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STRATTERA (ATOMOXETINE HCL): WARNINGS

Suicidal Ideation

Atomoxetine (Strattera) capsules increased the risk of suicidal ideation in short-term studies in children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD). Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of Atomoxetine HCl (Strattera) in children and adolescents have revealed a greater risk of suicidal ideation early during treatment in those receiving this drug. There were a total of 12 trials (11 in ADHD and 1 in enuresis) involving over 2200 patients (including 1357 patients receiving Atomoxetine HCl (Strattera) capsules and 851 receiving placebo). The average risk of suicidal ideation in patients receiving Strattera was 0.4% (5/1357 patients), compared to none in placebo-treated patients. There was 1 suicide attempt among these approximately 2200 patients, occurring in a patient treated with this medicine. No suicides occurred in these trials. All reactions occurred in children 12 years of age or younger. All reactions occurred during the first month of treatment. It is unknown whether the risk of suicidal ideation in pediatric patients extends to longer-term use. A similar analysis in adult patients treated with Atomoxetine Hydrochloride (Strattera) for either ADHD or major depressive disorder (MDD) did not reveal an increased risk of suicidal ideation or behavior in association with the use of Atomoxetine Hydrochloride (Strattera) capsules.

All pediatric patients being treated with this medication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

The following symptoms have been reported with Strattera (Atomoxetine): agitation, anxiety, panic attacks, irritability, insomnia, hostility, impulsivity, aggressiveness, akathisia (psychomotor restlessness), hypomania and mania. Although a causal link between the emergence of such symptoms and the emergence of suicidal impulses has not been established, there is a concern that such symptoms may represent precursors to emerging suicidality. Thus, patients being treated with Strattera (Atomoxetine) capsules should be observed for the emergence of such symptoms.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients who are experiencing emergent suicidality or symptoms that might be precursors to emerging suicidality, especially if these symptoms are severe or abrupt in onset, or were not part of the patient's presenting symptoms.

Families and caregivers of pediatric patients being treated with Strattera (Atomoxetine HCl) should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers.

Severe Liver Injury

Postmarketing reports indicate that Strattera (Atomoxetine HCl) capsules can cause severe liver injury. Although no evidence of liver injury was detected in clinical trials of about 6000 patients, there have been rare cases of clinically significant liver injury that were considered probably or possibly related to Strattera (Atomoxetine Hydrochloride) use in postmarketing experience. Because of probable underreporting, it is impossible to provide an accurate estimate of the true incidence of these reactions. Reported cases of liver injury occurred within 120 days of initiation of atomoxetine in the majority of cases and some patients presented with markedly elevated liver enzymes [ > 20 X upper limit of normal (ULN)], and jaundice with significantly elevated bilirubin levels ( > 2 X ULN), followed by recovery upon atomoxetine discontinuation. In one patient, liver injury, manifested by elevated hepatic enzymes up to 40 X ULN and jaundice with bilirubin up to 12 X ULN, recurred upon rechallenge, and was followed by recovery upon drug discontinuation, providing evidence that Strattera (Atomoxetine Hydrochloride) capsules likely caused the liver injury. Such reactions may occur several months after therapy is started, but laboratory abnormalities may continue to worsen for several weeks after drug is stopped. The patient described above recovered from his liver injury, and did not require a liver transplant. However, severe liver injury due to any drug may potentially progress to acute liver failure resulting in death or the need for a liver transplant.

Atomoxetine (Strattera) should be discontinued in patients with jaundice or laboratory evidence of liver injury, and should not be restarted. Laboratory testing to determine liver enzyme levels should be done upon the first symptom or sign of liver dysfunction (e.g., dark urine, pruritus, jaundice, right upper quadrant tenderness, or unexplained "flu like" symptoms).

Serious Cardiovascular Events

Sudden Death and Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems

Children and Adolescents

Sudden death has been reported in association with atomoxetine treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, atomoxetine generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the noradrenergic effects of atomoxetine.

Adults

Sudden deaths, stroke, and myocardial infarction have been reported in adults taking atomoxetine at usual doses for ADHD. Although the role of atomoxetine in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Consideration should be given to not treating adults with clinically significant cardiac abnormalities.

Assessing Cardiovascular Status in Patients being Treated with Atomoxetine

Children, adolescents, or adults who are being considered for treatment with atomoxetine should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during atomoxetine treatment should undergo a prompt cardiac evaluation.

