BRINTELLIX ORAL DROPS, SOLUTION 20MG/ML

H. Lundbeck A/S (DENMARK)🇸🇬 Health Sciences Authority

Approval Date: Aug 22, 2022
Approval ID: 2ad76dcdd17f069e
Company: H. Lundbeck A/S (DENMARK)
Type: Therapeutic

Approval Details

Approval Id: 2ad76dcdd17f069e
Drug Name: BRINTELLIX ORAL DROPS, SOLUTION 20MG/ML
Product Name: BRINTELLIX ORAL DROPS, SOLUTION 20MG/ML
Approval Number: SIN16577P
Approval Date: 2022-08-22
Registrant: ZUELLIG PHARMA PTE. LTD.
Licence Holder: ZUELLIG PHARMA PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: SOLUTION
Dosage: 4.2 Posology and method of administration Posology The starting and recommended dose of Brintellix is 10 mg vortioxetine once daily in adults less than 65 years of age. Depending on individual patient response, the dose may be increased to a maximum of 20 mg vortioxetine once daily or decreased to a minimum of 5 mg vortioxetine once daily. 5 mg corresponding to 5 drops. 10 mg corresponding to 10 drops. 15 mg corresponding to 15 drops. 20 mg corresponding to 20 drops. After the depressive symptoms resolve, treatment for at least 6 months is recommended for consolidation of the antidepressive response. Treatment discontinuation A gradual reduction in dosage may be considered to avoid the occurrence of discontinuation symptoms (see section 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). However, there is insufficient data to provide specific recommendations for a tapering schedule for patients treated with Brintellix. Special populations Elderly patients The lowest effective dose of 5 mg vortioxetine once daily should always be used as the starting dose in patients ≥ 65 years of age. Caution is advised when treating patients ≥ 65 years of age with doses higher than 10 mg vortioxetine once daily for which data are limited (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Cytochrome P450 inhibitors Depending on individual patient response, a lower dose of vortioxetine may be considered if a strong CYP2D6 inhibitor (e.g., bupropion, quinidine, fluoxetine, paroxetine) is added to vortioxetine treatment (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Cytochrome P450 inducers Depending on individual patient response, a dose adjustment of vortioxetine may be considered if a broad cytochrome P450 inducer (e.g., rifampicin, carbamazepine, phenytoin) is added to vortioxetine treatment (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Paediatric population Brintellix should not be used in paediatric patients (under 18 years of age) with major depressive disorder (MDD) because efficacy has not been demonstrated (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The safety of Brintellix in paediatric patients is described in section 4.4, 4.8 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Renal or hepatic impairment No dose adjustment is needed based on renal or hepatic function (see section 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Method of administration Brintellix is for oral use. The oral drops can be taken with or without food. The drops can be mixed with water or juice. The mixture should be consumed immediately. The bottle must be turned completely upside down. If no drops come out, the bottle can be tapped lightly to start the flow. <img src="/TGIF/Brintellix-Image1.png" alt="Brintellix Dosage Image 1" />
Route Of Administration: ORAL
Indication Info: 4.1 Therapeutic indications Brintellix is indicated for the treatment of major depressive episodes in adults.
Contraindications: 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Concomitant use with nonselective monoamine oxidase inhibitors (MAOIs) or selective MAO-A inhibitors (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Atc Code: N06AX26
Atc Item Name: vortioxetine
Pharma Manufacturer Name: LUNDBECK SINGAPORE PTE. LTD.

Active Ingredients

Vortioxetine (D,L)-lactate eqv vortioxetine

20 mg/mL

VORTIOXETINE (D,L)-LACTATE EQV VORTIOXETINE

20 MG/ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Aug 22, 2022

Approval ID

2ad76dcdd17f069e

Type

Therapeutic

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