Ropinirole

Registered South African indications: 

• Parkinson's disease
• Restless legs syndrome

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Severe renal impairment, except when on haemodialysis
• Pregnancy
• Lactation

Cautions

• Mild to moderate renal impairment
• Severe hepatic impairment (when on haemodialysis)
• Hepatic impairment
• Elderly
• Psychiatric or psychotic disorders  
• History of compulsive disorders
• Abrupt withdrawal
• Severe cardiac disease
• Glucose-galactose malabsorption  
• Galactose intolerance
• Lapp lactase deficiency  
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: tab, prolonged release tablet (tab PR)

Parkinson's syndrome

• Oral (tab): Initial: 0.25mg, 8hrly; Titrate by 0.25mg, 8hrly, at intervals of 1 week for 4 weeks; Thereafter, titrate by 0.5-1mg, 8hrly at intervals of 1 week, if needed; Max: 24mg/24hrs

• Oral (tab PR): Initial: 2mg, dly for 1 week, Titrate by 2mg, dly at intervals of 1 week for 4 weeks as needed; Thereafter, titrate by 2mg every 1-2weeks if needed; Max: 24mg/24hrs

Prolonged release tab: swallow whole, do not cut/crush/chew/dissolve

Discontinue gradually by reducing the number of daily doses over 1 week e.g. 12hrly for 4 days, dly for 3 days, then stop

If treatment is interrupted for one day or more, reinitiation by dose titration should be considered

Restless legs syndrome - moderate to severe

• Oral (tab): Initial: 0.25mg, dly for 2 days; If well tolerated, titrate to 0.5mg, dly for 5 days; Thereafter, titrate by 0.5mg, weekly for next 5 weeks as needed and 1mg, in 6th week if needed; Max: 4mg/24hrs

Take with meals, max 3hrs before bed (tab)  

Not established for use in children below 18 years

Pregnancy

• Contraindicated

Breastfeeding

• Contraindicated

Renal Impairment

• Mild to moderate: Caution; no dose adjustment recommended
• Severe with regular dialysis: Caution; dose adjustment recommended
• Severe without regular haemodialysis: Contraindicated

Hepatic Impairment

• Caution; no information available

Elderly

• Caution; no dose adjustment recommended

Central Nervous System Disorders

• Hallucinations
• Confusion
• Psychotic reactions 
• Pathological gambling
• Hypersexuality
• Compulsive spending
• Binge eating
• Aggression
• Somnolence
• Syncope
• Dyskinesia
• Dizziness

Cardiovascular Disorders

• Postural hypotension
• Hypotension
• Oedema

Gastrointestinal Disorders

• Nausea and vomiting
• Constipation
• Heartburn
• Abdominal pain

Hepatobiliary Disorders

• Hepatic reactions
• Increased hepatic enzymes

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions 

• Centrally acting dopamine antagonists
• Neuroleptics
• CYP1A2 inhibitors
• Hormone replacement therapy 
• Smoking

None routine. Specific cases may require

• Behaviour changes
• Blood pressure

Tablet 0.25mg, Tablet 0.5mg, Tablet 1mg, Tablet 5mg - EML (Tertiary)

Ropinirole is a non-ergoline D2 and D3 dopamine agonist which stimulates striatial dopamine receptors. It alleviates the dopamine deficiency which characterizes Parkinson's disease by stimulating striatal dopamine receptors. Ropinirole also acts in the hypothalamus and pituitary to inhibit the secretion of prolactin.

Tablet 0.25mg

• Accord ropinirole (Accord)
• Resure (Zydus)
• Requip (GSK) originator

Tablet 0.5mg

• Accord ropinirole (Accord)
• Resure (Zydus)
• Requip (GSK) originator

Tablet 1mg

• Accord ropinirole (Accord)
• Resure (Zydus)
• Requip (GSK) originator

Tablet 2mg

• Accord Ropinirole (Accord)
• Resure (Zydus)
• Requip (GSK) originator

Tablet 5mg

• Accord ropinirole (Accord)
• Resure (Zydus)
• Requip (GSK) originator

Tablet xl 2mg

• Requip XL (GSK) originator

Tablet xl 4mg

• Requip XL (GSK) originator

Tablet xl 8mg

• Requip XL (GSK) originator