FELIZ S 10 Escitalopram Oxalate 10mg Film-Coated Tablet 1's
RXDRUG-DRP-3538-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Used for the management of generalised anxiety disorder, obsessive-compulsive disorder, panic disorder with or without agoraphobia, social phobia, and post-traumatic stress disorder. Used for the acute and maintenance treatment of major depressive disorder in adults and adolescents 12 to 17 years of age.
Dosage/Direction for Use
Initial Treatment: (Adults): The recommended dose of Escitalopram is 10mg once daily. If the dose is increased to 20mg, this should occur after a minimum of one week. Escitalopram should be administered daily, in the morning or evening, with or without food.
Adolescents: The recommended dose of Escitalopram is 10 mg once daily. If the dose is increased to 20 mg, this should occur after a minimum of three week.
Special Populations: An initial dose of 5mg daily for the first two weeks of treatment is recommended dose for most elderly patients and patients with hepatic impairment. Depending on individual patient response, the dose may be increased to 10mg/day. No dosage adjustments are necessary for patients with mild or moderate renal impairment. Escitalopram should be used with caution in patients with severe renal impairment.
Maintenance Treatment: Systematic evaluation of continuing Escitalopram 10 or 20 mg/day for periods of up to 36 weeks in patients with major depressive disorder who responded while taking Escitalopram during and 8-week acute treatment phase demonstrated a benefit of such maintenance treatment. Panic disorder with or without agoraphobia: An initial dose of 5mg is recommended for the first week before increasing the dose to 10mg daily. The dose may be increased up to a maximum of 20mg daily, dependent on individual patient response.
Switching Patients To or From a Monoamine Oxidase Inhibitor: At least 14 days should elapse between discontinuation of an MAOI and inhibition of Escitalopram before starting a MAOI.
Or as prescribed by the physician.
Withdrawal: Escitalopram should be withdrawn gradually to reduce the risk of withdrawal symptoms.
Adolescents: The recommended dose of Escitalopram is 10 mg once daily. If the dose is increased to 20 mg, this should occur after a minimum of three week.
Special Populations: An initial dose of 5mg daily for the first two weeks of treatment is recommended dose for most elderly patients and patients with hepatic impairment. Depending on individual patient response, the dose may be increased to 10mg/day. No dosage adjustments are necessary for patients with mild or moderate renal impairment. Escitalopram should be used with caution in patients with severe renal impairment.
Maintenance Treatment: Systematic evaluation of continuing Escitalopram 10 or 20 mg/day for periods of up to 36 weeks in patients with major depressive disorder who responded while taking Escitalopram during and 8-week acute treatment phase demonstrated a benefit of such maintenance treatment. Panic disorder with or without agoraphobia: An initial dose of 5mg is recommended for the first week before increasing the dose to 10mg daily. The dose may be increased up to a maximum of 20mg daily, dependent on individual patient response.
Switching Patients To or From a Monoamine Oxidase Inhibitor: At least 14 days should elapse between discontinuation of an MAOI and inhibition of Escitalopram before starting a MAOI.
Or as prescribed by the physician.
Withdrawal: Escitalopram should be withdrawn gradually to reduce the risk of withdrawal symptoms.
Overdosage
Symptoms most often accompanying escitalopram 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.
Management of Overdose: Establish and maintain an airway to ensure adequate ventilation and oxygenation. Gastric evacuation by lavage and use of activated charcoal should be considered. Careful observation and cardiac and vital sign monitoring are recommended, along with general symptomatic and supportive care. Due to the large volume of distribution of Escitalopram, forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit. There are no specific antidotes for Escitalopram. In managing overdose, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any overdose.
Management of Overdose: Establish and maintain an airway to ensure adequate ventilation and oxygenation. Gastric evacuation by lavage and use of activated charcoal should be considered. Careful observation and cardiac and vital sign monitoring are recommended, along with general symptomatic and supportive care. Due to the large volume of distribution of Escitalopram, forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit. There are no specific antidotes for Escitalopram. In managing overdose, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any overdose.
Administration
May be taken with or without food: Take in the morning or evening.
Contraindications
Monoamine oxidase inhibitors (MAOIs): Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated.
Pimozide: Concomitant use in patients taking pimozide is contraindicated.
Hypersensitivity to escitalopram or citalopram: Contraindicated in patients with a hypersensitivity to escitalopram or citalopram or any of the inactive ingredients of Escitalopram (Feliz S) film-coated tablet.
Pimozide: Concomitant use in patients taking pimozide is contraindicated.
