Jovia

Escitalopram (Jovia) 10 mg tablet is a white, biconvex, oblong, one side scored film coated tablet.
Each film-coated tablet contains: Escitalopram (as oxalate) 10 mg.
Escitalopram (Jovia) 20 mg tablet is a white, biconvex, oblong, one side scored film coated tablet.
Each film-coated tablet contains: Escitalopram (as oxalate) 20 mg.

Pharmacology: Pharmacodynamics: Escitalopram, a selective serotonin-reuptake inhibitor (SSRI), is bicyclic pthalane-derivative antidepressant. Escitalopram is the S-enantiomer of citalopram, an SSRU that occurs as a 50:50 racemic mixture of the R- and S-enantiomers. Escitalopram is at least 100-fold more potent as an inhibitor of the reuptake of serotonin (5-hydroxy tryptamine or 5-HT) at the presynaptic membranes and the 5-HT neuronal firing rate than the R-enantiomer and is twice as potent as the racemic mixture.
Like other SSRIs, escitalopram's antidepressant effect is believed to involve potentiation of serotonin activity in the central nervous system (CNS) resulting from its inability effect on the reuptake of 5-HT from the synaptic cleft. Escitalopram appears to have little or no effect on reuptake of other neurotransmitters such as norepinephrine and dopamine. In vitro studies also have shown that escitalopram possesses little or no affinity for α- or β-adrenergic, dopamine D_1-5, histamine H_1-3, GABA-benzodiazepine, muscarinic M_1-5, or 5-HT_1-7 receptors or various ion channels (e.g., calcium, chloride, potassium, sodium channels).
Escitalopram has high affinity for the primary binding site and an allosteric modulating effect on the serotonin transporter. Allosteric modulating of the serotonin transporter enhances binding of escitalopram to the primary binding site, resulting in more complete serotonin reuptake inhibition.
Pharmacokinetics: Absorption is almost complete and independent of food intake. The mean time to maximum concentration (T_max) is about four hours after multiple dosing. As with racemic citalopram, the absolute bioavailability of escitalopram is expected to be about 80%. There is a linear pharmacokinetics. Steady-state plasma levels are achieved in about one week. Average steady-state concentrations of 50 nmol/L (range: 20 to 125 nmol/L) are achieved at a daily dose of 10 mg.
The apparent volume of distribution (V_d/f) of escitalopram is about 12 to 26 L/kg. The binding of escitalopram to plasma proteins is independent of drug plasma levels and averages 55%.
Escitalopram is metabolized in the liver to the demethylated and didemethylated metabolites. Both of these are pharmacologically active. Alternatively, the nitrogen may be oxidized to form the N-oxide metabolite. Both parent substance and metabolites are partly excreted as glucuronide. After multiple dosing, the mean concentrations of the dimethyl and didemethyl metabolites are usually 28 to 31% and <5%, respectively, of the escitalopram concentration. Biotransformation of escitalopram to the demethylated metabolite is primarily mediated by CYP2C19. Some contribution by the enzymes CYP3A4 and CYP2D6 is possible.
The elimination half-life (t_1/2) after multiple dosing is about 30 hours and the oral plasma clearance is about 0.6 L/min. The major metabolites have a significantly longer t_1/2. Escitalopram and major metabolites are assumed to be eliminated by both the hepatic and the renal routes, with the major part of the dose excreted as metabolites in the urine. Approximately 8% of escitalopram is eliminated unchanged in urine and 9.6% as the S-demethylcitalopram metabolite.
Special Population: Hepatic Impairment: In patients with mild to moderate hepatic impairment (Child-Pugh Criteria A and B), the t_¹/2 of escitalopram was about twice as long and the exposure was about 60% higher than in subjects with normal liver function.
Renal Impairment: While there are no specific data, the use of escitalopram in reduced renal function may be extrapolated from that of racemic citalopram. Escitalopram is expected to be eliminated more slowly in patients with mild to moderate reduction of renal function with no major impact on the escitalopram concentration in serum. At present no information is available for the treatment of patients with severely reduced renal function (creatinine clearance <20 mL/min).
Geriatric (65 years and older): Escitalopram appears to be eliminated more slowly in elderly patients compared to younger patients. Systemic exposure (AUC) is about 50% higher in elderly compared to young health volunteers.
Polymorphism: It has been observed that poor metabolizers with respect to CYP2C19 have twice as high a plasma concentration of escitalopram as extensive metabolizers. No significant change in exposure was observed in poor metabolizers with respect to CYP2D6.

For the treatment of the following: Major depressive disorder (MDD); Obsessive-compulsive disorder (OCD); Panic disorder with or without agoraphobia; Generalized anxiety disorder (GAD); Social anxiety disorder (social phobia).

Escitalopram should be administered as single oral daily dose, in the morning or evening, with or without food. (See Table.)

