Olanzapine

Sun Pharmaceutical Industries Limited

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use olanzapine safely and effectively. See full prescribing information for olanzapine tablets. Olanzapine Tablets, for Oral useInitial U.S. Approval: 1996 RECENT MAJOR CHANGES none BOXED WARNINGWARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Olanzapine is not approved for the treatment of patients with dementia-related psychosis. ( 5.1 , 5.14 , 17.2 ) When using olanzapine and fluoxetine in combination, also refer to the Boxed Warning section of the package insert for Symbyax*. INDICATIONS AND USAGEAs oral formulation for the: Treatment of schizophrenia. (1.1) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2) Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. As Olanzapine and Fluoxetine in Combination for the: Treatment of depressive episodes associated with bipolar I disorder. (1.5) Efficacy was established with Symbyax* (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax*. DOSAGE AND ADMINISTRATION Schizophrenia in adults (2.1) Oral: Start at 5 mg to 10 mg once daily; Target: 10 mg/day within several days Bipolar I Disorder (manic or mixed episodes) in adults (2.2) Oral: Start at 10 mg or 15 mg once daily Bipolar I Disorder (manic or mixed episodes) with lithium or valproate in adults (2.2) Oral: Start at 10 mg once daily Depressive Episodes associated with Bipolar I Disorder in adults (2.5) Oral in combination with fluoxetine: Start at 5 mg of oral olanzapine and 20 mg of fluoxetine once daily Lower starting dose recommended in debilitated or pharmacodynamically sensitive patients or patients with predisposition to hypotensive reactions, or with potential for slowed metabolism. (2.1) Olanzapine may be given without regard to meals. (2.1) Olanzapine and Fluoxetine in Combination: Dosage adjustments, if indicated, should be made with the individual components according to efficacy and tolerability. (2.5) Olanzapine monotherapy is not indicated for the treatment of depressive episodes associated with bipolar I disorder. (2.5) Safety of coadministration of doses above 18 mg olanzapine with 75 mg fluoxetine has not been evaluated. (2.5) DOSAGE FORMS AND STRENGTHS Tablets (not scored): 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg (3) CONTRAINDICATIONS None with olanzapine monotherapy. When using olanzapine and fluoxetine in combination, also refer to the Contraindications section of the package insert for Symbyax®*. (4) When using olanzapine in combination with lithium or valproate, refer to the Contraindications section of the package inserts for those products. (4) WARNINGS AND PRECAUTIONS Elderly Patients with Dementia-Related Psychosis: Increased risk of death and increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack). (5.1) Suicide: The possibility of a suicide attempt is inherent in schizophrenia and in bipolar I disorder, and close supervision of high-risk patients should accompany drug therapy, when using in combination with fluoxetine, also refer to the Boxed Warning and Warnings and Precautions sections of the package insert for Symbyax*. (5.2) Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring. (5.3)   Hyperglycemia: In some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients taking olanzapine. Patients taking olanzapine should be monitored for symptoms of hyperglycemia and undergo fasting blood glucose testing at the beginning of, and periodically during, treatment. (5.4) Hyperlipidemia: Undesirable alterations in lipids have been observed. Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodically during, treatment. (5.5) Weight Gain: Potential consequences of weight gain should be considered. Patients should receive regular monitoring of weight. (5.6) Tardive Dyskinesia: Discontinue if clinically appropriate. (5.7) Orthostatic Hypotension: Orthostatic hypotension associated with dizziness, tachycardia, bradycardia and, in some patients, syncope, may occur especially during initial dose titration. Use caution in patients with cardiovascular disease, cerebrovascular disease, and those conditions that could affect hemodynamic responses. (5.8) Leukopenia, Neutropenia, and Agranulocytosis: Has been reported with antipsychotics, including olanzapine. Patients with a history of a clinically significant low white blood cell count (WBC) or drug induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of olanzapine should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors. (5.9) Seizures: Use cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold. (5.11) Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. Use caution when operating machinery. (5.12) Hyperprolactinemia: May elevate prolactin levels. (5.15) Use in Combination with Fluoxetine, Lithium or Valproate: Also refer to the package inserts for Symbyax*, lithium, or valproate. (5.16) Laboratory Tests: Monitor fasting blood glucose and lipid profiles at the beginning of, and periodically during, treatment. (5.17) Side Effects  Oral Olanzapine Monotherapy: Schizophrenia (Adults) – postural hypotension, constipation, weight gain, dizziness, personality disorder, akathisia (6.1) Schizophrenia (Adolescents) – sedation, weight increased, headache, increased appetite, dizziness, abdominal pain, pain in extremity, fatigue, dry mouth (6.1) Manic or Mixed Episodes, Bipolar I Disorder (Adults) – asthenia, dry mouth, constipation, increased appetite, somnolence, dizziness, tremor (6.1) Manic or Mixed Episodes, Bipolar I Disorder (Adolescents) – sedation, weight increased, increased appetite, headache, fatigue, dizziness, dry mouth, abdominal pain, pain in extremity (6.1) Combination of Olanzapine and Lithium or Valproate: Manic or Mixed Episodes, Bipolar I Disorder (Adults) – dry mouth, weight gain, increased appetite, dizziness, back pain, constipation, speech disorder, increased salivation, amnesia, paresthesia (6.1) Olanzapine and Fluoxetine in Combination: Also refer to the Adverse Reactions section of the package insert for Symbyax*. (6)To report SUSPECTED ADVERSE REACTIONS, contact CARACO Pharmaceutical Laboratories Ltd. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchDRUG INTERACTIONS Diazepam: May potentiate orthostatic hypotension. (7.1, 7.2) Alcohol: May potentiate orthostatic hypotension. (7.1) Carbamazepine: Increased clearance of olanzapine. (7.1) Fluvoxamine: May increase olanzapine levels. (7.1) Olanzapine and Fluoxetine in Combination: Also refer to the Drug Interactions section of the package insert for Symbyax*. (7.1) CNS Acting Drugs: Caution should be used when taken in combination with other centrally acting drugs and alcohol. (7.2) Antihypertensive Agents: Enhanced antihypertensive effect. (7.2) Levodopa and Dopamine Agonists: May antagonize levodopa/dopamine agonists. (7.2) Other Concomitant Drug Therapy: When using olanzapine in combination with lithium or valproate, refer to the Drug Interactions sections of the package insert for those products. (7.2) USE IN SPECIFIC POPULATIONS Pregnancy: Olanzapine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. (8.1) Nursing Mothers: Breast-feeding is not recommended. (8.3) Pediatric Use: Safety and effectiveness of olanzapine in children

