Escitalopram Oxalate

Brand Name: Lexapro

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Description

Escitalopram Oxalate (Lexapro™) is a medicine for depression and other related problems. Lexapro is a potent selective serotonin reuptake inhibitor (SSRI). Lexapro (escitalopram) is the active isomer of the antidepressant drug Celexa (citalopram).

Pharmacology

You may have to take Lexapro for up to 4 weeks or longer before you begin to feel better. Do not discontinue use of the medication without first contacting your doctor.

Lexapro (Escitalopram Oxalate) is indicated for the treatment of major depressive disorder and maintenance therapy to prevent people with depression from suffering a relapse. The efficacy of Lexapro in the treatment of major depressive disorder was established in part in an 8-week controlled trial of outpatients who diagnoses corresponded most closely with the DSM-IV category of major depressive disorder.

A major depressive episode implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor retardation or aggitation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.

* Listen to the HealthyPlace.com Radio Show on attempting suicide and coping with thoughts of suicide. (show # 11)

The efficacy of Lexapro in hospitalized patients with major depressive disorders has not been adequately studied.

While the longer-term efficacy of Lexapro has not been systematically evaluated, the efficacy of racemic citalopram, of which escitalopram is the active isomer, in maintaining a response following 6-8 weeks of acute treatment in patients with major depressive disorder was demonstrated in two placebo-controlled trials, in which patients were observed for relapse for up to 24-weeks. The efficacy of racemic citalopram in maintaining a response in patients with recurrent major depressive disorder who had responsded and continued to be improved during an initial 22-25 weeks of treatment and were then followed for a period of up to 72-weeks was demonstrated in a third placebo-controlled trial. Nevertheless, the physician who elects to use Lexapro for extended periods of time should periodically re-evaluate the long-term usefullness of the drug for the individual patient.

Contraindications

Lexapro (Escitalopram Oxalate) is contraindicated in patients with known hypersensitivity to escitalopram oxalate or citalopram (Celexa) or any of the inactive ingredients of the drug product.

Monoamine Oxidase Inhibitors
In patients, receiving selective serotonin reuptake inhibitors (SSRIs) in combination with a monoamine oxidase inhibitor (MAOI), there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes, including extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have recently discontinued SSRI treatment and have been started on a MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Therefore, it is recommended that Lexapro (escitalopram) should not be used in combination with a MAOI or within 14 days of discontinuing treatment with a MAOI. Similarly, at least 14 days should elapse after discontinuing Lexapro treatment before starting a MAOI.

Warnings

Visit your prescriber or health care professional for regular checks on your progress. Continue to take your tablets even if you do not immediately feel better. It can take about 4 weeks before you feel the full effect of Lexapro. If you have suicidal thoughts, call your prescriber or health care professional at once. If you are going to have surgery, tell your prescriber or health care professional that you are taking Lexapro.

If you have been taking Lexapro regularly for some time, do not suddenly stop taking it. You must gradually reduce the dose, or your symptoms may get worse. Ask your prescriber or health care professional for advice.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how Lexapro affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of Lexapro. Avoid alcoholic drinks.

Do not treat yourself for coughs, colds, or allergies without asking your prescriber or health care professional for advice. Some ingredients can increase possible side effects.

Precautions

Suicide: The possibility of a suicide attempt is inherent in depression and may persist until remission occurs. Therefore, high risk patients should be closely supervised throughout therapy with Escitalopram Oxalate and consideration should be given to the possible need for hospitalization. In order to minimize the opportunity for overdosage, prescription for Lexapro should be written for the smallest quantity of drug consistent with good patient management.

Activation of Mania/Hypomania: In placebo-controlled trials with Lexapro, some of which included patients with bipolar disorder, mania/hypomania was reported in 0.1% of 715 patients treated with Lexapro versus none of the 592 patients treated with placebo. Activation of mania/hypomania has also been reported in a small proportion of patients with major affective disorders treated with other marketed antidepressants. If a patient enters a manic phase, Lexapro should be discontinued. As with all drugs effective in the treatment of major depressive disorder, Lexapro should be used cautiously in patients with a history of mania.

Seizures: Lexapro has not been systematically evaluated in patients with a seizure disorder. These patients were excluded from clinical studies during the premarketing testing of Lexapro. In clinical trials of Lexapro, no seizures occurred patients treated with Lexapro. Like other antidepressants, Lexapro should be used with caution in patients with a history of seizure disorder.