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Special Population: Geriatric: A longer t_¹/2 and decreased clearance have been shown in the elderly. Initial dosage is 5 mg once per day. Depending on individual response and tolerance, the dose may be increased to 10 mg per day.
Hepatic impairment: Dosages should be restricted to the lower end of the dose range in patients with mild to moderate hepatic insufficiency. Accordingly, an initial dose of 5 mg per day is recommended. Subsequently, the dose may be increased based on the patient's response and clinical judgment. A daily dose of 10 mg is the recommended maximum dose for most patients with hepatic impairment.
Renal impairment: Dosage adjustment is not necessary in patients with mild to moderate renal impairment. No information is available on the treatment of patients with severely reduced renal function.
Poor Metabolizers of CYP2C19: For patients who are known to be poor metabolizers with respect to CYP2C19, an initial dose of 5 mg per day during the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10 mg.
Discontinuation of treatment: Symptoms associated with discontinuation of escitalopram and other SSRIs and serotonin norepinephrine reuptake inhibitors (SNRIs) have been reported. Patients should be monitored for these symptoms when discontinuing treatment. A gradual dose reduction rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur after 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.
Switching a patient to or from a monoamine oxidase inhibitor (MAOI) intended to treat psychiatric disorders: At least 14 days should elapse between discontinuation of a MAOI intended to treat psychiatric disorders and initiation of therapy with escitalopram. Conversely, at least 14 days should be allowed after stopping escitalopram before starting a MAOI intended to treat psychiatric disorders.
Use of escitalopram with other MAOIs such as linezolid or methylene blue: Do not start escitalopram in a patient who is being treated with linezolid or intravenous (IV) methylene blue because there is an increased risk of serotonin syndrome. In a patient who required more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered.
In some cases, a patient already receiving escitalopram therapy may require urgent treatment with linezolid or IV methylene blue. If acceptable alternatives to linezolid or IV methylene blue treatment are not available and the potential benefits of linezolid or IV methylene blue treatment are judged to outweigh the risks of serotonin syndrome in particular patient, escitalopram should be stopped promptly, and linezolid or IV methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for two weeks or until 24 hours after the last dose of linezolid or IV methylene blue, whichever comes first, Therapy escitalopram may be resumed 24 hours after the last dose of linezolid or IV methylene blue.
The risk of administering methylene blue by non-IV routes (such as oral tablets or by local injection) or in IV doses much lower than 1 mg/kg with escitalopram is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use.
Or, as prescribed by a physician.

Clinical data on escitalopram overdose are limited and many cases involve concomitant overdoses of other drugs. In the majority of cases, mild or no symptoms have been reported. Doses between 400 and 800 mg escitalopram alone have been taken without any severe symptoms. No fatalities or sequelae were reported in the few cases with a higher dose (one patient survived ingestion of either 2,400 or 4,800 mg).
Symptoms seen in reported overdose of escitalopram include symptoms mainly related to the CNS (ranging from dizziness, tremor, and agitation; to rare cases of serotonin syndrome, convulsion, and coma), the GI system (nausea/vomiting), the cardiovascular system (hypotension, tachycardia, arrhythmia and ECG changes (including QT prolongation), and electrolyte/fluid balance conditions (hypokalemia, hyponatremia).
There is no specific antidote. Establish and maintain an airway, ensure adequate oxygenation and respiratory function. The use of activated charcoal should be considered. Activated charcoal may reduce absorption of the drug if given within one or two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected. Cardiac and vital signs monitoring are recommended along with general symptomatic supportive measures. ECG monitoring is advised in case of overdose in patients with congestive heart failure/bradyarrhythmias, in patients using concomitant drugs that prolong the QT interval, or in patient with altered metabolism (e.g., impairment).
Due to the large volume of distribution of escitalopram, forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit. In managing overdosage, the possibility of multiple drug involvement must be considered.

Known hypersensitivity to escitalopram or citalopram or to any ingredient in the formulation; MAOIs: Cases of serious reactions have been reported in patients receiving SSRIs in combination with MAOI or the reversible MAOI (moclobemide) and in patient who have recently discontinued an SSRI and have been started on a MAOI. With the co-administration of an SSRI with MAOI, there have been reports of serious, sometimes fatal reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible fluctuations of vital signs, and mental status changes, including extreme agitation progressing to delirium and coma. Some cases presented with features resembling serotonin syndrome.
Therefore, escitalopram should not be used in combination with a MAOI or within 14 days of discontinuing treatment with a MAOI, (including linezolid, an antibiotic which is a reversible non-selective MAOI, and methylene blue, which is a MAOI). Similarly, at least 14 days should be elapse after discontinuing escitalopram treatment before starting a MAOI.
In patients with known QT interval prolongation or congenital long QT syndrome; Concomitant use with drugs that are known to prolong the QT interval (e.g., pimozide).

