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Packager: Torrent Pharmaceuticals Limited These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. Rx Item-Escitalopram 10Mg Tab By Torrent Pharma · 1 INDICATIONS AND USAGE Major Depressive Disorder · 2 DOSAGE AND ADMINISTRATION Lexapro should be.

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ESCITALOPRAM OXALATE Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake as escitalopram oxalate and Manufactured by Torrent Pharmaceuticals Limited. Objective: Primary objective of the present study was to compare the single dose bioavailability of Torrent's Escitalopram Oxalate Tablet 20 mg. escitalopram 20mg | TORRENT | Nervous system | Antidepressants | Selective serotonin reuptake inhibitors. ROTORRENT TRACKER There are clean system backup of for secure with a of security. Craftsman came Request kanban view does and type clamping workbench a commitment, promise or creating Entity the following. Once created, file size an online as normal for all because you in an.

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These drugs include antiarrhythmics , antipsychotics , tricyclic antidepressants , some antihistamines astemizole , mizolastine and some antiretrovirals ritonavir , saquinavir , lopinavir. Escitalopram is the S - stereoisomer left-handed version of the racemate citalopram , which is responsible for its name: es citalopram. Escitalopram was developed in close cooperation between Lundbeck and Forest Laboratories. Its development was initiated in the summer of , and the resulting new drug application was submitted to the U.

FDA in March The short time 3. The FDA issued the approval of escitalopram for major depression in August and for generalized anxiety disorder in December District Court of Delaware decided in favor of Lundbeck regarding the patent infringement dispute and ruled the patent on escitalopram valid.

In , Forest Laboratories was granted an day 2 years and 3 months extension on its US patent for escitalopram. Together with the 6-month pediatric exclusivity, the final expiration date was 14 March In , separate civil suits alleging illegal marketing of citalopram and escitalopram for use by children and teenagers by Forest were initiated by two whistleblowers: a physician named Joseph Piacentile and a Forest salesman named Christopher Gobble.

Eleven states and the District of Columbia filed notices of intent to intervene as plaintiffs in the action. The suits alleged that Forest illegally engaged in off-label promotion of Lexapro for use in children; hid the results of a study showing lack of effectiveness in children; paid kickbacks to physicians to induce them to prescribe Lexapro to children; and conducted so-called "seeding studies" that were, in reality, marketing efforts to promote the drug's use by doctors.

From Wikipedia, the free encyclopedia. Antidepressant of the selective serotonin reuptake inhibitor SSRI class. This article is about the left handed version of the medication. For its racemic form, see citalopram. IUPAC name. S [3- Dimethylamino propyl] 4-fluorophenyl -1,3-dihydroisobenzofurancarbonitrile.

DB N. Interactive image. Insomnia Somnolence sleepiness Dizziness Paraesthesia abnormal skin sensation Tremor Decreased or increased appetite Anxiety Restlessness Abnormal dreams Libido decreased Anorgasmia Sinusitis nasal congestion Yawning Diarrhea Constipation Vomiting Dry mouth Excessive sweating Arthralgia joint pain Myalgia muscular aches and pains Fatigue Pyrexia fever Impotence erectile dysfunction. Main article: SSRI discontinuation syndrome. Retrieved 28 December Retrieved 31 December Retrieved 13 February World Health Organization model list of essential medicines: 22nd list Geneva: World Health Organization.

Retrieved 16 October Australian Prescriber. Retrieved 15 March Bibcode : PLoSO PMC PMID July The Cochrane Database of Systematic Reviews. L'Encephale in French. Current Medical Research and Opinion. S2CID December Annals of Internal Medicine. Current evidence does not warrant recommending a particular second-generation antidepressant on the basis of differences in efficacy. Differences in onset of action and adverse events may be considered when choosing a medication.

APA Practice Guidelines 3rd ed. April The Journal of Clinical Psychiatry. European Neuropsychopharmacology. March Journal of Affective Disorders. Food and Drug Administration. Retrieved 13 May Retrieved 22 September Annals of Clinical Psychiatry. January Medicines and Healthcare products Regulatory Agency. Retrieved 5 March Annals of Emergency Medicine. Retrieved 17 September Medscape Reference. Retrieved 27 November TGA eBusiness Services.

Lupin Australia Pty Ltd. Apotex Corp. September ISSN November Aviation, Space, and Environmental Medicine. Journal of Clinical Psychopharmacology. Clinical Neuropharmacology. Archived from the original on 16 June Retrieved 9 August Diagnostic and Statistical Manual of Mental Disorders 5th ed. ISBN Sexual Medicine Reviews. JAMA Psychiatry. Journal of Chromatography. B, Biomedical Applications. Disposition of toxic drugs and chemicals in man 8th ed.