Hypersensitivity to escitalopram or citalopram: Contraindicated in patients with a hypersensitivity to escitalopram or citalopram or any of the inactive ingredients of Escitalopram (Feliz S) film-coated tablet.
Warnings
General: Serotonin Syndrome: The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including escitalopram oxalate, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g.,tremor, rigidity, myoclonus, hyperreflexia, incoordination) seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
Patients should be monitored for the emergence of serotonin syndrome.
The concomitant use of escitalopram oxalate with MAOIs intended to treat psychiatric disorders is contraindicated. Treatment with escitalopram oxalate and any concomitant serotonergic agents, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.
Suicide: The possibility of a suicide attempt is inherent in major depressive disorder and may persist until significant remission occurs. Close supervision of high risk patients should accompany initial drug therapy.
Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g.,tremor, rigidity, myoclonus, hyperreflexia, incoordination) seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
Patients should be monitored for the emergence of serotonin syndrome.
The concomitant use of escitalopram oxalate with MAOIs intended to treat psychiatric disorders is contraindicated. Treatment with escitalopram oxalate and any concomitant serotonergic agents, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.
Suicide: The possibility of a suicide attempt is inherent in major depressive disorder and may persist until significant remission occurs. Close supervision of high risk patients should accompany initial drug therapy.
Special Precautions
Hyponatremia: Several cases of hyponatremia or SIADH (syndrome of inappropriate antidiuretic hormone secretion) have been reported in association with racemic citalopram. All patients with these events have recovered with discontinuation of Escitalopram or citalopram and/or medical intervention.
Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death.
Abnormal Bleeding: Patients should be cautioned about the risk of bleeding associated with the concomitant use of escitalopram oxalate and NSAIDS, aspirin or other drugs that affect coagulation.
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 citalopram and other marketed drugs effective in the treatment of major depressive disorder. Escitalopram should be used cautiously in patients with a history of mania.
Seizures: Escitalopram has not been systemically evaluated in patients with a seizure disorder. Like other drugs effective in the treatment of major depressive disorder, Escitalopram should be introduced with care in patients with a history of seizure disorder.
Use in Patients with Concomitant Illness: Caution is advisable in patients with diseases or conditions that produce altered metabolism or hemodynamic responses. Escitalopram has not been systematically evaluated tin patients with a recent history of myocardial infarction or unstable heart disease.
In subjects with hepatic impairment, clearance of racemic citalopram was decreased and plasma concentrations were increased. The recommended dose of Escitalopram in hepatically impaired patients is 10 mg/day.
Interference with Cognitive and Motor Performance: Any psychoactive drug may impair judgment, thinking, or motor skills, however, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that escitalopram tablets therapy does not affect their ability to engage susceptible activities.
Angle Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressants drugs including escitalopram oxalate may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Use in children: Safety and effectiveness in pediatric patients have not been established (younger than 12 years of age with major depressive disorder and less than 18 years of age for generalized anxiety disorder).
Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death.
Abnormal Bleeding: Patients should be cautioned about the risk of bleeding associated with the concomitant use of escitalopram oxalate and NSAIDS, aspirin or other drugs that affect coagulation.
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 citalopram and other marketed drugs effective in the treatment of major depressive disorder. Escitalopram should be used cautiously in patients with a history of mania.
Seizures: Escitalopram has not been systemically evaluated in patients with a seizure disorder. Like other drugs effective in the treatment of major depressive disorder, Escitalopram should be introduced with care in patients with a history of seizure disorder.
Use in Patients with Concomitant Illness: Caution is advisable in patients with diseases or conditions that produce altered metabolism or hemodynamic responses. Escitalopram has not been systematically evaluated tin patients with a recent history of myocardial infarction or unstable heart disease.
In subjects with hepatic impairment, clearance of racemic citalopram was decreased and plasma concentrations were increased. The recommended dose of Escitalopram in hepatically impaired patients is 10 mg/day.
Interference with Cognitive and Motor Performance: Any psychoactive drug may impair judgment, thinking, or motor skills, however, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that escitalopram tablets therapy does not affect their ability to engage susceptible activities.
Angle Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressants drugs including escitalopram oxalate may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Use in children: Safety and effectiveness in pediatric patients have not been established (younger than 12 years of age with major depressive disorder and less than 18 years of age for generalized anxiety disorder).
Use In Pregnancy & Lactation
Pregnancy Category C.
Pregnancy: There are no adequate and well-controlled studies in pregnant women; therefore, Escitalopram should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: Escitalopram is excreted in human breast milk.
Labor and Delivery: The effect of Escitalopram on labor and delivery in humans is unknown.
