Escitalopram oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations containing escitalopram as escitalopram oxalate.
Drugs List
Therapeutic Indications
Uses
Depressive illness
Obsessive-compulsive disorders
Panic disorders with or without agoraphobia
Treatment of generalised anxiety disorder (GAD)
Treatment of social phobia
Dosage
Adults
Major depressive episodes
Initial dose: 10mg (10 drops of 20 mg/ml oral solution) once daily. Dose may be increased to a maximum of 20mg daily (20 drops of 20 mg/ml oral solution), depending on individual patient response.
2 to 4 weeks of treatment is usually required to obtain 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
Initial dose: 5mg (5 drops of 20 mg/ml oral solution) once daily for the first 7 days before a dose increase to 10mg (10 drops of 20 mg/ml oral solution) daily. The dose may be further increased to a maximum of 20mg (20 drops of 20 mg/ml oral solution) daily, depending on the individual patient response.
Maximum effectiveness is reached after about 3 months. Treatment lasts several months.
Social Anxiety Disorder
Initial dose: 10mg (10 drops of 20 mg/ml oral solution) once daily. Usually between 2 to 4 weeks of treatment are necessary to obtain symptom relief. The dose may be subsequently decreased to 5mg (5 drops of 20 mg/ml oral solution) or increased to a maximum of 20mg (20 drops of 20 mg/ml oral solution) daily, depending on individual patient response.
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. The benefits of treatment 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 dose: 10mg (10 drops of 20 mg/ml oral solution) once daily. The dose may be increased to a maximum of 20mg (20 drops of 20 mg/ml oral solution) daily, depending on individual patient response.
Treatment dose and benefits should be reassessed at regular intervals.
Obsessive-compulsive Disorder
Initial dose: 10mg (10 drops of 20 mg/ml oral solution) once daily. The dose may be increased to a maximum of 20mg (20 drops of 20 mg/ml oral solution) daily, depending on individual patient response.
As obsessive-compulsive disorder 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.
Elderly
Aged 65 years and above
Initial treatment: 5mg daily (5 drops of 20 mg/ml oral solution). The dose may increased to a maximum dose of 10mg daily (10 drops of 20 mg/ml oral solution), depending on the patient response.
Patients with Hepatic Impairment
An initial dose of 5mg (5 drops of 20 mg/ml oral solution) daily for the first two weeks is recommended in patients with mild to moderate hepatic impairment. Depending on individual patient response, the dose may be increased to 10mg (10 drops of 20 mg/ml oral solution) daily.
Caution and extra careful titration is recommended in patients with severe hepatic impairment.
Additional Dosage Information
Escitalopram may be started not less than 14 days after discontinuing treatment with an irreversible monoamine oxidase inhibitor (MAOI) and at least one day after discontinuing treatment with the reversible MAOI (RIMA) moclobemide, or with linezolid. At least 7 days should elapse after discontinuing escitalopram treatment, before starting a non-selective MAOI.
Poor metabolisers with respect to CYP2C19
For patients known to be poor metabolisers with respect to CYP2C19, an initial dose of 5mg (5 drops of 20 mg/ml oral solution) daily during the first two weeks of treatment is recommended. Depending on the individual patient response, the dose may be increased to 10mg (10 drops of 20 mg/ml oral solution) daily.
Discontinuation symptoms seen when stopping treatment
Avoid abrupt withdrawal. When stopping treatment with escitalopram, the dose should be gradually reduced over a period of one or two weeks in order to reduce the risk of discontinuation symptoms.
If intolerable symptoms occur following a decrease in dose or upon discontinuation of treatment, consider resuming the previously prescribed dose. Subsequently decrease the dose at a more gradual rate.
