Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 Olanzapine is a yellow crystalline solid, which is practically insoluble in water.Olanzapine Orally Disintegrating Tablets, USP are intended for oral administration only.Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol).

An increase to a dose greater than the target dose of 10 mg/day (i.e., to a dose of 15 mg/day or greater) is recommended only after clinical assessment. The difference in mean changes between olanzapine and placebo was greater in patients with evidence of glucose dysregulation at baseline (patients diagnosed with diabetes mellitus or related adverse reactions, patients treated with anti-diabetic agents, patients with a baseline random glucose level ≥ 200 mg/dL, and/or a baseline fasting glucose level ≥ 126 mg/dL).

0000004743 00000 n Olanzapine-treated patients had a greater mean HbA1c increase from baseline of 0.04% (median exposure 21 days), compared to a mean HbA1c decrease of 0.06% in placebo-treated subjects (median exposure 17 days). In arriving at a diagnosis, it is important to exclude cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.)

For specific information about the warnings of lithium or valproate, refer to the Warnings section of the package inserts for these other products.

When using olanzapine and fluoxetine in combination, refer to the Clinical Studies section of the package insert for Symbyax.Olanzapine monotherapy is not indicated for the treatment of treatment resistant depression. Mean increase in weight in adolescents was greater than in adults.

Clinical monitoring, including baseline and periodic follow-up lipid evaluations in patients using olanzapine, is recommended Clinically significant, and sometimes very high (>500 mg/dL), elevations in triglyceride levels have been observed with olanzapine use. In postmarketing reports of overdose with olanzapine alone, symptoms have been reported in the majority of cases. A second traditional assessment, the Clinical Global Impression (CGI), reflects the impression of a skilled observer, fully familiar with the manifestations of schizophrenia, about the overall clinical state of the patient. 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 Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including olanzapine. Patients receiving olanzapine should receive regular monitoring of weight In an analysis of 13 placebo-controlled olanzapine monotherapy studies, olanzapine-treated patients gained an average of 2.6 kg (5.7 lb) compared to an average 0.3 kg (0.6 lb) weight loss in placebo-treated patients with a median exposure of 6 weeks; 22.2% of olanzapine-treated patients gained at least 7% of their baseline weight, compared to 3% of placebo-treated patients, with a median exposure to event of 8 weeks; 4.2% of olanzapine-treated patients gained at least 15% of their baseline weight, compared to 0.3% of placebo-treated patients, with a median exposure to event of 12 weeks.

There are no adequate and well-controlled trials with olanzapine in pregnant females. Olanzapine orally disintegrating tablets are not approved for the treatment of patients with dementia-related psychosis. Patients with these diagnoses were excluded from premarketing clinical studies.

3 0 obj Common side effects seen with olanzapine are: an inability to sit still (akathisia), constipation, dizziness, drowsiness, insomnia, dry mouth, orthostatic hypotension, tremor, and; weight gain. In phase 1 of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE), over a median exposure of 9.2 months, the mean increase in triglycerides in patients taking olanzapine was 40.5 mg/dL. As is common with compounds which increase prolactin release, an increase in mammary gland neoplasia was observed in the olanzapine carcinogenicity studies conducted in mice and rats In placebo-controlled olanzapine clinical studies (up to 12 weeks), changes from normal to high in prolactin concentrations were observed in 30% of adults treated with olanzapine as compared to 10.5% of adults treated with placebo. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect or predict the rates observed in practice.

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