S-OROPRAM FC TABLET 10MG

ACTAVIS LTD. (MALTA)🇸🇬 Health Sciences Authority

Approval Date: May 11, 2023
Approval ID: e6e67a092b90f220
Company: ACTAVIS LTD. (MALTA)
Type: Therapeutic

Approval Details

Approval Id: e6e67a092b90f220
Drug Name: S-OROPRAM FC TABLET 10MG
Product Name: S-OROPRAM FC TABLET 10MG
Approval Number: SIN16777P
Approval Date: 2023-05-11
Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
Licence Holder: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED
Dosage: 4.2 Posology and method of administration Safety of daily doses above 20 mg has not been demonstrated. S-OROPRAM is administered as a single daily dose and may be taken with or without food. Major depressive episodes Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. Usually 2–4 weeks are necessary to obtain antidepressant response. After the symptoms resolve, treatment for at least 6 months is required for consolidation of the response. Panic disorder with or without agoraphobia An initial dose of 5 mg is recommended for the first week before increasing the dose to 10 mg daily. The dose may be further increased, up to a maximum of 20 mg daily, dependent on individual patient response. Maximum effectiveness is reached after about 3 months. The treatment lasts several months. Generalised anxiety disorder Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. Treatment for 3 months is recommended to consolidate response. Long-term treatment of responders for 6 months has been shown to prevent relapse and can be considered on an individual basis; treatment benefits should be re-evaluated at regular intervals. Obsessive-compulsive disorder (OCD) Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to 20 mg daily. Long-term treatment has been studied for a maximum of 40 weeks. Patients responding to a 16-week open-label treatment phase were randomized to a 24-week placebo-controlled relapse prevention phrase, receiving 10 or 20 mg escitalopram daily. As OCD is a chronic disease, patients should be treated for a sufficient period to ensure that they are symptom free. This period may be several months or even longer. Elderly patients (> 65 years of age) Initial treatment with half the usually recommended dose and a lower maximum dose should be considered (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Children and adolescents (<18 years) S-Oropram should not be used in the treatment of children and adolescents under the age of 18 years (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Reduced renal function Dosage adjustment is not necessary in patients with mild or moderate renal impairment. Caution is advised in patients with severely reduced renal function (CLCR less than 30 ml/min.) (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Reduced hepatic function An initial dose of 5 mg daily for the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10 mg daily (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Poor metabolisers of CYP2C19 For patients who are known to be poor metabolisers with respect to CYP2C19, an initial dose of 5 mg daily during the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10 mg daily (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Discontinuation symptoms When stopping treatment with S-Oropram the dose should be gradually reduced over a period of at least one to two weeks in order to avoid possible discontinuations symptoms (see section 4.4 and 4.8 – 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 Treatment of major depressive episodes. Treatment of panic disorder with or without agoraphobia. Treatment of generalised anxiety disorder. Treatment of obsessive-compulsive disorder.
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 treatment with non-selective, irreversible monoamine oxidase inhibitors (MAO inhibitors) (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Concomitant treatment with pimozide.
Atc Code: N06AB10
Atc Item Name: escitalopram
Pharma Manufacturer Name: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Active Ingredients

Escitalopram oxalate eqv. to Escitalopram

10 mg

Escitalopram oxalate eqv. to Escitalopram

10 mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

May 11, 2023

Approval ID

e6e67a092b90f220

Type

Therapeutic

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