REMERON SOLTAB 15 MG

ANESTA LLC (UNITED STATES)🇸🇬 Health Sciences Authority

Approval Date: Mar 25, 2004
Approval ID: 08068832493528d9
Company: ANESTA LLC (UNITED STATES)
Type: Therapeutic

Approval Details

Approval Id: 08068832493528d9
Drug Name: REMERON SOLTAB 15 MG
Product Name: REMERON SOLTAB 15 MG
Approval Number: SIN12526P
Approval Date: 2004-03-25
Registrant: ORGANON SINGAPORE PTE. LTD.
Licence Holder: ORGANON SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET
Dosage: 4.2 Posology and method of administration In order to prevent crushing the tablet, do not push against the tablet pocket (Figure A). <img src="/TGIF/RemeronSolTab-Image1.png" alt="Remeron SolTab Dosage Image 1" /> Each strip contains six tablet pockets, which are separated by perforations. Tear off one tablet pocket along the dotted lines (Figure 1). <img src="/TGIF/RemeronSolTab-Image2.png" alt="Remeron SolTab Dosage Image 2" /> Carefully peel off the lidding foil, starting in the corner indicated by the arrow (Figures 2 and 3). <img src="/TGIF/RemeronSolTab-Image3.png" alt="Remeron SolTab Dosage Image 3" /> <img src="/TGIF/RemeronSolTab-Image4.png" alt="Remeron SolTab Dosage Image 4" /> The tablet should be taken out of the strip with dry hands and should be placed on the tongue (Figure 4). The tablet will rapidly disintegrate and can be swallowed without water. <img src="/TGIF/RemeronSolTab-Image5.png" alt="Remeron SolTab Dosage Image 5" /> Adults Treatment should begin with 15 mg daily. The dosage generally needs to be increased to obtain an optimal clinical response. The effective daily dose is usually between 15 and 45 mg (the dose should be taken at night). Mirtazapine begins to exert its effect in general after 1–2 weeks of treatment. Treatment with an adequate dose should result in a positive response within 2–4 weeks. With an insufficient response, the dose can be increased up to the maximum dose. If there is no response within a further 2–4 weeks, then treatment should be stopped. Elderly The recommended dose is the same as that for adults. In elderly patients an increase in dosing should be done under close supervision to elicit a satisfactory and safe response. Children and adolescents under the age of 18 years Remeron should not be used in children and adolescents under the age of 18 years (see section 4.4) as efficacy was not demonstrated in two short-term clinical trials (see section 5.1) and because of safety concerns (see sections 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 impairment The clearance of mirtazapine may be decreased in patients with moderate to severe renal impairment (creatinine clearance < 40 ml/min). This should be taken into account when prescribing Remeron to this category of patients (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Hepatic impairment The clearance of mirtazapine may be decreased in patients with hepatic impairment. This should be taken into account when prescribing Remeron to this category of patients, particularly with severe hepatic impairment, as patients with severe hepatic impairment have not been investigated (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Mirtazapine has an elimination half-life of 20–40 hours and therefore Remeron is suitable for once daily administration. It should be taken preferably as a single night-time dose before going to bed. Remeron may also be given in two divided doses (once in the morning and once at night-time; the higher dose should be taken at night). The tablets should be taken orally. The tablet will rapidly disintegrate and can be swallowed without water. Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms. It is recommended to discontinue treatment with mirtazapine gradually to avoid withdrawal symptoms (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Route Of Administration: ORAL
Indication Info: 4.1 Therapeutic indications Episode of major depression.
Contraindications: 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients. Concomitant use of mirtazapine with monoamine oxidase (MAO) inhibitors (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Atc Code: N06AX11
Atc Item Name: mirtazapine
Pharma Manufacturer Name: ORGANON SINGAPORE PTE. LTD.

Active Ingredients

COATED MIRTAZAPINE 62.5 mg EQV MIRTAZAPINE

15 mg

COATED MIRTAZAPINE 62.5 mg EQV MIRTAZAPINE

15 mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Mar 25, 2004

Approval ID

08068832493528d9

Type

Therapeutic

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