Psychotropics India


JF Draf
Full Prescribing Info
Escitalopram oxalate.
Each film-coated tablet contains: Escitalopram (as oxalate) 10mg.
Each film-coated tablet contains: Escitalopram (as oxalate) 20mg.
Pharmacokinetics: Escitalopram absorption is almost complete and independent of food intake. The apparent volume of distribution after oral administration is about 12 to 26 L/kg. The plasma protein binding is below 80% for escitalopram and its main metabolised  in the liver to the demethylated 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. 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 CYP2C19.
Some distributuin by the enzymes CYP3A4 and CYP2D6 is possible. The elimination half-life after multiple dosing is about 30 hours and the oral plasma clearance is about 0.69L/min. The major metabolites have significantly longer half-life. Escitalopram and 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 part of the dose excreted as metabolites in the urine.
Escitalopram is used in the following conditions: Major depressive episodes.
Panic anxiety disorder (social phobia).
Generalised anxiety disorder.
Obsessive-compulsive disorder.
Panic disorder with or without agoraphobia.
Dosage/Direction for Use
Escitalopram is administered as a single daily dose and may be taken with or without food.
For major depressive episodes, usual dosage 10mg daily. Depending on individual patients response, the dose may be increased to maximum of 20mg. 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.
For panic disorder with or without agoraphobia, an initial dose of 5mg is recommended for the first week before increasing the dose to 10mg daily. The dose may be further increased, up to a maximum of 20mg daily, dependent on individual patient response.
For generalised anxiety disorder and obsessive-compulsive disorder, initial dosage is 10mg once daily. Depending in the individual patient response, the dose may increased to a maximum of 20mg daily.
For social anxiety, usual dosage is 10mg once daily, usually 2-4 weeks are necessary to obtain symptom relief. The dose may subsequently, depending on individual patient response, be decreased to 5mg or increased to a maximum of 20mg daily.
For elderly patient, initial treatment with half the usually recommended dose and a lower maximum dose should be considered.
Special Precautions
Escitalopram should not be used in the treatment of children and adolescents under the age of 18 years.
Some patients with panic disorder may experience increased anxiety symptoms at the beginning of the treatment with antidepressants.
Escitalopram should be discontinued if the patients develops seizures for the first time, or if there is an increased in seizures frequency (in patients with a previous diagnosis of epilepsy).
It should be used with caution in patients with a history of mania/hypomania, diabetes.
Caution is advised in patients taking SSRIs, particularly in concomitant use with oral anticoagulants, with medicinal products known to affect platelet function and in patients with known bleeding.
Caution is advised if escitalopram is used concomitantly with medicinal products with serotonergic effects such as sumatriptan or other triptans, tramadol and tryptophan.
Caution is advised if escitalopram is used concomitantly with herbal remedies containing St. John's wort, it may result in an increased incidence of adverse reactions.
Use In Pregnancy & Lactation
Pregnancy: Escitalopram should not be used during pregnancy unless clearly necessary and only after careful consideration of the risk/benefit.
Neonates should be observed if maternal use of escitalopram continues into the later stages of pregnancy, particularly in the third trimester. Abrupt discontinuation  should be avoided during pregnancy.
Lactation: It is expected that escitalopram will be excreted into human milk. Consequently, breast-feeding is not recommended during treatment.
Adverse Reactions
Adverse reactions are most frequent during the first or second week of treatment and usually decrease in intensity and frequency with continued treatment.
Decreased appetite, increased appetite, weight increased, anxiety, restlessness, abnormal dreams, decreased libido, anorgasmia, insomnia, somnolence, dizziness, paraesthesia, tremor, sinusitis, yawning, nausea, diarrhea, constipation, vomiting, dry mouth, increased swearing, arthralgia, myalgia, ejaculation disorder and impotence are the common adverse reactions of escitalopram.
Anaphylactic reaction, aggression, depersonalization, hallucination, serotonin syndrome, bradycardia are rarely seen in patients taking escitalopram.
Weight decrease, bruxism, agitation, nervousness, panic attack, confusional state, taste disturbances, sleep disorder, syncope, mydriasis, visual disturbances, tinnitus, tachycardia, epistaxis, gastrointestinal haemorrhages (including rectal haemorrahges), urticara, alopecia, rash, pruritus, metrorrhagia and menorrhagia are some of the uncommon adverse reactions of escitalopram.
It has been associated with the development of akathisia, characteristic by a subjectively unpleasant or distress restlessness and need to move often accompanied by an ability to sit or stand still.
Drug Interactions
As SSRIs have occasionally been associated with bleeding disorders and other effects on the blood, caution is advised when they are given with drugs known to affect platelet function. Sequential prescribing of different types of antidepressant may also produce adverse reaction and an appropriate drug free interval should elapse between stopping one type of antidepressant and starting another.
SSRIs antidepressant should not generally be given to patients receiving MAOIs or for at least 2 weeks after use. No treatment-free period is necessary after stopping a reversible inhibitor of monoamine oxidase type A (RIMA) and starting an SSRI. Adverse effects such as the serotonin syndrome may also consequence of synergistic interaction.
SSRIs may increase anticoagulant activity of some anticoagulants including acenocoumarol and warfarin.
Antidepressants may antagonize the activity of antiepileptics by lowering the convulsive threshold.
Citalopram, fluoxetiene and fluvoxamine may increase plasma concentrations of astemizole or terfenadine by inhibition of their hepatic cytochrome P450 metabolsim and increase the risk of ventricular arrhythmias; together should be avoided.
Rapid development of delirium was reported in patients when Clarithromycin was added to the existing regimen of fluoxetine and nitrazepam, increased plasma-fluoxetine concentrations produced by the inhibition of cytochrome P450 enzymes by Clarithromycin.
Store at a temperature not exceeding 30°C. Protect from light.
MIMS Class
ATC Classification
N06AB10 - escitalopram ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.
FC tab 10 mg x 50's. 20 mg x 50's.
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