- Approval Id
- 2f3da5a22f77964d
- Drug Name
- AZILECT TABLET 1MG
- Product Name
- AZILECT TABLET 1MG
- Approval Number
- SIN15291P
- Approval Date
- 2017-07-07
- Registrant
- ZUELLIG PHARMA PTE. LTD.
- Licence Holder
- ZUELLIG PHARMA PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p>Rasagiline is administered orally, at a dose of 1 mg once daily with or without levodopa.</p>
<p>It may be taken with or without food.</p>
<p><u>Elderly</u>: No change in dose is required for elderly patients.</p>
<p><u>Paediatric population</u>: AZILECT is not recommended for use in children and adolescents due to lack of data on safety and efficacy.</p>
<p><u>Patients with hepatic impairment</u>: Rasagiline use in patients with severe hepatic impairment is contraindicated (see section 4.3). Rasagiline use in patients with moderate hepatic impairment should be avoided. Caution should be used when initiating treatment with rasagiline in patients with mild hepatic impairment. In case patients progress from mild to moderate hepatic impairment rasagiline should be stopped (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><u>Patients with renal impairment</u>: No change in dose is required for renal impairment.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>AZILECT is indicated for the treatment of idiopathic Parkinson's disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to the active substance or to any of the excipients (see section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Concomitant treatment with other monoamine oxidase (MAO) inhibitors (including medicinal and natural products without prescription e.g. St. John's Wort) or pethidine (see section 4.5 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). At least 14 days must elapse between discontinuation of rasagiline and initiation of treatment with MAO inhibitors or pethidine.</p>
<p>Rasagiline is contraindicated in patients with severe hepatic impairment.</p>
- Atc Code
- N04BD02
- Atc Item Name
- rasagiline
- Pharma Manufacturer Name
- LUNDBECK SINGAPORE PTE. LTD.
