Each tablet contains 10 mg escitalopram (12.77 mg escitalopram oxalate).
Excipients/Inactive Ingredients: Tablet core: Microcrystalline cellulose, colloidal anhydrous silica, talc, croscarmellose sodium, magnesium stearate.
Coating: Hypromellose, macrogol 400, titanium dioxide (E171).
Pharmacotherapeutic group: Antidepressants, selective serotonin reuptake inhibitors. ATC Code: N06AB10.
Pharmacology: Pharmacodynamics: Mechanism of action: Escitalopram is a selective inhibitor of serotonin (S-HT) re-uptake with high arfinity for the primary binding site. It also binds to an allosteric site on the serotonin transporter, with a 1000 fold lower affinity. Allosteric modulation of the serotonin transporter enhances binding of escitalopram to the primary binding site, resulting in more complete serotonin reuptake inhibition.
Escitatopram has no or low affinity for a number of receptors including 5-HT1A, 5-HT2, DA D1 and D2 receptors, α1, α2-, β-adrenoceptors, histamine H1, muscarine cholinergic, benzodiazepine, and opioid receptors.
The inhibition of 5-HT re-uptake is the only likely mechanism of action explaining the pharmacological and clinical effects of escitalopram.
Escitalopram is the S-enantiomerof the racemate (citalopram) and is the enantiomer to which the therapeutic activity ls attributed. Pharmacological studies have shown that the R-enantiomer is not inert but counteracts the serotonin-enhancing and consequent pharrnacological properties of the S-enantiomer.
Clinical Efficacy: Major Depressive Episodes: Escitalopram has been found to be effective in the acute treatment of major depressive episodes in three out of four double-blind, placebo controlled short-term (8-weeks) studies.
The antidepressant effect was evident as early as after two weeks for both 10 and 20 mg doses of escitalopram. After 8 weeks of therapy, escitalopram 20 mg was superior to citalopram 40 mg.
A dose-response relationship for escitalopram was clearly seen in the severely depressed patients indicating that they are likely to benefit from a higher dose of escitalopram (20 mg) than the usual starting dose (10 mg).
In a long term (24-week) double-blind study of escitalopram 10 mg vs citalopram 20 mg, escitalopram was as least as effective as citalopram, and half as many escitalopram patients withdrew because of adverse effects. In a long-term relapse prevention study, 274 patients who had responded during an initial 8-week open label treatment phase with escitalopram 10 or 20 mg/day, were randomised to continuation with escitalopram at the same dose, or to placebo, for up to 36 weeks. In this study, patients receiving continued escitalopram experienced a significantly longer time to relapse over the subsequent 36 weeks compared to those receiving placebo.
Generalised anxiety disorder: Escitalopram in doses of 10 and 20 mg/day was effective in four out of four placebo-controlled studies. 5 mg/day was not effective.
In pooled data from three studies with similar 8-week design and comprising 421 escitalopram-treated patients and 419 placebo-treated patients, there were 47.5% vs 28.9% responders and 37.1% vs 20.8% remitters (P≤0.001). Sustained effect was seen from week 1. In the fourth study (12 weeks), which included paroxetine, escitalopram 10 mg/day was significantly superior to paroxetine 20 mg/day. Transient discontinuation symptoms were seen. with significantly higher levels for paroxetine than for escitalopram 5, 10 and 20 mg/day (P≤0.01).
Escitalopram 20 mg/day significantly reduced the riskof relapse in a 24- to 76-week randomised, continuation study in 373 patients who had responded during initial 12-week open label treatment.
Pharmacokinetics: Absorption: Absorption is almost complete and independent of food intake. Mean time to maximum concentration (mean Tmax) is 4 hours after multiple dosing. As with racemic citalopram, the absolute bio-availability of escitalopram is expected to be about 80%.
Distribution: The apparent volume of distribution (Vdβ/F) after oral administartion is about 12 to 26 L/kg. The plasma protein binding is below 80% for escitalopram and its main metabolites.