FULL PRESCRIBING INFORMATION: CONTENTS*

• WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
• 1 OLANZAPINE INDICATIONS AND USAGE
  • 1.1 Schizophrenia
  • 1.2 Bipolar I Disorder (Manic or Mixed Episodes)
  • 1.3 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder
  • 1.5 Olanzapine and Fluoxetine in Combination: Depressive Episodes Associated with Bipolar I Disorder
• 2 OLANZAPINE DOSAGE AND ADMINISTRATION
  • 2.1 Schizophrenia
  • 2.2 Bipolar I Disorder (Manic or Mixed Episodes)
  • 2.5 Olanzapine and Fluoxetine in Combination: Depressive Episodes Associated with Bipolar I Disorder
  • 2.7 Olanzapine and Fluoxetine in Combination: Dosing in Special Populations
• 3 DOSAGE FORMS AND STRENGTHS
• 4 OLANZAPINE CONTRAINDICATIONS
• 5 WARNINGS AND PRECAUTIONS
  • 5.1 Elderly Patients with Dementia-Related Psychosis
  • 5.2 Suicide
  • 5.3 Neuroleptic Malignant Syndrome (NMS)
  • 5.4 Hyperglycemia
  • 5.5 Hyperlipidemia
  • 5.6 Weight Gain
  • 5.7 Tardive Dyskinesia
  • 5.8 Orthostatic Hypotension
  • 5.9 Leukopenia, Neutropenia, and Agranulocytosis
  • 5.10 Dysphagia
  • 5.11 Seizures
  • 5.12 Potential for Cognitive and Motor Impairment
  • 5.13 Body Temperature Regulation
  • 5.14 Use in Patients with Concomitant Illness
  • 5.15 Hyperprolactinemia
  • 5.16 Use in Combination with Fluoxetine, Lithium, or Valproate
  • 5.17 Laboratory Tests
• 6 OLANZAPINE ADVERSE REACTIONS
  • 6.1 Clinical Trials Experience
  • 6.2 Vital Signs and Laboratory Studies
  • 6.3 Postmarketing Experience
• 7 DRUG INTERACTIONS
  • 7.1 Potential for Other Drugs to Affect Olanzapine
  • 7.2 Potential for Olanzapine to Affect Other Drugs
• 8 USE IN SPECIFIC POPULATIONS
  • 8.1 Pregnancy
  • 8.2 Labor and Delivery
  • 8.3 Nursing Mothers
  • 8.4 Pediatric Use
  • 8.5 Geriatric Use
• 9 DRUG ABUSE AND DEPENDENCE
  • 9.3 Dependence
• 10 OVERDOSAGE
  • 10.1 Human Experience
  • 10.2 Management of Overdose
• 11 OLANZAPINE DESCRIPTION
• 12 CLINICAL PHARMACOLOGY
  • 12.1 Mechanism of Action
  • 12.2 Pharmacodynamics
  • 12.3 Pharmacokinetics
• 13 NONCLINICAL TOXICOLOGY
  • 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
  • 13.2 Animal Toxicology and/or Pharmacology
• 14 CLINICAL STUDIES
  • 14.1 Schizophrenia
  • 14.2 Bipolar I Disorder (Manic or Mixed Episodes)
• 16 HOW SUPPLIED/STORAGE AND HANDLING
  • 16.1 How Supplied
  • 16.2 Storage and Handling
• 17 PATIENT COUNSELING INFORMATION
  • 17.1 Information on Medication Guide
  • 17.2 Elderly Patients with Dementia-Related Psychosis: Increased Mortality and Cerebrovascular Adverse Events (CVAE), Including Stroke
  • 17.3 Neuroleptic Malignant Syndrome (NMS)
  • 17.4 Hyperglycemia
  • 17.5 Hyperlipidemia
  • 17.6 Weight Gain
  • 17.7 Orthostatic Hypotension
  • 17.8 Potential for Cognitive and Motor Impairment
  • 17.9 Body Temperature Regulation
  • 17.10 Concomitant Medication
  • 17.11 Alcohol
  • 17.13 Use in Specific Populations
  • 17.14 Need for Comprehensive Treatment Program in Pediatric Patients
• Medication Guide
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 2.5MG
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 5MG
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 7.5MG
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 10MG
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 15MG
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 20MG