Suicidality and Antidepressant Drugs: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of 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 24 years old; there was a reduction in risk with antidepressants compared to placebo in adults over 65 years 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 old.
Clinical Worsening and Suicide Risk: The risk of suicide attempt is inherent in depression and may persist until significant remission occurs. This risk much be considered in all depressed patients.
Patients with MDD, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant drugs, and this risk may persist until significant remission occurs.
All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, particularly during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. Close supervision of patients and in particular those at high risk should accompany drug therapy particularly in early treatment and following dose changes.
There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the drug, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Generally, when stopping an antidepressant, doses should be tapered rather than stopped abruptly.
Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increased the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with MDD and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond 24 years old; there was a reduction with antidepressants compared to placebo in adults 65 years and older.
The following symptoms have been reported in adult and pediatric patients being treated with antidepressants for MDD as well as for other indications, both psychiatric and non-psychiatric: anxiety, agitation, panic attacks, insomnia, irritability, hostility (aggressiveness), impulsivity, akathisia (psychomotor restlessness, hypomania, and mania. Although a causal link between the emergence of such symptoms and either worsening of depression and/or emergence of suicidal impulses has not been established, consideration should be given to changing the therapeutic regimen, including possibly discontinuing the drug, in patients for whom such symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.
Other psychiatric condition for which escitalopram is prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with MDD. The same precautions observed when treating patients with MDD should therefore be observed when treating with other psychiatric disorders.
Families and caregivers of patients being treated with antidepressants for MDD or other indications, both psychiatric and non-psychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior and other symptoms described previously, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers. It is particularly important that monitoring be undertaken during the initial few months of antidepressant treatment or at times of dose increase or decrease.
Prescriptions of escitalopram should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.
Paradoxical anxiety: Some patients with panic disorder may experience increased anxiety symptoms at the beginning of treatment with antidepressants. This paradoxical reaction usually subsides within two weeks during continued treatment. A low starting dose is advised to reduce the likelihood of an anxiogenic effect.
Screening Patients for Bipolar Disorder: A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described previously represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk of bipolar disorder; such screening should include a detailed psychiatric history, including family history of suicide, bipolar disorder, and depression. It should be noted that escitalopram is not approved for use in treating bipolar depression.
Abuse and Dependence: 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. Likewise, physicians should carefully evaluate escitalopram patients for history of drug abuse and follow such patients closely, observing them for sign of misuse or abuse (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).
Activation of Mania/Hypomania and Bipolar Disorder: As with other antidepressants, escitalopram should be used with caution in patients with a history of mania/hypomania.
A major depressive episode may be initial presentation of bipolar disorder. Patients with bipolar disorder may be at an increased risk of experiencing manic episodes when treated with antidepressants alone. Therefore, the decision to initiate symptomatic treatment of depression should only be made after patients have been adequately assessed to determine if they are at risk for bipolar disorder.
Electroconvulsive Therapy (ECT): The safety and efficacy of the concurrent use of either escitalopram or racemic citalopram and ECT have not been studies, and therefore, caution is advisable.
Akathisia/Psychomotor Restlessness: The use of SSRIs/SNRIs has been associated with the development of akathisia, characterized by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still. This is most likely to occur within the first weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental.
Seizures: Like other antidepressants, escitalopram should be used with caution in patients with a history of seizure disorder. Escitalopram should be discontinued if a patient develops seizures for the first time, or if there is an increase in seizure frequency (in patients with a previous diagnosis of epilepsy). SSRIs should be avoided in patients with uncontrolled epilepsy, and patients with controlled epilepsy should be closely monitored.
Serotonin Syndrome Neuroleptic Malignant Syndrome (NMS)-Like Events: On rare occasions, serotonin syndrome or NMS-like events have occurred in association with treatment with SSRIs, including escitalopram, particularly when given in combination with other serotonergic and/or neuroleptic drugs. As these syndromes may result in potentially life-threatening conditions, treatment with escitalopram should be discontinued if such events (characterized by clusters of symptoms such as hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes including confusion, irritability, extreme agitation progressing to delirium and coma) occur and supportive symptomatic treatment should be initiated. Escitalopram should not be used in combination with MAOI or serotonin-precursors (such as L-tryptophan, oxitriptan) and should be used with caution in combination with other serotonergic drugs (triptans, certain tricyclic antidepressants, lithium, tramadol, St. John's wort) due to the risk of serotonergic syndrome.
Reversible Cerebral Vasoconstriction Syndrome: Reversible cerebral vasoconstriction syndrome (thunderclap headache) has been associated with serotonergic agents such as SSRIs or triptans.
Abnormal bleeding: SSRIs and SNRIs, including escitalopram, may increase the risk of bleeding events by causing abnormal platelet aggregation. Concomitant use of acetylsalicylic acid (ASA), nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, and other anticoagulants may add to the risk. Studies have shown an association between use of drugs that interfere with serotonin reuptake and the occurrence gastrointestinal (GI) bleeding. Bleeding events related to SSRIs and SNRIs use have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages.
Patients should be cautioned about the risk of bleeding associated with the concomitant use of escitalopram and NSAIDs, ASA, or other drugs that affect coagulation. Caution is advised in patients with a history of bleeding disorder or predisposing conditions (e.g., thrombocytopenia).
