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Ropinirole oral modified release

Updated 2 Feb 2023 | Other dopaminergic drugs

Presentation

Modified release tablets containing ropinirole.

Drugs List

  • IPINNIA XL 2mg prolonged release tablet
  • IPINNIA XL 3mg prolonged release tablet
  • IPINNIA XL 4mg prolonged release tablet
  • IPINNIA XL 6mg prolonged release tablet
  • IPINNIA XL 8mg prolonged release tablet
  • RALNEA XL 2mg prolonged release tablet
  • RALNEA XL 4mg prolonged release tablet
  • RALNEA XL 8mg prolonged release tablet
  • RAPONER XL 2mg prolonged release tablet
  • RAPONER XL 4mg prolonged release tablet
  • RAPONER XL 8mg prolonged release tablet
  • REPINEX XL 2mg prolonged release tablet
  • REPINEX XL 4mg prolonged release tablet
  • REPINEX XL 8mg prolonged release tablet
  • REQUIP XL 2mg prolonged release tablet
  • REQUIP XL 4mg prolonged release tablet
  • REQUIP XL 8mg prolonged release tablet
  • ropinirole 2mg modified release tablet
  • ropinirole 3mg modified release tablet
  • ropinirole 4mg modified release tablet
  • ropinirole 6mg modified release tablet
  • ropinirole 8mg modified release tablet
  • ROPIQUAL XL 2mg modified release tablet
  • ROPIQUAL XL 4mg modified release tablet
  • ROPIQUAL XL 8mg modified release tablet
  • Therapeutic Indications

    Uses

    Moderate to severe idiopathic Restless Legs Syndrome: Symptomatic treatment
    Parkinson's disease

    Monotherapy in Parkinson's disease.

    Adjunctive therapy in Parkinson's disease, used in addition to levodopa to control 'on/off' fluctuations.

    Dosage

    When ropinirole modified release tablets are administered as adjunct therapy to levodopa, it may be possible to gradually reduce the levodopa dose, depending on clinical response.

    Adults

    Initially 2mg once daily for the first week, increased to 4mg once daily from the second week of treatment.
    If sufficient control is not achieved or maintained at 4mg once daily, the dose may be increased by 2mg at weekly or longer intervals up to a dose of 8mg once daily.
    If sufficient control is still not achieved or maintained at 8mg daily, the dose may be increased by 2mg to 4mg at two weekly or longer intervals up to a maximum daily dose of 24mg.

    Patients with Renal Impairment

    Creatinine clearance <30ml/min in patients receiving regular haemodialysis:
    Initially 2mg once daily, increased based on tolerability and efficacy. Maximum dose 18mg once daily. Supplemental doses after haemodialysis are not required.

    Creatinine clearance <30ml/min in patients not receiving regular haemodialysis:
    Contraindicated. Alternative sources indicate ropinirole may be used with caution in patients with a creatinine clearance <30ml/min with no dose adjustments.

    Additional Dosage Information

    Patients may be switched overnight from immediate release to modified release tablets.

    Patients who initiate treatment with a dose of 2mg/day modified release tablets and experience undesirable effects they cannot tolerate may benefit from switching to treatment with ropinirole immediate release tablets at a lower daily dose, divided into three equal doses.

    Patients should be prescribed the minimum number of modified release tablets that are necessary to achieve the required dose by using the highest available strengths.

    Switching from ropinirole immediate release tablets to ropinirole modified release tablets
    The dose of modified release tablets should be based on the total daily dose of immediate release tablets the patient was receiving:

    Patients receiving ropinirole immediate release tablets total daily dose of 0.75mg to 2.25mg should be switched to ropinirole modified release tablets total daily dose 2mg.
    Patients receiving ropinirole immediate release tablets total daily dose of 3mg to 4.5mg should be switched to ropinirole modified release tablets total daily dose 4mg.
    Patients receiving ropinirole immediate release tablets total daily dose of 6mg should be switched to ropinirole modified release tablets total daily dose 6mg.
    Patients receiving ropinirole immediate release tablets total daily dose of 7.5mg to 9mg should be switched to ropinirole modified release tablets total daily dose 8mg.
    Patients receiving ropinirole immediate release tablets total daily dose of 12mg should be switched to ropinirole modified release tablets total daily dose 12mg.
    Patients receiving ropinirole immediate release tablets total daily dose of 15mg to 18mg should be switched to ropinirole modified release tablets total daily dose 16mg.
    Patients receiving ropinirole immediate release tablets total daily dose of 21mg should be switched to ropinirole modified release tablets total daily dose 20mg.
    Patients receiving ropinirole immediate release tablets total daily dose of 24mg should be switched to ropinirole modified release tablets total daily dose 24mg.

