Buy Lexapro at CanPharm

Lexapro Information

Lexapro for Adults

• Lexapro (escitalopram oxalate) is indicated for the symptomatic relief of Major Depressive Disorder (MDD).

  
  

• The efficacy of Lexapro in maintaining an antidepressant response, in patients with major depressive disorder who responded during an 8-week, acute-treatment phase while taking Lexapro and were then observed for relapse during a period of up to 36 weeks, was demonstrated in a placebo-controlled trial.

  
  

• Lexapro (escitalopram oxalate) is indicated for the symptomatic relief of anxiety causing clinically significant distress in patients with Generalized Anxiety Disorder.

  
  

• Physicians who elect to use Lexapro for extended periods should periodically re-evaluate the usefulness of the drug for individual patients.

  
  

Lexapro Geriatrics

Although there was no evidence from clinical studies suggesting that use in geriatric population is associated with differences in safety and effectiveness, a greater sensitivity of some older individuals to effects of escitalopram cannot be ruled out. A brief discussion can be found in the appropriate sections (Action and Clinical Pharmacology, Pharmacokinetics; Warnings and Precautions and Dosage and Administration)

• Lexapro (escitalopram oxalate) is contraindicated in patients with known hypersensitivity to escitalopram or any of the excipients of the drug product.

  
  

• Monoamine Oxidase Inhibitors: Cases of serious reactions have been reported in patients receiving selective serotonin reuptake inhibitors (SSRIs) in combination with a monoamine oxidase inhibitor (MAOI) or the reversible MAOI (RIMA), moclobemide, and in patients who have recently discontinued an SSRI and have been started on a MAOI (see Drug Interactions). With the coadministration of an SSRI with MAOI, there have been reports of serious, sometimes fatal reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible fluctuations of vital signs, and mental status changes, including extreme agitation progressing to delirium and coma. Some cases presented with features resembling serotonin syndrome.

  
  

  Therefore, 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 escitalopram treatment before starting a MAOI.

  
  

• Pimozide: Escitalopram should not be used in combination with the anti-psychotic drug pimozide, as results from a controlled study with racemic citalopram indicate that concomitant use is associated with an increased risk of QTc prolongation compared to pimozide alone. This apparent pharmacodynamic interaction occurred in the absence of a clinically significant pharmacokinetic interaction; the mechanism is unknown (see Drug Interactions).

  
  

• Recent analyses of placebo-controlled clinical trial safety databases from SSRIs and other newer antidepressants suggest that use of these drugs in patients under the age of 18 may be associated with behavioral and emotional changes, including an increased risk of suicidal ideation and behavior over that of placebo.

  
  

• The small denominators in the clinical trial database, as well as the variability in placebo rates, preclude reliable conclusions on the relative safety profiles among these drugs.

  
  

• There are clinical trials and post-marketing reports with SSRIs and other newer antidepressants, in both pediatrics and adults, of severe agitation-type adverse events coupled with self-harm and harm to others. The agitation-type events include: akathisia, agitation, emotional lability, hostility, aggression, depersonalization. In some cases, the events occurred within several weeks of starting treatment.

  
  

  Rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behavior is advised in patients of all ages. This includes monitoring for agitation-type emotional and behavioral changes.

  
  

Patients currently taking escitalopram should not be discontinued abruptly, due to risk of discontinuation symptoms. At the time that a medical decision is made to discontinue an SSRI or other newer anti-depressant drug, a gradual reduction in the dose rather than an abrupt cessation is recommended.

When discontinuing treatment, patients should be monitored for symptoms that may be associated with discontinuation (e.g. dizziness, abnormal dreams, sensory disturbances [including paresthesias and electric shock sensations], agitation, anxiety, emotional indifference, impaired concentration, headache, migraine, tremor, nausea, vomiting and sweating) or other symptoms that may be of clinical significance (see Adverse Reactions). A gradual reduction in the dosage over several weeks, rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, dose titration should be managed on the basis of the patient's clinical response (see Adverse Reactions and Dosage and Administration).

Post-marketing reports indicate that some neonates exposed to SSRIs such as escitalopram and other antidepressants late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. When treating a pregnant woman with escitalopram during the third trimester, the physician should carefully consider the potential risks and benefits of treatment (see Warnings and Precautions, Special Populations, Pregnant Women and Nursing Women and Dosage and Administration).