Angle-Closure Glaucoma: SSRIs including escitalopram may have an effect on pupil size resulting in mydriasis. This mydriatic effect has the potential to narrow the eye angle resulting in increased intraocular pressure ang angle-closure glaucoma, particularly in predisposed patients. Therefore, escitalopram should be used with caution in patients with angle-closure glaucoma or history of glaucoma.
Bone Fracture Risk: Epidemiological studies shown an increased risk of bone fractures following exposure to some antidepressants, including SSRIs/SNRIs. The risk appears to be greater at the initial stages of treatment, but significant increased risks were also observed at later stages of treatment. The possibility of fracture should be considered in the care of patients treated with escitalopram. Elderly patients and patients with important risk factors for bone fractures should be advised of possible adverse events which increase the risk of falls such as dizziness and orthostatic hypotension, particularly at the early stages of treatment but also soon after withdrawal. Preliminary data from observational studies show association of SSRIs/SNRIs and low bone mineral density in older men and women. Until further information becomes available, a possible effect on bone mineral density with long term treatment with SSRIs/SNRIs, including escitalopram, cannot be excluded, and may be a potential concern for patients with osteoporosis or major risk factors for bone fractures.
Hyponatremia: As with other antidepressants, cases of hyponatremia and syndrome of inappropriate antidiuretic hormone secretion (SIADH) have been reported with escitalopram and racemic citalopram as a rare adverse event. The majority of these occurrences have been in elderly individuals, some in patients taking diuretics or who were otherwise volume-depleted. Elderly female patients in particular seem to be a group at risk. Caution should be exercised in patients at risk, such as the elderly, or patients with cirrhosis, or if used in combination with other medications which may cause hyponatremia.
Use in Patients with Concomitant Illness: Patients with cardiac disease: In line with other SSRIs, including racemic citalopram, escitalopram causes statistically significant, but clinically unimportant decrease in heart rate. In patients <60 years old, the mean decrease with escitalopram oxalate was approximately 2.3 bpm, while in patients ≥60 years old, the mean decrease was approximately 0.6 bpm. Consequently, caution should be observed when escitalopram is initiated in patients with pre-existing slow heart rate.
QT interval prolongation and torsade de pointes: Escitalopram has been found to cause a dose- dependent prolongation of the QT interval. In addition, there have been cases of QTc interval prolongation and torsade de pointes reported during the post-marketing period, predominantly in patients with risk factors for QTc prolongation.
Escitalopram should be used with caution in patients with risk for QTc prolongation/torsade de pointes. Risk factors include congenital long QT syndrome, >65 years old, female sex, structural heart disease/left ventricular dysfunction, hypokalemia, and severe hypomagnesemia, high plasma levels of escitalopram (e.g., high doses, medical conditions such as hepatic or renal disease, or use of medicines that inhibit the metabolism of escitalopram), and concomitant use of other QTc prolonging drugs.
In high risk patients (i.e., congenital long QT syndrome, pre-existing QT prolongation or multiple risk factors), an electrocardiogram (ECG) should be done prior starting treatment, at steady state, after dose increases or after starting any potentially interacting drugs. Electrolytes should be monitored periodically and any abnormalities should be corrected prior to starting escitalopram. An ECG should also be done in all patients experiencing symptoms that could indicative of an arrhythmia (e.g., dizziness, palpitations, syncope, or new onset seizure).
Consideration should be given to stopping escitalopram treatment or reducing the dose if the QTc interval is >500 ms or increases by >60 ms.
Diabetic patients: Treatment with an SSRI in patients with diabetes may alter glycemic control (hypoglycemia and hyperglycemia). Escitalopram should be used with caution in diabetic patients on insulin or oral hypoglycemic drugs.
Discontinuation of Treatment: Discontinuation symptoms when stopping treatment are common, particularly if discontinuation is abrupt.
The risk of discontinuation symptoms may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction. Dizziness, sensory disturbances (including paresthesia and electronic shock sensations), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, and visual disturbances are the most commonly reported reactions. Generally, these symptoms are mild to moderate; however, in some patients they may be severe in intensity.
They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose.
Generally, these symptoms are self-limiting and usually resolve within two weeks, though in some individuals they may be prolonged (2 to 3 months or more). Therefore, it is advised that escitalopram should be gradually tapered when discontinuing treatment over a period of several weeks or months, according to the patient's need.
Effects On Ability To Drive And Use Machine: Although escitalopram has been shown not to affect intellectual function or psychomotor performance, any psychoactive drug may impair judgment of skills. Patients should be cautioned about the potential risk of an influence on their ability to drive a car and operate machinery.
Hepatic Impairment: Based on a study conducted with escitalopram in patients with mild to moderate hepatic impairment, the t_¹/2 was approximately doubled and the exposure was increased by approximately two thirds, compared to subjects with normal liver function. Therefore, the use of escitalopram in hepatically impaired patients should be approached with caution and a lower dosage is recommended. Escitalopram should be used with additional caution in patients with severe hepatic impairment.
Renal Impairment: No information is available on the pharmacokinetic or pharmacodynamic effects of escitalopram in patients with renal impairment, particularly in patients with severely reduced function. Since no information is available on the pharmacokinetic or pharmacodynamic effects of either escitalopram in patients with severely reduced function (creatinine clearance <30 mL/min), escitalopram should be used with caution in these patients.
Use in Children: The safety and effectiveness of escitalopram have been established in adolescents (12 to 17 years old) for the treatment of MDD. Although maintenance efficacy in adolescent patients with MDD has not been systematically evaluated, maintenance efficacy can be extrapolated from adult data along with comparisons of escitalopram pharmacokinetic parameters in adults and adolescent patients.
The safety and effectiveness of escitalopram have not been established in pediatric (younger than 12 years old) patients with MDD.
Safety and effectiveness of escitalopram has not been established in pediatric patients less than 18 years old with GAD.
Decreased appetite and weight loss have been observed in association with the use of SSRIs. Likewise, regular monitoring of weight and growth should be done in children and adolescents treated with an SSRI such as escitalopram.
Use in Elderly: SSRIs and SNRIs, including escitalopram, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event.