Serotonin Syndrome: Rarely, the occurrence of serotonin syndrome has been reported in patients receiving SSRIs. A combination of symptoms, possibly including agitation, confusion, tremor, myoclonus and hyperthermia, may indicate the development of this condition.

Hyponatremia: Hyponatremia and SIADH (syndrome of inappropriate antidiuretic hormone secretion) have been reported with Lexapro use as a rare adverse event. All patients with these events have recovered with discontinuation of Lexapro and/or medical intervention.

Hepatic Impairment: The use of citalopram in hepatically impaired patients should be approached with caution and a lower maximum dosage (10 mg/day) is recommended.

Use in Patients with Cardiac Disease: Lexapro has not been systematically evaluated in patients with a recent history of myocardial infarction or unstable heart disease. Patients with these diagnoses were generally excluded from clinical trials during the drugs premarketing assessment.

Use in Diabetic Patients: Clinical experience with Lexapro in patients with concomitant systemic illnesses is limited. Lexapro should be used with caution in diabetic patients on insulin or other antidiabetic drugs.

Interference with Cognitive and Motor Performance: In studies in normal volunteers, Lexapro in doses of 40 mg/day did not impair cognitive function or psychomotor performance. However, psychotropic medications may impair judgement, thinking or motor skills. Consequently, patients should be cautioned against driving a car or operating hazardous machinery until they are reasonably certain that citalopram does not affect them adversely.

Pregnancy and Nursing Mothers: The safety of Lexapro during pregnancy and lactation has not been established. Therefore, Lexapro should not be used during pregnancy, unless, in the opinion of the physician, the expected benefits to the patient markedly outweigh the possible hazards to the fetus. Lexapro is excreted in human milk. Lexapro should not be administered to nursing mothers unless, in the opinion of the treating physician, the expected benefits to the patient markedly outweigh the possible hazards to the child.

Pediatric Use
Safety and effectiveness in children below the age of 18 years have not been established.

Geriatric Use:
Escitalopram pharmacokinetics in subjects age 65 and over were compared to younger subjects in a single and multi-dose study. No overall differences in safety or effectiveness between this group and the younger subjects was observed, but greater sensitivity of some elderly individuals cannot be ruled out. 10 mg is the recommended dosage for elderly patients.

Drug Interactions

Monoamine Oxidase Inhibitors (MAOI)

Do not take citalopram with any of the following medications: •medicines called MAO inhibitors - phenelzine (Nardil®), tranylcypromine (Parnate®), isocarboxazid (Marplan®), selegiline (Eldepryl®)

Switching from Celexa to MAOI or vice versa: At least 14 days should elapse between discontinuation of a MAOI and initiation of therapy with citalopram. Similarly, at least 14 days should be allowed after stopping citalopram before starting a MAOI.

Patients Already Taking Celexa: Lexapro is the active isomer of the Celexa. The patient should not be on both medications at the same time.

CNS Drugs - Given the primary CNS effects of escitalopram, caution should be used when it is taken in combination with other centrally acting drugs. Alcohol - Although racemic citalopram did not potentiate the cognitive and motor effects of alcohol in a clinical trial, as with other psychotropic medications, the use of alcohol by patients taking Lexapro™ is not recommended.

Cimetidine - In subjects who had received 21 days of 40 mg/day racemic citalopram, combined administration of 400 mg/day cimetidine for 8 days resulted in an increase in citalopram AUC and Cmax of 43% and 39%, respectively. The clinical significance of these findings is unknown.

Digoxin - In subjects who had received 21 days of 40 mg/day racemic citalopram, combined administration of citalopram and digoxin (single dose of 1 mg) did not significantly affect the pharmacokinetics of either citalopram or digoxin.

Lithium - Coadministration of racemic citalopram (40 mg/day for 10 days) and lithium (30 mmol/day for 5 days) had no significant effect on the pharmacokinetics of citalopram or lithium. Nevertheless, plasma lithium levels should be monitored with appropriate adjustment to the lithium dose in accordance with standard clinical practice. Because lithium may enhance the serotonergic effects of escitalopram, caution should be exercised when Lexapro™ and lithium are coadministered.

Sumatriptan - There have been rare postmarketing reports describing patients with weakness, hyperreflexia, and incoordination following the use of a selective serotonin reuptake inhibitor (SSRI) and sumatriptan. If concomitant treatment with sumatriptan and an SSRI (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, escitalopram) is clinically warranted, appropriate observation of the patient is advised.