In a study with healthy volunteers, racemic citalopram 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 escitalopram does not affect them adversely.

The following additional Precautions are listed alphabetically.

Lexapro Cardiovascular

Neither escitalopram nor racemic citalopram has 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 drug's premarketing assessment. However, the electrocardiograms (ECG) of patients participating in clinical trials with escitalopram and racemic citalopram indicate that the medications were not associated with the development of clinically significant ECG abnormalities. In line with other SSRIs, including racemic citalopram, escitalopram causes statistically significant, but clinically unimportant decrease in heart rate. In patients <60 years old, the mean decrease with escitalopram was approximately 2.3 bpm, while in patients ≥60 years old, the mean decrease was approximately 0.6 bpm.

Neither escitalopram nor racemic citalopram has been systematically evaluated in diabetic patients; in the case of racemic citalopram, diabetes constituted an exclusion criterion. Rare events of hypoglycaemia were reported for racemic citalopram. Treatment with an SSRI in patients with diabetes may alter glycaemic control (hypoglycaemia and hyperglycaemia). Escitalopram should be used with caution in diabetic patients on insulin or oral hypoglycaemic drugs.

There have been reports of cutaneous bleeding abnormalities, such as ecchymoses and purpura, associated with treatment with SSRIs. Caution is advised in patients taking SSRIs, particularly in concomitant use with drugs known to affect platelet function (e.g. atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti-inflammatory drugs (NSAIDs), as well as in patients with a history of bleeding disorders.

No information is available on the pharmacokinetic or pharmacodynamic effects of escitalopram on patients with hepatic impairment. Information is available for racemic citalopram: compared to normal subjects, the half-life and steady state concentrations were approximately doubled in patients with reduced hepatic function and oral clearance reduced by approximately one third. Consequently, the use of escitalopram in hepatically impaired patients should be approached with caution and a lower dosage is recommended (see Dosage and Administration).

Escitalopram has not been systematically evaluated in patients with a seizure disorder. These patients were excluded from the clinical studies. In clinical trials with escitalopram, convulsions have been reported very rarely (2 out of 3981 patients) in association with treatment with escitalopram. From post-marketing data, the reporting of seizures with escitalopram is comparable to that of other antidepressants. Like other antidepressants, escitalopram should be used with caution in patients with a history of seizure disorder.

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. Caution should be exercised when coadministering escitalopram with other serotonergic drugs.

There have been rare postmarketing reports describing patients with weakness, hyperreflexia and incoordination, following the concomitant use of an SSRI and the antimigraine drug sumatriptan, a 5-HT1 agonist. The possibility of such interaction should be considered if escitalopram is to be used in combination with a 5-HT1 agonist. St-John's Wort: In common with other SSRI's, pharmacodynamic interactions between escitalopram and the herbal remedy St-John's Wort may occur and may result in undesirable effects.

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 consideration to the possible need for hospitalization. In order to minimize the opportunity for overdosage, prescription for escitalopram should be written for the smallest quantity of drug consistent with good patient management.

Because of the well established comorbidity between depression and other psychiatric disorders, the same precautions observed when treating patients with depression should be observed when treating patients with other psychiatric disorders (see Warnings and Precautions, General, Potential Association with Behavioral and Emotional Changes, Including Self-harm ).

In placebo-controlled trials of Lexapro (escitalopram oxalate) activation of mania/hypomania was reported in one patient of the n=715, treated with escitalopram and in none of the n=592 patients treated with placebo. Activation of mania/hypomania has also been reported in a small proportion of patients treated with racemic citalopram, and with other marketed antidepressants. As with other antidepressants, escitalopram should be used with caution in patients with a history of mania/hypomania.

The safety and efficacy of the concurrent use of either escitalopram or racemic citalopram and ECT have not been studied.

As with other antidepressants, cases of hyponatremia and SIADH (syndrome of inappropriate antidiuretic hormone secretion) have been reported with escitalopram and racemic citalopram as a rare adverse event. The majority of these occurrences have been in elderly individuals, some in patients taking diuretics or who were otherwise volume-depleted. Elderly female patients in particular seem to be a group at risk.

