in the entacapone group, compared to placebo. In these studies, either entacapone or placebo was added to carbidopa-levodopa (or benserazide-levodopa). Table 5 Summary of Patients With Adverse Events After Start of Trial Drug Administration At Least 1% in Entacapone Group and Greater than Placebo SYSTEM ORGAN CLASS Preferred Term Entacapone (n = 603) % of patients Placebo (n = 400) % of patients SKIN AND APPENDAGES DISORDERS Sweating Increased 2 1 MUSCULOSKELETAL SYSTEM DISORDERS Back Pain 2 1 CENTRAL AND PERIPHERAL NERVOUS SYSTEM DISORDERS Dyskinesia 25 15 Hyperkinesia 10 5 Hypokinesia 9 8 Dizziness 8 6 SPECIAL SENSES , OTHER DISORDERS Taste Perversion 1 0 PSYCHIATRIC DISORDERS Anxiety 2 1 Somnolence 2 0 Agitation 1 0 GASTROINTESTINAL SYSTEM DISORDERS Nausea 14 8 Diarrhea 10 4 Abdominal Pain 8 4 Constipation 6 4 Vomiting 4 1 Mouth Dry 3 0 Dyspepsia 2 1 Flatulence 2 0 Gastritis 1 0 Gastrointestinal Disorders NOS 1 0 RESPIRATORY SYSTEM DISORDERS Dyspnea 3 1 PLATELET , BLEEDING AND CLOTTING DISORDERS Purpura 2 1 URINARY SYSTEM DISORDERS Urine Discoloration 10 0 BODY AS A WHOLE - GENERAL DISORDERS Back Pain 4 2 Fatigue 6 4 Asthenia 2 1 RESISTANCE MECHANISM DISORDERS Infection Bacterial 1 0 The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures do, however, provide the prescriber with some basis for estimating the relative contribution of drug and nondrug factors to the adverse events observed in the population studied. Effects of Gender and Age on Adverse Reactions No differences were noted in the rate of adverse events attributable to entacapone alone by age or gender.

Drug Interactions

Drug Interactions See PRECAUTIONS, Drug Interactions.

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