Escitalopram (Escitalopram)

Trade Name : Escitalopram

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 5 mg/1

ESCITALOPRAM OXALATE Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Escitalopram (Escitalopram) which is also known as Escitalopram and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 5 mg/1 per ml. Read more

Escitalopram (Escitalopram) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of escitalopram or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Escitalopram is not approved for use in pediatric patients less than 12 years of age .
  • WARNING: SUICIDALITY and ANTIDEPRESSANT DRUGS
  • See full prescribing information for complete boxed warning.
  • Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders. Escitalopram is not approved for use in pediatric patients less than 12 years of age ().
  • Escitalopram tablets are 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 ()
  • Escitalopram tablets should be administered once daily, in the morning or evening, with or without food.
  • Escitalopram tablets should generally be administered once daily, morning or evening with or without food (, ).
  • No additional benefits seen at 20 mg/day dose ().
  • 10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment ().
  • No dosage adjustment for patients with mild or moderate renal impairment. Use caution in patients with severe renal impairment ().
  • Discontinuing escitalopram tablets: A gradual dose reduction is recommended ().
  • Escitalopram tablets are film-coated, round tablets containing escitalopram oxalate in strengths equivalent to 5 mg, 10 mg and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The 5 mg tablet is debossed with u201c5850u201d on one side and u201cIvax hourglass logou201d and u201c5u201d on the other. The 10 mg tablet is debossed with u201c5851u201d on one side and u201cIvax hourglass logou201d and u201c10u201d on the other. The 20 mg tablet is debossed with u201c5852u201d on one side and u201cIvax hourglass logou201d and u201c20u201d on the other.
  • Tablets: 5 mg, 10 mg (scored) and 20 mg (scored) ()
  • No data
  • 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 ().
  • No data
  • 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, amphetamines, and St. Johnu2019s 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 ().
  • Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants ().
  • Use in Patients with Concomitant Illness: Use caution in patients with diseases or conditions that produce altered metabolism or hemodynamic responses ().
  • Most commonly observed adverse reactions (incidence u2265 5% and at least twice the incidence of placebo patients) are: insomnia, ejaculation disorder (primarily ejaculatory delay), nausea, sweating increased, fatigue and somnolence, decreased libido, and anorgasmia ().
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at u00a0or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • Concomitant use with SSRIs, SNRIs or Tryptophan is not recommended ().
  • Use caution when concomitant use with drugs that affect Hemostasis (NSAIDs, Aspirin, Warfarin) ().
  • Pregnancy: Use only if the potential benefit justifies the potential risk to the fetus ().
  • Nursing Mothers: Caution should be exercised when administered to a nursing woman ().
  • Pediatric Use: Safety and effectiveness of escitalopram has not been established in pediatric MDD patients less than 12 years of age ().
  • Physical and Psychological Dependence
  • Animal studies suggest that the abuse liability of racemic citalopram is low. Escitalopram has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. The premarketing clinical experience with escitalopram did not reveal any drug-seeking behavior. However, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate escitalopram patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).
  • No data
  • Escitalopram Tablets USP contain escitalopram oxalate, USP, an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate, USP, is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:
  • CHFNO u2022 CHOtM.W. 414.43
  • Escitalopram oxalate, USP, occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane.
  • Escitalopram Tablets USP are film-coated, round tablets containing 6.39 mg, 12.77 mg, 25.55 mg escitalopram oxalate, USP, in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively, of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: corn starch, croscarmellose sodium, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol and titanium dioxide.
  • No data
  • No data
  • No data
  • Escitalopram Tablets USP, 5 mg are available as white to off-white, round, biconvex, unscored, film-coated tablets, debossed u201c5850u201d on one side and u201cIvax hourglass logou201d u201c5u201d on the other side, packaged in bottles of 100 (0093-5850-01) and 500 (0093-5850-05) tablets.
  • Escitalopram Tablets USP, 10 mg are available as white to off-white, round, biconvex, scored, film-coated tablets, debossed u201c5851u201d on one side and u201cIvax hourglass logou201d, a score, and u201c10u201d on the other side, packaged in bottles of 100 (0093-5851-01) and 500 (0093-5851-05) tablets.