No information is available on the pharmacokinetic or pharmacodynamic effects of escitalopram on patients with renal impairment. Based on the information available for racemic citalopram, no dosage adjustment is needed in patients with mild to moderate renal impairment. Since no information is available on the pharmacokinetic or pharmacodynamic effects of either escitalopram or racemic citalopram in patients with severely reduced renal function (creatinine clearance <30 mL/min), escitalopram should be used with caution in these patients (see Dosage and Administration).

The safety of escitalopram during human pregnancy and lactation has not been established. Therefore, escitalopram should not be used during pregnancy, unless the potential benefit to the patient outweighs the possible risk to the foetus.

Studies with escitalopram have not been performed in nursing mothers, but it is known that racemic citalopram is excreted in human milk and it is expected that escitalopram is also excreted into breast milk. Escitalopram should not be administered to nursing mothers unless the expected benefits to the patient outweigh the possible risk to the child.

Post-marketing reports indicate that some neonates exposed to SSRIs such as Lexapro and other antidepressants 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 have included 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 either a direct toxic effect of SSRIs and other newer antidepressants, or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome (see Warnings and Precautions, Serotonin Syndrome). When treating a pregnant woman with Lexapro during the third trimester, the physician should carefully consider the potential risks and benefits of treatment (see Dosage and Administration).

Escitalopram is not indicated for use in patients below the age of 18 (see Warnings and Precautions, General, Potential Association with Behavioral and Emotional Changes, Including Self-harm ).

Approximately 5% of the 715 patients treated with escitalopram in clinical trials of depressive disorder were 60 years of age or over; elderly patients in these trials received daily doses between 10 and 20 mg. No overall significant differences in safety or effectiveness were observed between the elderly and younger subjects, but the number of elderly patients treated was insufficient to adequately assess for differential responses. Greater sensitivity of some older individuals to effects of escitalopram cannot be ruled out. In a multiple-dose pharmacokinetic study, the area under the curve (AUC) and half-life of escitalopram were increased by approximately 50% at steady-state in elderly subjects as compared to young subjects. Consequently, elderly patients should be administered lower doses and a lower maximum dose (see Action and Clinical Pharmacology, Pharmacokinetics and Dosage and Administration).

Adverse events information for Lexapro (escitalopram oxalate) was collected from 715 patients with major depressive disorder (MDD) who were exposed to escitalopram and from 592 patients who were exposed to placebo in double blind, placebo-controlled trials. During clinical trials, all treatment groups were comparable with respect to gender, age and race. The mean age of patients was 41 years (18 to 76 years). Of these patients, approximately 66% were females and 34% were males. The adverse event information for Lexapro in patients with generalized anxiety disorder (GAD) was collected from 832 patients exposed to escitalopram and from 566 patients exposed to placebo in 8-12 week double-blind, placebo-controlled trials. A total of 187 patients exposed to escitalopram and 188 patients exposed to placebo in a 24 to 76 week double-blind phase of a placebo-controlled long-term trial were also included. The demographics of the clinical trial population in GAD were similar to the population of patients included in MDD clinical trials.

From the short-term (8-week) placebo-controlled, phase III studies, the incidence of discontinuation was: 17.3% (124/715) on escitalopram, 15.7% (64/408) on citalopram and 16.4% (97/592) on placebo. Discontinuation due to adverse events was more common in the active treatment groups (5.9% in escitalopram and 5.4% in citalopram) than in the placebo group (2.2%).

The events that were associated with discontinuation of escitalopram in 1% or more of patients at a rate of at least twice that of placebo were: nausea (1.7% vs 0.2%) and ejaculation disorder (2% vs 0% of male patients).

Among the 832 GAD patients who received escitalopram 10-20 mg/day in placebo-controlled trials, 7.8% discontinued treatment due to an adverse event, as compared to 3.2 % of 566 patients receiving placebo. Adverse events that were associated with the discontinuation of at least 1% of patients treated with escitalopram, and for which the rate was higher than the placebo rate, were: dizziness (1.2% vs. 0.2%), fatigue (1.2% vs. 0.2%) and nausea (1.9% vs. 0.2%).

Adverse events that occurred in escitalopram-treated patients in the course of the short-term, placebo-controlled trials with an incidence greater than, or equal to, 10% were: headache and nausea. The incidence of headache was higher in the placebo group, which suggests that this is a non-specific symptom related to the underlying condition or treatment administration. The point prevalence of nausea increased during the first week (as expected with an SSRI) and then decreased to approach placebo levels by the end of the studies.