    Patients taking a different daily dose of immediate release tablets from shown above, should be switched to the nearest available equivalent dose of modified release tablets.

    Switching to ropinirole from another dopamine agonist
    Discontinue the dopamine agonist in line with the manufacturers guidelines before initiating ropinirole.

    Dose interruption or discontinuation
    Consider retitration if treatment is interrupted for one day or more.

    When discontinuing treatment, gradually reduce the daily dose over a period of one week.

    Contraindications

    Children under 18 years
    Breastfeeding
    Hepatic impairment
    Pregnancy
    Renal impairment - creatinine clearance below 30 ml/minute

    Precautions and Warnings

    Patients over 65 years
    Tobacco smoking
    Galactosaemia
    Glucose-galactose malabsorption syndrome
    Haemodialysis
    History of psychosis
    History of severe psychiatric disorder
    Lactose intolerance
    Psychosis
    Severe cardiovascular disorder
    Severe psychiatric disorder

    Advise ability to drive/operate machinery may be affected by side effects
    Advise patient that sudden onset sleep episodes may affect ability to drive
    Not all available brands are licensed for all indications
    Not all formulations are licensed for all uses
    Some formulations contain castor oil polyoxyl which may cause diarrhoea
    Some formulations contain lactose
    Some formulations contain sunset yellow (E110); may cause allergic reaction
    The release profile of some brands may be affected by short GI transit time
    Monitor blood pressure during titration and early maintenance treatment
    Monitor patients for impulse control disorders
    Monitor patients for mania regularly
    Review treatment if impulse control disorders symptoms occur
    Supervise patient closely during drug withdrawal
    Treatment of Restless Legs Syndrome may result in augmentation of symptoms
    Avoid abrupt withdrawal: Dopamine agonist withdrawal syndrome may occur
    Avoid abrupt withdrawal: May cause signs of neuroleptic malignant syndrome
    Reduce dose or discontinue if sudden onset of sleep during daily activities
    Consider dose reduction/tapered withdrawal if mania develops
    Dose adjustment required if patient starts/stops smoking during therapy
    If treatment is interrupted for >1 day, consider dose re-titration
    Maintain treatment at the lowest effective dose
    Advise patient/carer about symptoms of impulse control disorders
    Advise patients that hallucinations can occur

    In patients over 75 years slower titration during treatment initiation may be considered.

    Dopamine agonist withdrawal syndrome (DAWS) has been reported with ropinirole. Treatment should be tapered off when discontinuing treatment in patients with Parkinson's disease. Studies have shown a higher risk of development DAWS in patients with impulse control disorders and those receiving high daily dose and/or high cumulative doses of dopamine agonists. If the patient experiences severe and or persistent withdrawal symptoms, consideration should be made to restart treatment temporarily at the lowest effective dose.

    Pregnancy and Lactation

    Pregnancy

    Ropinirole is contraindicated during pregnancy.

    At the time of writing there is limited published information regarding the use of ropinirole during pregnancy.

    Animal studies show embryofoetal toxicity, teratogenicity and digital malformations in pregnancy of rats and rabbits.

    It is not known whether ropinirole can cross the human placenta. The molecular weight and protein binding suggest that it will cross over to the embryo and foetus. The lack of human data prevents an assessment of the human risk, but because of the potential for serious adverse effects, the manufacturers advise ropinirole is not used during pregnancy unless the benefits outweighs potential risk. A detailed foetal ultrasonography may be considered.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Lactation

    Ropinirole is contraindicated during breastfeeding.

    At the time of writing there is limited published information regarding the use of ropinirole during breastfeeding. Ropinirole is known to suppress prolactin levels even in men and would therefore be likely to lower milk production in breastfeeding mothers. The drug is excreted in the milk of lactating rats and excretion into human breast milk should be expected.

