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ZYPREXA ZYDIS 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: ZYPREXA (oral olanzapine) is indicated for • the acute treatment of schizophrenia and related psychotic disorders • maintenance treatment of schizophrenia and related psychotic disorders. In controlled clinical trials, ZYPREXA was found to improve both positive and negative symptoms. ZYPREXA has been shown to be…
Verbatim from this product's HC label. Tap a section to expand.
section). ZYPREXA IntraMuscular (intramuscular olanzapine) is indicated for • the rapid control of agitation in patients with schizophrenia and • related psychotic disorders, and • bipolar mania. The efficacy of ZYPREXA IntraMuscular for the control of agitation was established in 2 short-term (24 hours) placebo-controlled trials in agitated inpatients with schizophrenia and one short-term (24 hours) placebo- controlled trial in agitated patients with mania associated with bipolar disorder (see 14 CLINICAL TRIALS section).
1 Pediatrics Pediatrics: Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Zyprexa in pediatric patients has not been established. 2 Geriatrics Geriatrics: Evidence from clinical studies and experience suggests that use in the geriatric population with dementia is associated with differences in safety or effectiveness.
4 Geriatrics). 2. CONTRAINDICATIONS ZYPREXA (olanzapine) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the ZYPREXA Olanzapine / Olanzapine Tartrate Page 5 of 75 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 ZYPREXA Olanzapine / Olanzapine Tartrate Page 12 of 75 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 ZYPREXA may cause somnolence, patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that ZYPREXA 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 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). 4. 1 Special Populations). Given the limited experience with ZYPREXA in the elderly, and the higher incidence of concomitant illness and concomitant medication in this population, ZYPREXA should be used with caution.
, nonsmoking female patients), or who may be pharmacodynamically more sensitive to ZYPREXA. 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). 5 mg) should be considered when clinical factors warrant. 2 Recommended Dose and Dosage Adjustment ORAL ADMINISTRATION 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. Pharmacokinetic studies showed that the ZYPREXA Tablets and ZYPREXA ZYDIS dosage forms are bioequivalent. ZYPREXA ZYDIS orally disintegrating tablets can be used as an alternative to ZYPREXA Tablets.
2 Study results ). ZYPREXA Olanzapine / Olanzapine Tartrate Page 6 of 75 Schizophrenia and Related Disorders Adults: ZYPREXA (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 ZYPREXA 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 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.
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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 ZYPREXA, 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.
ZYPREXA Olanzapine / Olanzapine Tartrate Page 13 of 75 Hyperprolactinemia:
As with other drugs that block dopamine D2 and/or serotonin 5-HT2 receptors, olanzapine may elevate prolactin levels. Elevations associated with ZYPREXA 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, ZYPREXA 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 ZYPREXA 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 mammary tumorigenesis.
Long-standing hyperprolactinemia when associated with hypogonadism may […]
Maintenance Therapy in Schizophrenia:
It is recommended that responding patients with schizophrenia be continued on ZYPREXA 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 ZYPREXA, 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 ZYPREXA 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 5-20 mg per day.
Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment. Health Canada has not authorized an indication for pediatric use. 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 ZYPREXA IntraMuscular (see 14 CLINICAL TRIALS). Thus safety information on the use of repeated doses of ZYPREXA IntraMuscular 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 ZYPREXA Olanzapine / Olanzapine Tartrate Page 7 of 75 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 (oral and IM) is 20 mg, with no more than three injections in a 24 hour period. Zyprexa IntraMuscular is intended for intramuscular use only.
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