Contents (active pharmaceutical ingredients only): Escitalopram as oxalate 10 mg.
Indications/Uses
Used in the treatment of depression, panic disorder with or without agoraphobia, generalized anxiety disorder, social anxiety disorder, and obsessive-compulsive disorder.
Dosage/Direction for Use
It is given orally as the oxalate doses are expressed in terms of the base; escitalopram oxalate 12.8 mg is equivalent to about 10 mg of Escitalopram. In the treatment of depression, the usual dose is 10 mg once daily increased, after at least a week, to a maximum of 20 mg once daily if necessary. For the treatment of panic disorder with or without agoraphobia, initial doses are 5 mg once daily, 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. Initial treatment with half the usual recommended dose and a lower maximum doses should be considered in elderly patients. Patients with hepatic impairment or those who are poor metabolisers with respect to the cytochrome P450 isoenzyme CYP2C19 may also require lower doses. Escitalopram should be withdrawn gradually to reduce the risk of withdrawal symptoms or as prescribed by the physician.
Contraindications
Hypersensitivity to Escitalopram or to any of the excipients. Children; as safety and efficacy have not been established in this population. Monoamine Oxidase Inhibitors - Cases of serious reactions have been reported in patients receiving an SSRI such as Escitalopram in combination with a monoamine oxidase inhibitor (MAOI), and in patients who have recently discontinued as SSRI and have been started on a MAOI.
Special Precautions
Mania: Escitalopram should be discontinued in any patient entering a manic phase. Paradoxia anxiety: Some patients with panic disorder may experience increased anxiety symptoms at the start of treatment with antidepressants. Seizures: Escitalopram should be discontinued in any patient who develops seizures. Its should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be closely monitored. Diabetes mellitus: Patients with diabetes mellitus, treatment with Escitalopram may alter glycaemic control, due to improvement of depressive symptoms. Suicide: As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored during this period.
Adverse Reactions
Adverse reactions observed with Escitalopram are most frequently during the first one or two weeks of treatment and may decrease in intensity and frequency with continued treatment. After prolonged administration abrupt cessation of Escitalopram may produce withdrawal reactions in some patients. Common (>1/100,<1/10): Both genders: Nausea, insomnia, somnolence, sweating increased, diarrhea, constipation, dizziness, fatigue, appetite decreased, sinusitis, libido decreased, pyrexia, yawning.
Gender specific: Ejaculation disorder, impotence, abnormal orgasm (female). Uncommon (>1/1000,<1/100): Sleep disorder, taste disturbance.
Escitalopram has a low potential for clinically significant medicine interactions. In vitro studies have shown that the biotransformation of escitalopram to its demethylated metabolites depends on three parallel pathways (cytochrome P450, 2C19, 3A4 and 2D6). Escitalopram is very weak inhibitor of isoenzyme CYP1A2, 2C9, 2C19,2E1 and 3A.
Ritonavir - The pharmacokinetics of single doses of Escitalopram was not changed by co-administration with single dose of ritonavir (CYP3A4 inhibitor). Ketoconazole - Co-administration with ketoconazole (potent CYP3A4 inhibitor) did not change the pharmacokinetics of racemix citalopram. MAOI, Sumatriptan and Tramadol - Co-administration with MAO inhibitors may cause serotonin syndrome. Co-administration with other serotogenic medicines (e.g. tramadol, sumatriptan) as well as other antidepressants with serotogenic properties may lead to an enhancement of serotonin associated, e.g. serotonin syndrome.
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