Opicapone oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of opicapone.
Drugs List
Therapeutic Indications
Uses
Parkinson's disease - adjunct to levodopa + dopa-decarboxylase inhibitor
Dosage
Adults
50mg once daily at bedtime at least one hour before or after levodopa combinations.
Additional Dosage Information
Missed doses
If a 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.
Opicapone enhances the effects of levodopa. To reduce levodopa-related dopaminergic adverse reactions it is often necessary to adjust the daily dose of levodopa by extending the dosing intervals and/or reducing the amount of levodopa per dose within the first days to first weeks after initiating treatment with opicapone, according to the clinical condition of the patient.
Contraindications
Children under 18 years
Breastfeeding
Catecholamine-secreting tumour
Galactosaemia
History of neuroleptic malignant syndrome
History of non-traumatic rhabdomyolysis
Pregnancy
Severe hepatic impairment
Precautions and Warnings
Females of childbearing potential
Patients over 85 years
Glucose-galactose malabsorption syndrome
Lactose intolerance
Moderate hepatic impairment
Reduce dose in patients with moderate hepatic impairment
Advise ability to drive/operate machinery may be affected by side effects
Contains lactose
Monitor liver function if anorexia,nausea,vomiting,abdominal pain develop
Monitor patients for impulse control disorders
Review treatment if impulse control disorders symptoms occur
Female: Ensure adequate contraception during treatment
Advise patient not to take two doses on the same day if a dose is missed
Advise patient/carer about symptoms of impulse control disorders
Pregnancy and Lactation
Pregnancy
Opicapone is contraindicated during pregnancy.
The manufacturer does not recommend using opicapone during pregnancy. Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out.
Lactation
Opicapone is contraindicated during breastfeeding.
Use of opicapone when breastfeeding is contraindicated by the manufacturer. The presence of opicapone in human breast milk and the effects on exposed infants are unknown.
Side Effects
Abdominal distension
Abdominal pain
Anxiety
Auditory hallucinations
Chromaturia
Constipation
Creatine phosphokinase increased
Decreased appetite
Depression
Dizziness
Dream abnormalities
Dry eyes
Dry mouth
Dysgeusia
Dyskinesia
Dyspepsia
Dyspnoea
Ear congestion
Hallucinations
Headache
Hyperkinesia
Hypertension
Hypertriglyceridaemia
Hypotension
Insomnia
Muscle spasm
Muscle twitch
Myalgia
Nightmares
Nocturia
Orthostatic hypotension
Painful extremities
Palpitations
Sleep disorders
Somnolence
Stiffness
Syncope
Upper abdominal pain
Visual hallucinations
Vomiting
Weight loss
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: January 2020
Reference Sources
Summary of Product Characteristics: Ongentys 50mg hard capsules. Bile Pharm UK Ltd. Revised February 2019.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.