R5 0164 Pill — WHITE OVAL, 8mm — Olanzapine

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ImprintR5 / 0164
ColourWHITE
ShapeOVAL
Size8
Strengtholanzapine 5 mg
Dosage formTablet, Film Coated
ManufacturerREMEDYREPACK INC.
NDC52125-917
Schedule—
Availability—
Ingredientsolanzapine[OLANZAPINE]

What does this imprint mean?

The imprint "R5 0164" is a code stamped or printed on the tablet or capsule by the manufacturer, used to identify the drug, its strength and the maker.

Active ingredient

Olanzapine

Uses and warnings

BOXED WARNING: "Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death," with most deaths related to cardiovascular events or infection; olanzapine is "not approved for the treatment of patients with dementia-related psychosis." Major warnings include Neuroleptic Malignant Syndrome, "hyperglycemia, in some cases extreme and associated with ketoacidosis or...death," tardive dyskinesia, significant weight gain and dyslipidemia, leukopenia/neutropenia/agranulocytosis, orthostatic hypotension with syncope, and increased cerebrovascular events (including stroke) in elderly dementia patients.

Olanzapine is indicated for: - "Acute and maintenance treatment of Schizophrenia" in adults and certain adolescents - "Acute treatment of manic or mixed episodes associated with Bipolar I Disorder," as monotherapy or combined with lithium or valproate, and maintenance monotherapy - "Treatment of depressive episodes associated with Bipolar I disorder" and "treatment resistant depression," both in combination with fluoxetine - Treatment of acute agitation associated with schizophrenia or bipolar mania (injectable formulation)

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file 42382d21-1042-481d-9119-b2c0cf3aa309.xml