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AURO-OLANZAPINE ODT is a brand name for Olanzapine, supplied as a tablet (orally disintegrating). 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…
Verbatim from this product's HC label. Tap a section to expand.
The stated frequencies of adverse events represent the proportion of individuals who experienced at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.
It is important to emphasize that although the events were reported during therapy, they were not necessarily caused by the therapy. Clinical Trial Adverse Drug Reactions The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials.
Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The figures cited, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence in the populations studied.
Incidence of Adverse Events Associated with Discontinuation:
Schizophrenia and Related Disorders: In short-term, placebo-controlled trials, there was no statistically significant difference in rates of discontinuation of olanzapine or placebo attributed to adverse events. Overall, 5% of olanzapine- treated patients discontinued treatment for adverse events compared with 6% of placebo-treated patients.
Discontinuations due to ALT (SGPT) elevations, however, were considered to be drug related (2% for olanzapine versus 0% for placebo) (see WARNINGS AND PRECAUTIONS, Renal subsection).
Bipolar Disorder:
Bipolar Mania In short-term, placebo-controlled clinical trials, there was no difference overall in the incidence of discontinuation due to adverse events (2% for olanzapine versus 2% for placebo). Bipolar Maintenance In the long-term (1-year), placebo-controlled clinical trial, of the 225 olanzapine-treated patients, 16% (n = 35) discontinued due to an adverse event, compared with 9% (n = 12) of 136 placebo- treated patients.
In the long-term (1-year), active-controlled clinical trial, of the 217 olanzapine-treated patients, 19% (n = 41) discontinued due to an adverse event, compared with 26% (n = 55) of 214 lithium- treated patients.
, Special Populations, and DOSAGE AND ADMINISTRATION sections.
Pediatrics (< 18 years of age):
The safety and efficacy of olanzapine have not been established in pediatric populations and its use is not recommended. See also WARNINGS and PRECAUTIONS, Pediatrics (< 18 years of age) and ADVERSE REACTIONS, Other Investigational Trials, Adverse Events in Adolescent Patients (ages 13-17 years).
CONTRAINDICATIONS AURO-OLANZAPINE ODT (olanzapine) is contraindicated in those patients with a known hypersensitivity to the drug or the excipients of the product. For a complete listing, see DOSAGE FORMS, COMPOSITION and PACKAGING section.
WARNINGS AND PRECAUTIONS SERIOUS WARNINGS AND PRECAUTIONS Increased Mortality in Elderly Patients with Dementia: Elderly patients with dementia treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo.
6-fold increase in death rate in the drug-treated patients. , pneumonia) in nature. (See WARNINGS AND PRECAUTIONS, Special Populations, Use in Geriatric Patients with Dementia).
General Neuroleptic Malignant Syndrome:
Neuroleptic malignant syndrome (NMS) is a potentially fatal symptom complex that has been reported in association with antipsychotic drugs, including olanzapine. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia).
Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. ), and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system pathology.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Olanzapine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
All Short-Term Trials - Schizophrenia and Bipolar Mania Trials:
In short-term, active-controlled clinical trials, of the 1796 olanzapine-treated patients in comparative clinical trials with haloperidol, 98 (5%) discontinued treatment for adverse events compared with 66 of 810 (8%) haloperidol-treated patients.
9% (372/2500) discontinued due to an adverse event. About half (183/372) of these discontinuations were associated with the underlying psychopathology. 6%) reported as the reason for discontinuation among olanzapine-treated patients were: ALT (SGPT) increased, unintended pregnancy, creatine phosphokinase increased, and convulsion.
Incidence of Commonly Observed Adverse Events:
Schizophrenia and Related Disorders: In the schizophrenia placebo-controlled trials, the most commonly observed adverse events associated with the use of olanzapine (incidence of ≥ 5% and at least twice placebo) were: dizziness (11% for olanzapine vs 4% for placebo), constipation (9% vs 3%), ALT (SGPT) increased (8% vs 3%), personality disorder (8% vs 4%), weight gain (6% vs 1%), akathisia (5% vs 1%), and postural hypotension (5% vs 2%).