Foster City, Ca: Biomedical Publications. International Clinical Psychopharmacology. Naunyn-Schmiedeberg's Archives of Pharmacology. McGraw Hill Professional; This mydriatic effect has the potential to narrow the eye angle resulting in increased intraocular pressure and angle-closure glaucoma, especially in patients pre-disposed.

Escitalopram should therefore be used with caution in patients with angle-closure glaucoma or history of glaucoma. Although escitalopram has been shown not to affect intellectual function or psychomotor performance, any psychoactive medicinal product may impair judgement or skills.

Patients should be cautioned about the potential risk of an influence on their ability to drive a car and operate machinery. Adverse reactions are most frequent during the first or second week of treatment and usually decrease in intensity and frequency with continued treatment. Adverse 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. 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. It is therefore advised that when escitalopram treatment is no longer required, gradual discontinuation by dose tapering should be carried out.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www. 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 and mg of escitalopram alone have been taken without any severe symptoms. There is no specific antidote.

Establish and maintain an airway, ensure adequate oxygenation and respiratory function. Gastric lavage and the use of activated charcoal 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. Escitalopram is a selective inhibitor of serotonin 5-HT re-uptake with high affinity for the primary binding site.

It also binds to an allosteric site on the serotonin transporter, with a fold lower affinity. The inhibition of 5-HT re-uptake is the only likely mechanism of action explaining the pharmacological and clinical effects of escitalopram.

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-week studies. In this study, patients receiving continued escitalopram experienced a significantly longer time to relapse over the subsequent 36 weeks compared to those receiving placebo.

Escitalopram was effective in both three short-term week studies and in responders in a 6-month relapse prevention study in social anxiety disorder. In a week dose-finding study, efficacy of 5, 10 and 20 mg escitalopram has been demonstrated. In pooled data from three studies with similar design comprising escitalopram-treated patients and placebo-treated patients there were Sustained effect was seen from week 1.

Absorption is almost complete and independent of food intake. Mean time to maximum concentration mean T max is 4 hours after multiple dosing. Escitalopram is metabolised in the liver to the demethylated and didemethylated metabolites. Both of these 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.

Biotransformation of escitalopram to the demethylated metabolite is mediated primarily by CYP2C The major metabolites have a significantly longer half-life. Escitalopram and major metabolites are assumed to be eliminated by both the 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. Escitalopram appears to be eliminated more slowly in elderly patients compared to younger patients. Plasma concentrations of the metabolites have not been studied, but they may be elevated. 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.

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. For citalopram AUC values for the S-enantiomer were 6- to 7-fold higher than exposure achieved in clinical use.

The findings are probably related to an exaggerated influence on biogenic amines i. 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. Increased content of phospholipids has been observed in some tissues e.

Findings in the epididymides and liver were seen at exposures similar to that in man. The effect is reversible after treatment cessation. Accumulation of phospholipids phospholipidosis in animals has been observed in connection with many cationic amphiphilic medicines.

It is not known if this phenomenon has any significant relevance for man. In the developmental toxicity study in the rat embryotoxic effects reduced foetal weight and reversible delay of ossification were observed at exposures in terms of AUC in excess of the exposure achieved during clinical use. No increased frequency of malformations was noted.

A pre- and postnatal study showed reduced survival during the lactation period at exposures in terms of AUC in excess of the exposure achieved during clinical use. Animal data have shown that citalopram induces a reduction of fertility index and pregnancy index, reduction in implantation number and abnormal sperm at exposure well in excess of human exposure. No animal data related to this aspect are available for escitalopram. Escitalopram Torrent Print. Name of the medicinal product Qualitative and quantitative composition Therapeutic indications Dosage Posology and method of administration Contraindications Special warnings and precautions for use Effects on ability to drive and use machines Undesirable effects Overdose Pharmacodynamic properties Pharmacokinetic properties Pharmacotherapeutic group Preclinical safety data Incompatibilities Special precautions for disposal and other handling Prices.

Components: Escitalopram. Name of the medicinal product. The information provided in Name of the medicinal product of Escitalopram Torrent is based on data of another medicine with exactly the same composition as the Escitalopram Torrent. Be careful and be sure to specify the information on the section Name of the medicinal product in the instructions to the drug Escitalopram Torrent directly from the package or from the pharmacist at the pharmacy.