Pregnancy Category C: 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.
Pregnancy-Nonteratogenic Effects: Neonates exposed to escitalopram and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome.
Infants exposed to SSRIs in pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1 to 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. Several recent epidemiologic studies suggest a positive statistical association between SSRI use (including escitalopram) in pregnancy and PPHN. Other studies do not show a significant statistical association.
Women who discontinued antidepressant drug during pregnancy shower a significant increase in relapse of their major depression compared to those women who remained on antidepressant drug without pregnancy.
When treating a pregnancy woman with escitalopram, the physician should carefully consider both the potential risks of taking an SSRI, along with the established benefits of treating depression with an antidepressant. This decision can only be made on a case by case basis.
Labor and Delivery: The effect of escitalopram on labor and delivery in humans is unknown.
Lactation: Escitalopram is excreted in human breast milk. Limited data from women taking 10 to 20 mg showed that exclusively breast-fed infants receive approximately 3.9% of the maternal weight-adjusted dose of escitalopram and 1.7% of the maternal weigh-adjusted dose of desmethylcitalopram. Caution should be exercised and breastfeeding infants should be observed for adverse reactions when escitalopram is administered to a breastfeeding woman.
Fertility: Human case reports with some SSRIs have shown that an effect on sperm quality is reversible. Impact on human fertility has not been observed so far.

