FDA Label for Escitalopram

Label Display

NDC: 51655-151-52

MFG: 0093-5852-05

Escitalopram 20 mg

30 tablets

Rx only

Lot#:

Exp. Date:

Each tablet contains: escitalopram oxalate, USP equivalent to 20 mg escitalopram

Dosage: See package insert

Store at 6877 degrees F.

Store in a tight, light-resistant container (See USP). Keep out of the reach of children.

Mfg by: Cipla Ltd, Kurkumbh, India

Mfg for: Teva Pharmaceuticals USA, Sellersville, PA 18960 Lot#:

Repackaged by Northwind Pharmaceuticals, Indianapolis, IN 46256

Indications And Usage

Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for:

Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years

Acute Treatment of Generalized Anxiety Disorder (GAD) in adults

Contraindications

Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with escitalopram or within 14 days of stopping treatment with escitalopram.

Do not use escitalopram within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start escitalopram in a patient who is being treated with linezolid or intravenous methylene blue.

Pimozide: Do not use concomitantly.

Known hypersensitivity to escitalopram or citalopram or any of the inactive ingredients

Warnings And Precautions

Clinical Worsening/Suicide Risk: Monitor for clinical worsening, suicidality and unusual change in behavior, especially during the initial few months of therapy or at times of dose changes .

Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including escitalopram, both when taken alone, but especially when coadministered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone and St. John’s Wort). If such symptoms occur, discontinue escitalopram and initiate supportive treatment. If concomitant use of escitalopram with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.

Discontinuation of Treatment with Escitalopram: A gradual reduction in dose rather than abrupt cessation is recommended whenever possible.

Seizures: Prescribe with care in patients with a history of seizure.

Activation of Mania/Hypomania: Use cautiously in patients with a history of mania.

Hyponatremia: Can occur in association with SIADH (5.6).Abnormal Bleeding: Use caution in concomitant use with NSAIDs, aspirin, warfarin or other drugs that affect coagulation.

Interference with Cognitive and Motor Performance: Use caution when operating machinery.

Use in Patients with Concomitant Illness: Use caution in patients with diseases or conditions that produce altered metabolism or hemodynamic responses