Biotransformation: Escitalopram is metabolised in the liver to the demethylated and didemethylated metabolites. Both of theses are pharmacologically active. Alternatively, the nitrogen may be oxidised to form the N-oxide metabolite. Both parent substance and metabolites are partly excreted as glucuronides. After multiple dosing the mean concentrations of the demethyl and didemethyl metabolites are usually 28-31% and <5%, respectively, of the escitalopram concentration. Biotransformation of escitalopram to the demethylated metabolite is mediated primarily by CYPC19. Some contribution by the enzymes CYP3A4 and CYP2D6 is possible.
Elimination: The elimination half-life (t1/2β) after multiple dosing is about 30 hours and the oral plasma clearance (Cloral) is about 0.6 L/min. the major metabolites are assumed to be eliminated by both hepatic (metabolic) and the renal routes, with the major part of the dose excreted as metabolites in the urine.
There is linear pharmacokinetics. Steady-state plasma levels are achieved in about 1 week.
Average steady-state concentrations of 50 nmol/L (range 20-125 nmol/L) are achieved at daily dose of 10 mg.
Elderly patients (>65 years): Escitalopram appears to be eliminated more slowly in elderly patients compared to younger patients. Systemic exposure (AUC) is about 50% higher in elderly comapred to young healthy volunteers (see Dosage & Administration.)
Reduced hepatic function: In patients with mild or moderate hepatic impairment (Child-Pugh Criteria A and B), the half-life of escitalopram was about twice as long and the exposure was about 60% higher than in subjects with normal liver function (see Dosage & Administration).
Reduced renal function: With racemic citalopram, a longer half-life and a minor increase in exposure have been observed in patients with reduced kidney function (Clcr 10-53 ml/min). plasma concentrations of the metabolites have not been studied (see Dosage & Administration.)
Polymorphism: It has been observed that poor metabolisers with respect to CYP2C19 have twice as high a plasma concentration of escitalopram as extensive metabolisers. No significant change in exposure was observed in poor metabolisers with respect to CYP2D6 (see Dosage & Administration.)
Toxicology: Preclinical Safety Data: No complete conventional battery of preclinical studies was performed with escitalopram since the bridging toxicokinetic and toxicological studies conducted in rats with escitalopram and citalopram showed a similar profile. Therefore, all the citalopram information can be extrapolated to escitalopram.
In comparative toxicological studies in rats, escitalopram and citalopram caused cardiac toxicity, including congestive heart failure, after treatment for some weeks, when using dosages that caused general toxicity. The cardiotoxicity seemed to correlate with peak plasma concentrations rather than to systemic exposures (AUC). Peak plasma concentrations at no-effect-level were in excess (8-fold) of those achieved in clinical use, while AUC for escitalopram was only 3- to 4-fold higher than the exposure achieved in clinical use. The findings are probably related to an exaggerated influence on biogenic amines i.e secondary to the primary pharmacological effects, resulting in hemodynamic effects (reduction in coronary flow) and ischaemia. However, the exact mechanism of cardiotoxicity in rats is not clear. Clinical experience with citalopram and the clinical trial experience with escitalopram do not indicate that these findings have a clinical correlate.
Treatment of major depressive disorder, generalized and social anxiety disorder. Panic disorder and obsessive-compulsive disorder.
Safety of daily doses above 20 mg has not been demonstrated.
Lexapro is administered as a single daily dose and may be taken with food or without food.
Major depressive episodes: Usual dosage is 10 mg once daily. Depending on individual patient repsonse, the dose may be increased to a maximum of 20 mg daily.
Usually 2-4 weeks are necessary to obtain antidepressant response. After the symptoms resolve, treatment for at least 6 months is required for consolidation of the response.
Generalised anxiety disorder: Usual dosage is 10 mg once daily. Depending on individual patient repsonse, the dose may be increased to a maximum of 20 mg daily.
Treatment for 3 months is recommended to consolidate response. Long-term treatment of responders for 6 months has been shown to prevent relapse and can be considered on an individual basis; treatment benefits should be re-evaluated at regular intervals.
Panic disorder and obsessive-compulsive disorder: Usual dosage is 10 mg once daily. Depending on individual patient repsonse, the dose may be increased to a maximum of 20 mg daily.
Adult >18 years: Initially 10 mg once daily, may be increased to 20 mg once daily after at least 3 weeks.
