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IPINNIA XL is a brand name for Ropinirole. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of Parkinson’s disease under the following conditions: - Initial treatment as monotherapy, in order to delay the introduction of levodopa. - In combination with levodopa, over the course of the disease, when the effect of levodopa wears off or becomes inconsistent and fluctuations in the therapeutic effect…
Verbatim from this product's MHRA label. Tap a section to expand.
Individual dose titration against efficacy and tolerability is recommended. Ipinnia XL prolonged-release tablets should be taken once a day, at a similar time each day. The prolonged-release tablets may be taken with or without food.
2). Ipinnia XL prolonged-release tablets must be swallowed whole and must not be chewed, crushed or divided.
Adults Initial titration:
The starting dose of ropinirole prolonged-release tablets is 2 mg once daily for the first week; this should be increased to 4 mg once daily from the second week of treatment. A therapeutic response may be seen at a dose of 4 mg once daily of ropinirole prolonged-release tablets.
Patients who initiate treatment with a dose of 2 mg/day of ropinirole prolonged-release tablets and who experience side effects that they cannot tolerate, may benefit from switching to treatment with ropinirole film-coated (immediate-release) tablets at a lower daily dose, divided into three equal doses.
Therapeutic regimen:
Patients should be maintained on the lowest dose of ropinirole prolonged- release tablets that achieve symptomatic control. If sufficient symptomatic control is not achieved or maintained at a dose of 4 mg once daily of ropinirole prolonged-release tablets, the daily dose may be increased by 2 mg at weekly or longer intervals up to a dose of 8 mg once daily of ropinirole prolonged-release tablets.
If sufficient symptomatic control is still not achieved or maintained at a dose of 8 mg once daily of ropinirole prolonged-release tablets, the daily dose may be increased by 2 mg to 4 mg at two weekly or longer intervals. The maximum daily dose of ropinirole prolonged-release tablets is 24 mg.
It is recommended that patients are prescribed the minimum number of ropinirole prolonged-release tablets that are necessary to achieve the required dose by utilising the highest available strengths of ropinirole prolonged-release tablets.
When Ipinnia XL prolonged-release tablets are administered as adjunct therapy to levodopa, it may be possible to reduce gradually the levodopa dose, depending on the clinical response. In clinical trials, the levodopa dose was reduced gradually by approximately 30% in patients receiving ropinirole prolonged-release tablets concurrently.
). When switching treatment from another dopamine agonist to ropinirole, the marketing authorisation holder’s guidance on discontinuation should be followed before initiating ropinirole. 4). Switching from ropinirole film-coated (immediate-release) tablets to Ipinnia XL prolonged-release tablets Patients may be switched overnight from ropinirole film-coated (immediate- release) tablets to Ipinnia XL prolonged-release tablets.
The dose of Ipinnia XL prolonged-release tablets should be based on the total daily dose of ropinirole film-coated (immediate-release) tablets that the patient was taking. The table below shows the recommended dose of Ipinnia XL prolonged- release tablets for patients switching from ropinirole film-coated (immediate- release) tablets.
5 – 9 8 12 12 15 – 18 16 21 20 24 24 After switching to Ipinnia XL prolonged-release tablets, the dose may be adjusted depending on the therapeutic response (see “Initial titration” and “Therapeutic regimen” above). Dose interruption or discontinuation If treatment is interrupted for one day or more, re-initiation by dose titration should be considered (see above).
If it is necessary to discontinue ropinirole treatment, this should be done gradually by reducing the daily dose over the period of one week. Renal impairment In parkinsonian patients with mild to moderate renal impairment (creatinine clearance between 30 and 50 ml/min) no change in the clearance of ropinirole was observed, indicating that no dosage adjustment is necessary in this population.
A study into the use of ropinirole in patients with end stage renal disease (patients on haemodialysis) has shown that a dose adjustment in these patients is required as follows: the recommended initial dose of ropinirole is 2 mg once daily.
Further dose escalations should be based on tolerability and efficacy. The recommended maximum dose of ropinirole is 18 mg/day in patients receiving regular dialysis. 2). The use of ropinirole in patients with severe renal impairment (creatinine clearance less than 30 ml/min) without regular haemodialysis has not been studied.
Hypotension Due to the risk of hypotension, blood pressure monitoring is recommended, particularly at the start of treatment, in patients with severe cardiovascular disease (in particular coronary insufficiency). 5). Impulse control disorders Patients should be regularly monitored for the development of impulse control disorders.
Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, hypersexuality, increased libido, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists, including Ipinnia XL.
Dose reduction/tapered discontinuation should be considered if such symptoms develop. Impulse control disorders were reported especially at high doses and were generally reversible upon reduction of the dose or treatment discontinuation.
8). Mania Patients should be regularly monitored for the development of mania. 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 Ipinnia XL.
Dose reduction/tapered discontinuation should be considered if such symptoms develop. Somnolence and episodes of sudden sleep onset Ropinirole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’s disease.
8). Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with ropinirole. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines.
A reduction of dosage or termination of therapy may be considered. Neuroleptic malignant syndrome Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy. 2). Rapid gastrointestinal transit Ipinnia XL tablets are designed to release medication over a 24hr period.