Nursing Mothers: There have been two reports of infants experiencing excessive somnolence, decreased feeding, and weight loss in associated with breast feeding from a citalopram treated mother; in one case, the infant was reported to recover completely upon discontinuation of citalopram by its mother and, in the second case, no follow up information was available. The decision whether to continue or discontinue either nursing or Escitalopram therapy should take into account the risks of citalopram exposure for the infant and the benefits of Escitalopram treatment for the mother.
Pregnancy: There are no adequate and well-controlled studies in pregnant women; therefore, Escitalopram should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: Escitalopram is excreted in human breast milk.
Labor and Delivery: The effect of Escitalopram on labor and delivery in humans is unknown.
Nursing Mothers: There have been two reports of infants experiencing excessive somnolence, decreased feeding, and weight loss in associated with breast feeding from a citalopram treated mother; in one case, the infant was reported to recover completely upon discontinuation of citalopram by its mother and, in the second case, no follow up information was available. The decision whether to continue or discontinue either nursing or Escitalopram therapy should take into account the risks of citalopram exposure for the infant and the benefits of Escitalopram treatment for the mother.
Adverse Reactions
Adverse reactions are most frequent during the first or second week of treatment and usually decrease in intensity and frequency with continued treatment.
Tabulated list of adverse reactions: Adverse reactions known for SSRIs and also reported for escitalopram in either placebo-controlled clinical studies or as spontaneous post-marketing events are listed as follows by system organ class and frequency.
Frequencies are taken from clinical studies; they are not placebo-corrected. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data). (See table).
Tabulated list of adverse reactions: Adverse reactions known for SSRIs and also reported for escitalopram in either placebo-controlled clinical studies or as spontaneous post-marketing events are listed as follows by system organ class and frequency.
Frequencies are taken from clinical studies; they are not placebo-corrected. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data). (See table).
Patient must seek medical attention immediately at the first sign of any adverse drug reaction shall appear.
Drug Interactions
CNS Drugs: Due to CNS effects of Escitalopram, caution should be used when it is taken in combination with other centrally acting drugs.
Alcohol: Although racemic citalopram did not potentiate the cognitive and motor effects of alcohol, the use of alcohol by patients taking Escitalopram is not recommended.
Lithium: May enhance the serotonergic effects of Escitalopram, caution should be exercised when Escitalopram and lithium are co-administered.
Sumatriptan: There have been rare reports of weakness, hyperreflexia and in-coordination following the use of a selective serotonin reuptake inhibitor (SSRI) and sumatriptan. If concomitant treatment of sumatriptan and an SSRI is clinically warranted, appropriate observation of the patient is advised.
Ketoconazole: Combined administration of racemic citalopram (40mg), and Ketoconazole (200mg) decreased the Cmax, and AUC of Ketoconazole by 21% and 10%, respectively, and did not significantly affect the pharmacokinetics of citalopram.
CYP3A4 and - 2C19 inhibitors: The metabolism of escitalopram is mainly mediated by CYP2C19 and CYP3A4 may also contribute to the metabolism although to a smaller extent. Co-administration of escitalopram with omeprazole 30 mg once daily (a CYP2C19 inhibitor) resulted in moderate (approximately 50%) increase in the plasma concentrations of escitalopram. Co-administration of escitalopram with cimetidine 400 mg twice daily (moderately potent general enzyme-inhibitor) resulted in a moderate (approximately 70%) increase in the plasma concentrations of escitalopram.
Thus, caution should be exercised when used concomitantly with CYP2C19 inhibitors (e.g. omeprazole, esomeprazole, fluvoxamine, lansoprazole, ticlopidine) or cimetidine. A reduction in the dose of escitalopram may be necessary based on monitoring of side-effects during concomitant treatment.
Drugs Metabolized by Cytochrome P4502D6: Escitalopram is an inhibitor of the enzyme CYP2D6. Caution is recommended when escitalopram is co-administered with medicinal products that are mainly metabolized by this enzyme, and that have a narrow therapeutic index, e.g. flecainide, propafenone and metoprolol (when used in cardiac failure), or some CNS acting medicinal products that are mainly metabolised by CYP2D6, e.g. antidepressants such as desipramine, clomipramine and nortriptyline or antipsychotics like risperidone, thioridazine and haloperidol. Dosage adjustment may be warranted. Co-administration with desipramine cases in a two fold increase in the plasma levels of desipramine.