Elderly patients (>65 years of age): Initial treatment with half the usually recommended dose and a lower maximum dose should be considered (see Pharmacology: Pharmacokinetics under Actions).
Children and adolescents (<18 years): Lexapro should not be used in the treatment of children and adolescents under the age of 18 years, see Precautions.
Reduced renal function: Dosage adjustment is not necessary in patients with mild or moderate renal impairment. Depending on individual patient response, the dose may be increased to 10 mg daily (see Pharmacology: Pharmacokinetics under Actions).
Poor metabolisers of CYP2C19: For patients who are known to be poor metabolisers with respect to CYP2C19, an initial dose of 5 mg daily during the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10 mg daily (see Pharmacology: Pharmacokinetics under Actions).
Discontinuation symptoms: When stopping treatment with lexapro the dose should be gradually reduced over a period of atleast one to two weeks in order to avoid possible discontinuations sypmtoms (see Precautions and Adverse Reactions).
Toxicity: 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. fatal cases of escitalopram overdose have rarely been reported with escitalopram alone; the majority of cases have involved overdose with concomitant medications. Doses between 400 and 800 mg of escitalopram alone have been taken without any severe symptoms.
Symptoms: Symptoms seen in reported overdose of escitalopram include symptoms mainly related to the central nervous system (ranging from dizziness, tremor, and agitation to rare cases of serotonin syndrome, convulsion, and coma), the gastrointestinal system (nausea/vomiting), and the cardiovascular system (hypotension, tachycardia, QT prolongation, and arryhthmia) and electrolyte/fluid balance conditions hypokalemia, hyponatremia).
Treatment: There is no specific antidote. Establish and maintain an airway, ensure adequate oxygenation and resporatory function. Gastric lavage and the use of activated cahrcoal should be considered. gastric lavage should be carried out as soon as possible after oral ingestion. Cardiac and vital signs monitoring are recommended along with general symptomatic supportive measures.
Hypersensitivity to escitalopram or any of the excipients.
Concomitant treatment with non-selective, irreversible monoamine oxidase inhibitors (MAO-inhibitors) (see Interactions). Concomitant treatment with pimozide.
Antidepressants should not be used in the treatment of children and adolescents under age of 18 years. Suicide related behaviours (suicide attempt and suicidal thoughts), and hostility (predominately aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. lf, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms.
The following special warnings and precautions apply to the therapeutic class of SSRls (Selective Serotonin Re-uptake Inhibitors).
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 the first two weeks of treatment. A low starting dose is advised to reduce the likelihood of an anxiogenic effect (see Dosage & Administration).
Seizures: 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). SSRls should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be closely monitored.
Mania: SSRls should be used with caution in patients with a history of mania/hypomania. SSRls should be discontinued in any patient entering a manic phase.
Diabetes: In patients with diabetes, treatment with an SSRl may alter glycaemic control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted.
Suicide/suicidal thoughts or clinical worsening: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Other psychiatric conditions 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 major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorder. 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. A meta analysis of placebo controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old. Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Akathisia/psychomotor restlessness: The use of SSRls/SNRIs has been associated with the development of akathisia, characterised 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 few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental.
Hyponatraemia: Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported rarely with the use of SSRls and generally resolves on discontinuation of therapy. Caution should be exercised in patients at risk, such as elderly, or patients with cirrhosis or if used in combination with other medications which may cause hyponatraemia.
Haemorrhage: There have been reports of cutaneous bleeding abnormalities, such as ecchymoses and purpura, with SSRls. Caution is advised in patients taking SSRls, particularly with concomitant use of oral anticoagulants; medicinal products known to affect platelet function (e.g. atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti-inflammatory medicinal products (NSAIDs), ticlopidine and dipyridamole); and in patients with known bleeding tendencies.
ECT (electroconvulsive therapy): There is timited clinical experience of concurrent administrati on of SSRrs and ECT: therefore caution is advisable.
Reversible, selective MAO-A inhibitors: The combination of escitalopram with MAO-A inhibitors is generally not recommended due to the risk of onset of a serotonin syndrome (see Interactions).
