Escitalopram Oxalate

Trade Names:
Lexapro
- Tablets 5 mg
- Tablets 10 mg
- Tablets 20 mg
- Solution, oral 5 mg per 5 mL

Pharmacology

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Inhibits the CNS neuronal uptake of serotonin, potentiating serotonergic activity.

Pharmacokinetics

Absorption

T _max is approximately 5 h. Bioavailability is approximately 80%.

Distribution

Vd is approximately 12 L/kg. Approximately 56% is protein bound.

Metabolism

Metabolized in the liver to 2 metabolites (minimally active); CYP3A4 and CYP2C19 involved in N-demethylation.

Elimination

The half-life is approximately 27 to 32 h. Approximately 8% is recovered in urine as escitalopram and 10% as a metabolite. Cl is 600 mL/min (approximately 7% caused by renal Cl).

Special Populations

No data on patients with CrCl less than 20 mL/min.

Cl of escitalopram is decreased and half-life is prolonged in patients with reduced hepatic function.

AUC and half-life increased approximately 50%.

Pharmacokinetics similar in men and women.

Indications and Usage

Major depressive disorder (MDD); generalized anxiety disorder.

Unlabeled Uses

Panic disorder; posttraumatic stress disorder.

Contraindications

Concurrent use of MAOIs or within 14 days of discontinuing MAOI treatment; coadministration of pimozide; hypersensitivity to escitalopram or citalopram.

Dosage and Administration

PO Start with 10 mg once daily. Dosage may be increased to 20 mg once daily after 1 wk.

PO Start with 10 mg once daily. The dose may be increased to 20 mg after 1 wk. However, 20 mg has not shown a clinical benefit over 10 mg.

PO Start with 10 mg once daily. The dose may be increased to 20 mg after 3 wk.

PO 10 mg/day.

General Advice

• Do not coadminister with citalopram.
• Administer without regard to meals. Administer with food if GI upset occurs.
• Use dosing spoon, cup, or syringe to measure and administer prescribed dose of oral solution.
• Administer once daily in the morning or evening.

Storage/Stability

Store at controlled room temperature (59° to 86°F).

Drug Interactions

Risk of serotonin syndrome may be increased.

May potentiate the effects of alcohol; use of alcohol is not recommended.

Risk of bleeding may be increased.

Excessive beta blockade (eg, bradycardia) may occur.

Consider possibility of decreased escitalopram serum concentrations and reduced efficacy.

Serum levels may be increased by cimetidine.

Use with caution.

May decrease the pharmacologic effect of escitalopram.

Use with caution.

Plasma concentrations may be reduced by escitalopram, decreasing therapeutic effect of ketoconazole.

Serotonin syndrome may occur.

Serotonergic effects of escitalopram may be enhanced; use with caution.

Allow at least 14 days to elapse between discontinuing an MAOI and starting escitalopram. Similarly, allow at least 14 days after stopping escitalopram before starting an MAOI.

Risk of neurologic adverse reactions, including serotonin syndrome, may be increased.

Serum levels may be increased by escitalopram.

Escitalopram plasma concentrations may be elevated, increasing the pharmacologic effects and adverse reactions.

Concurrent use is contraindicated with escitalopram.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Hypertension, palpitation (at least 1%); atrial fibrillation, cardiac failure, deep vein thrombosis, hypotension, MI, orthostatic hypotension, phlebitis, QT prolongation, thrombosis, torsades de pointes, ventricular arrhythmia, ventricular tachycardia (postmarketing).

CNS

Headache (24%); insomnia (14%); somnolence (13%); fatigue (8%); decreased libido, dizziness (7%); abnormal dreaming, decreased appetite, lethargy (3%); paresthesia, yawning (2%); impaired concentration, increased appetite, irritability, light-headedness, migraine (at least 1%); abnormal gait, acute psychosis, aggression, akathisia, anger, choreoathetosis, delirium, delusion, dysarthria, dyskinesia, dystonia, extrapyramidal disorder, hypoesthesia, nightmare, NMS, paranoia, seizures, serotonin syndrome, tardive dyskinesia, tonic-clonic seizures, visual hallucinations (postmarketing).

Dermatologic

Increased sweating (8%); rash (at least 1%); erythema multiforme, necrolysis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria (postmarketing).

EENT

Rhinitis (5%); blurred vision, nasal congestion, tinnitus (at least 1%); diplopia, glaucoma, nystagmus (postmarketing).

Endocrine

Diabetes mellitus, hyperprolactinemia (postmarketing).

GI

Nausea (18%); diarrhea (14%); dry mouth (9%); constipation, indigestion (6%); vomiting (3%); abdominal pain, flatulence, toothache (2%); abdominal cramp, gastroenteritis, heartburn (at least 1%); GI hemorrhage, pancreatitis, rectal hemorrhage (postmarketing).

