Indications
Ventus is indicated in the-
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.
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Pharmacology
Escitalopram is an orally
administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the
pure S-enantiomer of the racemic bicyclic phthalate derivative citalopram.
Escitalopram is at least 100 fold more potent than the R-enantiomer with
respect to inhibition of 5-HT reuptake. Escitalopram has no or very low
affinity for serotonergic or other receptors including alpha- and
beta-adrenergic Dopamine, Histamine, Muscarinic and benzodiazepine receptors.
Dosage
Safety of daily doses above 20 mg
has not been demonstrated. Escitalopram Oxalate is administered as a single
daily dose and may be taken with or without food.
Major depressive episodes: Usual
dosage is 10 mg once daily. Depending on individual patient response, the dose
may be increased to a maximum of 20 mg daily. Usually, 2-4 weeks are necessary
to obtain an antidepressant response. After the symptoms resolve, treatment for
at least 6 months is required for consolidation of the response.
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. The dose may be further increased, up to a
maximum of 20 mg daily, dependent on individual patient response. Maximum
effectiveness is reached after about 3 months. The treatment lasts several
months.
Social anxiety disorder: Usual
dosage is 10 mg once daily. Usually, 2-4 weeks are necessary to obtain symptom
relief. The dose may subsequently, depending on individual patient response, be
decreased to 5 mg or increased to a maximum of 20 mg daily. Social anxiety
disorder is a disease with a chronic course, and treatment for 12 weeks is
recommended to consolidate response. Long-term treatment of responders has been
studied for 6 months and can be considered on an individual basis to prevent
relapse; treatment benefits should be re-evaluated at regular intervals. Social
anxiety disorder is a well-defined diagnostic terminology of a specific
disorder, which should not be confounded with excessive shyness.
Pharmacotherapy is only indicated if the disorder interferes significantly with
professional and social activities. The place of this treatment compared to
cognitive behavioural therapy has not been assessed. Pharmacotherapy is part of
an overall therapeutic strategy.
Generalised anxiety disorder:
Initial dosage is 10 mg once daily. Depending on the individual patient
response, the dose may be increased to a maximum of 20 mg daily. Long term
treatment of responders has been studied for at least 6 months in patients
receiving 20 mg/day. Treatment benefits and dose should be re-evaluated at
regular intervals.
Obsessive-Compulsive Disorder:
Initial dosage is 10 mg once daily. Depending on the individual patient
response, the dose may be increased to a maximum of 20 mg daily. As OCD is a
chronic disease, patients should be treated for a sufficient period to ensure
that they are symptom-free. Treatment benefits and dose should be re-evaluated
at regular intervals.
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Administration
Escitalopram should generally be
administered once daily, morning or evening with or without food.
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Interaction
As SSRI or related
antidepressants should not be started until 2 weeks after stopping an MAOI.
Conversely, an MAOI should not. be started until at least a week after an SSRI
or related antidepressant has been stopped (2 weeks in the case of paroxetine
and sertraline, at least 5 weeks in the case of fluoxetine).
Contraindications
Escitalopram is contraindicated
in patients with known hypersensitivity to Escitalopram or Citalopram or any of
the inactive ingredients of the drug product. Concomitant use of escitalopram
in patients taking monoamine oxidase/pimozide is contraindicated.
Side Effects
SSRIs are less sedating and have
fewer antimuscarinic and cardiotoxic effects than tricyclic antidepressants.
Side-effects of the SSRIs include gastrointestinal effects (dose-related and
fairly common include nausea, vomiting, dyspepsia, abdominal pain, diarrhoea,
constipation), anorexia with weight loss (increased appetite and weight gain
also reported) and hypersensitivity reactions including rash, urticaria,
angioedema, anaphylaxis, arthralgia, myalgia, and photosensitivity; other
side-effects include dry mouth, nervousness, anxiety, headache, insomnia,
tremor, dizziness, asthenia, hallucinations, drowsiness, convulsions,
galactorrhoea, sexual dysfunction, urinary retention, sweating, hypomania or mania,
movement disorders and dyskinesias, visual disturbances.
Pregnancy & Lactation
When treating a pregnant woman
with Escitalopram during the third trimester, the physician should carefully
consider the potential risks and benefits of treatment. It is excreted in human
breast milk. The decision whether to continue or discontinue either nursing or
Escitalopram therapy should take into account the risk of citalopram exposure
for the infant and the benefits Escitalopram treatment for the mother.
Precautions & Warnings
SSRIs should be used with caution
in patients with epilepsy (avoid if poorly controlled, discontinue if
convulsions develop), concurrent electroconvulsive therapy (prolonged seizures
reported with fluoxetine), history of mania, cardiac disease, diabetes
mellitus, angle-closure glaucoma, concomitant use of drugs that increase risk
of bleeding, history of bleeding disorders (especially gastro-lntestinal
bleeding), hepatic and renal impairment.
Use in Special Populations
Elderly patients (>65 years of
age): Initial dosage is 5 mg once daily. Depending on the individual patient
response the dose may be increased to 10 mg daily. The efficacy of escitalopram
in social anxiety disorder has not been studied in elderly patients.
Children and adolescents (<18
years): Ventus 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.
Caution is advised in patients with severely reduced renal function (CLCR less
than 30 ml/min).
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. Depending on individual
patient response, the dose may be increased to 10 mg daily. Caution and extra
careful dose titration is advised in patients with severely reduced hepatic
function.
Poor metabolizers 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. Discontinuation symptoms seen when stopping
treatment. Abrupt discontinuation should be avoided.
When stopping treatment with
escitalopram the dose should be gradually reduced over a period of at least one
to two weeks in order to reduce the risk of discontinuation symptoms. If
intolerable symptoms occur following 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.
Overdose Effects
Symptoms: Symptoms seen in a
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
interval, prolongation, and arrhythmia) and electrolyte/fluid balance
conditions (hypokalaemia, hyponatremia).
Management: 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. ECG monitoring is advised in case of
overdose, in patients with congestive heart failure/bradyarrhythmias, in
patients using concomitant medications that prolong the QT-interval, or in patients
with altered metabolism, e.g. liver impairment.
Therapeutic Class
SSRIs & related
anti-depressant drugs
Storage Conditions
Store below 30°C temperature and
protect from light & moisture. Keep the medicine out of the reach of
children.
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