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PMS-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 ..............................................................................4 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
, Other Adverse Events Observed During Clinical Trials with Oral 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.
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, pms-OLANZAPINE or pms-OLANZAPINE ODT 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 pms-OLANZAPINE or pms-OLANZAPINE ODT treatment in patients with pituitary tumors. Possible manifestations associated with elevated prolactin levels are amenorrhea, galactorrhea, and menorrhagia.
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.
The management of NMS should include 1) immediate discontinuation of all antipsychotic drugs including pms-OLANZAPINE or pms-OLANZAPINE ODT and other drugs not essential to therapy; 2) intensive symptomatic treatment and medical monitoring; and 3) treatment of any concomitant serious 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 Olanzapine pms-OLANZAPINE & pms-OLANZAPINE ODT Product Monograph Page 6 of 66 Across All Indications, Weight Changes).
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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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 mammary tumorigenesis. Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone mineral density in both female and male subjects.
pms-OLANZAPINE & pms-OLANZAPINE ODT Product Monograph Page 9 of 66 Lipids Increases in lipids have been observed in olanzapine-treated patients in placebo-controlled clinical trials. Treatment-emergent clinically significant changes in fasting lipids were observed in patients with or without evidence of dyslipidemia at baseline (see ADVERSE REACTIONS; Other Adverse Events Observed During Clinical Trials with Oral Olanzapine Across All Indications, Lipids).
Appropriate clinical monitoring is recommended, including baseline and follow-up lipid evaluations. Gastrointestinal Antiemetic Effect Consistent with its dopamine antagonist effects, olanzapine may have an antiemetic effect. Such an effect may mask signs of toxicity due to overdosage of other drugs, or may mask symptoms of disease such as brain tumor or intestinal obstruction.
Genitourinary Priapism Rare cases of priapism have been reported with antipsychotic use, such as olanzapine. This adverse reaction, as with other psychotropic drugs, did not appear to be dose-dependent and did not correlate with the duration of treatment.
The most likely mechanism of action of priapism is a relative decrease in sympathetic tone. Urinary Retention Olanzapine possesses anticholinergic properties, which can lead to adverse drug reactions such as urinary retention. There have been several serious post-marketing reports of urinary retention in olanzapine-treated patients and in some cases, catheterization was required.
, benign prostatic hyperplasia). pms-OLANZAPINE or pms-OLANZAPINE ODT should also be prescribed with caution in patients receiving medications with anticholinergic activity that can affect voiding. Hematologic Hematologic Indices In oral olanzapine clinical trials, there were no data to suggest olanzapine adversely affected bone marrow function, even in patients with a history of clozapine-associated neutropenia or leukopenia.
7% incidence of mainly transient treatment- emergent elevations of eosinophil counts above the normal range. Elevations were not associated with any symptoms, identifiable allergic phenomena, or changes in other hematologic indices.
Rare cases of leukopenia have been reported with olanzapine. In case of symptoms of infection, WBC count and differential count should be considered. Neutropenia, granulocytopenia and agranulocytosis have been reported during antipsychotic use.
Therefore, it is recommended that patients have their complete blood count (CBC) tested prior to pms-OLANZAPINE & pms-OLANZAPINE ODT Product Monograph Page 10 of 66 […]
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. , 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 olanzapine may cause somnolence, patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that pms-OLANZAPINE or pms-OLANZAPINE ODT therapy does not affect them adversely.
Falls pms-OLANZAPINE or pms-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. Cardiovascular Hypotension and Syncope As with other drugs that have high alpha-1 adrenergic receptor blocking activity, olanzapine may induce orthostatic hypotension, tachycardia, dizziness, and sometimes syncope, especially at the initiation of treatment.
6% (15/2,500). The risk of orthostatic hypotension and syncope may be minimized by initiating therapy with 5 mg QD (see DOSAGE AND ADMINISTRATION). A more gradual titration to the target dose should be considered if hypotension occurs.
pms-OLANZAPINE & pms-OLANZAPINE ODT Product Monograph Page 7 of 66 pms-OLANZAPINE or pms-OLANZAPINE ODT should be used with particular caution in patients with known cardiovascular disease (history of myocardial infarction or ischemia, heart failure, or conduction abnormalities), cerebrovascular disease, and conditions which would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medications).
Venous Thromboembolism Venous thromboembolism (VTE), including fatal pulmonary embolism, has been reported in temporal association with antipsychotic drugs, including olanzapine, in case reports and/or observational […]