Olanzapine (Page 13 of 15)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Olanzapine Tablets USP, 2.5 mg are yellow colored, circular, biconvex uncoated tablets, debossed with ‘C’ on one side and ‘45’ on the other side. They are available as follows:
NDC 42292-012-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).
Olanzapine Tablets USP, 5 mg are yellow colored, circular, biconvex uncoated tablets, debossed with ‘C’ on one side and ‘46’ on the other side. They are available as follows:
NDC 42292-013-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).
Olanzapine Tablets USP, 10 mg are yellow colored, circular, biconvex uncoated tablets, debossed with ‘C’ on one side and ‘48’ on the other side. They are available as follows:
NDC 42292-014-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).
Olanzapine Tablets USP, 15 mg are yellow colored, circular, biconvex uncoated tablets, debossed with ‘C’ on one side and ‘49’ on the other side. They are available as follows:
NDC 42292-015-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).
Olanzapine Tablets USP, 20 mg are yellow colored, circular, biconvex uncoated tablets, debossed with ‘C’ on one side and ‘50’ on the other side. They are available as follows:
NDC 42292-016-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).

16.2 Storage and Handling


Store olanzapine tablets at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.
Protect olanzapine tablets from light and moisture.

17 PATIENT COUNSELING INFORMATION

See FDA-approved Medication Guide for the oral formulations.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking olanzapine as monotherapy or in combination with fluoxetine. If you do not think you are getting better or have any concerns about your condition while taking olanzapine, call your doctor. When using olanzapine and fluoxetine in combination, also refer to the Patient Counseling Information section of the package insert for Symbyax.

17.1 Information on Medication Guide

Prescribers or other health professionals should inform patients, their families, and their caregivers about the potential benefits and potential risks associated with treatment with olanzapine, and should counsel them in its appropriate use. A patient Medication Guide is available for olanzapine. Prescribers or other health professionals should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. When using olanzapine and fluoxetine in combination, also refer to the Medication Guide for Symbyax.

17.2 Elderly Patients with Dementia-Related Psychosis: Increased Mortality and Cerebrovascular Adverse Events (CVAE), Including Stroke

Patients and caregivers should be advised that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Patients and caregivers should be advised that elderly patients with dementia-related psychosis treated with olanzapine had a significantly higher incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) compared with placebo.
Olanzapine is not approved for elderly patients with dementia-related psychosis [see Boxed Warning and Warnings and Precautions (5.1)] .

17.3 Neuroleptic Malignant Syndrome (NMS)

Patients and caregivers should be counseled that a potentially fatal symptom complex sometimes referred to as NMS has been reported in association with administration of antipsychotic drugs, including olanzapine. Signs and symptoms of NMS include hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia) [see Warnings and Precautions (5.3)] .

17.4 Hyperglycemia and Diabetes Mellitus

Patients should be advised of the potential risk of hyperglycemia-related adverse reactions. Patients should be monitored regularly for worsening of glucose control. Patients who have diabetes should follow their doctor’s instructions about how often to check their blood sugar while taking olanzapine [see Warnings and Precautions (5.4)] .

17.5 Dyslipidemia

Patients should be counseled that dyslipidemia has occurred during treatment with olanzapine. Patients should have their lipid profile monitored regularly [see Warnings and Precautions (5.4)] .

17.6 Weight Gain

Patients should be counseled that weight gain has occurred during treatment with olanzapine. Patients should have their weight monitored regularly [see Warnings and Precautions (5.4)] .

17.7 Orthostatic Hypotension

Patients should be advised of the risk of orthostatic hypotension, especially during the period of initial dose titration and in association with the use of concomitant drugs that may potentiate the orthostatic effect of olanzapine, e.g., diazepam or alcohol [see Warnings and Precautions (5.6) and Drug Interactions (7)] . Patients should be advised to change positions carefully to help prevent orthostatic hypotension, and to lie down if they feel dizzy or faint, until they feel better. Patients should be advised to call their doctor if they experience any of the following signs and symptoms associated with orthostatic hypotension: dizziness, fast or slow heart beat, or fainting.

17.8 Potential for Cognitive and Motor Impairment

Because olanzapine has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that olanzapine therapy does not affect them adversely [see Warnings and Precautions (5.10)] .

17.9 Body Temperature Regulation

Patients should be advised regarding appropriate care in avoiding overheating and dehydration. Patients should be advised to call their doctor right away if they become severely ill and have some or all of these symptoms of dehydration: sweating too much or not at all, dry mouth, feeling very hot, feeling thirsty, not able to produce urine [see Warnings and Precautions (5.11)] .

17.10 Concomitant Medication

Patients should be advised to inform their physicians if they are taking, or plan to take, Symbyax. Patients should also be advised to inform their physicians if they are taking, plan to take, or have stopped taking any prescription or over-the-counter drugs, including herbal supplements, since there is a potential for interactions [see Drug Interactions (7)] .

17.11 Alcohol

Patients should be advised to avoid alcohol while taking olanzapine [see Drug Interactions (7)] .

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