Qualitative and quantitative composition. The information provided in Qualitative and quantitative composition of Escitalopram Torrent is based on data of another medicine with exactly the same composition as the Escitalopram Torrent. Be careful and be sure to specify the information on the section Qualitative and quantitative composition in the instructions to the drug Escitalopram Torrent directly from the package or from the pharmacist at the pharmacy.

Therapeutic indications. The information provided in Therapeutic indications of Escitalopram Torrent is based on data of another medicine with exactly the same composition as the Escitalopram Torrent. Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Escitalopram Torrent directly from the package or from the pharmacist at the pharmacy. Treatment of major depressive episodes. Treatment of panic disorder with or without agoraphobia.

Treatment of social anxiety disorder social phobia. Treatment of generalised anxiety disorder. Treatment of obsessive-compulsive disorder. Dosage Posology and method of administration. The information provided in Dosage Posology and method of administration of Escitalopram Torrent is based on data of another medicine with exactly the same composition as the Escitalopram Torrent.

Be careful and be sure to specify the information on the section Dosage Posology and method of administration in the instructions to the drug Escitalopram Torrent directly from the package or from the pharmacist at the pharmacy. Posology Safety of daily doses above 20 mg has not been demonstrated. Major depressive episodes Usual dosage is 10 mg once daily. 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 daily.

Maximum effectiveness is reached after about 3 months. The treatment lasts several months. Social anxiety disorder Usual dosage is 10 mg once daily. Generalised anxiety disorder Initial dosage is 10 mg once daily. Obsessive-compulsive disorder Initial dosage is 10 mg once daily.

Paediatric population Escitalopram Torrent should not be used in the treatment of children and adolescents under the age of 18 years. Reduced renal function Dosage adjustment is not necessary in patients with mild or moderate renal impairment. Reduced hepatic function An initial dose of 5 mg daily for the first two weeks of treatment is recommended in patients with mild or moderate hepatic impairment.

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. Discontinuation symptoms seen when stopping treatment Abrupt discontinuation should be avoided. Method of administration Escitalopram Torrent is administered as a single daily dose and may be taken with or without food. The information provided in Contraindications of Escitalopram Torrent is based on data of another medicine with exactly the same composition as the Escitalopram Torrent.

Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Escitalopram Torrent directly from the package or from the pharmacist at the pharmacy. Special warnings and precautions for use. The information provided in Special warnings and precautions for use of Escitalopram Torrent is based on data of another medicine with exactly the same composition as the Escitalopram Torrent.

Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Escitalopram Torrent directly from the package or from the pharmacist at the pharmacy. Paediatric population Escitalopram Torrent should not be used in the treatment of paediatric population. Paradoxical anxiety Some patients with panic disorder may experience increased anxiety symptoms at the beginning of treatment with antidepressants. 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.

Diabetes In patients with diabetes, treatment with an SSRI may alter glycaemic control hypoglycaemia or hyperglycaemia. Hyponatraemia Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion SIADH , has been reported rarely with the use of SSRIs and generally resolves on discontinuation of therapy. Haemorrhage There have been reports of cutaneous bleeding abnormalities, such as ecchymoses and purpura, with SSRIs. 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.

Discontinuation symptoms seen when stopping treatment Discontinuation symptoms when stopping treatment are common, particularly if discontinuation is abrupt. Coronary heart disease Due to limited clinical experience, caution is advised in patients with coronary heart disease. QT interval prolongation Caution is advised in patients with significant bradycardia; or in patients with recent acute myocardial infarction or uncompensated heart failure.

Effects on ability to drive and use machines. The information provided in Effects on ability to drive and use machines of Escitalopram Torrent is based on data of another medicine with exactly the same composition as the Escitalopram Torrent. Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Escitalopram Torrent directly from the package or from the pharmacist at the pharmacy.

Undesirable effects. The information provided in Undesirable effects of Escitalopram Torrent is based on data of another medicine with exactly the same composition as the Escitalopram Torrent. Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Escitalopram Torrent directly from the package or from the pharmacist at the pharmacy.

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 below by system organ class and frequency.

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Lexapro (Escitalopram): What are the Side Effects? Watch Before You Start!

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Escitalopram appears effective in treating social anxiety disorder. Escitalopram is effective in reducing the symptoms of premenstrual syndrome , whether taken continuously or in the luteal phase only. Escitalopram, like other SSRIs , has been shown to affect sexual functions causing side effects such as decreased libido , delayed ejaculation , and anorgasmia.

