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Comtan

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Comtan

Comtan

SIDE EFFECTS

During the pre-marketing development of entacapone, 1450 patients with Parkinson's Disease were treated with entacapone. Included were patients with fluctuating symptoms, as well as those with stable responses to levodopa therapy. All patients received concomitant treatment with levodopa preparations, however, and were similar in other clinical aspects.

The most commonly observed adverse events ( > 5%) in the double-blind, placebo-controlled trials (N=1003) associated with the use of Comtan (entacapone) 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% vs. 1%), diarrhea (2% vs. 0%), dyskinesia/hyperkinesia (2% vs. 1%), nausea (2% vs. 1%), abdominal pain (1% vs. 0%), and aggravation of Parkinson's Disease symptoms (1% vs. 1%).

Adverse Event Incidence in Controlled Clinical Studies

Table 4 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 levodopa/carbidopa (or levodopa/benserazide).

Table 4 : Summary of Patients with Adverse Events after Start of Trial Drug Administration At least 1% in Comtan® (entacapone) group and > Placebo

SYSTEM ORGAN CLASS Preferred term Comtan (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 & 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 & 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 by age or gender.

Drug Abuse And Dependence

Comtan (entacapone) is not a controlled substance. Animal studies to evaluate the drug abuse and potential dependence have not been conducted. Although clinical trials have not revealed any evidence of the potential for abuse, tolerance or physical dependence, systematic studies in humans designed to evaluate these effects have not been performed.

Read the Comtan (entacapone) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

In vitro studies of human CYP enzymes showed that entacapone inhibited the CYP enzymes 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 and 3A only at very high concentrations (IC50 from 200 to over 1000 μM; an oral 200 mg dose achieves a highest level of approximately 5 μM in people); these enzymes would therefore not be expected to be inhibited in clinical use.

Protein Binding

Entacapone is highly protein bound (98%). In vitro studies have shown no binding displacement between entacapone and other highly bound drugs, such as warfarin, salicylic acid, phenylbutazone, and diazepam.

Drugs Metabolized by Catechol-O-methyltransferase (COMT)

See WARNINGS.

Hormone levels

Levodopa is known to depress prolactin secretion and increase growth hormone levels. Treatment with entacapone coadministered with levodopa/dopa decarboxylase inhibitor does not change these effects.

Effect of Entacapone on the Metabolism of Other Drugs

See WARNINGS regarding concomitant use of Comtan (entacapone) and non-selective MAO inhibitors.

No interaction was noted with the MAO-B inhibitor selegiline in two multiple-dose interaction studies when entacapone was coadministered with a levodopa/dopa decarboxylase inhibitor (n=29). More than 600 Parkinson's Disease patients in clinical trials have used selegiline in combination with entacapone and levodopa/dopa decarboxylase inhibitor.

As most entacapone excretion is via the bile, caution should be exercised when drugs known to interfere with biliary excretion, glucuronidation, and intestinal beta-glucuronidase are given concurrently with entacapone. These include probenecid, cholestyramine, and some antibiotics (e.g., erythromycin, rifampicin, ampicillin and chloramphenicol). No interaction with the tricyclic antidepressant imipramine was shown in a single-dose study with entacapone without coadministered levodopa/dopa-decarboxylase inhibitor.

Read the Comtan Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 11/4/2010
This monograph has been modified to include the generic and brand name in many instances.

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Comtan - User Reviews

Comtan User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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