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OLANZAPINE FOR is a brand name for Olanzapine, supplied as a powder for solution. 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.
Reconstitution. Olanzapine for Injection is intended for intramuscular use only. 7. WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General Clinical experience with olanzapine in patients with concomitant illness is limited.
Caution is thus advised when using Olanzapine for Injection in patients with diseases or conditions that could affect the metabolism or the pharmacodynamic activity of olanzapine (see 4 DOSAGE AND ADMINISTRATION section and 10 CLINICAL PHARMACOLOGY).
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.
Falls:
Olanzapine for Injection 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.
Anticholinergic effects 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.
Carcinogenesis and Mutagenesis For animal data, see 16 NON-CLINICAL TOXICOLOGY section. Cardiovascular Olanzapine 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.
Due to the more rapid and higher peak plasma concentrations following intramuscular compared to oral administration (see 10 CLINICAL PHARMACOLOGY section), particular caution is advised with the use of Olanzapine for Injection. Olanzapine for Injection should not be administered to patients with unstable medical conditions, such as acute or unstable cardiovascular conditions such as myocardial infarction, unstable angina pectoris, severe hypotension and/or bradycardia, or sick sinus syndrome.
If the patient’s medical history with regard to unstable medical conditions cannot be determined, the risks and benefits of IM olanzapine should be considered in relation to other alternative treatments.
Olanzapine for Injection Page 8 of 51 Hypotension and Syncope:
As with other drugs that have high alpha-1 adrenergic receptor blocking activity, Olanzapine for Injection may induce orthostatic hypotension, tachycardia, dizziness, and sometimes syncope, especially at the initiation of treatment.
, 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 Olanzapine for Injection Page 9 of 51 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 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%).
, Special Populations, Use in Geriatric Patients with Dementia). 5 mg and 10 mg of intramuscular olanzapine for injection have been shown to be effective in controlling agitation in patients with schizophrenia (see 14 CLINICAL TRIALS).
Individual doses of more than 10 mg of intramuscular olanzapine have not been studied and are not recommended.
Usual Dose for Agitated Patients with Schizophrenia and Bipolar Mania:
The usual initial dose for olanzapine injection is 10 mg, administered as a single intramuscular injection. 5 mg) may be given, on the basis of individual clinical status.
Repeat and Maximum Dose:
In clinical trials over a 24 hour period, a minority of patients required a second dose, and only a small percent of patients required a third dose of olanzapine (see 14 CLINICAL TRIALS). Thus safety information on the use of repeated doses of Olanzapine for Injection is limited.
Nevertheless, if warranted by the clinical situation, a second dose, 5-10 mg, may be administered 2 hours after the first injection. A third dose, if required, should be given no sooner than four hours after the second dose. The safety of total daily doses greater than 30 mg has not been evaluated in clinical trials.
The recommended maximum daily dose of olanzapine is 20 mg, with no more than three injections in a 24 hour period. Olanzapine for Injection is intended for intramuscular use only. Do not administer intravenously or subcutaneously. Inject slowly, deep into the muscle mass.
Concomitant administration of intramuscular olanzapine and parenteral benzodiazepine is not recommended (see 7 WARNINGS AND PRECAUTIONS). Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit Health Canada has not authorized an indication for pediatric use.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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6% (15/2500). The risk of orthostatic hypotension and syncope may be minimized by initiating therapy with 5 mg QD (see 4 DOSAGE AND ADMINISTRATION section). A more gradual titration to the target dose should be considered if hypotension occurs.
Hypotension and/or syncope associated with bradycardia has been observed infrequently with olanzapine. Patients receiving intramuscular olanzapine should be closely observed for hypotension including postural hypotension, bradyarrhythmia and/or hypoventilation, particularly for the first 2 to 4 hours following injection.
Patients should remain recumbent if dizzy or drowsy after injection until examination indicates that they are not experiencing hypotension including postural hypotension, bradyarrhythmia and/or hypoventilation. Caution is necessary in patients who receive intramuscular olanzapine with other drugs having effects that can induce hypotension, bradycardia, respiratory or central nervous system depression.
Concomitant administration of intramuscular olanzapine and parenteral benzodiazepine and/or other drugs with CNS depressant activity has been associated with post-marketing reports of serious adverse events, including fatalities and is therefore not recommended.
If the patient is considered to need parenteral benzodiazepine treatment, this should not be given until at least one hour after IM olanzapine administration. If the patient has received parenteral benzodiazepine, IM olanzapine administration should only be considered after careful evaluation of clinical status and the patient should be closely monitored for excessive sedation and cardiorespiratory depression (see 9 DRUG INTERACTIONS section).
Olanzapine for Injection 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).
1% to 1%) in patients treated with olanzapine, with no significant differences in associated cardiac events compared to placebo. However, as with other antipsychotics, caution should be exercised when olanzapine is prescribed with medicines known to increase QTc interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia (see 8 ADVERSE REACTIONS, 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 […]
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 Oral and Intramuscular 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, Olanzapine for Injection 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 for Injection treatment in patients with pituitary tumours. Possible manifestations associated with elevated prolactin levels are amenorrhea, galactorrhea, and menorrhagia.
Olanzapine for Injection Page 10 of 51 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 […]
1 mL of Sterile Water for Injection to provide a solution containing approximately 5 mg/mL of olanzapine. The resulting solution should appear clear and yellow. Olanzapine for Injection reconstituted with Sterile Water for Injection should be used immediately (within 1 hour) after reconstitution.
Discard any unused portion. 1 mL of Sterile Water for Injection 2 mL 5 mg/mL The following table provides injection volumes for delivering various doses of intramuscular olanzapine for injection reconstituted with Sterile Water for Injection.
5 Physical Incompatibility Information: Olanzapine for Injection Page 6 of 51 Olanzapine for Injection should be reconstituted only with Sterile Water for Injection. Olanzapine for Injection should not be combined in a syringe with diazepam injection because precipitation occurs when these products are mixed.
Lorazepam injection should not be used to reconstitute Olanzapine for Injection as this combination results in a delayed reconstitution time. Olanzapine for Injection should not be combined in a syringe with haloperidol injection because the resulting low pH has been shown to degrade olanzapine over time.
Ongoing Therapy:
If ongoing olanzapine therapy is clinically indicated, treatment with intramuscular olanzapine for injection should be discontinued and oral olanzapine may be initiated. Reconstituted Olanzapine for Injection may be stored at controlled room temperature 20°C-25°C [See USP] for up to 1 hour if necessary.
4 Administration Olanzapine for Injection is intended for intramuscular use only. Do not administer intravenously or subcutaneously. Inject slowly, deep into the muscle mass. Concomitant administration of intramuscular olanzapine and parenteral benzodiazepine is not recommended (see 7 WARNINGS and PRECAUTIONS).
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit. 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 acute overdose of approximately 2,000 mg of oral olanzapine. Management of Overdose There is no specific antidote for olanzapine.
Symptomatic treatment and monitoring of vital organ function should be instituted according to clinical presentation, including treatment of hypotension and circulatory collapse and support of respiratory function. Do not use epinephrine, dopamine, or other sympathomimetic agents with beta-agonist activity since beta stimulation may worsen hypotension.
For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669). 6.
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1:
Dosage Forms, Strengths, Composition and Packaging Olanzapine for Injection Page 7 of 51 Product Route of Administration Dosage Form / Strength Non-medicinal Ingredients Olanzapine for Injection intramuscular […]