Label: ESCITALOPRAM tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 51655-151-52 - Packager: Northwind Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 0093-5852
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 6, 2014
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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
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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
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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
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INGREDIENTS AND APPEARANCE
ESCITALOPRAM
escitalopram tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-151(NDC:0093-5852) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESCITALOPRAM OXALATE (UNII: 5U85DBW7LO) (ESCITALOPRAM - UNII:4O4S742ANY) ESCITALOPRAM 20 mg Product Characteristics Color white Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code 5852;20 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51655-151-52 30 in 1 BOTTLE, DISPENSING Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076765 03/21/2014 Labeler - Northwind Pharmaceuticals (036986393) Registrant - Northwind Pharmaceuticals (036986393) Establishment Name Address ID/FEI Business Operations Northwind Pharmaceuticals 036986393 repack(51655-151)