Escitalopram Oxalate (Escitalopram Oxalate)

Trade Name : Escitalopram Oxalate

Pharmaceutical Associates, Inc.

SOLUTION

Strength 10 mg/10mL

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 Oxalate) which is also known as Escitalopram Oxalate and Manufactured by Pharmaceutical Associates, Inc.. It is available in strength of 10 mg/10mL per ml. Read more

Escitalopram Oxalate (Escitalopram Oxalate) 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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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 Oxalate 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 Oxalate is not approved for use in pediatric patients less than 12 years of age.n n n n
WARNING:n n n n
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 Oxalate is not approved for use in pediatric patients less than 12 years of age (n n n ).n n n

Warnings and Precautions (n n n ) 01/2017n nn

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

Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12-17 years (n n n )n n n
Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (n n n )n n n

Escitalopram Oxalate should be administered once daily, in the morning or evening, with or without food.
Escitalopram Oxalate should generally be administered once daily, morning or evening with or without food (n n n ,n n n ).n nn

No additional benefits seen at 20 mg/day dose (n n n ).n n n
10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment (n n n ).n n n
No dosage adjustment for patients with mild or moderate renal impairment. Use caution in patients with severe renal impairment (n n n ).n n n
Discontinuing Escitalopram Oxalate: A gradual dose reduction is recommended (n n n ).n n n

Escitalopram Oxalate Oral Solution contains escitalopram oxalate equivalent to 1 mg/mL escitalopram base.

Oral solution: 1 mg per mL (n n n )n n n

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Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with escitalopram oxalate or within 14 days of stopping treatment with escitalopram oxalate. Do not use escitalopram oxalate within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start escitalopram oxalate in a patient who is being treated with linezolid or intravenous methylene blue (n n n ).n n n
Pimozide: Do not use concomitantly (n n n ).n n n
Known hypersensitivity to escitalopram or citalopram or any of the inactive ingredients (n n n ).n n n

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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 (n n n ).n n n
Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including escitalopram oxalate, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John's Wort). If such symptoms occur, discontinue Escitalopram oxalate and initiate supportive treatment. If concomitant use of escitalopram oxalate 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 (n n n ).n n n
Discontinuation of Treatment with Escitalopram Oxalate: A gradual reduction in dose rather than abrupt cessation is recommended whenever possible (n n n ).n n n
Seizures: Prescribe with care in patients with a history of seizure (n n n ).n n n
Activation of Mania/Hypomania: Use cautiously in patients with a history of mania (n n n ).n n n
Hyponatremia: Can occur in association with SIADH (n n n ).n n n
Abnormal Bleeding: Use caution in concomitant use with NSAIDs, aspirin, warfarin or other drugs that affect coagulation (n n n ).n n n
Interference with Cognitive and Motor Performance: Use caution when operating machinery (n n n ).n n n
Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants (n n n ).n n n
Use in Patients with Concomitant Illness: Use caution in patients with diseases or conditions that produce altered metabolism or hemodynamic responses (n n n ).n n n

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 (n n n ).n nn
To report SUSPECTED ADVERSE REACTIONS, contact Pharmaceutical Associates, Inc. at 1-800-845-8210, or FDA at 1-800-FDA-1088 orn n n n

Concomitant use with SSRIs, SNRIs or Tryptophan is not recommended (n n n ).n nn
Use caution when concomitant use with drugs that affect Hemostasis (NSAIDs, Aspirin, Warfarin) (n n n ).n nn

Pregnancy: Use only if the potential benefit justifies the potential risk to the fetus (n n n )n nn
Nursing Mothers: Caution should be exercised when administered to a nursing woman (n n n )n nn
Pediatric Use: Safety and effectiveness of Escitalopram Oxalate has not been established in pediatric MDD patients less than 12 years of age (n n n ).n nn

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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-(n n n -fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:n nn
The molecular formula is Cn n n Hn n n FNn n n O u2219 Cn n n Hn n n On n n and the molecular weight is 414.40.n nn
Escitalopram oxalate occurs as a fine, white to off 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.
Escitalopram Oxalate is available as an oral solution.
Escitalopram Oxalate Oral Solution contains escitalopram oxalate equivalent to 1 mg/mL escitalopram base. It also contains the following inactive ingredients: sorbitol, purified water, citric acid, sodium citrate, glycerin, propylene glycol, methylparaben, propylparaben, and peppermint flavor.

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Seen n n n

Escitalopram Oxalate (ES-sye-TAL-oh-pram OX-a-late)n n n Oral Solutionn nn
Read the Medication Guide that comes with Escitalopram Oxalate Oral Solution before you start taking it 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 Oxalate?
Escitalopram Oxalate and other antidepressant medicines may cause serious side effects, including:
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 Oxalate may be associated with these serious side effects:
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 stop Escitalopram Oxalate without first talking to your healthcare provider.
What is Escitalopram Oxalate?
Escitalopram Oxalate is 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 Oxalate is also used to treat:
Talk to your healthcare provider if you do not think that your condition is getting better with Escitalopram Oxalate treatment.
Who should not take Escitalopram Oxalate?
Do not take Escitalopram Oxalate if you:
People who take Escitalopram Oxalate 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 taking Escitalopram Oxalate? Ask if you are not sure.
Before starting Escitalopram Oxalate, tell your healthcare provider if you:
Tell your healthcare provider about all the n- that you take
Your healthcare provider or pharmacist can tell you if it is safe to take escitalopram oxalate with your other medicines. Do not start or stop any medicine while taking escitalopram oxalate without talking to your healthcare provider first.
How should I take Escitalopram Oxalate?
What should I avoid while taking Escitalopram Oxalate?
Escitalopram Oxalate 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 oxalate affects you. Do not drink alcohol while using escitalopram oxalate.
What are the possible side effects of Escitalopram Oxalate?
Escitalopram Oxalate may cause serious side effects, including all
Common possible side effects in people who take escitalopram oxalate 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 of escitalopram oxalate. 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 Oxalate?
Keep Escitalopram Oxalate Oral Solution and all medicines out of the reach of children.
General information about Escitalopram Oxalate
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Escitalopram Oxalate Oral Solution for a condition for which it was not prescribed. Do not give Escitalopram Oxalate Oral Solution to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about escitalopram oxalate. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about escitalopram oxalate that is written for healthcare professionals.
For more information about Escitalopram Oxalate Oral Solution call 1-800-845-8210.
What are the ingredients in Escitalopram Oxalate Oral Solution?
Active ingredient: escitalopram oxalate
Inactive ingredients:
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Trademarks are the property of their respective owners.
DISTRIBUTED BY
PACKAGED BYn- Array
R02/18

Delivers n n n n NDC 0121-0852-10n nn
Arrayn- En n n On n n n On n n Sn n n n
10 mg/ 10 mLn n n *Equivalent to 1 mg escitalopram base per mLn n n
Rx ONLYn n n FOR INSTITUTIONAL USE ONLYn n n
Pkg. by: Pharmaceutical Associates, Inc.n n n Greenville, SC 29605n nn
SEE INSERT
A0852100218

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Escitalopram Oxalate (Escitalopram Oxalate)

Trade Name : Escitalopram Oxalate

SOLUTION

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Escitalopram Oxalate (Escitalopram Oxalate)

Trade Name : Escitalopram Oxalate

SOLUTION

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

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