Drugs List

Therapeutic Indications

Uses

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

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

Patients and carers should be made aware that symptoms of mania can occur with or without the symptoms of impulse control disorders in patients treated with ropinirole.

Pregnancy and Lactation

Pregnancy

Use ropinirole with caution in pregnancy.

Parkinsonism is mainly seen in older patients, and is not normally a disease in pregnant women. For Restless Leg Syndrome better-evaluated drug groups should be used.

It is not known whether ropinirole can cross the human placenta. The molecular weight of about 260 for the free base, and the moderate degree of protein binding suggest it will cross over to the embryo and foetus. The lack of human data prevents an assessment of the human risk. The manufactures suggests ropinirole is not used during pregnancy unless the potential benefit to the patient outweighs the potential risk to the foetus . Schaefer (2015) states that inadvertent use of this drug does not justify the termination of pregnancy, nor does it justify invasive diagnostic procedures. A detailed foetal ultrasonography may be considered.

Reproduction studies have revealed embryo-foetal toxicity and teratogenicity in pregnancy rats and rabbits. Decreased foetal weight, increased foetal deaths and digital formations were seen in rats when given 24, 36 and 60 times, respectively, the maximum recommended human clinical dose. No harmful effects were observed when ropinirole was given to pregnant rabbits at a maternal toxic dose 16 times the maximum recommended human dose based on BSA (MRHD). However, when ropinirole (at 8 times the MRHD) was administered with levodopa, an increased incidence and severity of foetal malformations (primarily digit defects) occurred than when levodopa was used alone.

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. Animal studies of ropinirole-related materials have demonstrated transfer into the breast milk of rats. It is unknown if ropinirole is excreted in human breast milk. The effects of exposure on the breastfed infant are unknown. Ropinirole is known to suppress prolactin levels and would therefore be likely to lower milk production in breastfeeding mothers.

The manufacturers do not recommend using ropinirole during breastfeeding.

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

Presentation

Oral standard release formulations of ropinirole.

Drugs List

Therapeutic Indications

Uses

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

Dosage

Adults

Patients with Renal Impairment

Additional Dosage Information

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

Patients and carers should be made aware that symptoms of mania can occur with or without the symptoms of impulse control disorders in patients treated with ropinirole.

Pregnancy and Lactation

Pregnancy

Use ropinirole with caution in pregnancy.

Parkinsonism is mainly seen in older patients, and is not normally a disease in pregnant women. For Restless Leg Syndrome better-evaluated drug groups should be used.

It is not known whether ropinirole can cross the human placenta. The molecular weight of about 260 for the free base, and the moderate degree of protein binding suggest it will cross over to the embryo and foetus. The lack of human data prevents an assessment of the human risk. The manufactures suggests ropinirole is not used during pregnancy unless the potential benefit to the patient outweighs the potential risk to the foetus . Schaefer (2015) states that inadvertent use of this drug does not justify the termination of pregnancy, nor does it justify invasive diagnostic procedures. A detailed foetal ultrasonography may be considered.

Reproduction studies have revealed embryo-foetal toxicity and teratogenicity in pregnancy rats and rabbits. Decreased foetal weight, increased foetal deaths and digital formations were seen in rats when given 24, 36 and 60 times, respectively, the maximum recommended human clinical dose. No harmful effects were observed when ropinirole was given to pregnant rabbits at a maternal toxic dose 16 times the maximum recommended human dose based on BSA (MRHD). However, when ropinirole (at 8 times the MRHD) was administered with levodopa, an increased incidence and severity of foetal malformations (primarily digit defects) occurred than when levodopa was used alone.

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. Animal studies of ropinirole-related materials have demonstrated transfer into the breast milk of rats. It is unknown if ropinirole is excreted in human breast milk. The effects of exposure on the breastfed infant are unknown. Ropinirole is known to suppress prolactin levels and would therefore be likely to lower milk production in breastfeeding mothers.

The manufacturers do not recommend using ropinirole during breastfeeding.

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

Withdrawal Symptoms and Signs

Dopamine agonist withdrawal syndrome can occur when discontinuing ropinirole. Such symptoms include: apathy, anxiety, depression, fatigue, sweating and pain and do not respond to levodopa.

Prior to ropinirole discontinuation, patients should be counselled regarding potential withdrawal symptoms. When ropinirole treatment is being discontinued, it is advisable to taper the dose gradually by reducing the number of daily doses over a period of one week, to minimise symptoms of withdrawal. In the event of severe and/or persistent withdrawal symptoms, consideration may be given to temporarily re-administer ropinirole at the lowest effective dose.

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: February 2015

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. Wolters Kluwer Health, Philadelphia.

Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 17 February 2015.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Summary of Product Characteristics: Adartrel 0.25mg film coated Tablets. Glaxosmithkline UK Ltd. October 2021.

Summary of Product Characteristics: Adartrel 0.5mg film coated Tablets. Glaxosmithkline UK Ltd. October 2021.

Summary of Product Characteristics: Adartrel 2mg film coated Tablets. Glaxosmithkline UK Ltd. October 2021.

Summary of Product Characteristics: Requip 0.25mg Tablets. Glaxosmithkline UK Ltd. Revised January 2022.

Summary of Product Characteristics: Requip 1mg Tablets. Glaxosmithkline UK Ltd. Revised January 2022.

Summary of Product Characteristics: Requip 2mg Tablets. Glaxosmithkline UK Ltd. Revised January 2022.

Summary of Product Characteristics: Requip 5mg Tablets. Glaxosmithkline UK Ltd. Revised January 2022.

Summary of Product Characteristics: Ropinirole film coated tablets. Pliva Pharma Ltd. Revised November 2008.

Summary of Product Characteristics: Ropinirole film coated tablets. Winthrop. Revised November 2008.

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

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Ropinirole Last revised: 10 March 2015
Last accessed: 04 January 2018