1
A selective inhibitor of serotonin (5-HT)-uptake. For the treatment of major depressive episodes. MACLEODS ESCITALOPRAM is administered as a single daily dose and may be taken without regard to food intake. MACLEODS MACLEODS ESCITALOPRAM 10 mg ESCITALOPRAM 10 mg (film-coated tablets) MACLEODS MACLEODS ESCITALOPRAM 20 mg ESCITALOPRAM 20 mg (film-coated tablets) S5 Macleods Escitalopram Tablets 10 or 20. Reg. No.: 45/1.2/0881, 45/1.2/0882. Each film-coated tablet contains escitalopram oxalate corresponding to 10 mg or 20 mg escitalopram. Applicant: Macleods Pharmaceuticals SA [PTY] LTD, Stand 6D & E, Growthpoint Business Park, Tonetti Street, Halfway House, Midrand. South Africa. Marketed by: Activo Health (Pty) Ltd. Co. Reg. No.: 2009/009541/07. Block B, Arena Office Park, 272 West Avenue, Centurion, 0157, South Africa. PO Box 11911, Zwartkop, 0051, South Africa. Tel: 0800 (ACTIVO) 228486 | Fax: 086 619 5833, [email protected] | www.activo.co.za For full prescribing information please refer to the package insert approved by Medicines Regulatory Authority. Adults: Major Depressive episodes: MACLEODS ESCITALOPRAM should be administered as a single oral dose of 10 mg daily in otherwise healthy adults. 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. Elderly patients (> 65 years of age): A longer half-life and a decreased clearance have been demonstrated in the elderly, therefore a lower initial and maximum dose should be considered. The maximum recommended dose for elderly patients is 10 mg daily. Reduced renal function: Dosage adjustment is not necessary in patients with mild to moderate renal impairment. No information is available on the treatment of patients with severely reduced renal function (creatinine clearance < 30 ml/min). Reduced hepatic function: Dosages should be halved to the lower end of the dose range in patients with hepatic insufficiency. The maximum recommended dose for adult patients with hepatic impairment is 10 mg daily. When stopping MACLEODS ESCITALOPRAM therapy, gradual dose reduction should be considered. DOSAGE AND DIRECTIONS FOR USE:
