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APO-OLANZAPINE is a brand name for Olanzapine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
section). 1 Pediatrics Pediatrics: Based on the data submitted and reviewed by Health Canada, the safety and efficacy of olanzapine tablets/olanzapine orally disintegrating tablets in pediatric patients has not been established. 4 Geriatrics).
1 Dosing Considerations). APO-OLANZAPINE (Olanzapine Tablets) and APO-OLANZAPINE ODT (Olanzapine Orally Disintegrating Tablets) Page 5 of 78 2. CONTRAINDICATIONS APO-OLANZAPINE / APO-OLANZAPINE ODT is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
, Post-Market Adverse Drug Reactions).
Cardiac Death:
In a retrospective observational study, patients treated with atypical antipsychotics (including olanzapine) or typical antipsychotics had a similar dose-related increase of presumed sudden cardiac death (SCD) compared to non-users of antipsychotics (almost twice the risk than that for non-users).
In postmarketing reports with olanzapine, the event of SCD has been reported very rarely. Driving and Operating Machinery Potential Effect on Cognitive and Motor Performance: Because olanzapine may cause somnolence, patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that olanzapine therapy does not affect them adversely.
Exercise caution when driving or operating a vehicle or potentially dangerous machinery.
Endocrine and Metabolism 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 8 ADVERSE REACTIONS, Other Adverse Events Observed During Clinical Trials with 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.
APO-OLANZAPINE (Olanzapine Tablets) and APO-OLANZAPINE ODT (Olanzapine Orally Disintegrating Tablets) Page 12 of 78 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.
, Special Populations, Use in Geriatric Patients with Dementia). APO-OLANZAPINE/APO- OLANZAPINE ODT (olanzapine) is not approved for use in elderly patients with dementia. 4. 1 Special Populations). Given the limited experience with olanzapine in the elderly, and the higher incidence of concomitant illness and concomitant medication in this population, olanzapine should be used with caution.
, nonsmoking female patients), or who may be pharmacodynamically more sensitive to olanzapine. When indicated, dose escalation should be performed with caution in these patients.
Patients with Hepatic and/or Renal Impairment:
As clinical experience is lacking in these patients, the lower initial starting dose and slower titration to initial target dose should be considered. 1 Special Populations). 2 Recommended Dose and Dosage Adjustment Bioequivalence of the 15 mg and 20 mg tablets to multiple 5 mg tablets has been demonstrated.
These tablet formulations are equally well absorbed and can be readily interchanged.
Schizophrenia and Related Disorders Adults:
APO-OLANZAPINE should be administered on a once-a-day schedule without regard to meals, generally beginning with 5 to 10 mg, with a target dose of 10 mg/day within several days. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week, since steady state for olanzapine would not be achieved for approximately 1 week in the typical patient.
When dosage adjustments are necessary, dose increments/decrements of 5 mg per day are recommended. , to a dose of 15 mg/day or greater) is normally recommended only after clinical assessment. In clinical trials a dose range of 5 to 20 mg/day was studied (see 14 CLINICAL TRIALS).
Doses above 20 mg/day have been evaluated from a safety perspective (see Table 6 in Adverse Events, Dose-Dependent Adverse Events subsection); however, efficacy at doses above 20 mg/day has not been systematically evaluated.
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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The percentage of patients who gained ≥ 25% of their baseline body weight with long-term exposure was very common (≥ 10%).
Hyperglycaemia:
As with some other antipsychotics, exacerbation of pre-existing diabetes and hyperglycaemia have been reported rarely and diabetic ketoacidosis and diabetic coma including some fatal cases have been reported very rarely during the use of olanzapine, sometimes in patients with no reported history of hyperglycaemia (see 8 ADVERSE REACTIONS; Post-Market Adverse Drug Reactions section).
In some cases, a prior increase in body weight has been reported which may be a predisposing factor. Patients should have baseline and periodic monitoring of blood glucose and body weight. In clinical trials (up to 52 weeks) olanzapine was associated with a greater mean change in glucose relative to placebo.
