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TEVA-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.
Used for: AND CLINICAL USE .............................................................................. 3 CONTRAINDICATIONS .................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
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 Teva-Olanzapine 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.
Teva-Olanzapine Page 6 of 69 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 Across All Indications, Weight Changes).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 Teva-Olanzapine may cause somnolence, patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that Teva- Olanzapine therapy does not affect them adversely.
Falls:
Teva-Olanzapine 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, Teva- Olanzapine 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. Teva-Olanzapine 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 studies. When prescribing Teva-Olanzapine, all potential risk factors for VTE should be identified and preventative measures undertaken, particularly since […]