Genitourinary

Ejaculation disorder (14%); anorgasmia (6%); impotence (3%); menstrual disorder (2%); menstrual cramps, urinary frequency, UTI (at least 1%); acute renal failure, priapism, spontaneous abortion (postmarketing).

Hematologic-Lymphatic

Decreased prothrombin, ecchymosis, hemolytic anemia, increased INR, leukopenia, thrombocytopenia (postmarketing).

Hepatic

Fulminant hepatitis, hepatic failure, hepatic necrosis, hepatitis (postmarketing).

Hypersensitivity

Allergic reaction, angioedema (postmarketing).

Metabolic-Nutritional

Increased weight (at least 1%); hypoglycemia, hypokalemia, SIADH (postmarketing).

Musculoskeletal

Neck/shoulder pain (3%); arthralgia, limb pain, myalgia (at least 1%); myoclonus, rhabdomyolysis (postmarketing).

Respiratory

Sinusitis (3%); bronchitis, coughing, sinus congestion, sinus headache (at least 1%); pulmonary embolism (postmarketing).

Miscellaneous

Influenza-like symptoms (5%); allergy, chest pain, fever, hot flushes (at least 1%).

Precautions

Pregnancy

Category C .

Lactation

Excreted in breast milk.

Children

Safety and efficacy not established for treatment for generalized anxiety disorder. Safety and effectiveness established in children 12 to 17 yr of age for the treatment of MDD.

Elderly

The number of elderly patients studied was insufficient to assess difference in safety and efficacy based on age.

Renal Function

Use with caution in patients with severe renal function impairment.

Hazardous Tasks

May impair judgement, thinking, or motor skills.

Abnormal bleeding

Bleeding episodes have been reported in patients treated with drugs that interfere with serotonin reuptake.

Concomitant illness

Use with caution in patients with concurrent systemic illness.

Discontinuation

When discontinuing treatment, taper the dose to avoid adverse reactions. If treatment is to be discontinued or the dose reduced, gradually taper dose and monitor patient for withdrawal symptoms (eg, abnormal skin sensations, agitation, anxiety, confusion, dizziness, dysphoric mood, irritability, nausea, sweating). If significant withdrawal symptoms develop, reinstitute previous dosing schedule and attempt a less rapid tapering regimen after patient has stabilized.

Hyponatremia

Cases of hyponatremia or SIADH have been reported.

Mania/Hypomania

May activate hypomania or mania.

Screening for bipolar disorder

Not indicated for bipolar depression. Therefore, prior to starting treatment in patients with depressive symptoms, determine if patient is at risk for bipolar disorder.

Seizures

Have been reported. Use with caution in patients with history of seizures.

Serotonin syndrome

Life-threatening serotonin syndrome may occur, particularly with coadministration of serotonergic drugs.

Suicide

Supervise depressed patients at risk of suicide during therapy. Prescribe the smallest quantity consistent with good patient management in order to reduce the risk of overdose. Frequently assess patient being treated for depression for clinical worsening and suicidality, especially when initiating therapy or when the escitalopram dose is increased or decreased.

Overdosage

Symptoms

Coma, dizziness, ECG changes (including QTc prolongation and very rare cases of torsades de pointes), hypotension, insomnia, nausea, seizures, sinus tachycardia, somnolence, vomiting. Acute renal failure has been reported rarely.

Patient Information

• Advise patient to read patient information leaflet before starting therapy and with each refill.
• Advise patient that the medication is usually started at a low dose and then gradually increased until max benefit is obtained.
• Advise patient to take prescribed dose once daily, in the morning or evening, without regard to meals, but to take with food if stomach upset occurs.
• Advise patient, family, or caregiver to use dosing spoon, cup, or syringe to measure and administer prescribed dose of oral solution.
• Advise patient that it may take 1 to 4 wk to note improvement in symptoms and to continue with the prescribed therapy once improvement has been noted.
• Instruct patient to notify health care provider if symptoms do not appear to be getting better or are getting worse, or if bothersome adverse reactions (eg, changes in sexual function, diarrhea, drowsiness, headache, insomnia, nausea, nervousness, unusual sweating) occur.
• Advise patient being treated for depression, and family or caregiver of patient, to be alert for abnormal changes in mood or thinking and to report the following symptoms immediately to health care provider: agitation, anxiety, hostility or aggressiveness, impulsivity, irritability, panic attacks, suicidal thoughts or behavior.
• Advise patient that if medication needs to be discontinued, it will be slowly withdrawn unless safety concerns (eg, rash) require a more rapid withdrawal.
• Advise patient to take frequent sips of water, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs.
• Advise patient to avoid alcoholic beverages and other depressants while taking escitalopram.
• Advise patient that the drug may impair judgement, thinking, or reflexes, and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.

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