Treatment-emergent clinically significant changes in fasting glucose were observed in patients with or without evidence of glucose dysregulation at baseline (see 8 ADVERSE REACTIONS, Other Adverse Events Observed During Clinical Trials with Olanzapine Across All Indications, Glucose Changes).
Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population.
Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood. However, epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with the atypical antipsychotics.
Precise risk estimates for hyperglycemia- related adverse events in patients treated with atypical antipsychotics are not available. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness.
Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.
, obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control.
APO-OLANZAPINE (Olanzapine Tablets) and APO-OLANZAPINE ODT (Olanzapine Orally Disintegrating Tablets) Page 13 of 78 Hyperprolactinemia: As with other drugs that block dopamine D2 and/or serotonin 5-HT2 receptors, olanzapine may elevate prolactin levels.
Elevations associated with olanzapine treatment are generally mild, and may decline during continued administration. Since tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin-dependent in vitro, olanzapine should only be administered to patients with previously detected breast cancer if the benefits outweigh the potential risks.
Caution should also be exercised when considering olanzapine treatment in patients with pituitary tumours. Possible manifestations associated with elevated prolactin levels are amenorrhea, galactorrhea, and menorrhagia. As is common with compounds which stimulate prolactin release, the administration of olanzapine resulted in an increase in the incidence of mammary neoplasms in both rats and mice.
The physiological differences between rats and humans with regard to prolactin make the clinical significance of these findings unclear. To date, neither clinical nor epidemiological studies have shown an association between chronic administration of these drugs and […]
Maintenance Therapy in Schizophrenia:
It is recommended that responding patients with schizophrenia be continued on olanzapine at the lowest dose needed to maintain remission. Patients should be reassessed periodically to determine the need for maintenance treatment. While there is no body of evidence available to answer the question of how long the patient should be treated with olanzapine, the effectiveness of maintenance treatment is well established for many other antipsychotic drugs.
Bipolar Disorder Bipolar Mania Adults:
The recommended starting dose for olanzapine is 15 mg administered once a day in monotherapy and 10 mg daily in combination therapy. It may be given without regard to meals as its absorption is not affected by food. The dosage range of olanzapine is from 5 mg to 20 mg per day.
Daily dosage should be adjusted in response to clinical assessment.
Maintenance Therapy in Bipolar Disorder:
Patients who have been receiving and responding to olanzapine for the treatment of acute manic or mixed episodes of bipolar disorder should initially continue maintenance therapy at the same dose (see 14 CLINICAL TRIALS). Subsequent daily dosage should be adjusted on the basis of clinical status within a range of 5 to 20 mg per day.
APO-OLANZAPINE (Olanzapine Tablets) and APO-OLANZAPINE ODT (Olanzapine Orally Disintegrating Tablets) Page 7 of 78 Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
The recommended maximum daily dose of olanzapine is 20 mg. Health Canada has not authorized an indication for pediatric use. 4 Administration APO-OLANZAPINE ODT (orally disintegrating tablet) is intended for oral administration only.
It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. The orally disintegrating tablet breaks easily and should be handled carefully, with dry hands. Direct contact with hands should be avoided if possible.
The orally disintegrating tablet should be pushed out and placed directly in the mouth. The orally disintegrating tablet may also be stirred into 125 mL (4 ounces) of water, milk, coffee, orange juice or apple juice and the contents promptly consumed.
5 Missed Dose If a patient misses a dose by a few hours, advise patient to take as soon as he/she remembers. If most of the day has passed, advise patient to wait until the next scheduled dose. Advise patients to not take 2 doses of olanzapine at once.
5. OVERDOSE Signs and Symptoms Very common symptoms reported in olanzapine overdose (≥ 10% incidence) include tachycardia, agitation/aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
Other medically significant sequelae of olanzapine overdose include delirium, convulsion, possible neuroleptic malignant syndrome, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmias (< 2% of overdose cases) and cardiopulmonary arrest.
Fatal outcomes have been reported for acute overdoses as low as 450 mg of oral olanzapine but survival has also been reported following […]