Effects on Blood Pressure and Heart Rate

Atomoxetine (Strattera) capsules should be used with caution in patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease because it can increase blood pressure and heart rate. Pulse and blood pressure should be measured at baseline, following Atomoxetine HCl (Strattera) dose increases, and periodically while on therapy.

In pediatric placebo-controlled trials, Strattera treated subjects experienced a mean increase in heart rate of about 6 beats/minute compared with placebo subjects. At the final study visit before drug discontinuation, 2.5% (36/1434) of Atomoxetine HCl (Strattera) capsules treated subjects had heart rate increases of at least 25 beats/minute and a heart rate of at least 110 beats/minute, compared with 0.2% (2/850) of placebo subjects. There were 1.1% (15/1417) pediatric Atomoxetine Hydrochloride (Strattera) treated subjects with a heart rate increase of at least 25 beats/minute and a heart rate of at least 110 beats/minute on more than one occasion. Tachycardia was identified as an adverse event for 0.3% (5/1597) of these pediatric subjects compared with 0% (0/934) of placebo subjects. The mean heart rate increase in extensive metabolizer (EM) patients was 5.0 beats/minute, and in poor metabolizer (PM) patients 9.4 beats/minute.

Atomoxetine Hydrochloride (Strattera) capsules treated pediatric subjects experienced mean increases of about 1.6 and 2.4 mm Hg in systolic and diastolic 179 blood pressures, respectively compared with placebo. At the final study visit before drug discontinuation, 4.8% (59/1226) of 180 Strattera treated pediatric subjects had high systolic blood pressure measurements compared with 3.5% (26/748) of placebo subjects. High systolic blood pressures were measured on 2 or more occasions in 4.4% (54/1226) of Strattera (Atomoxetine) treated subjects and 1.9% (14/748) of placebo subjects. At the final study visit before drug discontinuation, 4.0% (50/1262) of Strattera (Atomoxetine) capsules treated pediatric subjects had high diastolic blood pressure measurements compared with 1.1% (8/759) of placebo subjects. High diastolic blood pressures were measured on 2 or more occasions in 3.5% (44/1262) of Strattera (Atomoxetine HCl) treated subjects and 0.5% (4/759) of placebo subjects. (High systolic and diastolic blood pressure measurements were defined as those exceeding the 95th percentile, stratified by age, gender, and height percentile - National High Blood Pressure Education Working Group on Hypertension Control in Children and Adolescents.)

In adult placebo-controlled trials, Strattera (Atomoxetine HCl) capsules treated subjects experienced a mean increase in heart rate of 5 beats/minute compared with placebo subjects. Tachycardia was identified as an adverse event for 1.5% (8/540) of these adult atomoxetine subjects compared with 0.5% (2/402) of placebo subjects.

Strattera (Atomoxetine Hydrochloride) treated adult subjects experienced mean increases in systolic (about 2.0 mm Hg) and diastolic (about 1.0 mm Hg) blood pressures compared with placebo. At the final study visit before drug discontinuation, 2.2% (11/510) of Strattera (Atomoxetine Hydrochloride) capsules treated adult subjects had systolic blood pressure measurements >= 150 mm Hg compared with 1.0% (4/393) of placebo subjects. At the final study visit before drug discontinuation, 0.4% (2/510) of Atomoxetine (Strattera) treated adult subjects had diastolic blood pressure measurements >= 100 mm Hg compared with 0.5% (2/393) of placebo subjects. No adult subject had a high systolic or diastolic blood pressure detected on more than one occasion.

Orthostatic hypotension and syncope have been reported in patients taking Atomoxetine (Strattera) capsules. In child and adolescent trials, 0.2% (12/5596) of Atomoxetine HCl (Strattera) treated patients experienced orthostatic hypotension and 0.8% (46/5596) experienced syncope. In short199 term child and adolescent controlled trials, 1.8% (6/340) of Atomoxetine HCl (Strattera) capsules treated patients experienced orthostatic hypotension compared with 0.5% (1/207) of placebo-treated patients. Syncope was not reported during short-term child and adolescent placebo-controlled ADHD trials. Atomoxetine Hydrochloride (Strattera) should be used with caution in any condition that may predispose patients to hypotension, or conditions associated with abrupt heart rate or blood pressure changes.

Peripheral vascular effects

There have been spontaneous postmarketing reports of Raynaud's phenomenon (new onset and exacerbation of preexisting condition).

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