Metoprolol: Administration of 20 mg/day Escitalopram for 21 days resulted in a 50% increase in Cmax and 82% increase in AUC of the beta-adrenergic blocker Metoprolol (given in a single dose of 100 mg). Increased Metoprolol plasma levels have been associated with decreased cardio-selectivity. Co-administration of Escitalopram and Metoprolol had no clinically significant effects on blood pressure or heart rate.
Drugs that Interfere with Hemostasis (NSAIDs, Aspirin, Warfarin, etc): NSAIDS and Aspirin may potentiate the risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs and SNRIs are coadministered with warfarin.
Alcohol: Although racemic citalopram did not potentiate the cognitive and motor effects of alcohol, the use of alcohol by patients taking Escitalopram is not recommended.
Lithium: May enhance the serotonergic effects of Escitalopram, caution should be exercised when Escitalopram and lithium are co-administered.
Sumatriptan: There have been rare reports of weakness, hyperreflexia and in-coordination following the use of a selective serotonin reuptake inhibitor (SSRI) and sumatriptan. If concomitant treatment of sumatriptan and an SSRI is clinically warranted, appropriate observation of the patient is advised.
Ketoconazole: Combined administration of racemic citalopram (40mg), and Ketoconazole (200mg) decreased the Cmax, and AUC of Ketoconazole by 21% and 10%, respectively, and did not significantly affect the pharmacokinetics of citalopram.
CYP3A4 and - 2C19 inhibitors: The metabolism of escitalopram is mainly mediated by CYP2C19 and CYP3A4 may also contribute to the metabolism although to a smaller extent. Co-administration of escitalopram with omeprazole 30 mg once daily (a CYP2C19 inhibitor) resulted in moderate (approximately 50%) increase in the plasma concentrations of escitalopram. Co-administration of escitalopram with cimetidine 400 mg twice daily (moderately potent general enzyme-inhibitor) resulted in a moderate (approximately 70%) increase in the plasma concentrations of escitalopram.
Thus, caution should be exercised when used concomitantly with CYP2C19 inhibitors (e.g. omeprazole, esomeprazole, fluvoxamine, lansoprazole, ticlopidine) or cimetidine. A reduction in the dose of escitalopram may be necessary based on monitoring of side-effects during concomitant treatment.
Drugs Metabolized by Cytochrome P4502D6: Escitalopram is an inhibitor of the enzyme CYP2D6. Caution is recommended when escitalopram is co-administered with medicinal products that are mainly metabolized by this enzyme, and that have a narrow therapeutic index, e.g. flecainide, propafenone and metoprolol (when used in cardiac failure), or some CNS acting medicinal products that are mainly metabolised by CYP2D6, e.g. antidepressants such as desipramine, clomipramine and nortriptyline or antipsychotics like risperidone, thioridazine and haloperidol. Dosage adjustment may be warranted. Co-administration with desipramine cases in a two fold increase in the plasma levels of desipramine.
Metoprolol: Administration of 20 mg/day Escitalopram for 21 days resulted in a 50% increase in Cmax and 82% increase in AUC of the beta-adrenergic blocker Metoprolol (given in a single dose of 100 mg). Increased Metoprolol plasma levels have been associated with decreased cardio-selectivity. Co-administration of Escitalopram and Metoprolol had no clinically significant effects on blood pressure or heart rate.
Drugs that Interfere with Hemostasis (NSAIDs, Aspirin, Warfarin, etc): NSAIDS and Aspirin may potentiate the risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs and SNRIs are coadministered with warfarin.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Pharmacodynamics: The mechanism of antidepressant action of Escitalopram, the S-enantiomer of racemic citalopram, is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT). Escitalopram is at least 100 fold more potent than the R-enantiomer with respect to inhibition of 5-HT reuptake and inhibition of 5-HT neuronal firing rate. Escitalopram has no or very low affinity for serotonergic (5-HT1-7) or other receptors including alpha-and beta-adrenergic, dopamine (D-1-5), histamine (H1-3), muscarinic (M-1-5) and benzodiazepine receptors. Escitalopram also does not bind to or 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: The single and multiple-dose pharmacokinetics of Escitalopram are linear and dose-proportional in a dose range of 10 to 30 mg/day.
Biotransformation of Escitalopram is mainly hepatic, with a mean terminal half-life of about 27-32 hours. With once daily dosing, steady state plasma concentrations are achieved within approximately one week. At steady state, the extent of accumulation of Escitalopram in plasma in young healthy subjects was 2.2-2.5 times the plasma concentrations observed after a single dose.