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

1.1 Schizophrenia

[see Clinical Studies (14.1)].

When [see Warnings and Precautions (5.5, 5.6)]

Information describing the use of olanzapine tablets in pediatric patients with schizophrenia is approved for Eli Lilly and Company’s olanzapine drug product labeling. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

1.2 Bipolar I Disorder (Manic or Mixed Episodes)

Monotherapy [see Clinical Studies (14.2)].

When [see Warnings and Precautions (5.5, 5.6)]

Information describing the use of olanzapine tablets in pediatric patients with bipolar 1 disorder is approved for Eli Lilly and Company’s olanzapine drug product labeling. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Adjunctive Therapy to Lithium or Valproate [see Clinical Studies (14.2)]

1.3 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder

Informat ion on treating pediatric patients with schizophrenia and bipolar 1 disorder is approved for Eli Lilly and Company’s olanzapine drug product labeling. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

1.5 Olanzapine and Fluoxetine in Combination: Depressive Episodes Associated with Bipolar I Disorder

2 DOSAGE AND ADMINISTRATION

2.1 Schizophrenia

Adults

Dose Selection 



Dosing in Special Populations[see Warnings and Precautions (5.14), Drug Interactions (7), and Clinical Pharmacology (12.3)]

Maintenance Treatment [see Clinical Studies (14.1)]

Adolescents

Pediatric dosing information in pediatric patients with schizophrenia is approved for Eli Lilly and Company’s olanzapine drug product labeling. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

2.2 Bipolar I Disorder (Manic or Mixed Episodes)

Adults

Dose Selection for Monotherapy

[see Clinical Studies (14.2)]

Maintenance Monotherapy[see Clinical Studies (14.2)]

Dose Selection for Adjunctive Treatment

Antimanic efficacy [see Clinical Studies (14.2)]

Adolescents

Pediatric dosing information in pediatric patients with bipolar I disorder is approved for Eli Lilly and Company’s olanzapine drug product labeling. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

2.5 Olanzapine and Fluoxetine in Combination: Depressive Episodes Associated with Bipolar I Disorder

Table 1: Approximate Dose Correspondence Between Symbyax^a* and the Combination of Olanzapine and Fluoxetine

For Symbyax* (mg/day)	Use in Combination
	Olanzapine (mg/day)	Fluoxetine (mg/day)
a Symbyax* (olanzapine/fluoxetine hydrochloride) is a fixed-dose combination of olanzapine and fluoxetine.
3 mg olanzapine/25 mg fluoxetine	2.5	20
6 mg olanzapine/25 mg fluoxetine	5	20
12 mg olanzapine/25 mg fluoxetine	10+2.5	20
6 mg olanzapine/50 mg fluoxetine	5	40+10
12 mg olanzapine/50 mg fluoxetine	10+2.5	40+10

Olanzapine

2.7 Olanzapine and Fluoxetine in Combination: Dosing in Special Populations

[see Warnings and Precautions (5.14), Drug Interactions (7), and Clinical Pharmacology (12.3)]

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

• None with olanzapine monotherapy.
• When using olanzapine and fluoxetine in combination, also refer to the Contraindications section of the package insert for Symbyax*.
• For specific information about the contraindications of lithium or valproate, refer to the Contraindications section of the package inserts for these other products.

