Full Prescribing Info
Escitalopram oxalate.
Each film-coated tablet contains escitalopram oxalate 10 mg.
Pharmacology: Pharmacokinetics: The single- and multiple-dose pharmacokinetics of escitalopram are linear and dose-proportional in a dose range of 10-30 mg/day. Biotransformation of escitalopram is mainly hepatic with a mean terminal t½ of about 27-32 hrs. With once daily dosing, steady-state plasma concentrations are achieved within approximately 1 week. At steady-state, the extent of accumulation of escitalopram in plasma in young healthy subjects was 2.2-2.5 times the plasma concentrations observed after a single dose. The tablet and the oral solution dosage forms of escitalopram oxalate are bioequivalent.
Treatment of depression, panic disorder with or without agoraphobia, generalized and social anxiety disorders, and obsessive-compulsive disorder.
Dosage/Direction for Use
Depression, Generalized and Social Anxiety Disorders: Usual Dose: 10 mg once daily, may be increased after at least a week up to maximum of 20 mg once daily, if necessary.
Panic Disorder With or Without Agoraphobia: Initial Dose: 5 mg once daily, may be increased after a week to 10 mg once daily; further increases up to a maximum of 20 mg daily may be necessary in some patients.
Patients with Hepatic Impairment or Poor Metabolizers with Respect to the Cytochrome P450 isoenzyme CYP2C19: Initial Dose: 5 mg daily, may be increased to 10 mg daily after 2 weeks depending on response.
Elderly: Initial treatment with ½ the usual recommended dose and a lower maximum dose should be considered in elderly patients.
Escitalopram should be withdrawn gradually to reduce the risk of withdrawal symptoms.
Hypersensitivity to escitalopram or citalopram or to any of the excipients of Morcet. Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs).
Special Precautions
Because of its epileptogenic effect, selective serotonin reuptake inhibitors (SSRIs) should be used with caution in patients with epilepsy or a history of such disorders (and should be avoided if the epilepsy is poorly controlled). Treatment should be stopped if seizures develop or when there is an increase in seizure frequency. Care is advised in patients receiving electroconvulsive therapy (ECT) as prolonged seizures have occurred rarely. SSRIs should also be used with caution in patients with cardiac disease or a history of bleeding disorders. Although SSRIs are preferred to tricyclics for the treatment of depression in patients with diabetes, that may alter glycemic control and therefore, caution is also warranted in diabetic subjects. SSRIs should also be used with caution in patients with angle-closure glaucoma.
Adverse Reactions
Selective serotonin reuptake inhibitors are less sedating than tricyclic antidepressants (TCAs) and have fewer antimuscarinic and cardiotoxic effects. Adverse effects reported with SSRIs include dry mouth and gastrointestinal disturbances eg, nausea, vomiting, dyspepsia, constipation and diarrhea. Anorexia and weight loss may also occur. Neurological adverse effects have included either anxiety, restlessness, nervousness, insomnia or drowsiness and fatigue; headache, tremor, dizziness, seizures, hallucinations, confusion, agitation, extrapyramidal effects, depersonalization, mania, panic attacks, sexual dysfunction and symptoms suggestive of a serotonin syndrome have occurred. Excessive sweating, pruritus, skin rashes, alopecia, photosensitivity and urticaria have been reported. Angioedema and anaphylactoid reactions have occurred.
Excessive sweating, pruritus, skin rashes, alopecia, photosensitivity and urticaria have been reported. Angioedema and anaphylactoid reactions have occurred.
Drug Interactions
Selective serotonin reuptake inhibitors interact with other drugs mainly as a result of its inhibitory activity on hepatic cytochrome P450 isoenzymes. Individual SSRIs do not all exhibit the same degree of inhibition nor react with the isoenzymes. The drugs inhibited by specific SSRIs depend on the isoenzyme affected.
As SSRIs have occasionally been associated with bleeding disorders and other effects on the blood, caution is advised when given with drugs known to affect platelet function.
Although different antidepressants have been used together under expert supervision in refractory cases of depression, severe adverse reactions including the serotonin syndrome may occur.
Store at a temperature not exceeding 30°C.
MIMS Class
ATC Classification
N06AB10 - escitalopram ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.
FC tab 10 mg x 14's, 30's.
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