Infections and Infestations: Abscess, appendicitis, bronchitis acute, atrophic vaginitis, bronchitis viral, carbuncle. cellulitis, cystitis, dental caries, ear infection, erysipelas, folliculitis, fungal infection, furuncle, GI infection, gastroenteritis, genital infection, genitourinary chlamydia infection, gingival infection, hepatitis, hepatitis fulminant, herpes simplex, herpes zoster, impetigo, infection (bacterial, fungal, parasitic, viral), infection tuberculosis, influenza, laryngitis. lung infection, mastitis moniliasis, moniliasis genital, nasopharyngitis, onychomycosis, otitis externa, otitis media, pelvic inflammatory disease, peritonsillar abscess, pharyngitis, pharyngitis streptococcal, pneumonia, pyelonephritis acute, respiratory tract infection, salmonellosis, sinusitis, skin infection, staphylococcal infection, streptococcal infection, tracheitis, tooth abscess, tonsilitis, tooth infection, urinary tract infection, vaginal candidiasis, vaginal infection, vaginitis, varicella, viral infection, viral upper respiratory tract infection, vulvovaginal mycotic infection, wound infection.
Neoplasms benign, malignant and unspecifies (including cysts and polyps): Breast neoplasm, benign breast neoplasm, cyst, cyst ovarian, lipoma, marrow hyperplasia, skin papilloma, uterine fibroid, uterine leiomyoma.
Blood and Lymphatic System Disorders: Agranulocytosis, anemia (aplastic, hemolytic, hypochromic); bleeding abnormal predominantly of the skin and mucous membranes, including purpura, epistaxis, hematoma, vaginal bleeding, and GI bleeding; hematoma, idiopathic thrombocytopenia purpura, leukocytosis, leukopenia, lymphadenopathy, lymphadenitis, thrombocytopenia.
Immune System Disorders: Allergic edema, allergic reactions, allergy seasonal, allergy aggravated, anaphylactic reaction, angioedema, house dust allergy, epidermal necrolysis, hypersensitivity, Stevens-Johnson syndrome.
Endocrine Disorders: Goiter, hyperprolactinemia, hyperthyroidism, SIADH, thyroiditis.
Metabolism and Nutrition Disorder: Anorexia, appetite decreased/increased, carbohydrate craving, dehydration, diabetes mellitus, fluid retention, food craving, glucose tolerance abnormal, gout, hypercholesterolemia, hyperglycemia, hyperlipemia, hypermagnesemia, hyperphagia, hypoglycemia, hyponatremia, latent tetany, thirst, xerophthalmia.
Nervous System Disorders: Amnesia, akathisia, ataxia, balance disorder, burning sensation, carpal tunnel syndrome, cerebrovascular accident, choreoathetosis, clonic convulsion, coma, coordination, dizziness, dizziness postural, disturbance in attention, dysarthria, disequilibrium, dysesthesia, dysgeusia, dysphasia, dystonia, extrapyramidal disorder, facial palsy, facial paresis, facial spasm, grand mal convulsion, head discomfort, headache, hyperkinesia, hyperreflexia, hypersomnia, hypertonia, hypoesthesia, hypogeusia, lethargy, light headedness, loss of consciousness, memory impairment, migraine, muscle contractions involuntary, movement disorder, myoclonus, nerve root lesion, neuroleptic malignant syndrome, neuralgia, neuralgia ischial, neuropathy, nystagmus, paralysis, paresthesia, Parkinsonism, petit mal epilepsy, psychomotor hyperactivity, restless legs syndrome, sciatica, sedation, sensory disturbance, sleep talking, somnolence, speech disorder, tardive dyskinesia, taste disturbance, tension headache, tetany, tics, tremor, twitching, vasovagal attack.
Eye Disorders: Accommodation disorder, amblyopia, asthenopia, blepharospasm, conjunctivitis, chromatopsia, diplopia, dry eyes, eye hemorrhage, eye irritation, eye pain, eye pruritus, eye swelling, eyelid edema, iritis, keratoconus, mydriasis, myopia, night blindness, ocular hemorrhage, photopsia, retinal detachment, scotoma, vision abnormal, vision blurred, visual disturbance, vitreous detachment.
Ear and Labyrinth Disorders: Cerumen impaction, deafness, ear disorder, ear pain, earache, Meniere's disease, motion sickness, otosalpingitis, tinnitus, tympanic membrane perforation, vertigo.
Cardiac Disorders: Angina pectoris, atrial fibrillation, atrial ventricular block first degree, bradycardia, cardiac arrest, cardiac failure, chest pain, chest tightness, extrasystoles, myocardial infarction, myocardial ischemia, myocarditis, nodal rhythm, palpitations, sinus bradycardia, syncope, syncope vasovagal, tachycardia, torsade de pointes, ventricular arrhythmia, ventricular tachycardia.
Vascular Disorders: Cerebrovascular disorder, circulatory collapse, flushing, hematoma, hot flush, hypertension, hypotension, orthostatic hypotension, pallor, peripheral ischemia, varicose vein, vein disorder, vein distended.
Respiratory, Thoracic and Mediastinal Disorders: Asthma, choking, dysphonia, dyspnea, epistaxis, hyperventilation, nasal congestion, nasal polyps, pharyngolaryngeal pain, postnasal drip, pulmonary embolism, pulmonary hypertension of the newborn, respiratory tract infection upper, rhinitis allergic, rhinitis perennial, rhinorrhea, shortness of breath, sleep apnea, sinus congestion, sinus headache, throat irritation, throat tightness, tracheal disorder, tracheitis, wheezing, yawning.