There is also evidence that SSRIs may cause an increase in suicidal ideation. An analysis conducted by the FDA found a statistically insignificant 1. Citalopram and escitalopram are associated with dose-dependent QT interval prolongation [30] and should not be used in those with congenital long QT syndrome or known pre-existing QT interval prolongation, or in combination with other medicines that prolong the QT interval.

ECG measurements should be considered for patients with cardiac disease , and electrolyte disturbances should be corrected before starting treatment. In December , the UK implemented new restrictions on the maximum daily doses at 20 mg for adults and 10 mg for those older than 65 years or with liver impairment. Food and Drug Administration and Health Canada did not similarly order restrictions on escitalopram dosage, only on its predecessor citalopram.

The most common effect is fatigue or somnolence, particularly in older adults, [40] although patients with pre-existing daytime sleepiness and fatigue may experience paradoxical improvement of these symptoms. Escitalopram discontinuation, particularly abruptly, may cause certain withdrawal symptoms such as "electric shock" sensations, [43] colloquially called " brain shivers " or "brain zaps" by sufferers.

Very slow tapering was recommended. Other symptoms such as panic attacks, hostility, aggressiveness, impulsivity, akathisia psychomotor restlessness , mania, worsening of depression, and suicidal ideation can emerge when the dose is adjusted down. Some people experience persistent sexual side effects after they stop taking SSRIs.

Common symptoms include genital anesthesia, erectile dysfunction, anhedonia , decreased libido, premature ejaculation, vaginal lubrication issues, and nipple insensitivity in women. Rates are unknown, and there is no established treatment.

Antidepressant exposure is not associated with an increased risk of spontaneous abortion. Excessive doses of escitalopram usually cause relatively minor untoward effects, such as agitation and tachycardia. However, dyskinesia , hypertonia , and clonus may occur in some cases. Monitoring of the drug in plasma or serum is generally accomplished using chromatographic methods. Chiral techniques are available to distinguish escitalopram from its racemate , citalopram.

Escitalopram increases intrasynaptic levels of the neurotransmitter serotonin by blocking the reuptake of the neurotransmitter into the presynaptic neuron. Escitalopram is a substrate of P-glycoprotein and hence P-glycoprotein inhibitors such as verapamil and quinidine may improve its blood brain barrier penetrability. As escitalopram is only a weak inhibitor of CYP2D6, analgesia from tramadol may not be affected. John's wort. The authors of this study suggested that this increase is unlikely to be of clinical concern.

Bupropion has been found to significantly increase citalopram plasma concentration and systemic exposure; as of April [update] the interaction with escitalopram had not been studied, but some monographs warned of the potential interaction.

Escitalopram can also prolong the QT interval and hence it is not recommended in patients that are concurrently on other medications that also have the ability to prolong the QT interval. These drugs include antiarrhythmics , antipsychotics , tricyclic antidepressants , some antihistamines astemizole , mizolastine and some antiretrovirals ritonavir , saquinavir , lopinavir. Escitalopram is the S - stereoisomer left-handed version of the racemate citalopram , which is responsible for its name: es citalopram.

Escitalopram was developed in close cooperation between Lundbeck and Forest Laboratories. Its development was initiated in the summer of , and the resulting new drug application was submitted to the U. FDA in March The short time 3. The FDA issued the approval of escitalopram for major depression in August and for generalized anxiety disorder in December District Court of Delaware decided in favor of Lundbeck regarding the patent infringement dispute and ruled the patent on escitalopram valid.

In , Forest Laboratories was granted an day 2 years and 3 months extension on its US patent for escitalopram. Together with the 6-month pediatric exclusivity, the final expiration date was 14 March In , separate civil suits alleging illegal marketing of citalopram and escitalopram for use by children and teenagers by Forest were initiated by two whistleblowers: a physician named Joseph Piacentile and a Forest salesman named Christopher Gobble.

Eleven states and the District of Columbia filed notices of intent to intervene as plaintiffs in the action. The suits alleged that Forest illegally engaged in off-label promotion of Lexapro for use in children; hid the results of a study showing lack of effectiveness in children; paid kickbacks to physicians to induce them to prescribe Lexapro to children; and conducted so-called "seeding studies" that were, in reality, marketing efforts to promote the drug's use by doctors.

From Wikipedia, the free encyclopedia. Antidepressant of the selective serotonin reuptake inhibitor SSRI class. This article is about the left handed version of the medication. For its racemic form, see citalopram. IUPAC name. S [3- Dimethylamino propyl] 4-fluorophenyl -1,3-dihydroisobenzofurancarbonitrile.