    Effects on exposed infants are unknown. The manufacturers advise that ropinirole should not be used in patients that breast feed.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

    Side Effects

    Abdominal pain
    Aggression
    Angioedema
    Binge eating
    Compulsive behaviour
    Confusion
    Constipation
    Daytime sedation
    Delirium
    Delusions
    Dizziness
    Dopamine agonist withdrawal syndrome
    Dopamine dysregulation syndrome
    Dyskinesia
    Fatigue
    Hallucinations
    Heartburn
    Hepatic disorders
    Hypersensitivity reactions
    Hypersexuality
    Hypotension
    Impulse control disorders
    Increased libido
    Increases in hepatic enzymes
    Mania
    Nausea
    Nervousness
    Oedema of legs
    Paradoxical worsening of restless leg syndrome
    Paranoia
    Pathological gambling
    Peripheral oedema
    Postural hypotension
    Pruritus
    Psychotic reactions
    Rash
    Somnolence
    Sudden sleep onset episodes
    Syncope
    Urticaria
    Vertigo
    Vomiting

    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: May 2018.

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

    Summary of Product Characteristics: Ralnea XL 2mg prolonged release tablets. Consilient Health Ltd. Revised January 2013.

    Summary of Product Characteristics: Ralnea XL 4mg prolonged release tablets. Consilient Health Ltd. Revised January 2013.

    Summary of Product Characteristics: Ralnea XL 8mg prolonged release tablets. Consilient Health Ltd. Revised January 2013.

    Summary of Product Characteristics: Raponer XL 2mg prolonged release tablets. Actavis UK Ltd. Revised January 2018.

    Summary of Product Characteristics: Raponer XL 4mg prolonged release tablets. Actavis UK Ltd. Revised January 2018.

    Summary of Product Characteristics: Raponer XL 8mg prolonged release tablets. Actavis UK Ltd. Revised January 2018.

    Summary of Product Characteristics: Requip XL prolonged release tablets. GlaxoSmithKline UK. Revised November 2017.

    Summary of Product Characteristics: Requip XL 0.25mg prolonged release tablets. GlaxoSmithKline UK. Revised November 2017.

    Summary of Product Characteristics: Requip XL 1mg prolonged release tablets. GlaxoSmithKline UK. Revised November 2017.

    Summary of Product Characteristics: Requip XL 2mg prolonged release tablets. GlaxoSmithKline UK. Revised November 2017.

    Summary of Product Characteristics: Requip XL 5mg prolonged release tablets. GlaxoSmithKline UK. Revised November 2017.

    Summary of Product Characteristics: Repinex XL 2mg prolonged release tablets. Aspire Pharma Ltd. Revised July 2017.

    Summary of Product Characertistics: Repinex XL 4mg prolonged rlease tablets. Aspire Pharma Ltd. Revised July 2017.

    Summary of Product Characteristics: Repinex XL 8mg prolonged release tablets. Aspire Pharma Ltd. Revised July 2017.

    Summary of Product Characteristics: Spiroco XL 2mg prolonged release tablets. Ratiopharm Ltd. Revised March 2016.

    Summary of Product Characteristics: Spiroco XL 4mg prolonged release tablets. Ratiopharm Ltd. Revised March 2016.

    Summary of Product Characteristics: Spiroco XL 8mg prolonged release tablets. Ratiopharm Ltd. Revised March 2016.

    Summary of Product Characteristics: Ipinnia XL 2mg Prolonged Release Tablets. Ethypharm UK Ltd. Revised March 2017.

    Summary of Product Characteristics: Ipinnia XL 3mg Prolonged Release Tablets. Ethypharm UK Ltd. Revised March 2017.

    Summary of Product Characteristics: Ipinnia XL 4mg Prolonged Release Tablets. Ethypharm UK Ltd. Revised March 2017.

    Summary of Product Characteristics: Ipinnia XL 6mg Prolonged Release Tablets. Ethypharm Ltd. Revised March 2017.

    Summary of Product Characteristics: Ipinnia XL 8mg Prolonged Release Tablets. Ethypharm Ltd. Revised March 2017.

    Summary of Product Characteristics: Ropilynz XL 2 mg Prolonged-Release Tablets. Lupin UK Limited. Revised July 2020.

    Summary of Product Characteristics: Ropilynz XL 4 mg Prolonged-Release Tablets. Lupin UK Limited. Revised July 2020.

    Summary of Product Characteristics: Ropilynz XL 8 mg Prolonged-Release Tablets. Lupin UK Limited. Revised July 2020.

    Summary of Product Characteristics: Ropiqual XL 2mg prolonged release tablets. Aurobindo Pharma Milpharm LTD. Revised March 2017.

    Summary of Product Characteristics: Ropiqual XL 4mg prolonged release tablets. Aurobindo Pharma Milpharm LTD. Revised March 2017.

    Summary of Product Characteristics: Ropiqual XL 8mg prolonged release tablets. Aurobindo Pharma Milpharm LTD. Revised March 2017.

    The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.

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