Gastrointestinal Disorders: Abdominal cramp, abdominal discomfort, abdominal distension, abdominal pain upper, anal fissure, belching, bloating, bowel movements frequent, colitis, colitis ulcerative, colonic polyp, constipation, Crohn's disease, diarrhea, dry mouth, dysphagia, dyspepsia, enteritis, epigastric discomfort, eructation, flatulence, food poisoning, gastritis, gastroesophageal reflux disease, GI pain gastritis, GI hemorrhage, gingival bleeding, gingival pain, heartburn, hematemesis, hematochezia, hemorrhoids, ileitis, indigestion, irritable bowel syndrome, lip dry, melena, nausea, oral pain, pancreatitis, periodontal destruction, pruritus ani, rectal hemorrhage, reflux gastritis, stomach discomfort, stomatitis, stool frequency increased, taste perversion, taste alteration, tongue black hairy, tongue disorder, toothache, tooth disorder, tooth erosion, ulcerative stomatitis, vomiting.
Hepatobiliary Disorders: Hepatic failure, hepatic necrosis.
Skin and Subcutaneous Tissue Disorders: Acne, alopecia, cold sweat, dermal cyst, dermatitis, (acneiform, allergic, atopic, contact, fungal, hand, lichenoid), dry skin, ecchymosis, eczema, furunculosis, hyperhidrosis, increased, tendency to bruise, ingrown nail, night sweats, photosensitivity reaction, pruritus, rash (erythematous, maculopapular, pustular), psoriasis aggravated, skin disorder, skin irritation, skin nodule, skin odor abnormal, skin warm, urticaria, verruca.
Musculoskeletal and Connective Tissue Disorders: Arthralgia, arthritis, arthropathy, arthrosis, bursitis, costochondritis, exostosis, fasciitis plantar, fibromyalgia, finger deformity, ganglion, intervertebral disc protrusion, jaw stiffness, joint stiffness, leg cramps, muscle contracture, muscle cramps, muscle spasms, muscle tightness, muscle twitching, muscle weakness, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, musculoskeletal stiffness, myalgia, myopathy, neck pain, osteoarthritis, osteoporosis, plantar fasciitis, rhabdomyolysis, rheumatoid arthritis, sensation of heaviness, tendon disorder, tendinitis, tenosynovitis, trismus.
Renal and Urinary Disorders: Bladder dilatation, bladder discomfort, chromaturia, cystitis, dysuria, hematuria, micturition disorder, micturition frequency, micturition urgency, nocturia, pollakiuria, polyuria, renal calculus, renal failure acute, renal pain, urinary frequency, urinary hesitation, urinary incontinence, urinary retention.
Pregnancy, Puerperium and Perinatal Conditions: Pregnancy, pregnancy unintended, spontaneous abortion.
Reproductive System and Breast Disorders: Amenorrhea, anorgasmia, breast discharge, breast pain, breast tenderness, dysmenorrhea, ejaculation delayed, epididymitis, erectile disorder, erectile dysfunction, ejaculation failure, galactorrhea, genital pain, intermenstrual bleeding, libido decreased/increased, loss of libido, menopausal symptoms, menstrual cramps, menstrual disorder, menorrhagia, menometrorrhagia, menstruation irregular, metrorrhagia, orchitis noninfective, orgasm abnormal, painful erection, pelvic pain, premenstrual syndrome, premenstrual tension, priapism, postmenopausal hemorrhage, prostatic disorder, sexual dysfunction, sexual function abnormality, testicular pain, uterine spasm, vaginal discharge, vaginal hemorrhage.
Congenital, Familial and Genetic Disorders: Epidermal naevus, Gilbert's syndrome.
General Disorder and Administration Site Conditions: Asthenia, back pain, chest wall pain, chest discomfort, chest pain, chills, death, edema, edema extremities, edema face, edema peripheral pain, fatigue, feeling abnormal, feeling hot, feeling jittery, gait abnormal, hernia, hunger, irritability, leg pain, limb pain, local swelling, malaise, neck pain, pain in extremity, pain in jaw, performance status decreased, pyrexia, respiratory sighs, rigors, satiety early, sensation of blood flow, shoulder pain, sluggishness, thirst.
Investigations: Alanine aminotransferase increased, aspartate aminotransferase increased, arthroscopy, blood alkaline phosphatase increased, blood bilirubin increased/decreased, blood cholesterol increased, blood glucose increased, blood pressure increased, blood uric acid increased, blood urine present, drug level increased, body temperature increased, ECG PR shortened, ECG QT prolonged, heart rate increased, hemoglobin decreased, hepatic enzyme increased, INR increased, liver function tests abnormal, neurotransmitter level altered, platelet count decreased, pregnancy test positive, prothrombin decreased, weight increased/decreased.
Injury, Poisoning and Procedural Complications: Ankle fracture, arthropod bite, arthropod sting, bite, bite animal, burn, concussion, contusion, electrical shock, excoriation fall, facial bones fracture, food poisoning, foot fracture, fractured neck of femur, injury (accidental, back, eye, joint, inflicted, ligament, limb, lumbar disc lesion, mouth, neck, sports, tooth, whiplash), intentional overdose, joint dislocation, joint sprain, muscle rupture, post-traumatic pain, procedural pain, radius fracture, rib fracture, road traffic accident, skin laceration, sting poisoning, sunburn, thermal burn, ulna fracture.
Surgical and Medical Procedures: Colon polypectomy, gingival operation, scar excision, surgical intervention, tooth extraction.
Social Circumstances: Alcohol problem, drug abuse, family stress, stress at work.