Contraindications
Children under 18 years
Within 2 weeks of discontinuing MAOIs
Breastfeeding
Hypomanic psychosis
Long QT syndrome
Manic psychosis
Uncontrolled epileptic disorder
Precautions and Warnings
Electroconvulsive therapy
Family history of long QT syndrome
Patients over 65 years
Predisposition to hyponatraemia
Suicidal ideation
Bradyarrhythmia
Cardiac disorder
Coagulopathy
CYP2C19 poor metaboliser genotype
Decompensated cardiac failure
Diabetes mellitus
Epileptic disorder
Hepatic cirrhosis
History of glaucoma
History of hypomania
History of mania
History of torsade de pointes
Hypocalcaemia
Hypokalaemia
Hypomagnesaemia
Hypomania
Ischaemic heart disease
Narrow angle glaucoma
Pregnancy
Recent myocardial infarction
Renal impairment - creatinine clearance below 30 ml/minute
Severe renal impairment
Correct electrolyte disorders before treatment
Patients at risk of suicide should be closely supervised
Reduce dose in patients with severe hepatic impairment
Reduce dose in patients with severe renal impairment
Advise ability to drive/operate machinery may be affected by side effects
May reduce seizure threshold
Diabetic control may need adjustment
Discontinue treatment if patient develops seizures
May cause hyponatraemia
Monitor ECG in patients at risk of QT prolongation
Monitor ECG prior to and during treatment in existing cardiac abnormalities
Monitor patients for adverse reactions including restlessness & agitation
Monitor patients with epilepsy while taking this treatment
Advise patient to report any signs of cardiac arrhythmias
Advise patients/carers to seek medical advice if suicidal intent develops
Do not increase dosage in patients who develop akathisia
Increased risk of fractures in patients over 50 years
Patients with panic disorder may experience increased anxiety on initiation
Potential for withdrawal symptoms
To discontinue, reduce dose gradually over at least 1-2 weeks
Discontinue if epilepsy is exacerbated
Discontinue if patient enters a manic phase
Discontinue if serotonin syndrome develops
Reduce dose in elderly
Advise patient not to take NSAIDs unless advised by clinician
Advise patient not to take St John's wort concurrently
Advise patient to avoid alcohol during treatment
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 self harm is highest shortly after presentation and the risk of suicide may increase again in the early stages of recovery. There is evidence that in children and adolescents, antidepressants may increase the risk of suicidal thoughts and self harm.
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 disorders.
Patients with a history of suicide related events, those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, and young adults, are at a greater risk of suicidal thought or suicide attempt, and should receive careful monitoring during treatment. (see CSM warnings)
Patients, (and caregivers of patients) should be alerted about the need to monitor for the emergence of suicidal thoughts and behaviour, and to seek medical advice immediately if these symptoms present.
A paradoxical increase in anxiety may be seen in patients with panic disorder at the beginning of antidepressant treatment which usually subsides within 2 weeks. A low starting dose is recommended.
Monitoring of serum magnesium is advised, particularly in elderly patients who may taking diuretics or proton pump inhibitors.
If cardiovascular symptoms, such as palpitations, vertigo, syncope, or seizures develop during treatment, cardiac evaluation including an ECG should be undertaken to exclude a possible malignant cardiac arrhythmia.
When stopping therapy with escitalopram, gradually taper the dose over a period of several weeks or months, according to the patient's need, in order to reduce the risk of discontinuation symptoms, which are more common if discontinuation is abrupt. The risk of symptoms may depend on several factors, including the duration and dose of therapy and the rate of dose reduction. Symptoms usually occur within the first few days of discontinuing treatment, but there are very rare reports in patients who have missed a dose. Symptoms are generally self-limiting and usually resolve within 2 weeks.
Escitalopram has been shown not to affect intellectual function or psychomotor performance. However, any psychoactive medicine 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.
Pregnancy and Lactation
Pregnancy
In pregnancy escitalopram should only be used with caution and with monitoring of the infant.
The safety of SSRIs, such as escitalopram, in human pregnancy has not been established; use only if the potential benefit outweighs the risk.
Escitalopram is the s-enantiomer of citalopram. Citalopram has been found to be present in cord blood. It is not known if escitalopram crosses the human placenta but its molecular weight, protein binding and foetal effects suggests that it will do so.
Most studies do not show an increased risk of major congenital abnormalities after first trimester exposure to SSRIs. Associations have been made between SSRI use and an increased risk of eye abnormalities, omphalocele, craniosynostosis, and cardiac anomalies, the absolute risk appears to be low. Likewise associations have been made between SSRI use and adverse obstetric outcomes including pre-term delivery, low birth weight and spontaneous abortion. Schaefer considers that inadvertent administration of any SSRI in pregnancy does not require termination of pregnancy. Detailed ultrasound may be offered and regular psychiatric and obstetric care to monitor for relapse or complications is recommended (Schaefer 2007).
In the later stages of pregnancy (one study suggesting an association from beyond the 20th week), the use of SSRIs may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). After birth, close observation of neonates exposed to SSRIs for signs of PPHN is recommended. SSRIs may also increase the risk of postpartum haemorrhage within the month prior to birth.
The following symptoms may occur in the neonate after maternal SSRI use in later stages of pregnancy: respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence and difficulty sleeping. These symptoms may be due to either the serotoninergic effects or discontinuation symptoms. In the majority of instances the complications occur immediately or soon after birth, and may present up to 5 days following birth. Dose reduction or tapered discontinuation of treatment in the mother may be considered near term if the mother's clinical course allows. Consideration should be given to restarting immediately after delivery. Observation of the neonate for withdrawal symptoms or adaptation problems for at least 2 days has been recommended when SSRIs have been used up to delivery (Schaefer 2007).
After SSRI treatment near term, it is important to be aware of an increased hemorrhagic tendency in the newborn.
Lactation
Escitalopram is contraindicated in breastfeeding.
Escitalopram is excreted into human milk.
Escitalopram is the s-enantiomer of citalopram. Limited information indicates that maternal doses of escitalopram up to 20 mg daily produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. Based on limited data, escitalopram appears to be preferable to racemic citalopram during breastfeeding because of the lower dosage and milk levels and general lack of adverse reactions in breastfed infants.
Women who take an SSRI during pregnancy and post-partum may have difficulty establishing breastfeeding, additional support may be required. If the mother continues to take escitalopram during breastfeeding, the infant should be observed for drowsiness and poor feeding. (Also note the monitoring required above following near-term exposure in pregnancy).
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Counselling
Patients and caregivers should be alerted about the need to monitor for the emergence of suicidal thoughts and behaviour and the need to seek medical advice immediately if they present.
Advise patients to report any signs of cardiac arrhythmia (e.g. palpitations, fainting).
Advise patients not to self medicate with Aspirin or other NSAID's unless advised by their clinician due to increased risk of bleeding.
Patients should be advised not to take St John's Wort during treatment with escitalopram.
Caution patients about the potential risk of an influence on their ability to drive a car and operate machinery.
Advise patients to avoid alcohol.
Side Effects
Abnormal liver function tests
Abnormal vision
Aggression
Agitation
Akathisia
Alopecia
Anaphylactic reaction
Angioedema
Anorexia
Anorgasmia
Anxiety
Arthralgia
Bradycardia
Bruxism
Confusion
Constipation
Convulsions
Decreased appetite
Depersonalisation
Diarrhoea
Dizziness
Dream abnormalities
Dry mouth
Dyskinesia
Ecchymosis
Ejaculation disorders
Epistaxis
Fatigue
Galactorrhoea
Gastro-intestinal haemorrhage
Hallucinations
Headache
Hepatitis
Hyponatraemia
Impotence
Inappropriate secretion of antidiuretic hormone
Increased appetite
Increased risk of fractures
Increased sweating
Insomnia
Mania
Menorrhagia
Metrorrhagia
Movement disturbances
Myalgia
Mydriasis
Nausea
Nervousness
Oedema
Orthostatic hypotension
Panic attack
Paraesthesia
Priapism
Prolongation of QT interval
Pruritus
Psychomotor restlessness
Pyrexia
Rash
Reduced libido
Restlessness
Serotonin syndrome
Sexual dysfunction
Sinusitis
Sleep disturbances
Somnolence
Suicidal tendencies
Syncope
Tachycardia
Taste disturbances
Thrombocytopenia
Tinnitus
Torsades de pointes
Tremor
Urinary retention
Urticaria
Ventricular arrhythmias
Vomiting
Weight gain
Weight loss
Yawning
Withdrawal Symptoms and Signs
Withdrawal symptoms (dizziness, sensory disturbances, sleep disturbances, agitation, anxiety, nausea, vomiting, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability and visual disturbances) have been observed in some patients after abrupt discontinuation of escitalopram treatment. Most symptoms were mild and self-limiting. In order to avoid withdrawal reactions, tapered discontinuation is recommended.
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last full review date: July 04, 2014
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Summary of Product Characteristics: Cipralex 5mg, 10mg and 20mg film-coated tablets. Lundbeck Ltd. Revised March 2020.
Summary of Product Characteristics: Cipralex oral drops solution, 20mg/ml. Lundbeck Ltd. Revised March 2020.
MHRA 4th February 2008
https://www.mhra.gov.uk/NewsCentre/Pressreleases/CON2033960
Last accessed: July 04, 2014
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https://www.mhra.gov.uk/home/groups/pl-p/documents/publication/con081866.pdf
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MHRA Drug Safety Update December 2011
https://www.mhra.gov.uk/home/groups/dsu/documents/publication/con137782.pdf
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MHRA Drug Safety Update May 2010
https://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON085136
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MHRA Drug Safety Update January 2021 Available at: https://www.mhra.gov.uk
Last accessed: 11 February 2021
NICE Evidence Services Available at: www.nice.org.uk
Last accessed: 24 February 2021
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Escitalopram May 15, 2014
Last accessed: July 04, 2014
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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