Dosing and uses of Lexapro (escitalopram)
Adult dosage forms and strengths
tablet
- 5mg
- 10mg
- 20mg
oral solution
- 5mg/5mL
Major Depressive Disorder
10 mg PO qDay; may increase to 20 mg/day after 1 week
Generalized Anxiety Disorder
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
Dosing Considerations
For extended therapy, maintain at lowest effective dose and assess periodically the need for continued therapy
Pediatric dosage forms and 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
Geriatric dosage forms and strengths
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
Lexapro (escitalopram) adverse (side) effects
>10%
Headache (24%)
Nausea (18%)
Ejaculation disorder (9-14%)
Somnolence (4-13%)
Insomnia (7-12%)
1-10%
Xerostomia (4-9%)
Constipation (3-6%)
Fatigue (2-8%)
Libido decrease (3-7%)
Anorgasmia (2-6%)
Flatulence (2%)
Toothache (2%)
Weight gain (1%)
Menstrual disorder (2%)
Neck/shoulder pain (3%)
Rhinitis (5%)
Flu-like syndrome (5%)
Ejaculation disorder (9-14%)
<1%
Arthralgia
Abdominal pain
Abnormal bleeding
Abnormal dreams
Allergy
Blurred vision
Bronchitis
Chest pain
Constipation
Decreased appetite
Decreased concentration
Disrupts platelets/hemostasis
Dizziness
Dyspepsia
Fever
Heartburn
Hot flashes
Impotence
Irritability
Jaw stiffness
Lethargy
Lightheadedness
Menstrual disorder
Hypertension
Palpitations
Migraine
Myalgia
Paresthesia
Rash
Sweating
Tinnitus
Tremor
Urinary frequency
Urinary tract infection
Vertigo
Vomiting
Yawning
Warnings
Black box warnings
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
Drug is not FDA appored for treatment of bipolar depression
In children and young adults, the risks must be weighed against the benefits of taking antidepressants
Patients should be monitored closely for changes in behavior, clinical worsening, and suicidal tendencies; this should be done during initial 1-2 months of therapy and dosage adjustments
The patient’s family should communicate any abrupt changes in behavior to the health-care provider
Worsening behavior and suicidal tendencies that are not part of the presenting symptoms may require discontinuation of therapy
This drug is not approved for use in pediatric patients <12 years
Contraindications
Hypersensitivity
Coadministration with serotonergic drugs
- Concomitant use or within 14 days of MAOIs increases risk of serotonin syndrome
- Symptoms include tremor, myoclonus, diaphoresis, nausea, vomiting, flushing, dizziness, hyperthermia with features resembling neuroleptic malignant syndrome, seizures, rigidity, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma
- Starting escitalopram in a patient who is being treated with linezolid or IV methylene blue is contraindicated because of an increased risk of serotonin syndrome
- If linezolid or IV methylene blue must be administered, discontinue SSRI immediately and monitor for CNS toxicity; may resume 24 hr after last linezolid or methylene blue dose, or after 2 weeks of monitoring (5 weeks for fluoxetine), whichever comes first
Cautions
Pregnancy: 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
NRIs/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 mypomania 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
Prescriptions should be written for smallest quantity consistent with good patient care and the family or care giver alerted to monitor patient for emergence of suicidality and associated behaviors (anxiety, agitation, panic attacks, insomnia, hostility, akathisia, impulsivity, irritabilty)
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 or conditions predisposing to seizures including brain damage and alcoholism
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
Risk of serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions have been reported with SSRIs alone or with concomitant use of serotonergic drugs, with drugs that impair metabolism of serotonin, or with antipsychotics or other dopamine antagonists
No additional benefits at 20 mg/day
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
Pregnancy and lactation
Pregnancy
Pregnancy category: C
Use late in the third trimester associated with complications in newborns and may require prolonged hospitalization, respiratory support, and tube feeding
Persistent pulmonary hypertension of the newborn
- Potential risk of persistent pulmonary hypertension of the newborn when used during pregnancy
- Initial Public Health Advisory in 2006 was based on a single published study; since then, there have been conflicting findings from new studies, making it unclear whether use of SSRIs during pregnancy can cause PPHN
- FDA has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN
- FDA recommendation: FDA advises health-care professionals not to alter their current clinical practice of treating depression during pregnancy and to report any adverse events to the FDA MedWatch program
- A meta-analysis of 7 observational studies, found exposure to SSRIs in late pregnancy (ie, >20 weeks' gestation) more than doubled the risk of PPHN that could not be explained by other etiologies (eg, congenital malformations, meconium aspiration) (BMJ 2014;348:f6932)
Lactation
Excreted in breast milk; consider risk/benefit ratio
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 of Lexapro (escitalopram)
Mechanism of action
S-enantiomer of racemic citalopram; inhibits the reuptake of serotonin, with little or no effect on norepinephrine or dopamine reuptake
Absorption
Bioavailability: 80%
Peak plasma time: 3.5-6.5 hr
Distribution
Protein bound: 56%
Vd: 20 L/kg
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%)