Contraindicated combinations: Irreversible non-selective MAOIs: Cases of serious reactions have been reported in patients receiving an SSRI in combination with non-selective, irreversible MAOI, and in patients who have recently discontinued SSRI treatment and have been started on so much MAOI treatment. In some cases, the patient developed serotonin syndrome.
Escitalopram is contraindicated in combination with non-selective, irreversible MAOIs. Escitalopram may be started 14 days after discontinuing treatment with an irreversible MAOI. At least seven days should elapse after discontinuing escitalopram treatment, before starting a non-selective, irreversible MAOI.
Reversible, selective MAO-A inhibitor (moclobemide): Due to the risk of serotonin syndrome, the combination of escitalopram with a MAO-A inhibitor such as moclobemide is contraindicated. If the combination proves necessary, it should be started at the minimum recommended dosage and clinical monitoring should be reinforced.
Reversible, non-selective MAO-B inhibitor (linezolid): The antibiotic linezolid is a reversible non-selective MAO-inhibitor and should not be given to patients treated with escitalopram because of an increased risk of serotonin syndrome. If the combination proves necessary, it should be given with minimum dosages and under close clinical monitoring.
Irreversible, selective MAO-B inhibitor (selegiline): In combination with selegiline (irreversible MAO-B inhibitor), caution is required due to the risk of developing serotonin syndrome. Selegiline doses up to 10 mg per day have been safely co-administered with racemic citalopram.
QT interval prolongation: Pharmacokinetic and pharmacodynamic studies of escitalopram combined with other drugs that prolong the QT interval have not been done. An additive effect of escitalopram and these drugs cannot be excluded. Therefore, concomitant use of escitalopram with drugs that prolong the QT interval, such as Class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment particularly halofantrine), certain antihistamines (e.g., astemizole, mizolastine), is contraindicated.
Combinations requiring precautions for use: Alcohol: No pharmacodynamic or pharmacokinetic interactions are expected between escitalopram and alcohol. However, as with other psychotropic drugs, the combination with alcohol is not recommended.
Lithium and tryptophan: Enhanced effects when SSRIs have been given together with lithium and tryptophan; therefore, concomitant use of SSRIs with these drugs should be undertaken with caution.
St. John's wort: Concomitant use of SSRIs and herbal remedies containing St. John's wort (Hypericum perforatum) may result in an increased incidence of adverse reactions.
Serotonergic drugs (e.g., tramadol, sumatriptan and other triptans): Concomitant use of serotonergic drugs (e.g., tramadol, sumatriptan and other triptans) may lead to serotonin syndrome.
If concomitant treatment of escitalopram with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
Drugs that interfere with hemostasis (NSAIDS, aspirin, warfarin): Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort studies that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper GI bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate the risk of bleeding.
Altered anticoagulant effect may occur when escitalopram is combined with oral anticoagulants (e.g., warfarin). Patients receiving oral anticoagulant therapy should receive careful coagulation monitoring when escitalopram is started or stopped.
Drugs lowering the seizure threshold (e.g., antidepressants, neuroleptic, mefloquine, bupropion, and tramadol): SSRI can lower the seizure threshold. Caution is advised when concomitantly using other drugs capable of lowering the seizure threshold such as antidepressants (e.g., tricyclics and SSRIs), neuroleptics (e.g., phenothiazines, thioxanthenes and butyrophenones), mefloquine, bupropion, and tramadol.
Drugs affecting the CNS: Given the primary CNS effects of escitalopram, caution should be used when it is taken in combination with other centrally acting drugs.
Drugs inducing hypokalemia/hypomagnesemia: Cautions is warranted for concomitant use of hypokalemia/hypomagnesemia inducing drugs as these conditions increase the risk of malignant arrhythmias.
CYP2C19 inhibitors (e.g., omeprazole, esomeprazole, fluvoxamine, lansoprazole, ticlopidine) or cimetidine: Caution should be exercised when used concomitantly with these drugs. A reduction in the dose of escitalopram may be necessary based on monitoring of side effects during concomitant treatment.
In vitro studies have shown that escitalopram may also cause weak inhibition of CYP2C19. Caution is recommended with concomitant use of drugs that are metabolized by CYP2C19.
Concomitant use with omeprazole resulted in moderate (approximately 50%) increased in the plasma concentrations of escitalopram.
Concomitant use with cimetidine resulted in a moderate (approximately 70%) increase in the plasma concentration of escitalopram. Caution is advised when administering escitalopram in combination with cimetidine. Dose adjustment may be warranted.
Drugs metabolized by CYP2D6: Escitalopram is an inhibitor of the enzyme CYP2D6. Caution is recommended when escitalopram is concomitantly used with drugs that are mainly metabolized by this enzyme, and that have a narrow therapeutic index, such as flecainide, propafenone, metoprolol (when used in cardiac failure), or some CNS acting drugs that are mainly metabolized by CYP2D6, such as antidepressants (e.g., desipramine, clomipramine, and nortriptyline) or antipsychotics (e.g., risperidone, thioridazine, and haloperidol). Dosage adjustment may be warranted.
Desipramine or metoprolol: Concomitant use with desipramine or metoprolol resulted in both cases in a twofold increase in the plasma levels of these two CYP2D6 substrates.

Store at temperatures not exceeding 30°C.

Antidepressants

N06AB10 - escitalopram ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.

Rx