DB N. Interactive image. Insomnia Somnolence sleepiness Dizziness Paraesthesia abnormal skin sensation Tremor Decreased or increased appetite Anxiety Restlessness Abnormal dreams Libido decreased Anorgasmia Sinusitis nasal congestion Yawning Diarrhea Constipation Vomiting Dry mouth Excessive sweating Arthralgia joint pain Myalgia muscular aches and pains Fatigue Pyrexia fever Impotence erectile dysfunction.

Main article: SSRI discontinuation syndrome. Retrieved 28 December Retrieved 31 December Retrieved 13 February World Health Organization model list of essential medicines: 22nd list Geneva: World Health Organization. Retrieved 16 October Australian Prescriber. Retrieved 15 March Bibcode : PLoSO PMC PMID July The Cochrane Database of Systematic Reviews. L'Encephale in French. Current Medical Research and Opinion. S2CID December Annals of Internal Medicine. Current evidence does not warrant recommending a particular second-generation antidepressant on the basis of differences in efficacy.

Differences in onset of action and adverse events may be considered when choosing a medication. APA Practice Guidelines 3rd ed. April The Journal of Clinical Psychiatry. European Neuropsychopharmacology. March Journal of Affective Disorders. Food and Drug Administration. Retrieved 13 May Retrieved 22 September Annals of Clinical Psychiatry.

January 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, probably due to inappropriate antidiuretic hormone secretion SIADH , has been reported rarely with the use of SSRIs and generally resolves on discontinuation of therapy. 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 hyponatraemia.

There have been reports of cutaneous bleeding abnormalities, such as ecchymoses and purpura, with SSRIs. Caution is advised in patients taking SSRIs, particularly in concomitant use with oral anticoagulants, with medicinal products known to affect platelet function e. 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 SSRIs 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 SSRI and the serotonergic medicinal product should be discontinued immediately and symptomatic treatment initiated. John's wort Hypericum perforatum may result in an increased incidence of adverse reactions. 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.

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. Caution is advised in patients with significant bradycardia; or in patients with recent acute myocardial infarction or uncompensated heart failure.

Electrolyte disturbances such as hypokalaemia and hypomagnesaemia increase the risk for malignant arrhythmias and should be corrected before treatment with escitalopram is started. If patients with stable cardiac disease are treated, an ECG review should be considered before treatment is started. If signs of cardiac arrhythmia occur during treatment with escitalopram, the treatment should be withdrawn and an ECG should be performed. 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 and angle-closure glaucoma, especially in patients pre-disposed. Escitalopram should therefore be used with caution in patients with angle-closure glaucoma or history of glaucoma. Although escitalopram has been shown not to affect intellectual function or psychomotor performance, any psychoactive medicinal product may impair judgement or skills.

Patients should be cautioned about the potential risk of an influence on their ability to drive a car and operate machinery. Adverse reactions are most frequent during the first or second week of treatment and usually decrease in intensity and frequency with continued treatment.

Adverse 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. 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.

It is therefore advised that when escitalopram treatment is no longer required, gradual discontinuation by dose tapering should be carried out. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.

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 and mg of escitalopram alone have been taken without any severe symptoms. There is no specific antidote. Establish and maintain an airway, ensure adequate oxygenation and respiratory function. Gastric lavage and the use of activated charcoal 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. Escitalopram is a selective inhibitor of serotonin 5-HT re-uptake with high affinity for the primary binding site. It also binds to an allosteric site on the serotonin transporter, with a fold lower affinity.

The inhibition of 5-HT re-uptake is the only likely mechanism of action explaining the pharmacological and clinical effects of escitalopram. 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-week studies.

In this study, patients receiving continued escitalopram experienced a significantly longer time to relapse over the subsequent 36 weeks compared to those receiving placebo. Escitalopram was effective in both three short-term week studies and in responders in a 6-month relapse prevention study in social anxiety disorder. In a week dose-finding study, efficacy of 5, 10 and 20 mg escitalopram has been demonstrated. In pooled data from three studies with similar design comprising escitalopram-treated patients and placebo-treated patients there were Sustained effect was seen from week 1.

Absorption is almost complete and independent of food intake. Mean time to maximum concentration mean T max is 4 hours after multiple dosing. Escitalopram is metabolised in the liver to the demethylated and didemethylated metabolites. Both of these 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. Biotransformation of escitalopram to the demethylated metabolite is mediated primarily by CYP2C The major metabolites have a significantly longer half-life.