Serotonin syndrome: Caution is advisable if escitalopram is used concomitantly with medicinal products with serotonergic effects such as sumatriptan or other triptans, tramadol and tryptophan. In rare cases, serotonin syndrome has been reported in patients using SSRls concomitantly with serotonergic medicinal products. A combination of symptoms, such as agitation, tremor, myoclonus and hyperthermia may indicate the development of this condition. If this occurs, treatment with the SSRJ and the serotonergic medicinal product should be discontinued immediately and symptomatic treatment initiated.
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 (see Interactions).
Discontinuation symptoms seen when stopping treatment: Discontinuation symptoms when stopping treatment are common, particularly if discontinuation is abrupt (see Adverse Reactions). In clinical trials adverse events seen on treatment discontinuation occurred in approximately 25% of patients treated with escitalopram and 15% of patients taking placebo.
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 paraesthesia and electric shock sensations), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhoea, 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 2 weeks, though in some individuals they may be prolonged (2-3 months or more). It is therefore advised that escitalopram should be gradually tapered when discontinuing treatment over a period of several weeks or months, according to the patients needs (see Discontinuation symptoms seen when stopping treatment under Dosage & Administration).
Effects on the Ability to Drive or Operate Machinery: Although Esopam has been shown not to affect intellectual function or psychomotor performance, any psychoactive product may impair judgment or skills. patients should be cautioned about the potential risk of an influence on their ability to drive a car or operate machinery.
Use in Pregnancy: Limited clinical data are available regarding exposure to escitalopram during pregnancy.
In reproductive toxicity studies performed in rats, embryo-fetotoxic effects (reduced foetal weight and minor delay in ossification) were observed with exposure to escitalopram, but there was no effect on foetal viability and no increased incidence of malformations (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
Newborns should be observed if maternal use of ewcitalopram continues into the later stages of pregnancy, particularly in the third trimester. If escitalopram is used until or shortly before birth, discontinuation effects in the newborn are possible.
The following symptoms may occur in the neonate after maternal SSRI/SNRI use in later stages of pregnancy: respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence and difficulty sleeping. Thes esymptoms could be due to either serotonergic effects or discontinuation symptoms. in a majority of instances the complications begin immediately or soon (<24 hours) after delivery.
Escitalopram should not be used during pregnancy unless clearly needed and after careful consideration of the risk/benefit ratio.
Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHn). the observed risk was approximately 5 cases per 1000 pregnancies. In the general population 1 to 2 cases of PPHN per 1000 pregnancies occur.
Use in Lactation: It is expected that escitalopram will be excreted into human milk and, breast-feeding is not recommended during the treatment.
Adverse reactions are most frequent during the first or second week of treatment and usually decrease in intensity and frequency with continued treatment.
Adverse drug reactions known for SSRIs and also reported for escitalopram in either placebo controlled clinical studies or as spontaneous post-marketing events are listed below 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 (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare(<1/10000), or not known (can not be estimated from the available data).
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Cases of QT-prolongation have been reported during the post marketing period, predominantly in patients with pre-existing cardiac disease. In a double-blind, placebo-controlled ECG study in healthy subjects, the change from baseline in QTC (Fridericia-correction) was 4.3 msec at the 10 mg/day dose and 10.7 msec at the 30 mg/day dose.
Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. the mechanism leading to this risk is unknown.
Discontinuation symptoms seen when stopping treatment: Discontinuation of SSRIs/SNRIs (particularly when abrupt) commonly leads to discontinuation symptoms. Dizziness, sensory disturbances (including paraesthesia and electric 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 events are mild to moderate and are self-limiting, however, in some patients they may be severe and/or prolonged. It is therefore advised that when escitalopram treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see Dosage & Administration and Precautions.)
Pharmacodynamic interactions: Contraindicated combinations: Non-selective irreversible MAOIs: Cases of serious reactions have been reported in patients receiving an SSRI in combination with a non-selective irreversible monoamine oxidase inhibitor (MAOI), and in patients who have recently discontinued SSRI treatment and have been started on MAOI treatment (see Contraindications). In some cases, the patient developed serotonin syndrome (see Adverse Reactions).
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 7 days should elapse after discontinuing escitalopram treatment before starting a non-selective irreversible MAOI.
