OLANZAPINE (Page 10 of 12)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

For Olanzapine Tablets, USP

The tablets are available as follows :

Olanzapine 2.5 mg tablets, USP are yellow colored, round, biconvex, uncoated tablets, debossed with “2.5” on one side and “66” on other side.

Bottles of 30 NDC 13668-166-30

Bottles of 60 NDC 13668-166-60

Bottles of 100 NDC 13668-166-01

Bottles of 500 NDC 13668-166-05

Bottles of 1000 NDC 13668-166-10

Bottles of 3000 NDC 13668-166-43

100 Unit dose Tablets NDC 13668-166-74

Olanzapine 5 mg tablets, USP are yellow colored, round, biconvex, uncoated tablets, debossed with “5” on one side and “67” on other side.

Bottles of 30 NDC 13668-167-30

Bottles of 60 NDC 13668-167-60

Bottles of 100 NDC 13668-167-01

Bottles of 500 NDC 13668-167-05

Bottles of 1000 NDC 13668-167-10

Bottles of 2000 NDC 13668-167-20

100 Unit dose Tablets NDC 13668-167-74

Olanzapine 7.5 mg tablets, USP are yellow colored, capsule shaped, biconvex, uncoated tablets, debossed with “7.5” on one side and “168” on other side.

Bottles of 30 NDC 13668-168-30

Bottles of 60 NDC 13668-168-60

Bottles of 100 NDC 13668-168-01

Bottles of 500 NDC 13668-168-05

Bottles of 1000 NDC 13668-168-10

Bottles of 2000 NDC 13668-168-20

100 Unit dose Tablets NDC 13668-168-74

Olanzapine 10 mg tablets, USP are yellow colored, round, biconvex, uncoated tablets, debossed with “10” on one side and “169” on other side.

Bottles of 30 NDC 13668-169-30

Bottles of 60 NDC 13668-169-60

Bottles of 100 NDC 13668-169-01

Bottles of 500 NDC 13668-169-05

Bottles of 1000 NDC 13668-169-10

Bottles of 1500 NDC 13668-169-15

100 Unit dose Tablets NDC 13668-169-74

Olanzapine 15 mg tablets, USP are yellow colored, oval shaped, biconvex, uncoated tablets, debossed with “15” on one side and “1170” on other side.

Bottles of 30 NDC 13668-170-30

Bottles of 60 NDC 13668-170-60

Bottles of 100 NDC 13668-170-01

Bottles of 500 NDC 13668-170-05

Bottles of 1000 NDC 13668-170-10

100 Unit dose Tablets NDC 13668-170-74

Olanzapine 20 mg tablets, USP are yellow colored, round, biconvex, uncoated tablets, debossed with “20” on one side and “1171” on other side.

Bottles of 30 NDC 13668-171-30

Bottles of 60 NDC 13668-171-60

Bottles of 100 NDC 13668-171-01

Bottles of 500 NDC 13668-171-05

Bottles of 1000 NDC 13668-171-10

100 Unit dose Tablets NDC 13668-171-74

For Olanzapine Orally Disintegrating Tablets, USP

The tablets are available as follows :

Olanzapine orally disintegrating 5 mg tablets, USP are yellow colored, round, flat, bevel edged uncoated tablets debossed with “86” on one side and “5” on other side.

Bottles of 30 NDC 13668-086-30

Bottles of 90 NDC 13668-086-90

Bottles of 500 NDC 13668-086-05

100 Unit dose Tablets NDC 13668-086-74

Olanzapine orally disintegrating 10 mg tablets, USP are yellow colored, round, flat, bevel edged uncoated tablets debossed with “88” on one side and “10” on other side.

Bottles of 30 NDC 13668-088-30

Bottles of 90 NDC 13668-088-90

Bottles of 500 NDC 13668-088-05

100 Unit dose Tablets NDC 13668-088-74

Olanzapine orally disintegrating 15 mg tablets, USP are yellow colored, round, flat, bevel edged uncoated tablets debossed with “89” on one side and “15” on other side.

