SANDOZ ATOMOXETINE 40 MG — DIN 02386445

What is SANDOZ ATOMOXETINE?

SANDOZ ATOMOXETINE 40 MG contains ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) : 40 MG. It is listed in the Health Canada Drug Product Database under DIN 02386445, held by SANDOZ CANADA INCORPORATED, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 30-May-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 SANDOZ ATOMOXETINE used for?

Sandoz 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. Sandoz 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?

Sandoz 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 Sandoz Atomoxetine varies widely. Sandoz Atomoxetine (atomoxetine hydrochloride) 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 Sandoz Atomoxetine in any 24-hour period. Sandoz 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 Sandoz 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. Sandoz 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 Sandoz Atomoxetine. Do not exceed the recommended maximum total daily dose of 100 mg. Sandoz 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

Atomoxetine hydrochloride is contraindicated in patients known to be hypersensitive to atomoxetine or other constituents of the product. Atomoxetine hydrochloride 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 atomoxetine hydrochloride. Atomoxetine hydrochloride 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 Disorder: Atomoxetine hydrochloride 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. Rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behaviour is advised in patients of all ages. Families and caregivers of pediatric patients being treated with atomoxetine hydrochloride 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. 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. 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. Pre-Existing Psychosis: Administration of medications for ADHD may also exacerbate symptoms of behaviour disturbance and thought disorder in patients with a pre-existing psychotic disorder. Severe Liver Injury: Post-marketing reports indicate that atomoxetine can cause severe liver injury in rare cases, including acute liver failure. Atomoxetine hydrochloride should be discontinued in patients with jaundice or laboratory evidence of liver injury, and should not be restarted. Allergic Events: Although uncommon, allergic reactions, including anaphylactic reactions, rash, angioneurotic edema, and urticaria, have been reported in patients taking atomoxetine hydrochloride. Cardiovascular: Atomoxetine hydrochloride can increase heart rate and blood pressure. Sudden Death and Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems: 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 as well as in some patients without structural heart problems. All drugs with sympathomimetic effects prescribed in the management of ADHD should be used with caution in patients who: a) are involved in strenuous exercise or activities, b) use stimulants, or c) have a family history of sudden/cardiac death. Priapism: Rare post-marketing cases of priapism, defined as painful and non-painful penile erection lasting more than 4 hours, have been reported for pediatric and adult patients treated with atomoxetine hydrochloride. Prompt medical attention is required in the event of suspected priapism. Peripheral Vasculopathy, Including Raynaud's Phenomenon: Medications used to treat ADHD, including stimulants and non-stimulant (Sandoz Atomoxetine), are associated with peripheral vasculopathy, including Raynaud's phenomenon. Aggressive Behaviour or Hostility: Patients beginning treatment for ADHD should be monitored for the appearance of, or worsening of, aggressive behaviour or hostility.