Theophylline - Combined administration of racemic citalopram (40 mg/day for 21 days) and the CYP1A2 substrate theophylline (single dose of 300 mg) did not affect the pharmacokinetics of theophylline. The effect of theophylline on the pharmacokinetics of citalopram was not evaluated.

Warfarin - Administration of 40 mg/day racemic citalopram for 21 days did not affect the pharmacokinetics of warfarin, a CYP3A4 substrate. Prothrombin time was increased by 5%, the clinical significance of which is unknown.

Carbamazepine - Combined administration of racemic citalopram (40 mg/day for 14 days) and carbamazepine (titrated to 400 mg/day for 35 days) did not significantly affect the pharmacokinetics of carbamazepine, a CYP3A4 substrate. Although trough citalopram plasma levels were unaffected, given the enzyme inducing properties of carbamazepine, the possibility that carbamazepine might increase the clearance of escitalopram should be considered if the two drugs are coadministered.

Triazolam - Combined administration of racemic citalopram (titrated to 40 mg/day for 28 days) and the CYP3A4 substrate triazolam (single dose of 0.25 mg) did not significantly affect the pharmacokinetics of either citalopram or triazolam.

Ketoconazole - Combined administration of racemic citalopram (40 mg) and ketoconazole (200 mg) decreased the Cmax and AUC of ketoconazole by 21% and 10%, respectively, and did not significantly affect the pharmacokinetics of citalopram. Ritonavir - Combined administration of a single dose of ritonavir (600 mg), both a CYP3A4 substrate and a potent inhibitor of CYP3A4, and escitalopram (20 mg) did not affect the pharmacokinetics of either ritonavir or escitalopram.

CYP3A4 and -2C19 Inhibitors - In vitro studies indicated that CYP3A4 and -2C19 are the primary enzymes involved in the metabolism of escitalopram. However, coadministration of escitalopram (20 mg) and ritonavir (600 mg), a potent inhibitor of CYP3A4, did not significantly affect the pharmacokinetics of escitalopram. Because escitalopram is metabolized by multiple enzyme systems, inhibition of a single enzyme may not appreciably decrease escitalopram clearance.

Drugs Metabolized by Cytochrome P4502D6 - In vitro studies did not reveal an inhibitory effect of escitalopram on CYP2D6. In addition, steady state levels of racemic citalopram were not significantly different in poor metabolizers and extensive CYP2D6 metabolizers after multiple-dose administration of citalopram, suggesting that coadministration, with escitalopram, of a drug that inhibits CYP2D6, is unlikely to have clinically significant effects on escitalopram metabolism. However, there are limited in vivo data suggesting a modest CYP2D6 inhibitory effect for escitalopram, i.e., coadministration of escitalopram (20 mg/day for 21 days) with the tricyclic antidepressant desipramine (single dose of 50 mg), a substrate for CYP2D6, resulted in a 40% increase in Cmax and a 100% increase in AUC of desipramine. The clinical significance of this finding is unknown. Nevertheless, caution is indicated in the coadministration of escitalopram and drugs metabolized by CYP2D6.

Metoprolol - Administration of 20 mg/day Lexapro™ for 21 days resulted in a 50% increase in Cmax and 82% increase in AUC of the beta-adrenergic blocker metoprolol (given in a single dose of 100 mg). Increased metoprolol plasma levels have been associated with decreased cardioselectivity. Coadministration of Lexapro™ and metoprolol had no clinically significant effects on blood pressure or heart rate.

Electroconvulsive Therapy (ECT) - There are no clinical studies of the combined use of ECT and escitalopram.

BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. Also tell your prescriber or health care professional if you are a frequent user of grapefruit juice, drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

Adverse Reactions

Side effects that you should report to your prescriber or health care professional as soon as possible:

Rare or uncommon:

confusion, dizziness or lightheadedness, skin rash, itching (hives), fast talking and excited feelings or actions that are out of control, suicidal thoughts, vomiting.

Other Side Effects:

The following additional adverse reactions have been reported: agitation or restlessness, blurred vision, diarrhea, difficulty sleeping, drowsiness, dry mouth, fever, frequent urination, headache, indigestion, nausea, increased or decreased appetite, increased sweating, sexual difficulties (decreased sexual ability or desire, ejaculatory delay), taste alterations, tremor (shaking), weight changes.

