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Escitalopram Oxalate (Escitalopram)

Trade Name : Escitalopram

Proficient Rx LP

TABLET, FILM COATED

Strength 10 mg/1

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

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Escitalopram Oxalate (Escitalopram) which is also known as Escitalopram and Manufactured by Proficient Rx LP. It is available in strength of 10 mg/1 per ml. Read more

Escitalopram Oxalate (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

Packaging and Delivery

Validated Cold Chain Shipment

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.

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About GNH

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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  • Warnings and Precautionsu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a01/2017
  • 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 oxalateu00a0or 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 oxalateu00a0is not approved for use in pediatric patients less than 12 years of age. .n
  • Escitalopram oxalateu00a0is a selective serotonin reuptake inhibitor (SSRI) indicated for:
  • 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 (, ).
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  • u2022
  • (3.1)
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  • 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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • (6.1)
  • 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 oxalateu00a0has not been established in pediatric MDD patients less than 12 years of age .
  • Physical and Psychological Dependenceu00a0n Animal studies suggest that the abuse liability of racemic citalopram is low. Escitalopram oxalateu00a0has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. The premarketing clinical experience with escitalopram oxalateu00a0did 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 oxalateu00a0patients 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).
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  • Escitalopram oxalate is 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 is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:
  • The molecular formula is CHFNO u2022 CHO and the molecular weight is 414.40.n Escitalopram oxalate USP occurs as a white to almost white, crystalline 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.n Escitalopram oxalate USPu00a0is available as tablets.n Escitalopram tablets USPu00a0are film-coated, containing escitalopram oxalate USPu00a0in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: butylated hydroxyl anisole, butylated hydroxy toluene, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicified microcrystalline cellulose, and talc. The film coating contains hypromellose, polyethylene glycol 400, and titanium dioxide.
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  • Seeu00a0n
  • Read the Medication Guide that comes withu00a0escitalopram 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 aboutu00a0escitalopram tablets?
  • Escitalopramu00a0tablets 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.u00a0Escitalopram tablets may be associated with these serious side effects:n- 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.n- 8. Low salt (sodium) levels in the blood.
  • 9. Visual problems
  • Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.
  • Do not stopu00a0escitalopram tablets without first talking to your healthcare provider.
  • What areu00a0escitalopram tablets?
  • Escitalopramu00a0tablets 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.u00a0Escitalopram tablets are also used to treat:
  • Talk to your healthcare provider if you do not think that your condition is getting better withu00a0escitalopram tablets treatment.
  • Who should not takeu00a0escitalopram tablets?
  • Do not takeu00a0escitalopram tablets if you:
  • People who takeu00a0escitalopram tablets close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:
  • What should I tell my healthcare provider before takingu00a0escitalopram tablets? Ask if you are not sure.
  • Before startingu00a0escitalopram 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 takeu00a0escitalopram tablets with your other medicines. Do not start or stop any medicine while takingu00a0escitalopram tablets without talking to your healthcare provider first.
  • How should I takeu00a0escitalopram tablets?
  • What should I avoid while takingu00a0escitalopram tablets?
  • Escitalopramu00a0tablets 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 howu00a0escitalopram tablets affect you. Do not drink alcohol while usingu00a0escitalopram tablets.
  • What are the possible side effects ofu00a0escitalopram tablets?
  • Escitalopram tablets may cause serious side effects, including alln- u201cWhat is the most important information I should know aboutu00a0escitalopram tablets?u201d
  • Common possible side effects in people who takeu00a0escitalopram tablets include:
  • 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 ofu00a0escitalopram 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 storeu00a0escitalopram tablets?
  • Keepu00a0escitalopram tablets and all medicines out of the reach of children.
  • General information aboutu00a0escitalopram tablets
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not useu00a0escitalopram tablets for a condition for which it was not prescribed. Do not giveu00a0escitalopram tablets to other people, even if they have the same condition.u00a0It may harm them.
  • This Medication Guide summarizes the most important information aboutu00a0escitalopram tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information aboutu00a0escitalopram tablets that is written for healthcare professionals.
  • For more information aboutu00a0escitalopram tablets call 1-866-850-2876.
  • What are the ingredients inu00a0escitalopram tablets?
  • Active ingredient: escitalopram oxalate
  • Inactive ingredients: butylated hydroxyl anisole, butylated hydroxy toluene, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicified microcrystalline cellulose, and talc. The film coating contains hypromellose, polyethylene glycol 400, and titanium dioxide.
  • Coumadin is a registered trademark of Bristol Myers Squibb.
  • Jantoven is a registered trademark of Upsher-Smith Laboratories Inc.
  • Orap is a registered trademark of Teva Pharmaceuticals USA.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Dispense with Medication Guide available at: n
  • Distributed by:n n 279 Princeton-Hightstown RoadEast Windsor, NJ 08520n Manufactured by:n n Hyderabad-500 038, India
  • Repackaged by:n n Thousand Oaks, CA 91320n Revised: 05/2018u00a0
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