Finished product reference
Rotigotine
Patch · Transdermal · 13.5 mg/30cm2
- List code
- 50757
- Pharmacologic class
- Dopamine receptor agonist (non-ergot, transdermal)
What it is and how it works
Rotigotine is a non-ergot dopamine agonist acting mainly at D3, D2 and D1 receptors. Delivered continuously through the skin from a once-daily patch, it provides stable plasma concentrations and stimulates striatal dopamine receptors.
Indications
Parkinson’s disease, as monotherapy in early disease or with levodopa in advanced disease; moderate to severe idiopathic restless legs syndrome.
Dosage and administration (summary)
One patch applied once daily to clean, dry, intact skin, rotating the site. Parkinson’s disease: start at 2 mg/24 hours (early) or 4 mg/24 hours (advanced) and increase weekly by 2 mg/24 hours to an effective dose (maximum 8 mg/24 hours early, 16 mg/24 hours advanced). Restless legs syndrome: 1 mg/24 hours, up to 3 mg/24 hours.
Contraindications
Hypersensitivity to rotigotine or patch components; the patch must be removed before magnetic resonance imaging or cardioversion because of its aluminium backing layer.
Warnings and precautions
Somnolence and sudden onset of sleep may occur, so patients should not drive if affected; impulse control disorders (pathological gambling, hypersexuality, binge eating), hallucinations and orthostatic hypotension may occur. Application-site reactions are common; withdraw gradually to avoid neuroleptic malignant-like syndrome or withdrawal symptoms, and augmentation may occur in restless legs syndrome.
Pregnancy
Avoid in pregnancy unless clearly necessary; it inhibits prolactin and may suppress lactation.
Storage and supply
Store below 30 °C in the original sachet.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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