1. - Severe renal impairment (creatinine clearance <30 ml/min) without regular haemodialysis. - Hepatic impairment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In patients with advanced Parkinson's disease receiving ropinirole prolonged- release tablets in combination with L-dopa, dyskinesias can occur during the initial titration of ropinirole prolonged-release tablets. 8 Undesirable effects).
When switching treatment from another dopamine agonist to ropinirole, the marketing authorisation holder’s guidance on discontinuation should be followed before initiating ropinirole. 4). Switching from ropinirole film-coated (immediate-release) tablets to Ipinnia XL prolonged-release tablets Patients may be switched overnight from ropinirole film-coated (immediate- release) tablets to Ipinnia XL prolonged-release tablets.
The dose of Ipinnia XL prolonged-release tablets should be based on the total daily dose of ropinirole film-coated (immediate-release) tablets that the patient was taking. The table below shows the recommended dose of Ipinnia XL prolonged- release tablets for patients switching from ropinirole film-coated (immediate- release) tablets.
5 – 9 8 12 12 15 – 18 16 21 20 24 24 After switching to Ipinnia XL prolonged-release tablets, the dose may be adjusted depending on the therapeutic response (see “Initial titration” and “Therapeutic regimen” above). Dose interruption or discontinuation If treatment is interrupted for one day or more, re-initiation by dose titration should be considered (see above).
If it is necessary to discontinue ropinirole treatment, this should be done gradually by reducing the daily dose over the period of one week. Renal impairment In parkinsonian patients with mild to moderate renal impairment (creatinine clearance between 30 and 50 ml/min) no change in the clearance of ropinirole was observed, indicating that no dosage adjustment is necessary in this population.
A study into the use of ropinirole in patients with end stage renal disease (patients on haemodialysis) has shown that a dose adjustment in these patients is required as follows: the recommended initial dose of ropinirole is 2 mg once daily.
Further dose escalations should be based on tolerability and efficacy. The recommended maximum dose of ropinirole is 18 mg/day in patients receiving regular dialysis. 2). The use of ropinirole in patients with severe renal impairment (creatinine clearance less than 30 ml/min) without regular haemodialysis has not been studied.
Hepatic impairment The use of ropinirole in patients with hepatic impairment has not been studied. Administration of ropinirole to such patients is not recommended. Elderly The clearance of ropinirole is decreased by approximately 15% in patients aged 65 years or above.
Although a dose adjustment is not required, ropinirole dose should be individually titrated, with careful monitoring of tolerability, to the optimal clinical response. In patients aged 75 years and above, slower titration during treatment initiation may be considered.
[…]
Hepatic impairment The use of ropinirole in patients with hepatic impairment has not been studied. Administration of ropinirole to such patients is not recommended. Elderly The clearance of ropinirole is decreased by approximately 15% in patients aged 65 years or above.
Although a dose adjustment is not required, ropinirole dose should be individually titrated, with careful monitoring of tolerability, to the optimal clinical response. In patients aged 75 years and above, slower titration during treatment initiation may be considered.
Paediatric population Ipinnia XL prolonged-release tablets are not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy. Method of administration Oral use. 1. - Severe renal impairment (creatinine clearance <30 ml/min) without regular haemodialysis.
- Hepatic impairment. 4 Special warnings and precautions for use Hypotension Due to the risk of hypotension, blood pressure monitoring is recommended, particularly at the start of treatment, in patients with severe cardiovascular disease (in particular coronary insufficiency).
5). Impulse control disorders Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, hypersexuality, increased libido, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists, including Ipinnia XL.
Dose reduction/tapered discontinuation should be considered if such symptoms develop. Impulse control disorders were reported especially at high doses and were generally reversible upon reduction of the dose or treatment discontinuation.
8). Mania Patients should be regularly monitored for the development of mania. 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 Ipinnia XL.
Dose reduction/tapered discontinuation should be considered if such symptoms develop. Somnolence and episodes of sudden sleep onset Ropinirole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’s disease.
8). Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with ropinirole. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines.
A reduction of dosage or termination of therapy may be considered. Neuroleptic malignant […]
If rapid gastrointestinal transit occurs, there may be risk of incomplete release of medication, and of medication residue being passed in the stool. 8). 2). Limited data suggests that patients with impulse control disorders and those receiving high daily dose and/or high cumulative doses of dopamine agonists may be at higher risk for developing DAWS.
Withdrawal symptoms may include apathy, anxiety, depression, fatigue, sweating and pain and do not respond to levodopa. Prior to tapering off and discontinuing ropinirole, patients should be informed about potential withdrawal symptoms.
Patients should be closely monitored during tapering and discontinuation. In case of severe and/or persistent withdrawal symptoms, temporary re-administration of ropinirole at the lowest effective dose may be considered. Hallucinations Hallucinations are known as a side effect of treatment with dopamine agonists and levodopa.
Patients should be informed that hallucinations can occur. Excipients Lactose This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Ipinnia XL prolonged-release tablets contain castor oil. Sodium Each Ipinnia XL prolonged-release tablet contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium free’.