| MHRA SPC Approval received on 17th February 2012
Section 4.2 Posology and method of administration
Major Depressive Episodes
Addition of:
Elderly patients (> 65 years of age)
Initial dosage is 5 mg (5 drops) once daily. Depending on individual patient response the dose may be increased to 10 mg (10 drops) daily (see section 5.2)
Section 4.3 Contraindications
Addition of:
Escitalopram is contraindicated in patients with known QT-interval prolongation or congenital long QT syndrome.
Escitalopram is contraindicated together with medicinal products that are known to prolong the QT-interval (see section 4.5).
Section 4.4 Special warnings and precautions for use
Addition of:
QT-interval prolongation
Escitalopram has been found to cause a dose-dependent prolongation of the QT-interval. Cases of QT interval prolongation and ventricular arrhythmia including torsade de pointes have been reported during the post-marketing period, predominantly in patients of female gender, with hypokalaemia, or with pre-existing QT prolongation or other cardiac diseases (see sections 4.3, 4.5, 4.8, 4.9 and 5.1).
Caution is advised in patients with significant bradycardia; or in patients with recent acute myocardial infarction or uncompensated heart failure.
Electrolyte disturbances such as hypokalaemia and hypomagnesaemia increase the risk for malignant arrhythmias and should be corrected before treatment with escitalopram is started.
If patients with stable cardiac disease are treated, an ECG review should be considered before treatment is started.
If signs of cardiac arrhythmia occur during treatment with escitalopram, the treatment should be withdrawn and an ECG should be performed.
Section 4.5 Interactions
Contraindicated combinations
Addition of:
QT interval prolongation
Pharmacokinetic and pharmacodynamic studies between escitalopram combined with other medicinal products that prolong the QT interval have not been performed. An additive effect of escitalopram and these medicinal products cannot be excluded. Therefore, co-administration of escitalopram with medicinal products that prolong the QT interval, such as Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine), is contraindicated.
Influence of other medicinal products on the pharmacokinetics of escitalopram
Co-administration of escitalopram with cimetidine 400 mg twice daily (moderately potent general enzyme-inhibitor) resulted in a moderate (approximately 70%) increase in the plasma concentrations of escitalopram. Caution is advised when administering escitalopram in combination with cimetidine. Dose adjustment may be warranted.
Section 4.8 Undesirable effects
Addition to table:
Frequency not known: ventricular arrhythmia including torsade de pointes
Addition below table:
Cases of QT-prolongation and ventricular arrhythmia including torsade de pointes have been reported during the post-marketing period, predominantly in patients of female gender, with hypokalaemia, or with pre-existing QT prolongation or other cardiac diseases (see sections 4.3, 4.4, 4.5, 4.9 and 5.1).
Section 4.9 Overdose
Addition of:
ECG monitoring is advisable in case of overdose, in patients with congestive heart failure/bradyarrhythmias, in patients using concomitant medications that prolong the QT interval, or in patients with altered metabolism, e.g. liver impairment.
Section 5.1 Pharmacodynamic properties
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In a double-blind, placebo-controlled ECG study in healthy subjects, the change from baseline in QTc (Fridericia-correction) was 4.3 msec (90%CI 2.2, 6.4) at the 10 mg/day dose and 10.7 msec (90%CI 8.6, 12.8) at the supratherapeutic dose of 30 mg day (see sections 4.3, 4.4, 4.5, 4.8 and 4.9).
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