Male and Female Sexual Dysfunction with SSRIs

Although changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of pharmacologic treatment. In particular, some evidence suggests that SSRIs can cause undesirable sexual experiences.

Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, sexual performance and sexual satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of undesirable sexual experience and performance cited in product labeling are likely to underestimate their actual incidence.

The incidence rates of sexual side effects in patients with major depressive disorder in placebo-controlled trials is as follows:

Adverse Event	Lexapro	Placebo

	In Males Only
Ejaculation Disorder (primarily ejaculatory delay)	9 %	< 1 %
Decreased Libido	4 %	2 %
Impotence	3 %	< 1 %
	In Females Only
Decreased Libido	2 %	< 1 %
Anorgasmia	2 %	< 1 %

There are no adequately designed studies examining sexual dysfunction with Lexapro treatment. Priapism has been reported with all SSRIs.

While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects.

Drug Abuse and Dependence

Lexapro is not a controlled substance.

Physical and Psychological Dependence

Animal studies suggest that the abuse liability of Lexapro is low. Lexapro has not been systematically studied in humans for its potential for abuse, tolerance or physical dependence. The premarketing clinical experience with Lexapro did not reveal any drug seeking behavior. However, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate Lexapro patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse (eg., development of tolerance, incrementations of dose, drug seeking behavior).

Overdose

Signs and Symptoms

There have been 3 reports of overdoses with Lexapro involving doses up to 600 mg. All 3 patients recovered and no symptoms associated with the overdoses were reported. During the post marketing evaluation of Celexa, like other SSRIs, a fatal outcome in a patient who has taken an overdose of Celexa has been rarely reported.

Symptoms most often accompanying citalopram overdose included dizziness, sweating, nausea, vomiting, tremor, and somnolence. In more rare cases, observed symptoms included confusion, loss of consciousness, convulsions, coma, sinus tachycardia, cyanosis, hyperventilation and rhabdomyolysis.

Treatment

Establish and maintain an airway to ensure adequate ventilation and oxygenation. Gastric lavage and use of activated charcoal should be considered. Cardiac and vital sign monitoring are recommended, along with general symptomatic and supportive measures. There are no specific antidotes for Lexapro.

In managing an overdose of Lexapro, consider the possibility of multiple drug involvement.

Dosage

HOW TO USE THIS MEDICINE:

DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed.

Follow the directions for using this medicine provided by your doctor.
Take this medicine with water.
Escitalopram Oxalate (Lexapro) should be administered once daily, in the morning or evening, with or without food. Follow the directions on the prescription label.
Store this medicine at room temperature, away from heat and light.
If you miss a dose of this medicine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Follow your prescriber or health care professional's advice on missed doses. Do not take double or extra doses.
Do not stop taking this medicine without first checking with your doctor.

Adults: The initial dose of Lexapro is 10 mg once daily. (A fixed dose trial of Lexapro demonstrated the effectiveness of both 10mg and 20 mg of Lexapro, but failed to demonstrate a greater benefit of 20 mg over 10 mg.) If the dose is increased to 20 mg, this should occur after a minimum of one week.

Elderly: A single oral dose of 10 mg/day is the recommended dose for most elderly patients.

Hepatic Impairment: Patients with reduced hepatic function should receive dosages of no more than 10 mg/day.

Renal Impairment: No dosage adjustment is necessary for patients with mild or moderate renal impairment. Lexapro should be used with caution in patients with severe renal impairment.

Additional Information: Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.

IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.

How Supplied

5 mg tablets: White to off-white, round, non-scored film coated. Imprint "FL" on one side of the tablet and "5" on the other side. Bottles of 30, 100, 1000 tablets.

10 mg tablets: White to off-white, round, non-scored film coated. Imprint on scored side with "F" on the left side and "L" on the right side. Imprint on the non-scored side with "10." Bottles of 30, 100, 1000 tablets.

20 mg tablets: White to off-white, round, non-scored film coated. Imprint on scored side with "F" on the left side and "L" on the right side. Imprint on the non-scored side with "20." Bottles of 30, 100, 1000 tablets.

NOTE: This information is not intended to cover all possible uses, precautions, interactions, or adverse effects for this drug. If you have questions about the drug(s) you are taking, check with your health care professional.

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The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.