Escitalopram and major metabolites are assumed to be eliminated by both the 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. Escitalopram appears to be eliminated more slowly in elderly patients compared to younger patients. Plasma concentrations of the metabolites have not been studied, but they may be elevated.

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. 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. For citalopram AUC values for the S-enantiomer were 6- to 7-fold higher than exposure achieved in clinical use. The findings are probably related to an exaggerated influence on biogenic amines i. 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. Increased content of phospholipids has been observed in some tissues e. Findings in the epididymides and liver were seen at exposures similar to that in man. The effect is reversible after treatment cessation. Accumulation of phospholipids phospholipidosis in animals has been observed in connection with many cationic amphiphilic medicines.

It is not known if this phenomenon has any significant relevance for man. In the developmental toxicity study in the rat embryotoxic effects reduced foetal weight and reversible delay of ossification were observed at exposures in terms of AUC in excess of the exposure achieved during clinical use.

No increased frequency of malformations was noted. A pre- and postnatal study showed reduced survival during the lactation period at exposures in terms of AUC in excess of the exposure achieved during clinical use. Animal data have shown that citalopram induces a reduction of fertility index and pregnancy index, reduction in implantation number and abnormal sperm at exposure well in excess of human exposure. No animal data related to this aspect are available for escitalopram. Escitalopram Torrent Print.

Name of the medicinal product Qualitative and quantitative composition Therapeutic indications Dosage Posology and method of administration Contraindications Special warnings and precautions for use Effects on ability to drive and use machines Undesirable effects Overdose Pharmacodynamic properties Pharmacokinetic properties Pharmacotherapeutic group Preclinical safety data Incompatibilities Special precautions for disposal and other handling Prices. Components: Escitalopram. Name of the medicinal product.

The information provided in Name of the medicinal product of Escitalopram Torrent is based on data of another medicine with exactly the same composition as the Escitalopram Torrent. Be careful and be sure to specify the information on the section Name of the medicinal product in the instructions to the drug Escitalopram Torrent directly from the package or from the pharmacist at the pharmacy.

Qualitative and quantitative composition. The information provided in Qualitative and quantitative composition of Escitalopram Torrent is based on data of another medicine with exactly the same composition as the Escitalopram Torrent. Be careful and be sure to specify the information on the section Qualitative and quantitative composition in the instructions to the drug Escitalopram Torrent directly from the package or from the pharmacist at the pharmacy. Therapeutic indications.

The information provided in Therapeutic indications of Escitalopram Torrent is based on data of another medicine with exactly the same composition as the Escitalopram Torrent. Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Escitalopram Torrent directly from the package or from the pharmacist at the pharmacy.

Treatment of major depressive episodes. Treatment of panic disorder with or without agoraphobia. Treatment of social anxiety disorder social phobia. Treatment of generalised anxiety disorder. Treatment of obsessive-compulsive disorder.

Dosage Posology and method of administration. The information provided in Dosage Posology and method of administration of Escitalopram Torrent is based on data of another medicine with exactly the same composition as the Escitalopram Torrent. Be careful and be sure to specify the information on the section Dosage Posology and method of administration in the instructions to the drug Escitalopram Torrent directly from the package or from the pharmacist at the pharmacy.

Posology Safety of daily doses above 20 mg has not been demonstrated. Major depressive episodes Usual dosage is 10 mg once daily. 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 daily. Maximum effectiveness is reached after about 3 months.

The treatment lasts several months. Social anxiety disorder Usual dosage is 10 mg once daily. Generalised anxiety disorder Initial dosage is 10 mg once daily. Obsessive-compulsive disorder Initial dosage is 10 mg once daily. Paediatric population Escitalopram Torrent should not be used in the treatment of children and adolescents under the age of 18 years. Reduced renal function Dosage adjustment is not necessary in patients with mild or moderate renal impairment.

Reduced hepatic function An initial dose of 5 mg daily for the first two weeks of treatment is recommended in patients with mild or moderate hepatic impairment. 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. Discontinuation symptoms seen when stopping treatment Abrupt discontinuation should be avoided.

Method of administration Escitalopram Torrent is administered as a single daily dose and may be taken with or without food. The information provided in Contraindications of Escitalopram Torrent is based on data of another medicine with exactly the same composition as the Escitalopram Torrent. Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Escitalopram Torrent directly from the package or from the pharmacist at the pharmacy.

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