TEVA-ATOMOXETINE 60 MG — DIN 02314592

What is TEVA-ATOMOXETINE?

TEVA-ATOMOXETINE 60 MG contains ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) : 60 MG. It is listed in the Health Canada Drug Product Database under DIN 02314592, held by TEVA CANADA LIMITED, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 01-Jun-2012. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is TEVA-ATOMOXETINE used for?

TEVA-ATOMOXETINE (atomoxetine hydrochloride) is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children 6 years of age and over, adolescents, and adults. A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age 7 years. The symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and must be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes, lack of sustained attention, poor listener, failure to follow through on tasks, poor organization, avoids tasks requiring sustained mental effort, loses things, easily distracted, forgetful. For the Hyperactive-Impulsive type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming, leaving seat, inappropriate running/climbing, difficulty with quiet activities, “on the go,” excessive talking, blurting answers, can't wait turn, intrusive. For a Combined Type diagnosis, both inattentive and hyperactive-impulsive criteria must be met. TEVA-ATOMOXETINE is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Drug treatment is not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential in children and adolescents with this diagnosis and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe drug treatment medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

TEVA-ATOMOXETINE should be administered starting at the lowest possible dose. Dosage should then be individually and slowly adjusted to the lowest effective dose, since individual patient response to TEVA-ATOMOXETINE varies widely. TEVA-ATOMOXETINE is intended for oral administration and may be taken with or without food, either as a single daily dose in the morning or as divided doses in the morning and late afternoon/early evening. Initial improvement of ADHD symptoms is generally observed within 1 to 4 weeks of initiating therapy. If patients miss a dose, they should take it as soon as possible; however, they should not take more than the prescribed total daily amount of TEVA-ATOMOXETINE in any 24-hour period. TEVA-ATOMOXETINE may be discontinued without tapering the dose. Children (6 years and over) and Adolescents up to 70 kg Body Weight: Do not exceed the recommended initial dose and subsequent dose escalations of TEVA-ATOMOXETINE. More rapid dose escalation may be associated with increased rates of somnolence and digestive system complaints. Do not exceed the recommended maximum total daily dose of 1.4 mg/kg or 100 mg, whichever is less. No additional benefit has been demonstrated at doses greater than 1.2 mg/kg/day. The safety of single doses over 1.8 mg/kg/day and total daily doses above 1.8 mg/kg have not been systematically evaluated, and therefore should not be administered because of potential side-effects. TEVA-ATOMOXETINE should be initiated at a total daily dose of approximately 0.5 mg/kg (Step 1) for 7 to 14 days. Based on tolerability, the dose should be successively increased to approximately 0.8 mg/kg/day (Step 2) for 7 to 14 days, and then to approximately 1.2 mg/kg/day (Step 3). After a minimum of 30 days, the maintenance dose should be reassessed and adjusted according to clinical response. The total daily dose in children and adolescents up to 70 kg should not exceed 1.4 mg/kg or 100 mg, whichever is less. As the lowest available capsule strength is 10 mg, the child should weigh at least 20 kg at the time of initiation of therapy. Only whole capsules should be administered. Children and Adolescents over 70 kg Body Weight, and Adults: Do not exceed the recommended initial dose and subsequent dose escalations of TEVA-ATOMOXETINE. Do not exceed the recommended maximum total daily dose of 100 mg. The safety of single doses over 120 mg and total daily doses above 150 mg have not been systematically evaluated and therefore should not be administered because of potential side effects. TEVA-ATOMOXETINE should be initiated at a total daily dose of 40 mg/day (Step 1) for 7 to 14 days. Based on tolerability, the dose should be successively increased to 60 mg/day (Step 2) for 7 to 14 days, and then to 80 mg/day (Step 3). After 2 to 4 additional weeks, the total daily dose may be increased to a maximum of 100 mg in patients who have not achieved an optimal response. The maximum recommended total daily dose in children and adolescents over 70 kg and adults is 100 mg.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

TEVA-ATOMOXETINE (atomoxetine hydrochloride) is contraindicated in patients known to be hypersensitive to atomoxetine or other constituents of the product. TEVA-ATOMOXETINE should not be taken with monoamine oxidase inhibitors (MAOI), or within 2 weeks after discontinuing MAOI. Treatment with MAOI should not be initiated within 2 weeks after discontinuing TEVA-ATOMOXETINE. TEVA-ATOMOXETINE should not be used in patients with pheochromocytoma or a history of pheochromocytoma. In clinical trials, atomoxetine hydrochloride use was associated with an increased risk of mydriasis and therefore its use is not recommended in patients with narrow angle glaucoma. Symptomatic cardiovascular disease. Severe Cardiovascular Disorders: TEVA-ATOMOXETINE should not be used in patients with severe cardiovascular disorders whose condition would be expected to deteriorate if they experienced increases in blood pressure or heart rate that could be clinically important. Moderate to severe hypertension. Advanced arteriosclerosis. Uncontrolled hyperthyroidism.

Warnings and precautions

POTENTIAL ASSOCIATION WITH THE OCCURRENCE OF BEHAVIOURAL AND EMOTIONAL CHANGES, INCLUDING SELF-HARM: An increased risk over placebo for suicide-related events in children and adolescents taking atomoxetine hydrochloride, was identified in a pooled analysis of placebo-controlled trials of 6-18 weeks duration. Of 1357 patients who received atomoxetine hydrochloride, 5 (0.37%) had reports of suicidal ideation compared to 0% of 851 patients who received placebo. In addition, one suicide attempt (overdose) was identified, which occurred in an atomoxetine hydrochloride patient. No completed suicides occurred during these trials. There have been very rare reports of suicidal ideation, suicidal attempts, suicidal depression and completed suicides in children, adolescents and adults. ADHD and its related co-morbidities may be associated with increased risk of suicidal ideation and/or behavior. 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 of emotional and behavioral changes, and clinical worsening. Families and caregivers of pediatric patients being treated with TEVA-ATOMOXETINE should be alerted about the need to monitor patients for the emergence of agitation, anxiety, panic attacks, hostility, irritability, hypomania or mania, unusual changes in behaviour, and other symptoms, as well as the emergence of suicidality particularly after starting treatment or changing the dose. Such symptoms should be reported immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers. Screening Patients for Bipolar Disorder: Particular care should be taken in treating ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in patients at risk for bipolar disorder. Prior to initiating treatment with TEVA-ATOMOXETINE, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. Emergence of New Psychotic or Manic Symptoms: Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania can occur with atomoxetine use at usual doses. If such symptoms occur, consideration should be given to a possible causal role of atomoxetine, and discontinuation of treatment should be considered. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.2% (4 patients with events out of 1939 exposed to atomoxetine for several weeks at usual doses) of atomoxetine-treated patients compared to 0 out of 1056 placebo-treated patients. Pre-Existing Psychosis: Administration of medications for ADHD may also exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Severe Liver Injury: Post-marketing reports indicate that atomoxetine hydrochloride can cause severe liver injury in rare cases, including acute liver failure. Although no evidence of liver injury was detected in clinical trials of about 6000 patients, there have been rare cases in postmarketing experience of clinically significant liver injury that were considered probably or possibly related to atomoxetine hydrochloride. In one patient, liver injury, manifested by elevated hepatic enzymes (up to 40 X upper limit of normal [ULN]) and jaundice (bilirubin up to 12 X ULN), recurred upon rechallenge and was followed by recovery upon drug discontinuation, providing evidence that atomoxetine hydrochloride likely caused the liver injury. This patient recovered from his liver injury, and did not require a liver transplant. Such reactions may occur several m