Absorption and Distribution: Following a single oral dose (20mg tablet) of Escitalopram, the mean Tmax was 5+1.5 hours. Absorption of Escitalopram is not affected by food. The absolute bioavailability of citalopram is about 80% relative to an intravenous dose, and the volume of distribution of citalopram is about 12L/kg. Data specific to Escitalopram are unavailable. The binding of Escitalopram to human plasma proteins is approximately 56%.
Metabolism and Elimination: Following oral administrations of Escitalopram, the fraction of drug recovered in the urine as Escitalopram and S-demethycitalopram (S-DCT) is about 8% and 10% respectively. The oral clearance of the Escitalopram is 600 mL/min, with approximately 7% of that due to renal clearance.
Escitalopram is metabolized to S-DCT and S-didemethylcitalopram (S-DDCT). In humans, unchanged Escitalopram is the predominant compound in plasma. At steady state, the concentration of Escitalopram metabolite S-DCT in plasma is approximately one-third that of Escitalopram. CYP3A4 and CYP2C19 are the primary isozymes involved in the demethylation of Escitalopram.
Population Subgroups: Age: Escitalopram AUC and half-life is increased by approximately 50% in elderly subjects, and Cmax is unchanged. 10mg is the recommended dose for elderly.
Gender: There are no differences in AUC, Cmax and half-life between the male and female subjects so no adjustment of dosage on the basis of gender is needed.
Reduced renal function: In patients with mild to moderate renal function impairment, oral clearance of citalopram was reduced by 17% compared to normal subjects. No adjustment of dosage for such patients is recommended. No information is available about the pharmacokinetics of Escitalopram in patients with severely reduced renal function (creatinine clearance <20mL/min).
Reduced Hepatic function: Citalopram oral clearance was reduced by 37% and half life was doubled in patients with reduced hepatic function compared to normal subjects. 10 mg is recommended dose of Escitalopram for most hepatically impaired patients.
Pharmacokinetics: The single and multiple-dose pharmacokinetics of Escitalopram are linear and dose-proportional in a dose range of 10 to 30 mg/day.
Biotransformation of Escitalopram is mainly hepatic, with a mean terminal half-life of about 27-32 hours. With once daily dosing, steady state plasma concentrations are achieved within approximately one week. At steady state, the extent of accumulation of Escitalopram in plasma in young healthy subjects was 2.2-2.5 times the plasma concentrations observed after a single dose.
Absorption and Distribution: Following a single oral dose (20mg tablet) of Escitalopram, the mean Tmax was 5+1.5 hours. Absorption of Escitalopram is not affected by food. The absolute bioavailability of citalopram is about 80% relative to an intravenous dose, and the volume of distribution of citalopram is about 12L/kg. Data specific to Escitalopram are unavailable. The binding of Escitalopram to human plasma proteins is approximately 56%.
Metabolism and Elimination: Following oral administrations of Escitalopram, the fraction of drug recovered in the urine as Escitalopram and S-demethycitalopram (S-DCT) is about 8% and 10% respectively. The oral clearance of the Escitalopram is 600 mL/min, with approximately 7% of that due to renal clearance.
Escitalopram is metabolized to S-DCT and S-didemethylcitalopram (S-DDCT). In humans, unchanged Escitalopram is the predominant compound in plasma. At steady state, the concentration of Escitalopram metabolite S-DCT in plasma is approximately one-third that of Escitalopram. CYP3A4 and CYP2C19 are the primary isozymes involved in the demethylation of Escitalopram.
Population Subgroups: Age: Escitalopram AUC and half-life is increased by approximately 50% in elderly subjects, and Cmax is unchanged. 10mg is the recommended dose for elderly.
Gender: There are no differences in AUC, Cmax and half-life between the male and female subjects so no adjustment of dosage on the basis of gender is needed.
Reduced renal function: In patients with mild to moderate renal function impairment, oral clearance of citalopram was reduced by 17% compared to normal subjects. No adjustment of dosage for such patients is recommended. No information is available about the pharmacokinetics of Escitalopram in patients with severely reduced renal function (creatinine clearance <20mL/min).
Reduced Hepatic function: Citalopram oral clearance was reduced by 37% and half life was doubled in patients with reduced hepatic function compared to normal subjects. 10 mg is recommended dose of Escitalopram for most hepatically impaired patients.
MedsGo Class
Antidepressants
Features
Brand
Feliz10
Full Details
Dosage Strength
10 mg
Drug Ingredients
- Esomeprazole
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Escitalopram Oxalate
Dosage Form
Film-Coated Tablet
Registration Number
DRP-3538
Drug Classification
Prescription Drug (RX)
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