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ESCERT

Quick Overview

Our aim is to reach out to the globe within shortest possible time frame. 


To promote this objective, not only we distribute and market our CNS  range of products globally through our distribution channels but we also undertake ‘contract manufacturing’& ‘formulation development ’of our wide range of generic products such as Escert  which contains Escitalopram 20 mg.


 


 

Escert-20

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Details

Each film-coated tablet contains:

Escltalopram Oxalate USP 

equivalent to  Escitalopram……..  20 mg

Excipients     q.s.

Colour: Yellow oxide of Iron, Red oxide of iron &Thanium Dioxide

CHEMISTRY: S-(+)-5-lsobenzofurancarbonitrile,143-(dimethylamino)propyff -1-(4-fluorophenyI)-1,3-dihydro-,oxalate;

CATEGORY: Antidepressant

PHARMACOLOGY

PHARMACODYNAM ICS:

Escltalopram is a highly selective serotonin reuptake inhibitor (SSRI) with minimal effects on norepinephrine and dopamine neuronal reuptake. Escltalopram has no or very low affinity for serotonergic (5-HT1-7) or other receptors including alpha- and beta-adrenergic, dopamine (D1-5), histamine (H1-3), muscarinic (M1-5), and benzodiazepine receptors. Escitalopram also does not bind to, nor has low affinity for, various ion channels including Na+ , K+, Cl-, and Ca + + channels. Antagonism of muscarinic, histaminergic, and adrenergic receptors has been hypothesized to be associated with various anticholinergic, sedative, and cardiovascular side effects of other psychotropic drugs.

PHARMACOKINETICS:

Absorption

Following a single oral dose (20 mg tablet) of escltalopram, peak blood levels occur at about 5 hours. With once-daily dosing, steady state plasma concentrations are achieved within approximately one week. Absorption of escltalopram is not affected by food.

Distribution

Data specific on escltalopram are unavailable. The binding of escltalopram to human plasma proteins is approximately 56%.

Metabolism

Following oral administrations of escitalopram, the fraction of drug recovered in the urine as escltalopram and S-demethylcitalopram (S-DCT) is about 8% and 10%, respectively.

Elimination

The oral clearance of escltalopram is 600 mUmin, with approximately 7% of that due to renal clearance. Biotransformation of escitalopram is mainly hepatic, with a mean terminal half-life of about 27-32 hours.

INDICATIONS:

Major Depressive Disorder

Escltalopram Tablets is indicated forthe acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age. A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dyspholic mood that usually interferes with daily functioning, and includes at least he of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.

Generalized Anxiety Disorder

Escltalopram Tablets is indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults. Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.

DOSAGE AND ADMINISTRATION:

Escltalopram Tablets should be administered once daily, in the morning or evening, with or wfthout food.

Major Depressive Disorder

Initial Treatment

Adolescents

The recommended dose of Escitalopram Tablets is 10 mg once daily.

Adults

The recommended dose of Escltalopram Tablets is 10 mg once daily. lithe dose is increased to 20 mg, this should occur after a minimum of one week.

Generalized Anxiety Disorder

Initial Treatment

Adults

The recommended starting dose of Escltalopram Tablets is 10 mg once daily. If the dose is increased to 20 mg, this should occur after a minimum of one week.

Special Populations

10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment.

No dosage adjustment is necessary for patients with mild or moderate renal impairment. Escltalopram Tablets should be used with caution in patients with severe renal impairment.

CONTRAINDICATIONS:

Monoamine oxidase inhibitors (MA015)

Concomitant use in patients taking monoamine oxidase inhibitors (MA015) is contraindicated.

Pimozide

Concomitant use in patients taking pimozide is contraindicated.

Hypersensitivity to escitalopram or citalopram

Escitalopram Tablets is contraindicated in patients with a hypersensitivity to escltalopram or cltalopram or any of the inactive ingredients in Escltalopram Tablets.

WARNINGS AND PRECAUTIONS:

WARNINGS: SUICIDALITY AND ANTIDEPRESSANT DRUGS

Anyone considering the use of Escltalopram Tablets or any other antidepressant in a child, adolescent or young adult must balance the risk of suicidality with the clinical need. Short-term study reports did not show an increase in the risk of suicidallty with antidepressants in adults beyond age 24; a reduction in risk with antidepressants 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, suicidallty or unusual changes in behaviour. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Escitalopram Tablets is not approved for use in pediatric patients less than 12 years of age.

Clinical Worsening and Suicide Risk

Prescriptions for Escltalopram Tablets should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

Screening Patients for Bipolar Disorder

It should be noted that Escltalopram Tablets is not approved for use in treating bipolar depression.

Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions

The concomitant use of Escltalopram Tablets with serotonin precursors (such as tryptophan) is not recommended. Treatment with Escitalopram Tablets and any concomitant serotonergic or antidopaminergic agents, including antipsychotics, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.

Discontinuation of Treatment with Escitalopram Tablets

Patients should be monitored for these symptoms when discontinuing treatment with Escltalopram Tablets. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

Seizures

Escitalopram Tablets has not been systematically evaluated in patients with a seizure disorder. Escltalopram Tablets should be introduced with care in patients with a history of seizure disorder.

