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NRA-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…
Verbatim from this product's HC label. Tap a section to expand.
Schizophrenia and Related Disorders Adults:
NRA-OLANZAPINE ODT (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 5-20 mg/day was studied (see Part II:
CLINICAL TRIALS). Doses above 20 mg/day have been evaluated from a safety perspective (see Table 5 in Adverse Events, Dose-Dependent Adverse Events subsection); however, efficacy at doses above 20 mg/day has not been systematically evaluated.
Maintenance Therapy in Schizophrenia:
It is recommended that responding patients with schizophrenia be continued on NRA- OLANZAPINE ODT 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 NRA-OLANZAPINE ODT, 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 NRA-OLANZAPINE ODT for the treatment of acute manic or mixed episodes of bipolar disorder should initially continue maintenance therapy at the same dose (see Part II: CLINICAL TRIALS).
section). NRA-OLANZAPINE ODT is not approved for the treatment of elderly patients with dementia. There is insufficient evidence to determine whether CVAEs in elderly patients with dementia are associated specifically with olanzapine or all antipsychotic agents.
Clinical trial data appear to suggest that patients with a dementia diagnosis of vascular or mixed type had a higher likelihood of experiencing CVAEs than other types of dementia. The risks and benefits of the use of NRA-OLANZAPINE ODT in elderly patients with dementia should be assessed taking into account the risk predictors for CVAEs in the individual patient.
Patients/caregivers should be advised to immediately report signs and symptoms of potential CVAEs, such as sudden weakness or numbness in the face, arms, or legs, and speech or vision problems.
Use in Patients with Other Concomitant Illness:
Clinical experience with olanzapine in patients with concomitant illness is limited. Caution is thus advised when using NRA-OLANZAPINE ODT in patients with diseases or conditions that could affect the metabolism or the pharmacodynamic activity of olanzapine (see DOSAGE AND ADMINISTRATION section and Part II: DETAILED PHARMACOLOGY).
Use in Patients with Cardiac Disorders:
NRA-OLANZAPINE ODT has not been evaluated in patients with a recent history of myocardial infarction or unstable heart disease. Patients with these conditions were excluded from pre-marketing clinical trials.
Use in Patients with Diabetes and Risk Factors for Development of Diabetes:
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 ADVERSE REACTIONS, Post-Market Adverse Drug Reactions section).
NRA-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.
The management of NMS should include 1) immediate discontinuation of all antipsychotic drugs including NRA-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.
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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Subsequent daily dosage should be adjusted on the basis of clinical status within a range of 5-20 mg per day. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
General Considerations for Oral Dosing in Special Populations The Elderly or Debilitated Patient: In clinical trials, 44 patients with schizophrenia or related disorders who were 65 years of age or over were treated with olanzapine (5-20 mg daily) (see WARNINGS AND PRECAUTIONS, Special Populations).
Given the limited experience with NRA- OLANZAPINE ODT in the elderly, and the higher incidence of concomitant illness and concomitant medication in this population, NRA-OLANZAPINE ODT should be used with caution. , nonsmoking female patients), or who may be pharmacodynamically more sensitive to NRA-OLANZAPINE ODT.
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. Further dose escalation, when indicated, should be conservative (see WARNINGS AND PRECAUTIONS, Special Populations).
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 NRA-OLANZAPINE ODT at once.
Administration of NRA-OLANZAPINE ODT NRA-OLANZAPINE ODT 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. One blister cell must be separated from the strip prior to peeling the blister backing. The blister backing should be carefully peeled back and the orally disintegrating tablet 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. OVERDOSAGE 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 acute overdose of approximately 2,000 mg of oral olanzapine. Management of Overdose There is no specific antidote for olanzapine.
Induction of emesis is not recommended. , gastric lavage, administration of activated charcoal). The concomitant administration of activated charcoal was shown to reduce the oral bioavailability of olanzapine by 50 to 60%. Symptomatic treatment and monitoring of vital organ function should be instituted according to clinical presentation, including treatment of hypotension and […]
In some cases, a prior increase in body weight has been reported which may be a pre-disposing factor. Appropriate clinical monitoring is advisable in diabetic patients and in patients with risk factors for the development of diabetes mellitus.
Use in Patients with Renal and Hepatic Impairment:
Small single-dose clinical pharmacology studies (see Part II: DETAILED PHARMACOLOGY section) did not reveal any major alterations in olanzapine pharmacokinetics in subjects with renal or hepatic impairment. Given the limited clinical experience with NRA-OLANZAPINE ODT in patients with these conditions, caution should be exercised (see DOSAGE AND ADMINISTRATION section).
Other Concomitant Illnesses:
As olanzapine demonstrated anticholinergic activity in vitro, caution is advised when prescribing for patients with symptomatic prostatic enlargement, narrow-angle glaucoma or paralytic ileus and related conditions. In clinical trials, a single case of pre-existing intracranial hypertension was exacerbated.
ADVERSE REACTIONS 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 NRA-OLANZAPINE ODT Page 13 of 55 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.
All Short-Term Trials - Schizophrenia and Bipolar Mania Trials:
In short-term, active-controlled clinical trials, of the 1796 oral 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. Other adverse events most commonly […]
The patients 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 Across All Indications, Weight Changes).
4 kg. The mean change in weight was comparable for patients with schizophrenia and bipolar mania. A NRA-OLANZAPINE ODT Page 5 of 55 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 NRA-OLANZAPINE ODT may cause somnolence, patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that NRA-OLANZAPINE ODT therapy does not affect them adversely.
Falls:
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, NRA- 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. NRA-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 […]