  • Escitalopram Tablets USP, 20 mg are available as white to off-white, round, biconvex, scored, film-coated tablets, debossed u201c5852u201d on one side and u201cIvax hourglass logou201d, a score, and u201c20u201d on the other side, packaged in bottles of 100 (0093-5852-01) and 500 (0093-5852-05) tablets.
  • Storage and Handling
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a tight container as defined in the USP, with a child-resistant closure as required.
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • See FDA-approved Medication Guide
  • Escitalopram (esu2033 sye talu2032 oh pram) Tablets
  • Read the Medication Guide that comes with escitalopram tablets before you start taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.
  • What is the most important information I should know about escitalopram tablets?
  • Escitalopram tablets and other antidepressant medicines may cause serious side effects, including:
  • 1. Suicidal thoughts or actions:
  • Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
  • Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:
  • Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Escitalopram tablets may be associated with these serious side effects:
  • 2. Serotonin Syndrome. This condition can be life-threatening and may include:
  • 3. Severe allergic reactions:
  • 4. Abnormal bleeding:
  • 5. Seizures or convulsions
  • 6. Manic episodes:
  • 7. Changes in appetite or weight.
  • 8. Low salt (sodium) levels in the blood.
  • 9. Visual problems
  • Do not stop escitalopram tablets without first talking to your healthcare provider
  • What are escitalopram tablets?
  • Escitalopram tablets are a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider. Escitalopram tablets are also used to treat:
  • Talk to your healthcare provider if you do not think that your condition is getting better with escitalopram tablets treatment.
  • Who should not take escitalopram tablets?
  • Do not take escitalopram tablets if you:
  • What should I tell my healthcare provider before taking escitalopram tablets? Ask if you are not sure.
  • Before starting escitalopram tablets, tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines that you take,
  • Your healthcare provider or pharmacist can tell you if it is safe to take escitalopram tablets with your other medicines. Do not start or stop any medicine while taking escitalopram tablets without talking to your healthcare provider first.
  • How should I take escitalopram tablets?
  • What should I avoid while taking escitalopram tablets?
  • Escitalopram tablets can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how escitalopram tablets affect you. Do not drink alcohol while using escitalopram tablets.
  • What are the possible side effects of escitalopram tablets?
  • Escitalopram tablets may cause serious side effects, including alln- What is the most important information I should know about escitalopram tablets?
  • Common possible side effects in people who take escitalopram tablets includen
  • Other side effects in children and adolescents include:
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of escitalopram tablets. For more information, ask your healthcare provider or pharmacist.
  • CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.
  • How should I store escitalopram tablets?
  • Keep escitalopram tablets and all medicines out of the reach of children.
  • General information about escitalopram tablets
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use escitalopram tablets for a condition for which they were not prescribed. Do not give escitalopram tablets to other people, even if they have the same condition. They may harm them.
  • This Medication Guide summarizes the most important information about escitalopram tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about escitalopram tablets that is written for healthcare professionals.
  • For more information about escitalopram tablets call Teva Pharmaceuticals at .
  • What are the ingredients in escitalopram tablets?
  • Active ingredient: escitalopram oxalate
  • Inactive ingredients: corn starch, croscarmellose sodium, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol and titanium dioxide.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
  • Manufactured In India By:
  • Cipla Ltd.
  • Kurkumbh, India
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. F 3/2019
  • NDCn- 5850
  • Escitalopram
  • Tablets USP
  • 5 mg*
  • PHARMACIST: Dispense the
  • accompanying Medication Guide
  • to each patient.
  • Rx only
  • 100 TABLETS
  • TEVA
  • NDCn- 5851
  • Escitalopram
  • Tablets USP
  • 10 mg*
  • PHARMACIST: Dispense the
  • accompanying Medication Guide
  • to each patient.
  • Rx only
  • 100 TABLETS
  • TEVA
  • NDCn- 5852
  • Escitalopram
  • Tablets USP
  • 20 mg*
  • PHARMACIST: Dispense the
  • accompanying Medication Guide
  • to each patient.
  • Rx only
  • 100 TABLETS
  • TEVA

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