Bottles of 30 NDC 13668-089-30

Bottles of 90 NDC 13668-089-90

Bottles of 500 NDC 13668-089-05

100 Unit dose Tablets NDC 13668-089-74

Olanzapine orally disintegrating 20 mg tablets, USP are yellow colored, round, flat, bevel edged uncoated tablets debossed with “90” on one side and “20” on other side.

Bottles of 30 NDC 13668-090-30

Bottles of 90 NDC 13668-090-90

Bottles of 500 NDC 13668-090-05

100 Unit dose Tablets NDC 13668-090-74

16.2 Storage and Handling

Store olanzapine tablets or orally disintegrating tablets at controlled room temperature, 20° to 25°C (68° to 77°F) [ see USP]. 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 or orally disintegrating tablets from light and moisture.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (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 olanzapine and fluoxetine hydrochloride capsules.

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)].

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)].

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

Patients should be advised to report to their health care provider at the earliest onset of any signs and symptoms that may be associated with Drug Reaction with Eosinophilia and Systemic symptoms (DRESS) [see Warnings and Precautions (5.4)].

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 (5.5)].

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 (5.5)].

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 (5.5)].

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 (5.7) 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.

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 (5.12)].

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 (5.13)].

Concomitant Medication

Patients should be advised to inform their physicians if they are taking, or plan to take, olanzapine and fluoxetine hydrochloride capsules. 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)].

Alcohol

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

Phenylketonurics

Olanzapine orally disintegrating tablets contain phenylalanine (0.672, 1.344, 2.016, or 2.688 mg per 5, 10, 15, or 20 mg tablet, respectively). [see Description (11)].

Use in Specific Populations

Pregnancy — Advise women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with olanzapine. Advise patients that olanzapine may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to olanzapine during pregnancy [see Use in Specific Populations (8.1)].

Lactation — Advise breastfeeding women using olanzapine to monitor infants for excess sedation, irritability, poor feeding and extrapyramidal symptoms (tremors and abnormal muscle movements) and to seek medical care if they notice these signs [see Use in Specific Populations (8.3)].

Infertility — Advise females of reproductive potential that olanzapine may impair fertility due to an increase in serum prolactin levels. The effects on fertility are reversible [see Use in Specific Populations (8.3)].

Pediatric Use — Olanzapine is indicated for treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents 13 to 17 years of age. Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin, and hepatic aminotransferase levels. Patients should be counseled about the potential long-term risks associated with olanzapine and advised that these risks may lead them to consider other drugs first [see Indications and Usage (1.1, 1.2)]. Safety and effectiveness of olanzapine in patients under 13 years of age have not been established. Safety and efficacy of olanzapine and fluoxetine in combination in patients 10 to 17 years of age have been established for the acute treatment of depressive episodes associated with bipolar I disorder. Safety and effectiveness of olanzapine and fluoxetine in combination in patients < 10 years of age have not been established [see Warnings and Precautions (5.5) and Use in Specific Populations (8.4)].

Need for Comprehensive Treatment Program in Pediatric Patients

Olanzapine is indicated as an integral part of a total treatment program for pediatric patients with schizophrenia and bipolar disorder that may include other measures (psychological, educational, social) for patients with the disorder. Effectiveness and safety of olanzapine have not been established in pediatric patients less than 13 years of age. Atypical antipsychotics are not intended for use in the pediatric patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders. Appropriate educational placement is essential and psychosocial intervention is often helpful. The decision to prescribe atypical antipsychotic medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms [see Indications and Usage (1.3)].

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Manufactured by:

TORRENT PHARMACEUTICALS LTD., INDIA.

Manufactured for:

TORRENT PHARMA INC., Basking Ridge, NJ 07920.

8078680 Revised June 2020

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