Escitaloborg
Each tablet contains:
Active ingredients:
• For Escitaloborg 5 mg Tablets:
Escitalopram oxalate ……………………… 6.387 mg
(Equivalent to Escitalopram 5 mg)
• For Escitaloborg 20 mg Film Coated Tablets:
Escitalopram oxalate …………………… 25.548 mg
(Equivalent to Escitalopram 20 mg)
Indications:
– Treatment of major depressive episodes.
– Treatment of panic disorder with or without agoraphobia.
– Treatment of social anxiety disorder (social phobia).
– Treatment of generalized anxiety disorder.
– Treatment of obsessive-compulsive disorder.
Dosage and administration:
– Maximum dose for adults under 65 years is 20 mg per day.
– 10 mg per day is the maximum recommended dose for patients with hepatic impairment, who are greater than 65 yearsof age, who are CYP 2C19 poor metabolizers, or who are taking concomitant cimetidine (TagametR), because these drugsfactors lead to increased blood levels of Escitalopram, increasing the risk of QT interval prolongation and Torsade de Pointes.
– Safety of daily doses above 20 mg has not been demonstrated.
– Escitaloborg 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 maximumof 20 mg daily.
Usually 2-4 weeks are necessary to obtain antidepressant response. After the symptoms resolve, treatment for at least 6months 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 furtherincreased, 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.
– Social anxiety disorder:
Usual dosage is 10 mg once daily. Usually 2-4 weeks are necessary to obtain symptom relief. The dose may subsequently,depending on individual patient response, be decreased to 5 mg or increased to a maximum of 20 mg daily.
– Generalised anxiety disorder:
Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum
of 20 mg daily.
Long-term treatment of responders has been studied for at least 6 months in patients receiving 20 mg daily. Treatmentbenefits and dose should be re-evaluated at regular intervals.
– Obsessive-compulsive disorder:
Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum
of 20 mg daily.
– Elderly patients (> 65 years of age):
Initial dosage is 5 mg once daily. Depending on individual patient response the dose may be increased to 10 mg daily.
The efficacy of Escitaloborg in social anxiety disorder has not been studied in elderly patients.
– Children and adolescents ( Escitaloborg should not be used in the treatment of children and adolescents under the age of 18 years.
– 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.)
– Reduced hepatic function:
An initial dose of 5 mg daily for the first two weeks of treatment is recommended in patients with mild or moderate hepatic
impairment. Depending on individual patient response, the dose may be increased to 10 mg daily. Caution and extra carefuldose titration is advised in patients with severely reduced hepatic function.
Package and Storage:
– For Escitaloborg 5 mg Tablets:
Carton box containing one blister (PVC/Alu) of 10 tablets and insert leaflet.
– For Escitaloborg 20 mg Film Coated Tablets:
Carton box containing one blister (PVC/Alu) of 10 film coated tablets and insert leaflet.
– Store at a temperature not exceeding 30 °C, in a dry place.
– Keep out of the reach of children.
– Do not use unless under physician supervision.