Activation of Mania/Hypomania

Activation of mania/hypomania has also been reported in a small proportion of patients with major affective disorders treated with racemic cltalopram and other marketed drugs effective in the treatment of major depressive disorder. As with all drugs effective in the treatment of major depressive disorder Escitalopram Tablets should be used cautiously in patients with a history of mania.

Pimozide and Celexa

The mechanism of this pharmacodynamic interaction is not known.

Sumatriptan

If concomitant treatment with sumatriptan and an SSRI (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, escltalopram) is clinically warranted, appropriate observation of the patient is advised.

Theophylline

The effect of theophylline on the pharmacokinetics of citalopram was not evaluated.

Warfarin

The clinical significance of which is unknown.

Carbamazepine

Although trough cltalopram plasma levels were unaffected, given the enzyme- inducing properties of carbamazepine, the possibility that carbamazepine might increase the clearance of escltalopram should be considered if the two drugs are coadministered.

Triazolam

The clinical significance of which is unknown.

Ketoconazole

The clinical significance of which is unknown.

Ritonavir

The clinical significance of which is unknown.

CYP3A4 and -2C19 Inhibitors

Escltalopram Tablets is metabolized by multiple enzyme systems, inhibition of a single enzyme may not appreciably decrease escltalopram clearance.

Drugs Metabolized by Cytochrome P450206

Caution is indicated in the coadministration of escltalopram and drugs metabolized by CYP2D6.

Metoprolol

Coadministralion of Escitalopram Tablets and metoprolol has no clinically significant effects on blood pressure or heart rate.

Electroconvulsive Therapy (ECT)

There are no studies of the combined use of ECT and escitalopram.

PREGNANCY AND LACTATION:

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women; therefore, Escltalopram Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Caution should be exercised and breastfeeding infants should be observed for adverse reactions when Escltalopram Tablets is administered to a nursing woman.

Labor and Delivery

The effect of Escitalopram Tablets on labor and delivery in humans is unknown.

 

EFFECT TO DRIVE & USE THE MACHINE:

Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Escltalopram Tablets therapy does not affect their ability to engage in such activities.

ADVERSE DRUG REACTIONS:

Pediatrics (6 -17 years)

Safety and effectiveness of Escltalopram Tablets in pediatric patients less than 12 years of age has not been established.

Adverse Events Associated with Discontinuation of Treatment

Major Depressive Disorder

Pediatrics (6 -17 years)

The most common adverse event associated with discontinuation was insomnia.

Adults

Adverse events that were associated with the discontinuation with Escltalopram Tablets were nausea and ejaculation disorder.

Generalized Anxiety Disorder

Adults

Adverse events that were associated with the discontinuation of Escltalopram Tablets were nausea, insomnia and fatigue.

OVERDOSAGE:

Reports of Escltalopram Tablets overdose, including overdoses of up to 600 mg, with no associated fatalities.

Symptoms most often accompanying Escltalopram Tablets overdose, alone or in combination with other drugs and/or alcohol, included convulsions, coma, dizziness, hypotension, insomnia, nausea, vomiting, sinus tachycardia, somnolence and ECG changes (including QT prolongation and very rare cases of torsade de pointes). Acute renal failure has been very rarely reported accompanying overdose.

PRESENTATION: Blister of 10 Tablets.

STORAGE: Store below 25°C.

Protect from light. Keep out of reach of children.

 

Hyponatremia

Discontinuation of Escltalopram Tablets should be considered in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted.

Abnormal Bleeding

Patients should be cautioned about the risk of bleeding associated with the concomitant use of Escltalopram Tablets and NSAIDs, aspirin or other drugs that affect coagulation.

Use in Patients with Concomitant Illness

Caution is advisable in using Escltalopram Tablets in patients with diseases or conditions that produce altered metabolism or hemodynamic responses. Recommended dose of Escltalopram Tablets in hepatically impaired patients is 10 mg/day.

Potential for Interaction with Monoamine Oxidase Inhibitors (MA01)

It is recommended that Escitalopram Tablets should not be used in combination with an MA01 or within 14 days of discontinuing treatment with an MAOL Similarly, at least 14 days should be allowed after stopping Escitalopram Tablets before starting an MAOL

Serotonin syndrome has been reported in two patients who were concomitantly receiving linezolid, an antibiotic which is a reversible non-selective MAOL

INTERACTIONS:

Serotonergic Drugs

Caution is advised when Escltalopram Tablets is coadministered with other drugs that may affect the serotonergic neurotransmitter systems, such as triptans, linezolid (an antibiotic which is a reversible non-selective MA01), Ilthium, tramadol or St. John's.

The concomitant use of Escitalopram Tablets with other SSR1s, SNRIs or tryptophan is not recommended.

Triptans

If concomitant treatment of Escitalopram Tablets with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.

CNS Drugs

Given the primary CNS effects of Escltalopram Tablets, caution should be used when it is taken in combination with other centrally acting drugs.

Alcohol

Use of alcohol by patients taking Escltalopram Tablets is not recommended.

Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc.) Patients receiving warfarin therapy should be carefully monitored when Escitalopram Tablets is initiated or discontinued.

Cimetidine

The clinical significance of these findings is unknown.

Digoxin

No significant effect on the pharmacokinetics of elther citalopram or digoxin.

Lithium

Caution should be exercised when Escitalopram Tablets and Mum are coadministered.

 

 

 
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