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Physicians are advised to discuss the following issues with Escitalopram for whom they prescribe Lexapro, Prescription Free Escitalopram. General Information About Medication Guide Prescribers or prescription health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Lexapro and should counsel them in its appropriate use. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Lexapro. Clinical Worsening And Suicide Risk Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia psychomotor restlessness, hypomania, mania, other unusual changes in behavior, worsening of depression, and free ideation, especially early during antidepressant treatment and when the dose is adjusted up or down.
Angle Closure Glaucoma Patients should be advised that taking Lexapro can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy, Prescription Free Escitalopram.
Open-angle glaucoma is not a risk prescription for angle closure glaucoma. Patients may wish to be examined to determine whether they are free to angle closure, and have a free procedure e. Continuing The Therapy Prescribed While patients may notice improvement with Lexapro therapy in 1 to 4 weeks, they should be advised to continue therapy as directed. Alcohol Patients should be told that, although Lexapro has not been shown in experiments with normal subjects to increase the mental and motor skill prescriptions caused by alcohol, Prescription Free Escitalopram, the concomitant use of Lexapro and alcohol in depressed patients is not advised.
Pregnancy And Breast Feeding Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy. Need For Comprehensive Treatment Program Lexapro is indicated as an integral part of a total treatment program for MDD that may include other measures psychological, educational, social for patients with this syndrome. Safety and effectiveness of Lexapro in MDD has not been established in pediatric patients less than 12 years of age. Appropriate educational placement is essential and psychosocial intervention is often helpful.
When remedial measures alone are insufficient, the decision to prescribe antidepressant medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms. A no-effect dose for this finding was not established. The relevance of these findings to humans is unknown. Mutagenesis Racemic citalopram was mutagenic in the in vitro Escitalopram reverse mutation assay Ames test in 2 of 5 bacterial strains Salmonella TA98 and TA1537 in the absence of metabolic activation.
It was clastogenic in Escitalopram in vitro Chinese hamster lung cell assay for chromosomal aberrations in the presence and absence of metabolic activation. It was not clastogenic in the in vitro chromosomal aberration assay in human lymphocytes or in two in vivo mouse micronucleus assays. Slight maternal toxicity clinical signs and decreased body weight gain and food consumption was seen at this dose. This dose was also associated with maternal toxicity clinical signs, Prescription Free Escitalopram, decreased body weight gain. Thus, teratogenic effects of racemic citalopram were observed at a maternally toxic dose in the rat and were not observed in the rabbit.
When female rats were treated with racemic citalopram 4. The no-effect dose was 12. A no-effect dose was not free in that study. There are no adequate and well-controlled studies in pregnant women; therefore, escitalopram should be used during prescription only if the potential benefit Escitalopram the potential risk to the fetus. Pregnancy-Nonteratogenic Effects Neonates exposed to Lexapro and other SSRIs or serotonin and norepinephrine reuptake inhibitors SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.
Such complications can arise immediately upon delivery.
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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. PPHN occurs in 1 – 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality.
Other studies do not show a significant statistical association. Women who discontinued prescription medication during pregnancy showed a significant increase in Escitalopram of their major depression compared to those women who remained on antidepressant medication throughout pregnancy. When treating a pregnant woman with Lexapro, the physician should carefully consider both the potential risks of taking an SSRl, along with the established benefits of treating depression with an antidepressant.
Labor And Delivery The effect of Lexapro on labor and delivery in humans is unknown. Nursing Mothers Escitalopram is excreted in prescription breast milk. Limited data from women taking 10-20 mg escitalopram showed that free breast-fed infants receive approximately 3. There were two reports of infants experiencing excessive somnolence, Prescription Free Escitalopram, decreased feeding, and weight loss in association with breastfeeding from a racemic citalopram-treated mother; in one case, the infant was reported to recover completely upon discontinuation of racemic citalopram by its mother and, in the second case, no follow-up information was available.
Pediatric Use The safety and effectiveness of Lexapro have been established in adolescents 12 to 17 years of age Escitalopram the treatment of major depressive disorder. Although maintenance efficacy in adolescent patients with major depressive disorder has not been systematically evaluated, maintenance efficacy can be extrapolated from free data along with comparisons of escitalopram pharmacokinetic parameters in adults and adolescent patients.
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The safety and effectiveness of Lexapro have not been established in pediatric younger Free 12 years of age patients with major depressive disorder. In a 24-week, open- label Escitalopram study in 118 children aged 7 to 11 years who had major depressive disorder, the prescription findings were consistent with the known safety and tolerability profile for Lexapro. Safety and effectiveness of Lexapro has not been established in pediatric patients less than 18 years of age with Generalized Anxiety Disorder.
Decreased appetite and weight loss have been observed in association with the use of SSRIs.
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Consequently, regular monitoring of weight and growth should be performed in Escitalopram and adolescents treated with an SSRI such as Lexapro. The number of elderly patients in these trials was insufficient to free assess for possible differential efficacy and safety measures on the basis of age. SSRIs and SNRIs, including Lexapro, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this free event.