5 WARNINGS AND PRECAUTIONS

5.1 Elderly Patients with Dementia-Related Psychosis

Increased Mortality — Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Olanzapine is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning, Warnings and Precautions (5.14), and Patient Counseling Information (17.2)].
 


Cerebrovascular Adverse Events (CVAE), Including Stroke [see Boxed Warning and Patient Counseling Information (17.2)]

5.2 Suicide

5.3 Neuroleptic Malignant Syndrome (NMS)

[see Patient Counseling Information (17.3)]

5.4 Hyperglycemia

17.4







Olanzapine Monotherapy in Adults

Table 2: Changes in Fasting Glucose Levels from Adult Olanzapine Monotherapy Studies

			Up to 12 weeks exposure		At least 48 weeks exposure
Laboratory Analyte	Category Change (at least once) from Baseline	Treatment Arm	N	Patients	N	Patients
Fasting Glucose	Normal to High (<100 mg/dL to ≥126 mg/dL)	Olanzapine	543	2.2%	345	12.8%
		Placebo	293	3.4%	NANot Applicable.	NANot Applicable.
	Borderline to High (≥100 mg/dL and <126 mg/dL to ≥126 mg/dL)	Olanzapine	178	17.4%	127	26%
		Placebo	96	11.5%	NANot Applicable.	NANot Applicable.

Olanzapine Monotherapy in Adolescents

Table 3: Changes in Fasting Glucose Levels from Adolescent Olanzapine Monotherapy Studies

			Up to 12 weeks exposure		At least 24 weeks exposure
Laboratory Analyte	Category Change (at least once) from Baseline	Treatment Arm	N	Patients	N	Patients
Fasting Glucose	Normal to High (<100 mg/dL to ≥126 mg/dL)	Olanzapine	124	0%	108	0.9%
		Placebo	53	1.9%	NANot Applicable.	NANot Applicable.
	Borderline to High (≥100 mg/dL and <126 mg/dL to ≥126 mg/dL)	Olanzapine	14	14.3%	13	23.1%
		Placebo	13	0%	NANot Applicable.	NANot Applicable.

5.5 Hyperlipidemia

[see Patient Counseling Information (17.5)]



Olanzapine Monotherapy in Adults

Table 4: Changes in Fasting Lipids Values from Adult Olanzapine Monotherapy Studies

			Up to 12 weeks exposure		At least 48 weeks exposure
Laboratory Analyte	Category Change (at least once) from Baseline	Treatment Arm	N	Patients	N	Patients
Fasting Triglycerides	Increase by ≥50 mg/dL	Olanzapine	745	39.6%	487	61.4%
		Placebo	402	26.1%	NANot Applicable.	NANot Applicable.
	Normal to High (<150 mg/dL to ≥200 mg/dL)	Olanzapine	457	9.2%	293	32.4%
		Placebo	251	4.4%	NANot Applicable.	NANot Applicable.
	Borderline to High (≥150 mg/dL and <200 mg/dL to ≥200 mg/dL)	Olanzapine	135	39.3%	75	70.7%
		Placebo	65	20%	NANot Applicable.	NANot Applicable.
Fasting Total Cholesterol	Increase by ≥40 mg/dL	Olanzapine	745	21.6%	489	32.9%
		Placebo	402	9.5%	NANot Applicable.	NANot Applicable.
	Normal to High (<200 mg/dL to ≥240 mg/dL)	Olanzapine	392	2.8%	283	14.8%
		Placebo	207	2.4%	NANot Applicable.	NANot Applicable.
	Borderline to High (≥200 mg/dL and <240 mg/dL to ≥240 mg/dL)	Olanzapine	222	23%	125	55.2%
		Placebo	112	12.5%	NANot Applicable.	NANot Applicable.
Fasting LDL Cholesterol	Increase by ≥30 mg/dL	Olanzapine	536	23.7%	483	39.8%
		Placebo	304	14.1%	NANot Applicable.	NANot Applicable.
	Normal to High (<100 mg/dL to ≥160 mg/dL)	Olanzapine	154	0%	123	7.3%
		Placebo	82	1.2%	NANot Applicable.	NANot Applicable.
	Borderline to High (≥100 mg/dL and <160 mg/dL to ≥160 mg/dL)	Olanzapine	302	10.6%	284	31%
		Placebo	173	8.1%	NANot Applicable.	NANot Applicable.