Pimozide: Co-administration of a single dose of pimozide 2 mg to subjects treated with racemic citalopram 40 mg/day for 11 days caused an increase in AUC and Cmax of pimozide, although not consistently throughout the study. The co-administration of pimozide and citalopram resulted in a mean increase in the QTc interval of approximately 10 msec. Due to the interaction noted at a low dose of pimozide, concomitant administration of escitalopram and pimozide is contraindicated.
Combinations requiring precautions for use: Reversible selective MAO-A inhibitor (moclobemide): Due to the risk of serotonin syndrome, the combination of escitatopram with a MAO-A inhibitor is not recommended (see Precautions). If the combination proves necessary, it should be started at the minimum recommended dosage and clinical monitoring is strongly recommended.
Escitalopram may be started at least one day after discontinuing treatment with the reversible MAOI (RIMA), moclobemide.
Selegiline: In combination with selegiline (irreversible MAO-B inhibitor), caution is required due to the risk of developing serotonin syndrome.
Serotonergic medicinal products: Co-administration with serotonergic medicinal products (e.g. tramadol, sumatriptan and other triptans) may lead to serotonin syndrome.
Medicinal products lowering the seizure threshold: SSRIs can lower the seizure threshold. Caution is advised when concomitantly using other medicinal products capable of lowering the seizure threshold (e.g. antidepressants (tricyclics, SSRls) neuroleptics (phenothiazines, thioxanthenes, butyrophenones) mefloquine, bupropion and tramadol).
Lithium, tryptophan: There have been reports of enhanced effects when SSRls have been given together with lithium or tryptophan, therefore concomitant use of SSRls with these medicinal products should be undertaken with caution.
St. John's Wort: Concomitant use of SSRls and herbal remedies containing St. John's Wort (Hypericum perforatum) may result in an increased incidence of adverse reactions (see Precautions).
Haemorrhage: Altered anti-coagulant effects may occur when escitalopram is combined with oral anticoagulants. Patients receiving oral anticoagulant therapy should receive careful coagulation monitoring when escitalopram is started or stopped (see Precautions).
Concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) may increase bleeding-tendency (see Precautions).
Alcohol: No pharmacodynamic or pharmacokinetic Interactions are expected between escitaloprarn and alcohol. However as with other psychotropic medicinal products, the combination with alcohol is not advisable.
Pharmacokinetic Interactions: Influence of other medicinal products on the pharmacokinetics of escitalopram: The metabolism of escitalopram is mainly mediated by CYP2C19. CYP3A4 and CYP2D6 may also contribute to the metabolism although to a smaller extent. The metabolism of the major metabolite S-DCT (demethylated escitalopram) seems to be partly catalysed by CYP2D6.
Co-administration of escitalopram with omeprazole (a CYP2C19 inhibitor) resulted in moderate (approximately 50%) increase in the plasma concentrations of escitalopram.
Co-administration of escitalopram with cimetidine (moderately potent general enzyme-inhibitor) resulted in moderate (approximately 70%) increase in the plasma concentrations or escitalopram.
Caution should thus be exercised at the upper end of the dose range of escitalopram when used concomitantly with CYP2C19 inhibitors (e.g. omeprazole, fluoxetine, fluvoxamine, lansoprazole, ticlopidine) and with cimetidine.
A reduction in the dose of escitalopram maybe necessary based on clinical judgement.
Effect of escitalopram on the pharmacokinetics of other medicinal products: Escitalopram is an inhibitor of the enzyme CYP2D6. Caution is recommended when escitalopram is co-administered with medicinal products that are mainly metabolised 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 CYP206, e.g. antidepressants such as desipramine, clomipramine and nortryptyline or antipsychotics like risperidone, thioridazine and haloperidol. Dosage adjustment maybe warranted.
Co-administration with desipramine or metoprolol resulted in a twofold increase in the plasma levels of these two CYP2D6 substrates.
In vitro studies have demonstrated that escitalopram may also cause weak inhibition of CYP2C19.
Caution is recommended with concomitant use of medicinal products that are metabolised by CYP2C19.
Incompatibilities: Not applicable.
N06AB10 - escitalopram ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.
Tab 10 mg (oval, white, scored, marked with "E" and "L" on each side of the score on one side of the tablet) x 1 x 7's, 4 x 7's.