Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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 Holdings, Inc.
at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/med watch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions (number of unique patients experiencing an adverse reaction associated with treatment/total number of patients treated) observed in the clinical trials of a drug cannot be directly compared to the incidence of adverse reactions in the clinical trials of another drug and may not reflect the incidence of adverse reactions observed in clinical practice.
Entacapone The most commonly observed adverse reactions (incidence at least 3% greater than placebo incidence) in the double-blind, carbidopa-levodopa-placebo-controlled trials of entacapone (N=1,003 patients) associated with the use of carbidopa-levodopa-entacapone alone and not seen at an equivalent frequency among the placebo-treated patients were: dyskinesia, diarrhea, nausea, hyperkinesia, abdominal pain, vomiting, dry mouth, and urine discoloration.
The treatment difference incidence for premature study discontinuation for entacapone with levodopa and dopa decarboxylase inhibitor in the double-blind, placebo-controlled trials was 5%.
The treatment difference incidence for the most frequent causes of study discontinuation was 2% for diarrhea, and 1% for other specific adverse reactions including psychiatric reasons, dyskinesia/ hyperkinesia, nausea, or abdominal pain.
Adverse Reaction Incidence in Controlled Clinical Studies of Entacapone Table 2 lists treatment emergent adverse reactions that occurred in at least 1% of patients treated with carbidopa/levodopa and 200 mg of entacapone who participated in the double-blind, placebo-controlled studies, and that were numerically more common in this group than in the carbidopa/levodopa plus placebo group.
In these studies, either entacapone or placebo was added to carbidopa/levodopa (or benserazide/levodopa).
Table 2: Summary of Patients With Adverse Reactions After Start of Trial Drug Administration At Least 1% in Entacapone Group and Greater Than Placebo SYSTEM ORGAN CLASS Adverse Reaction Carbidopa/levodopa plus Entacapone (n=603) % of patients Carbidopa/levodopa plus Placebo (n=400) % of patients SKIN AND APPENDAGES DISORDERS Sweating Increased 2 1 MUSCULOSKELETAL SYSTEM DISORDERS Back Pain 5 3 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 Fatigue 6 4 Asthenia 2 1 RESISTANCE MECHANISM DISORDERS Infection Bacterial 1 0 6.2 Postmarketing Experience The following spontaneous reports of adverse events temporally associated with entacapone or carbidopa, levodopa and entacapone tablets have been identified since market introduction and are not listed in Table
Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish causal relationship to entacapone or carbidopa, levodopa and entacapone tablets exposure.
5 WARNINGS AND PRECAUTIONS The following adverse reactions described in this section are related to at least one of the components of carbidopa, levodopa and entacapone tablets (i.e., levodopa, carbidopa, and/or entacapone) based upon the safety experience in clinical trials (especially pivotal trials) or in postmarketing reports.
May cause falling asleep during activities of daily living without apparent warning, and daytime drowsiness and somnolence ( 5.1 ) May cause syncope and hypotension/orthostatic hypotension ( 5.2 ) May cause or exacerbate dyskinesia ( 5.3 ) May cause depression and suicidality ( 5.4 ) May cause hallucinations and/or other psychotic-like behavior ( 5.5 ) May cause problems with impulse control and compulsive behaviors ( 5.6 ) Abrupt discontinuation may cause hyperpyrexia and confusion ( 5.7 ) May cause diarrhea and/or drug-induced colitis ( 5.8 ) May cause rhabdomyolysis ( 5.9 ) 5.1 Falling Asleep During Activities of Daily Living and Somnolence Patients with Parkinson’s disease treated with carbidopa, levodopa and entacapone tablets or other carbidopa/levodopa products have reported suddenly falling asleep without prior warning of sleepiness while engaged in activities of daily living (including the operation of motor vehicles).
Some of these episodes resulted in accidents.
Although many of these patients reported somnolence while taking entacapone, some did not perceive warning signs, such as excessive drowsiness, and believed that they were alert immediately prior to the event.
Some of these events have been reported to occur up to one year after initiation of treatment.
Like all medications, Carbidopa, Levodopa And Entacapone can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: