Dosing & Uses
Dosage Forms & Strengths
tablet
- 5mg
- 10mg
- 20mg
oral solution
- 5mg/5mL
Major Depressive Disorder
Indicated for acute and maintenance treatment of major depressive disorder (MDD)
10 mg PO qDay; may increase to 20 mg/day after 1 week
Generalized Anxiety Disorder
Indicated for acute treatment of generalized anxiety disorder (GAD)
10 mg PO qDay; may increase to 20 mg/day after 1 week; maintain at lowest effective dose and assess need of therapy periodically if extended therapy required
Obsessive-Compulsive Disorder (Off-label)
10 mg PO qDay; may increase to 20 mg/day after 1 week; maintain at lowest effective dose and assess need of therapy periodically if extended therapy required
Insomnia (Off-label)
Secondary to Depression: 5-20 mg PO over 8 week period
Secondary to panic disorder in women: 5-10 mg PO over 8 week period
Vasomotor Symptoms Associated with Menopause (Off-label)
10 mg PO qDay; may increase to 20 mg PO qDay after 4 weeks if symptoms not adequately controlled
Dosage Modifications
Renal impairment
- Mild-to-moderate: No dosage adjustment necessary
- Severe: Use with caution; insufficient number of patients have been evaluated during chronic escitalopram treatment
Hepatic impairment
- Mild-to-severe: 10 mg/day; racemic citalopram clearance decreased resulting in increased plasma concentration
Dosing Considerations
For extended therapy, maintain at lowest effective dose and assess periodically the need for continued therapy
Discontinuation of treatment
- Symptoms associated with discontinuation of SSRIs and SNRIs have been; monitor for symptoms when discontinuing treatment
- Gradual dose reduction rather than abrupt cessation is recommended
- If intolerable symptoms occur following a dose reduction or discontinuation of treatment, then consider resuming the previously prescribed dose; subsequently, continue decreasing the dose at a more gradual rate
Switching to or from a monoamine oxidase inhibitor (MAOI) used to treat for psychiatric disorders
- At least 14 days should elapse between discontinuation of an MAOI and initiation of escitalopram
- Conversely, allow at least 14 days after stopping escitalopram before starting an MAOI
Dosage Forms & Strengths
tablet
- 5mg
- 10mg
- 20mg
oral solution
- 5mg/5mL
Major Depressive Disorder
<12 years: Safety and efficacy not established
≥12 years: 10 mg PO qDay; may increase dose after at least 3 weeks; not to exceed 20 mg/day
Dosage Modifications
Renal impairment
- Mild-to-moderate: No dosage adjustment necessary
- Severe: Use with caution; insufficient number of patients have been evaluated during chronic escitalopram treatment
Hepatic impairment
- Mild-to-severe: 10 mg/day; clearance of racemic citalopram was decreased and plasma concentration were increased.
Dosing Considerations
For extended therapy, maintain at lowest effective dose and assess periodically the need for continued therapy
Discontinuation of treatment
- Symptoms associated with discontinuation of SSRIs and SNRIs have been; monitor for symptoms when discontinuing treatment
- Gradual dose reduction rather than abrupt cessation is recommended
- If intolerable symptoms occur following a dose reduction or discontinuation of treatment, then consider resuming the previously prescribed dose; subsequently, continue decreasing the dose at a more gradual rate
Switching to or from a monoamine oxidase inhibitor (MAOI) used to treat for psychiatric disorders
- At least 14 days should elapse between discontinuation of an MAOI and initiation of escitalopram
- Conversely, allow at least 14 days after stopping escitalopram before starting an MAOI
Major Depressive Disorders/Generalized Anxiety Disorder
10 mg/day is recommended for most elderly; no additional benefits seen at 20 mg/day dose
Dosing Considerations
The elderly are more prone to SSRI/SNRI-induced hyponatremia
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Headache (24%)
Nausea (15-18%)
Ejaculation disorder (9-14%)
Somnolence (4-13%)
Insomnia (7-12%)
1-10%
Xerostomia (4-9%)
Constipation (3-6%)
Fatigue (2-8%)
Diarrhea (8%)
Libido decrease (3-7%)
Anorgasmia (2-6%)
Indigestion (1-6%)
Rhinitis (5%)
Flu-like syndrome (5%)
Neck/shoulder pain (3%)
Decreased appetite (3%)
Vomiting (3%)
Sinusitis (3%)
Lethargy (3%)
Menstrual disorder (2%)
Flatulence (2%)
Toothache (2%)
Yawning (2%)
Menstrual disorder (1%)
Weight gain (1%)
Postmarketing Reports
Blood and lymphatic system disorders: Anemia, agranulocytosis, aplastic anemia, hemolytic anemia, idiopathic thrombocytopenia purpura, leukopenia, thrombocytopenia
Cardiac disorders: Atrial fibrillation, bradycardia, cardiac failure, myocardial infarction, tachycardia, torsades de pointes, ventricular arrhythmia, ventricular tachycardia
Ear and labyrinth disorders: Vertigo
Endocrine disorders: Diabetes mellitus, hyperprolactinemia, SIADH
Eye disorders: Angle closure glaucoma, diplopia, mydriasis, visual disturbance
Gastrointestinal disorder: Dysphagia, gastrointestinal hemorrhage, gastroesophageal reflux, pancreatitis, rectal hemorrhage
General disorders and administration site conditions: Abnormal gait, asthenia, edema, fall, feeling abnormal, malaise
Hepatobiliary disorders: Fulminant hepatitis, hepatic failure, hepatic necrosis, hepatitis
Immune system disorders: Allergic reaction, anaphylaxis
Investigations: Bilirubin increased, decreased weight, QT prolongation, hepatic enzymes increased, hypercholesterolemia, INR increased, prothrombin decreased
Metabolism and nutrition disorders: Hyperglycemia, hypoglycemia, hypokalemia, hyponatremia
Musculoskeletal and connective tissue disorders: Muscle cramp, muscle stiffness, muscle weakness, rhabdomyolysis
Nervous system disorders: Akathisia, amnesia, ataxia, choreoathetosis, cerebrovascular accident, dysarthria, dyskinesia, dystonia, extrapyramidal disorders, grand mal seizures (or convulsions), myoclonus, nystagmus, Parkinsonism, restless legs, seizures, syncope, tardive dyskinesia, tremor
Pregnancy, puerperium and perinatal conditions: Spontaneous abortion
Psychiatric disorders: Acute psychosis, aggression, agitation, anger, anxiety, apathy, completed suicide, confusion, depersonalization, depression aggravated, delirium, delusion, disorientation, feeling unreal, hallucinations (visual and auditory), mood swings, nervousness, nightmare, panic reaction, paranoia, restlessness, self-harm or thoughts of self-harm, suicide attempt, suicidal ideation, suicidal tendency
Renal and urinary disorders: Acute renal failure, dysuria, urinary retention
Reproductive system and breast disorders: Menorrhagia, priapism
Respiratory, thoracic and mediastinal disorders: Dyspnea, epistaxis, pulmonary embolism, pulmonary hypertension of the newborn
Skin and SC tissue disorders: Alopecia, angioedema, dermatitis, ecchymosis, erythema multiforme, photosensitivity reaction, Stevens Johnson syndrome, toxic epidermal necrolysis, urticaria
Vascular Disorders: Deep vein thrombosis, flushing, hypertensive crisis, hypotension, orthostatic hypotension, phlebitis, thrombosis
Warnings
Black Box Warnings
Suicidality and antidepressants
- In short-term studies, antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults (<24 years) taking antidepressants for major depressive disorders and other psychiatric illnesses
- This increase was not seen in patients >24 years; a slight decrease in suicidal thinking was seen in adults >65 years
- Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide
- Monitor patients of all ages initiating antidepressant therapy and closely observe for clinical worsening, suicidality, or unusual changes in behavior
- Advise families and caregivers of the need for close observation and communication with the prescriber
- Not approved children aged <12 years
Contraindications
Hypersensitivity to escitalopram or citalopram
Pimozide
Monoamine oxidase inhibitors (MAOIs)
- Use of MAOIs intended to treat psychiatric disorders with escitalopram or within 14 days of discontinuation
- Use of escitalopram within 14 days of stopping an MAOI intended to treat psychiatric disorders
- Starting escitalopram in a patients being treated with MAOIs such as linezolid or IV methylene blue
Cautions
Conflicting evidence regarding use of SSRIs during pregnancy and increased risk of persistent pulmonary hypertension of the newborn, or PPHN (see Pregnancy)
In neonates exposed to SNRIs/SSRIs late in third trimester: risk of complications such as feeding difficulties, irritability, and respiratory problems
Caution with seizure disorder, bipolar mania, severe renal impairment; not FDA approved for the treatment of bipolar depression
SNRIs/SSRIs have been associated with the development of SIADH; hyponatremia has been reported rarely
May worsen psychosis in some patients and precipitate a shift to mania or hypomania in patients with bipolar disorder
Risk of hyponatremia
Risk of mydriasis; may trigger angle closure attack in patients with angle closure glaucoma with anatomically narrow angles without a patent iridectomy
Bone fractures are associated with antidepressant therapy; consider the possibility of a fracture in patients with unexplained bone pain, swelling, or bruising
Prescribe the smallest quantity of tablets consistent with good patient care and alert family or caregiver to monitor for emergence of suicidality and associated behaviors (anxiety, agitation, panic attacks, insomnia, hostility, akathisia, impulsivity, irritability)
SSRIs/SNRIs increase risk of abnormal bleeding (further increased if concomitant aspirin, NSAIDs or anticoagulants, or hemorrhagic diathesis)
Prolongation of QT interval and ventricular arrhythmias reported, especially in female patients with preexisting QT prolongation or other risk factors
Risk of cognitive and motor function impairment; use caution when operating heavy machinery
Use with caution in patients with history of seizure disorders or conditions predisposing to seizures including brain damage and alcoholism
May cause or exacerbate sexual dysfunction
Gradually taper dose before discontinuation; abrupt discontinuation may cause dysphoric mood, dizziness, sensory disturbances, agitation, confusion, anxiety, headache, insomnia, tinnitus, seizures, irritability
Drug interaction overview
- Escitalopram is a CYP3A4 and CYP2C19 substrate
- Risk of serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions have been reported with SSRIs and SNRIs both when taken alone, but especially when coadministered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort); if symptoms occur, discontinue therapy and initiate supportive treatment; if concomitant use of escitalopram with other serotonergic drugs is clinically warranted, be aware of the increased risk for serotonin syndrome, particularly during treatment initiation and dose increases
- May impair platelet aggregation that can result in increased risk of bleeding events including GI bleeding especially if taken concomitantly with aspiring, warfarin, or NSAIDs
- Owing to primary CNS effects, caution when coadministered with other centrally acting drugs
- Did not potentiate cognitive and motor effects of alcohol in a clinical trial; however, as with other psychotropic medications, alcohol is not recommended
Pregnancy & Lactation
Pregnancy
There are no adequate and well-controlled studies in pregnant women; therefore, use during pregnancy only if the potential benefit justifies the potential risk to the fetus
In some cases, the clinical picture is consistent with serotonin syndrome
Effect on labor and delivery in humans is unknown
Neonates exposed to escitalopram and other SSRIs/SNRIs
- Neonates exposed to SSRIs/SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding
- Such complications can arise immediately upon delivery
- Reported clinical findings include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying
- These features are consistent with toxic effects of SSRIs and SNRIs or, possibly, drug discontinuation syndrome
Lactation
Escitalopram is excreted in human breast milk
Limited data from women taking 10-20 mg escitalopram showed that exclusively breast-fed infants receive a ~3.9% of the maternal weight-adjusted dose of escitalopram and 1.7% of the maternal weight-adjusted dose of desmethylcitalopram
Caution should be exercised and breastfeeding infants should be observed for adverse reactions when administered to a nursing woman
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
S-enantiomer of racemic citalopram; inhibits the reuptake of serotonin, with little or no effect on norepinephrine or dopamine reuptake
Absorption
Peak plasma time: 5 hr (single 20-mg dose)
Bioavailability: 80% (IV citalopram)
Distribution
Protein bound: 56%
Vd: 12 L/kg (citalopram)
Metabolism
CYP3A4, CYP2C19
Metabolites: Insignificant potency
Enzymes inhibited: CYP2D6
Elimination
Half-life: 27-32 hr
Dialyzable: No
Renal clearance: 42 mL/min
Total body clearance: 600 mL/min
Excretion: Urine (8%)
Administration
Oral Administrationº
Administer once daily, in the morning or evening, with or without food
Storage
Store at 20-25ºC (68-77ºF); excursions permitted to 15-30°C (59-86ºF)
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Formulary
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