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Central nervous system

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Business
Life Science
ETC
혈액순환개선제
Ongentys Cap. 50mg
Category
ETC
Indication(s)·Usage
  • Adjunctive therapy to preparations of levodopa/DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations.
Effective components
Opicapone 50mg

Active ingredient(s) and Contents

  • Effective components

    • Opicapone 50mg

  • Other

    • lactose, magnesium stearate, pregelatinized starch, and sodium starch glycolate

Dosage and administration

    • 1. Dosing and Administration Information
      The recommended dose is 50 mg of opicapone. It should be taken once daily at bedtime at least one hour before or after levodopa combinations.
    • 2. Dose adjustments of antiparkinsonian therapy
      Ongentys® is to be administered as an adjunct to levodopa treatment and enhances the effects of levodopa. Hence, it is often necessary to adjust levodopa dosage by extending the dosing intervals and/or reducing the amount of levodopa per dose within the first days to first weeks after initiating the treatment with opicapone according to the clinical condition of the patient.
    • 3. Missed Dose
      If one dose is missed, the next dose should be taken as scheduled. The patient should not take an extra dose to make up for the missed dose.
    • 4. Elderly
      No dose adjustment is needed for elderly patients. Caution must be exercised in patients ≥85 years of age as there is limited experience in this age group.
    • 5. Pediatric population
      There is no relevant use of Ongentys® in the pediatric population with PD and motor fluctuations.
    • 6. Renal impairment
      No dose adjustment is necessary in patients with renal impairment, as opicapone is not excreted by the kidney.
    • 7. Hepatic impairment
      No dose adjustment is necessary in patients with mild hepatic impairment (Child?Pugh Class A). There is limited clinical experience in patients with moderate hepatic impairment (Child?Pugh Class B). Caution must be exercised in these patients and dose adjustment may be necessary. There is no clinical experience in patients with severe hepatic impairment (Child?Pugh Class C), therefore Ongentys® is not recommended in these patients.

Storage and handling

  • Airtight container, keep at room temperature (1~30°C)
  • 310 Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do
    463-400 Korea [13494]
  • Copyright(c) SK chemicals. All Rights Reserved.

Ethical Management

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