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RIVA-ATOMOXETINE is a brand name for Atomoxetine, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ...........................................................................3 CONTRAINDICATIONS .................................................................................................4 WARNINGS AND PRECAUTIONS ...............................................................................5…
Verbatim from this product's HC label. Tap a section to expand.
POTENTIAL ASSOCIATION WITH THE OCCURRENCE OF BEHAVIOURAL AND EMOTIONAL CHANGES, INCLUDING SELF-HARM Pediatric Placebo-Controlled Clinical Trial Data: 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.
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.
) Post-Marketing Data: There have been very rare reports of suicidal ideation, suicidal attempts, suicidal depression and completed suicides in children, adolescents and adults (see ADVERSE REACTIONS, Post-Market Adverse Drug Reactions, Tables 8 and 9).
ADHD and its related co-morbidities may be associated with increased risk of suicidal ideation and/or behaviour. Rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behaviour is advised in patients of all ages.
This includes monitoring for agitation-type of emotional and behavioural changes, and clinical worsening. 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.
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 atomoxetine hydrochloride, 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.
, 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. Product Monograph - RIVA-ATOMOXETINE Page 6 of 49 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. Although no evidence of liver injury was detected in clinical trials of about 6000 patients, there have been rare cases in post-marketing 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 months after therapy is started, but laboratory abnormalities may continue to worsen for several weeks after drug is stopped.
One case of hepatic failure leading to a liver transplant has been reported in a child taking atomoxetine. Because of probable under-reporting, it is impossible to provide an accurate estimate of the true incidence of these events. 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 hydrochloride should be discontinued in patients with jaundice or laboratory evidence of liver injury, and should not be restarted. , pruritus, dark urine, jaundice, right upper quadrant tenderness, or unexplained "flu-like" symptoms).
(See also CONSUMER INFORMATION). Allergic Events Although uncommon, allergic reactions, including anaphylactic reactions, rash, angioneurotic edema, and urticaria, have been reported in patients taking atomoxetine hydrochloride. Effects on Growth Growth and development should be monitored during treatment with atomoxetine.
Patients requiring long-term therapy should be monitored and consideration should be given to dose reduction or interrupting therapy in patients who are not growing or gaining weight satisfactorily. Associated with decreased appetite, some patients experienced growth retardation early in therapy in terms of both weight and height gain.
On average, after an initial decrease in weight and height gain, patients treated with atomoxetine recovered to mean weight and height as predicted by group baseline data […]