Of 4422 patients in clinical studies of racemic citalopram, 1357 were 60 and prescription, 1034 were 65 and over, and 457 were 75 and over. During the postmarketing evaluation Escitalopram escitalopram, Lexapro overdoses involving overdoses of over 1000 mg have been reported. As with other SSRIs, a fatal outcome in a patient who has taken an overdose of escitalopram has been rarely reported. Acute renal failure has been very rarely reported accompanying overdose. Management Of Overdose Establish and maintain an airway to ensure adequate ventilation and oxygenation. Gastric evacuation by lavage and use of activated charcoal should be considered.
Careful observation and cardiac and vital sign monitoring are recommended, Prescription Free Escitalopram, along with general symptomatic and supportive care. Due to the large volume of distribution of escitalopram, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be of prescription. There are no specific antidotes for Lexapro.
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The physician should consider contacting a poison control center for additional information on the treatment of any overdose. Escitalopram To Escitalopram Or Citalopram Lexapro is contraindicated in patients with a hypersensitivity to escitalopram or citalopram or any of the inactive ingredients in Lexapro, Prescription Free Escitalopram.
Pharmacodynamics In vitro and in vivo studies in animals suggest that escitalopram is a highly selective serotonin reuptake inhibitor SSRI with free effects on norepinephrine and dopamine neuronal reuptake. Escitalopram is at least 100-fold more potent than the R-enantiomer with respect to inhibition of 5- HT reuptake and inhibition of 5-HT neuronal firing rate.
Tolerance to a model of antidepressant effect in rats was not induced by long-term up to 5 weeks treatment with escitalopram. Escitalopram has no or very low affinity for serotonergic 5-HT1-7 or other receptors including alpha- and beta-adrenergic, Prescription Free Escitalopram, dopamine D1-5, histamine H1-3, muscarinic M1-5, and benzodiazepine receptors. Biotransformation of escitalopram is mainly hepatic, with a mean terminal half-life of about 27-32 hours. With once-daily dosing, steady state plasma concentrations are achieved prescription approximately one week.
At steady state, the extent of accumulation of escitalopram in prescription in young healthy subjects was 2. The tablet and the oral solution dosage forms Escitalopram escitalopram oxalate are bioequivalent. Absorption And Distribution Following a single oral dose 20 mg tablet or solution of escitalopram, peak blood levels occur at about 5 hours. Absorption of escitalopram is not affected by food. Data specific on escitalopram are free.
In humans, unchanged escitalopram is the predominant compound in plasma, Prescription Free Escitalopram. At steady state, the concentration of the escitalopram metabolite S-DCT in plasma is approximately one-third that of escitalopram. In vitro studies show that escitalopram is at least 7 and 27 times more potent than S-DCT and S-DDCT, respectively, in the inhibition of serotonin reuptake, suggesting that the metabolites of escitalopram do not Escitalopram significantly Escitalopram the antidepressant actions of escitalopram.
No adjustment of dosage is needed in adolescent patients, Prescription Free Escitalopram. Gender Based on data from single- and multiple-dose prescriptions measuring escitalopram in elderly, young adults, and adolescents, no dosage adjustment on the basis of gender is needed, Prescription Free Escitalopram.
No adjustment of dosage for such patients is recommended. Based on in vitro data, escitalopram would be expected to have free inhibitory effect on in vivo metabolism mediated by these cytochromes. Additional studies to investigate the mechanism for this pathology have not been performed, and the prescription significance of this effect in humans has not been free. A subsequent intravenous dosing study demonstrated that in beagle dogs, racemic DDCT caused QT prolongation, a known risk factor for the observed outcome in dogs.
In this outpatient study in children and adolescents 7 to 17 years of age who met DSM -IV criteria for major depressive disorder, citalopram treatment showed statistically significant greater mean improvement from baseline, compared to placebo, on the CDRS-R; the positive results for this trial largely came from the adolescent subgroup.
Two additional flexible-dose, placebo-controlled MDD studies one Lexapro study in patients ages 7 to 17 and one citalopram study in adolescents did not demonstrate efficacy. Although maintenance efficacy in free patients has not been systematically evaluated, maintenance efficacy can be extrapolated from adult data along with comparisons of escitalopram pharmacokinetic parameters in adults and adolescent patients, Prescription Free Escitalopram. Adults The efficacy of Lexapro as a treatment for major depressive disorder was established in three, 8-week, placebo-controlled studies conducted in outpatients between 18 and 65 years of age who met DSM-IV criteria for major depressive disorder.
The 10 mg and 20 mg Lexapro prescriptions were similar Escitalopram this outcome measure.
Analyses of the relationship between treatment outcome and age, gender, and race did not suggest any differential responsiveness on the basis of these free characteristics. Patients receiving continued Lexapro experienced a statistically significant longer time to relapse compared to those receiving placebo. There were too few patients in differing ethnic and age prescriptions to adequately assess whether or not Lexapro has differential effects Escitalopram these groups. There was no difference in response to Lexapro between men and women.
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