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  • Nexito 5 mg or 10 mg Escitalopram oxatate tablets side effects


    Escitalopram MN tablets 5 mg and 10 mg

    Nexito 5: Each film coated tablet contains Escitalopram oxatate equivalent, to


    NeadtolO: Each fflm coated tablet contains Escitalopram oxalate equivalent to

    Escitalopram INN 10 mg.

    Onteai Pharmacotogy

    Escitalopram is a selective serotonin (5HT) reuptake inhibitor.

    Mechanism of Artleo

    The pharmacological and clinical effects of escitalopram are attributed to 5-HT reuptake inhibition, ft has low affinity for a number of receptors including 5-HT1A, 5-HT2, D1 and 02 receptors, alpha!, alphaZ, beta-adrenoreqeptofs, histamine, muscarinic, benzodiazepine and opiokJ receptors.

    The absorption of escitalopram is almost completely independent of food intake. As’ with raeemic dtatopram, the absolute bioavailability of escitalopnim is expected to be 80%. Steady state plasma levels are reached in about 1 week. Escitalopram is metabolised in the liver to the demethylated and dktemethylated metabolites, both of these are pharmaccHogicaHy active. Bibtransfcfrnation of escitalopram to’the demethylated metabolite is mediated primarily by CYP2C19 with some possible contribution by the enzymes CYP3A4 and CYP2D6. The apparent volume of distribution after oral administration is about 12 to 28 L/kg. The plasma protein binding is below 80% for escitalopram and its main metabolites.

    The elimination half life after multiple dosing is about 30 hours and the oral plasma clearance is about O.eUmin. Elimination of escftalopram and the major metabolites are assumed to occur both by the hepatic and the renal routes; with the major part of the dose excreted as metabolites in the urine. The elimination of escitaJopram is more slow in elderly patients as compared to younger patients. Systemic exposure (AUC) is about 50% higher in elderly compared to young healthy volunteers.


    Nextto is indicated for:

    Treatment of major depressive episodes.

    Treatment of panic disorder with or without agoraphobia.

    Treatment of social anxiety dtoofi* (social phobia).


    Hypersensitivtty to escitalopram or any other ingredient of She

    Concomitant treatment with non-selective, irreversible oxidase inhibitors (MAO-inhibitors).

    In some patients with panic disorder who experience increased anxiety symptoms, a low starting dose is advised to reduce the likelihood of an anxiogenic effect. Selective Serotonin Re-uptake Inhibitors (SSRIs) snoufd be avoided In patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored. SSRIs should be Discontinued tf there ft an increase in seizure frequency. SSRIs should be used with caution in patients with a history of mania/hypomania and should be dfeeontihued in any patient entering a manic phase. In patients with diabetes, treatment with an SSRI may after gtycaemic control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted- SSRIs may increase the risk of suicide during the first weeks of therapy. Close monitoring of the patient during this period is important.

    There have been reports of cutaneous bleeding abnormalities such as eochyrnoees and purpurawith SSRIs. Caution is advised in concomitant use with oral anticoagulants, with medicinal products known to affect platelet function (e.g., atypical antipsychotics, phenothiazines, most tricyctic antktepressants, ASA and NSAIDs, tictopidtae and dipyridamote) and in patients with known bleeding tendencies.

    If serotonin syndrome occurs treatment with the SSRI and the serotonergfo medicinal product should be discontinued immediately. When stopping therapy with escitalopram, the close should be gradually reduced over a period of one or two weeks in order to avoid possible withdrawal reactions. Caution is advised in patients with coronary heart disease. Patients should be cautioned about the potential risk of an influence on their ability to drive a car and operate ma<rfwery. CaiJtion is acMsed with the concurrent use of SSRIs and ECT.

    Hyponatraemia has been reported rarely with SSRIs due to inappropriate antidiuretic hormone secretion (SIADH). This generally resolves on discontinuation of therapy but caution is advised in patients’at risk such as elderly, drrhotic patients or patients

    No clinical data are available regarding exposed pregnancies and the risk for humans is unknown. Therefore, escitalopram should be used during pregnancy only if the potential benefit outweighs the potential risk.

    It is expected that escjtatopram win be excreted into human milk, therefore, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drugto the mother.