Bipolar Disorder:
Bipolar Mania In the bipolar mania monotherapy placebo-controlled trials, the most commonly observed adverse events associated with the use of olanzapine (incidence of ≥ 5% and at least twice placebo) were: somnolence (35% vs 13%), dry mouth (22% vs 7%), dizziness (18% vs 6%), asthenia (15% vs 6%), constipation (11% vs 5%), dyspepsia (11% vs 5%), increased appetite (6% vs 3%), and tremor (6% vs 3%).
In bipolar mania combination placebo-controlled trials, the most commonly observed adverse events associated with the combination of olanzapine and lithium or valproate (incidence of ≥ 5% and at least twice placebo) were: dry mouth (32% for olanzapine combination vs 9% for placebo), weight gain (26% vs 7%), increased appetite (24% vs 8%), dizziness (14% vs 7%), back pain (8% vs 4%), constipation (8% vs 4%), speech disorder (7% vs 1%), increased salivation (6% vs 2%), amnesia (5% vs 2%), and paresthesia (5% vs 2%).
In addition to the latter list of adverse events identified during bipolar mania combination clinical trials tremor (≥ 10%) has also been identified. 9%).
Other Indication Trials:
Abnormal gait and falls have been observed very commonly (≥ 10%) in clinical trials with elderly patients with dementia-related psychosis. Also, urinary incontinence and pneumonia were commonly reported (≥ 1% and < 10%) in these patients.
Page 16 of 63 In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with Parkinson’s disease, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo.
Adverse Events Occurring at an Incidence of 1% or More Among Oral Olanzapine-Treated Patients: Certain portions of the discussion below relating to objective or numeric safety parameters are derived from studies in patients with schizophrenia and have not been duplicated for bipolar […]
The management of NMS should include 1) immediate discontinuation of all antipsychotic drugs including AURO-OLANZAPINE ODT and other drugs not essential to therapy; 2) intensive symptomatic treatment and medical monitoring; and 3) treatment of any concomitant serious Page 5 of 63 medical problems for which specific treatments are available.
There is no general agreement about specific pharmacological treatment for uncomplicated NMS. If a patient requires antipsychotic drug treatment after recovery from NMS, the potential re- introduction of therapy should be very carefully considered.
The patient should be carefully monitored since recurrences of NMS have been reported.
Weight Gain:
Olanzapine was associated with weight gain during clinical trials. Clinically significant weight gain was observed across all baseline body mass index (BMI) categories (see ADVERSE REACTIONS, Other Adverse Events Observed During Clinical Trials with Oral and Intramuscular Olanzapine Across All Indications, Weight Changes).
4 kg. The mean change in weight was comparable for patients with schizophrenia and bipolar mania. A retrospective analysis of 573 patients receiving olanzapine for up to 3 years found that dose was not a significant predictor of greater long-term changes in weight.
In long-term studies (at least 48 weeks), both the magnitude of weight gain and the proportion of olanzapine-treated patients who had clinically significant weight gain were greater than in short- term studies. The percentage of patients who gained ≥ 25% of their baseline body weight with long-term exposure was very common (≥ 10%).
Body Temperature Regulation:
Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents. g. exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration.
Potential Effect on Cognitive and Motor Performance:
Because AURO-OLANZAPINE ODT may cause somnolence, patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that AURO-OLANZAPINE ODT therapy does not affect them adversely.
Falls:
AURO-OLANZAPINE ODT may cause somnolence, postural (orthostatic) hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long- term antipsychotic therapy.
Carcinogenesis and Mutagenesis For animal data, see Part II:
TOXICOLOGY section.
Page 6 of 63 Cardiovascular Hypotension and Syncope:
As with other drugs that have high alpha-1 adrenergic receptor blocking activity, AURO- OLANZAPINE ODT may induce orthostatic hypotension, tachycardia, dizziness, and sometimes syncope, especially at the initiation of treatment. 6% (15/2500).
The risk of orthostatic hypotension and syncope may be minimized by initiating therapy with 5 mg QD (see DOSAGE AND ADMINISTRATION section). A more gradual titration to the target dose should be considered if hypotension occurs. AURO-OLANZAPINE ODT should be used with particular caution in […]