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NEUPRO is a brand name for Rotigotine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Neupro is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dose recommendations made are in nominal dose.
Dosing in patients with early-stage Parkinson’s disease:
A single daily dose should be initiated at 2 mg/24 h and then increased in weekly increments of 2 mg/24 h to an effective dose up to a maximum dose of 8 mg/24 h. 4 mg/24 h may be an effective dose in some patients. For most patients an effective dose is reached within 3 or 4 weeks at doses of 6 mg/24 h or 8 mg/24 h, respectively.
The maximum dose is 8 mg/24 h.
Dosing in patients with advanced stage Parkinson’s disease with fluctuations:
A single daily dose should be initiated at 4 mg/24 h and then increased in weekly increments of 2 mg/24 h to an effective dose up to a maximum dose of 16 mg/24 h. 4 mg/24 h or 6 mg/24 h may be effective doses in some patients. For most patients an effective dose is reached within 3 to 7 weeks at doses of 8 mg/24 h up to a maximum dose of 16 mg/24 h.
g. 10 mg/24 h may be reached by combination of a 6 mg/24 h and a 4 mg/24 h patch. Neupro is applied once a day. The patch should be applied at approximately the same time every day. The patch remains on the skin for 24 hours and will then be replaced by a new one at a different site of application.
If the patient forgets to apply the patch at the usual time of the day or if the patch becomes detached, another patch should be applied for the remainder of the day. Treatment discontinuation Neupro should be discontinued gradually.
4). Special populations Hepatic impairment Adjustment of the dose is not necessary in patients with mild to moderate hepatic impairment. Caution is advised when treating patients with severe hepatic impairment, which may result in lower rotigotine clearance.
Rotigotine has not been investigated in this patient group. A dose reduction might be needed in case of worsening of the hepatic impairment. Renal impairment Adjustment of the dose is not necessary in patients with mild to severe renal impairment, including those requiring dialysis.
2). Paediatric population There is no relevant use of Neupro in the paediatric population in Parkinson’s disease. Method of administration Neupro is for transdermal use. The patch should be applied to clean, dry, intact healthy skin on the abdomen, thigh, hip, flank, shoulder, or upper arm.
0% of patients on placebo reported at least one adverse reaction. At the beginning of therapy dopaminergic adverse reactions such as nausea and vomiting may occur. These are usually mild or moderate in intensity and transient even if treatment is continued.
Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Neupro transdermal patch are nausea, vomiting, application site reactions, somnolence, dizziness and headache. 7% of 830 patients using the Neupro transdermal patch, experienced application site reactions.
3% of all subjects receiving Neupro. Tabulated list of adverse reactions The following table covers adverse drug reactions from the pooled studies mentioned above in patients with Parkinson’s disease and from post-marketing experience.
Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. System/orga n classes acc. to MedDRA Very common Common Uncommon Rare Not known Immune system disorders Hypersensiti vity, which may include angioedema, tongue oedema and lip oedema Psychiatric disorders Perception disturbances a (incl.
hallucination , hallucination visual, hallucination auditory, illusion), insomnia, sleep disorder, nightmare, abnormal dreams, impulse- control disordersa,d (incl. pathological gambling, stereotypy/ punding, binge eating/eating disorderb, compulsive shoppingc) Sleep attacks/sudde n onset of sleep, paranoia, sexual desire disordersa (incl.
1) Magnetic resonance imaging and cardioversion The backing layer of Neupro contains aluminium. To avoid skin burns, Neupro should be removed if the patient has to undergo magnetic resonance imaging (MRI) or cardioversion. Orthostatic hypotension Dopamine agonists are known to impair the systemic regulation of the blood pressure resulting in postural/orthostatic hypotension.
These events have also been observed during treatment with rotigotine, but the incidence was similar to that observed in placebo-treated patients. It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the general risk of orthostatic hypotension associated with dopaminergic therapy.
Syncope In clinical studies with rotigotine, syncope has been observed at a rate that was similar to that observed in patients treated with placebo. Because patients with clinically relevant cardiovascular disease were excluded in these studies, patients with severe cardiovascular disease should be asked about symptoms of syncope and pre-syncope.
Sudden onset of sleep and somnolence Rotigotine has been associated with somnolence and episodes of sudden sleep onset. Sudden onset of sleep during daily activities, in some cases without awareness of any warning signs, has been reported.
Prescribers should continually reassess patients for drowsiness or sleepiness, as patients may not acknowledge drowsiness or sleepiness until directly questioned. A reduction of dosage or termination of therapy should be carefully considered.
Impulse control and other related disorders Patients should be regularly monitored for the development of impulse control disorders and related disorders including dopamine dysregulation syndrome. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathologic gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists, including rotigotine.
