A-Z Drug Facts > Escitalopram Oxalate

Escitalopram Oxalate

Pronouncation: (es-sye-TAL-oh-pram ox-AL-ate)
Class: SSRI

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 t _½ 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

Renal Function Impairment

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

Elderly

AUC and t _½ increased approximately 50%.

Indications and Usage

Major depressive disorder; generalized anxiety 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

Generalized Anxiety Disorder
Adults

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

Major Depressive Disorder
Adults

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.

Elderly/Hepatic Function Impairment
Adults

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.

Storage/Stability

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

Drug Interactions

5-HT ₁ agonists (eg, sumatriptan)

Risk of serotonin syndrome may be increased.

Alcohol

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

Aspirin, NSAIDs (eg, ibuprofen), warfarin

Risk of bleeding may be increased.

Carbamazepine

Consider possibility of decreased escitalopram serum concentrations and reduced efficacy.

Cimetidine

Serum levels may be increased by cimetidine.

CNS drugs

Use with caution.

Cyproheptadine

May decrease the pharmacologic effect of escitalopram.

Drugs metabolized by CYP2D6

Use with caution.

Ketoconazole

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

Linezolid, St. John's wort, tramadol

Serotonin syndrome may occur.

Lithium

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

MAOIs

Do not use in patients receiving MAOI therapy or within 14 days of stopping treatment.

Metoprolol

Serum levels may be increased by escitalopram.

Pimozide

Concurrent use is contraindicated with escitalopram.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

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

CNS

Headache (24%); insomnia (14%); somnolence (13%); 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, aggression, akathisia, anger, choreoathetosis, delirium, delusion, dysarthria, dyskinesia, dystonia, extrapyramidal disorder, generalized tonic-clonic seizures, hypoesthesia, nightmare, nystagmus, paranoia, seizures, tardive dyskinesia, visual hallucinations (postmarketing).

Dermatologic

Rash (at least 1%); erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (postmarketing).

EENT

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

Endocrine

Prolactinemia (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 (postmarketing).

Genitourinary

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

Hematologic-Lymphatic

Decreased prothrombin, ecchymosis, hemolytic anemia, increased INR, leukopenia, pulmonary embolism, 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%).

Miscellaneous

Fatigue, increased sweating (8%); influenza-like symptoms (5%); allergy, chest pain, fever, hot flushes (at least 1%); neuroleptic malignant syndrome, photosensitivity, serotonin syndrome (postmarketing).

Precautions

Warnings Antidepressants increased the risk of suicidal thinking and behavior in short-term studies in children and adolescents with major depressive disorder and other psychiatric disorders. Closely observe patients who are started on therapy for clinical worsening, suicidality, or unusual changes in behavior.

Monitor Ensure that therapy is periodically reviewed to determine if it needs to be continued without change or if a dose change (eg, increase, decrease, discontinuation) is indicated.

Pregnancy

Category C .

Lactation

Excreted in breast milk.

Children

Safety and efficacy not established.

Renal Function

Use with caution in patients with severe renal function impairment.

Abnormal bleeding

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

Cognitive and motor performance

Inform patients to use caution when operating potentially hazardous machinery (eg, cars) until they know whether the drug impairs their ability.

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.

Serotonin syndrome

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

Seizures

Use with caution in patients with history of seizures. Seizures have been reported.

Suicide

Supervise depressed patients at risk of suicide during initial 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. Instruct patient to immediately notify health care provider if depression worsens or suicidal ideation or behavior occurs.

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 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 not to change the dose or stop taking unless advised by health care provider.
• 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. The following symptoms should be reported 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 drug may impair judgment, thinking, or reflexes and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.

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