    Cases of serious reactions have been reported^ patients receiving an SSRI in combination with a non selective monoamtne pxkjasa inhibitor and in patients who have recently discontinued SSRI treatnwnt arid have been stert^ Escitalopram may be started after 14 days of Discontinuing treatment with an irreversible MAOi and atteastone dayjtft$r discontinuing treatment with the reversible MAOI, modobemide. Similarly, atleast 7 days should elapse after stopping escitalopram, before starting a nonsetefctive MAOC Doe to the risk’of serotonin

    recommended. If the combination proves necessary, it should be started at the minimum recommended dosage and clinical monitoring should be reinforced. In combination with selegiHne (irreversible MAO-B inhibitor), caution is required due to the risk of developingserotonin syndrome.

    triptans may lead to serotonin syndrome. Caution is advised when-SSRIs are given with drugs that lower the seizure threshold. There have been reports of enhanced effects when SSRfeiin6fceen given together with Hthium or tryptophan, therefore concomitant use should be done with caution. Altered anticoagulan* effects may occur when escitalopram is combined with oral anticoagulants. As with other psychotropic drugs, the combination with alcohol should be avoided.

    (drrinistration of drugs that inhibit CYP2C13 can resutt in elevated plasma concentrations of escftalopram. Caution is recommended in the concomitant use of such drugs e.g., omeprazote. In vitro studies have demonstrated that escftalopram may also cause weak inhibition of CYP2C19, therefore, caution is advised with the conconitant use of drugs that are metabolised by CYP2C19.

    Caution should be exercised at the upper end of the dose range ofesdteJopram when , used concomtentfy with high closes of cimetidine. Escitalopram is an inhibitor of the enzyme CYP2D6. Caution is recommended when escitalopram is coadministeTed with medicinal products that are mainly metabolised by this enzyme and that have a narrow therapeutic index, e.g., ftecainide, propafenone and metoprotoi or some CNS acting drugs that are mainly metabolised by CYP2D6 e.g., antidepressants such as desipramine, domipramine and nortriptyline or antipsychotics like risperidone, thioridazine and hatoperidol. Dosage adjustment may be warranted. Coadministration with desipramine or metoprotol resulted in both cases Hi a twofold increase in the plasma levels of these two CYP2O6 substrates.

    the two drugs are coadministered. Side effects

    Adverse reactions are most frequent during tire first or second week of treatment and usually decrease in intensity and frequency with continued treatment. The most commonly reported adverse effects with escitalopram are decreased appetite, decreased Kbido, anorgasmia (female), insomnia, somnolence, dizziness, taste disturbance, sleep disorder, sinusitis, yawning, nausea, diarrhoea, constipation, abdominal pain, increased sweating, ejaculation disorder, impotence, fatigue, pyrexia.

    Escitalopram is administered as a single daily dose, in the morning or evening, and

    dose should be gradually reduced over a period of one or two weeks in order to avoid possible withdrawal reactions.

    .jteodes: Usual dosage is 10 mg once daily. Depending on the

    it patient response, the dose may Be increased to a maximum of 20mg daily. Usually 2-4 weeks are necessary to obtain antidepressant response. After the


    Panic disorder with or without agoraphobia: An initial dose of 5 mg is recommended for the first week before increasing the dose to 10 mg once daily. The dose may be further increased upto a maximum of 20 mg daily, depending on the individual patient response. Maximum effect is reached after about 3 months. The treatment lasts several months.

    Social anxiety disorder: Usual dose is 10 mg once daily. Usually 2-4 weeks are necessary to obtain symptom relief. The dose may subsequently, depending on the individual patient reports*, be decreased to 5 rngor increased to a maxirnum of 20 mg daily. Treatment for 12 weeks is recommended to consolidate reponse. Treatment benefits should be reevatuated at regular intervals.

    Elderly: Initial treatment with half the usually recommended dose and a lower maximum dose should be considered. The efficacy of escftalopram in social anxiety disorder has not been studied in elderly patients.

    Renal Impairment Dosage adjustment is not necessary in patients with mid to moderate renal impairment. Caution is advised in patients with severely reduced renal function (creatinine clearance < 30ml/min).

    Hepatic impairment: An initial dose of 5 mg dairy for the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased tolOmg.

    Poor metaboKsers of CYP2C19: For patients who are poor metabofoers with respect

    to CYP2C19, an initial dose of 5 mg daily during the first two wee


4 Responses to “Nexito 5 mg or 10 mg Escitalopram oxatate tablets side effects”

  1. syed mohammed said on

    dosage recommended initially for child of 10 years

  2. noushad said on

    my wife taking nexito 5for depression and i just want know if there i any side effect because we are planing to make baby
    thank you

  3. will it cause heart attack taken with hypertention medicines?

  4. son veer singh said on

    yes i m using nexito5mg last osne and half year for my psychytric problem

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