1. 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Reapplication to the same site within 14 days should be avoided. 4). Use and handling Each patch is packed in a sachet and should be applied directly after the sachet has been opened. One half of the release liner should be removed and the sticky side should be applied and pressed firmly to the skin.
Then, the patch is fold back and the second part of the release liner is removed. The sticky side of the patch should not be touched. The patch should be pressed down firmly with the palm of the hand for about 30 seconds, so that it sticks well.
The patch should not be cut into pieces.
hypersexualit y, libido increased), confusional state, disorientation d, agitationd Psychotic disorder, obsessive- compulsive disorder, aggressive behaviour/ aggressionb, delusiond, deliriumd Dopamine dysregulation syndromec Nervous system disorders Somnolence, dizziness, headache Disturbances in consciousne ss NECa (incl.
syncope, syncope vasovagal, loss of consciousne ss), dyskinesia, dizziness postural, lethargy Convulsion Dropped head syndromec Eye disorders Vision blurred, visual impairment, photopsia Ear and labyrinth disorders Vertigo Cardiac disorders Palpitations Atrial fibrillation Supraventric ular tachycardia Vascular disorders Orthostatic hypotension, hypertension Hypotension Respiratory, thoracic and mediastinal disorders Hiccups Gastrointesti nal disorders Nausea, vomiting Constipation , dry mouth, dyspepsia Abdominal pain Diarrhoeac Skin and subcutaneou s tissue disorders Erythema, hyperhidrosi s, pruritus Pruritus generalised, skin irritation, dermatitis contact Rash generalised Reproductiv e system and breast disorder Erectile dysfunction General disorders and administrati on site conditions Application and instillation site reactionsa (incl.
erythema, pruritus, irritation, rash, dermatitis, vesicles, pain, eczema, inflammation , swelling, discolouratio n, papules, exfoliation, urticaria, hypersensitivi ty) Oedema peripheral, asthenic conditionsa (incl. fatigue, asthenia, malaise) Irritability Investigation s Weight decreased Hepatic enzyme increased (incl.
AST, ALT, GGT), weight increased, heart rate increased, CPK increasedd Injury, poisoning and procedural complication s Fall Musculoskel etal and connective tissue disorders Rhabdomyol ysisc a High Level Term b Observed in open-label studies c Observed during post-marketing d Observed in 2011 data pool of double-blind placebo-controlled studies Description of selected adverse reactions Sudden onset of sleep and somnolence Rotigotine has been associated with somnolence including excessive daytime somnolence and sudden sleep onset episodes.
7). 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
In some patients, dopamine dysregulation syndrome was observed under the treatment with rotigotine. Dose reduction/tapered discontinuation should be considered if such symptoms develop. Neuroleptic malignant syndrome Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy.
2). 2). Abnormal thinking and behaviour Abnormal thinking and behaviour have been reported and can consist of a variety of manifestations including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behaviour, disorientation, aggressive behaviour, agitation, and delirium.
Fibrotic complications Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, pericarditis and cardiac valvulopathy have been reported in some patients treated with ergot-derived dopaminergic agents.
While these complications may resolve when treatment is discontinued, complete resolution does not always occur. Although these adverse reactions are believed to be related to the ergoline structure of these compounds, whether other, nonergot derived dopamine agonists can cause them is unknown.
5). Ophthalmologic monitoring Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur. Heat application External heat (excessive sunlight, heating pads and other sources of heat such as sauna, hot bath) should not be applied to the area of the patch.
Application site reactions Application site skin reactions may occur and are usually mild or moderate in intensity. g. from the right side to the left side and from the upper body to the lower body). The same site should not be used within 14 days.
If application site reactions occur which last for more than a few days or are persistent, if there is an increase in severity, or if the skin reaction spreads outside the application site, an assessment of the risk/benefit balance for the individual patient should be conducted.
If there is a skin rash or irritation from the transdermal system, direct sunlight on the area should be avoided until the skin heals, as exposure could lead to changes in the skin color. g. allergic rash, including erythematous, macular, papular rash or pruritus) associated with the use of Neupro is observed, Neupro should be discontinued.
Peripheral oedema In clinical studies in Parkinson’s patients, the 6 month-specific rates of peripheral oedema remained at about 4% through the entire observation period up to 36 months. Dopaminergic adverse reactions The incidence of some dopaminergic adverse reactions, such as hallucinations, dyskinesia, and peripheral oedema generally is higher when given in combination with L-dopa in Parkinson’s patients.
This should be considered when prescribing rotigotine. Dystonic reactions Dystonic reactions including dystonia, abnormal posture, torticollis and pleurothotonus (Pisa Syndrome) have occasionally been reported in patients with Parkinson’s disease following initiation or incremental dose increase of rotigotine.
Although dystonic reactions may be a symptom of Parkinson’s disease, the symptoms in some of these patients have improved after […]