Olanzapine Monotherapy in Adolescents

Table 5: Changes in Fasting Lipids Values from Adolescent Olanzapine Monotherapy Studies

			Up to 6 weeks exposure		At least 24 weeks exposure
Laboratory Analyte	Category Change (at least once) from Baseline	Treatment Arm	N	Patients	N	Patients
Fasting Triglycerides	Increase by ≥50 mg/dL	Olanzapine	138	37%	122	45.9%
		Placebo	66	15.2%	NANot Applicable.	NANot Applicable.
	Normal to High (<90 mg/dL to >130 mg/dL)	Olanzapine	67	26.9%	66	36.4%
		Placebo	28	10.7%	NANot Applicable.	NANot Applicable.
	Borderline to High (≥90 mg/dL and ≤130 mg/dL to >130 mg/dL)	Olanzapine	37	59.5%	31	64.5%
		Placebo	17	35.3%	NANot Applicable.	NANot Applicable.
Fasting Total Cholesterol	Increase by ≥40 mg/dL	Olanzapine	138	14.5%	122	14.8%
		Placebo	66	4.5%	NANot Applicable.	NANot Applicable.
	Normal to High (<170 mg/dL to ≥200 mg/dL)	Olanzapine	87	6.9%	78	7.7%
		Placebo	43	2.3%	NANot Applicable.	NANot Applicable.
	Borderline to High (≥170 mg/dL and <200 mg/dL to ≥200 mg/dL)	Olanzapine	36	38.9%	33	57.6%
		Placebo	13	7.7%	NANot Applicable.	NANot Applicable.
Fasting LDL Cholesterol	Increase by ≥30 mg/dL	Olanzapine	137	17.5%	121	22.3%
		Placebo	63	11.1%	NANot Applicable.	NANot Applicable.
	Normal to High (<110 mg/dL to ≥130 mg/dL)	Olanzapine	98	5.1%	92	10.9%
		Placebo	44	4.5%	NANot Applicable.	NANot Applicable.
	Borderline to High (≥110 mg/dL and <130 mg/dL to ≥130 mg/dL)	Olanzapine	29	48.3%	21	47.6%
		Placebo	9	0%	NANot Applicable.	NANot Applicable.

5.6 Weight Gain

[see Patient Counseling Information (17.6)]

Olanzapine Monotherapy in Adults

Table 6: Weight Gain with Olanzapine Use in Adults

Amount Gained kg (lb)	6 Weeks (N=7465) (%)	6 Months (N=4162) (%)	12 Months (N=1345) (%)	24 Months (N=474) (%)	36 Months (N=147) (%)
≤0	26.2	24.3	20.8	23.2	17
0 to ≤5 (0 to 11 lb)	57	36	26	23.4	25.2
>5 to ≤10 (11 to 22 lb)	14.9	24.6	24.2	24.1	18.4
>10 to ≤15 (22 to 33 lb)	1.8	10.9	14.9	11.4	17
>15 to ≤20 (33 to 44 lb)	0.1	3.1	8.6	9.3	11.6
>20 to ≤25 (44 to 55 lb)	0	0.9	3.3	5.1	4.1
>25 to ≤30 (55 to 66 lb)	0	0.2	1.4	2.3	4.8
>30 (>66 lb)	0	0.1	0.8	1.2	2

Olanzapine Monotherapy in Adolescents

Table 7: Weight Gain with Olanzapine Use in Adolescents from 4 Placebo-Controlled Trials

	Olanzapine-treated patients	Placebo-treated patients
Mean change in body weight from baseline (median exposure = 3 weeks)	4.6 kg (10.1 lb)	0.3 kg (0.7 lb)
Percentage of patients who gained at least 7% of baseline body weight	40.6% (median exposure to 7% = 4 weeks)	9.8% (median exposure to 7% = 8 weeks)
Percentage of patients who gained at least 15% of baseline body weight	7.1% (median exposure to 15% = 19 weeks)	2.7% (median exposure to 15% = 8 weeks)

Table 8: Weight Gain with Olanzapine Use in Adolescents

Amount Gained kg (lb)	6 Weeks (N=243) (%)	6 Months (N=191) (%)
≤0	2.9	2.1
0 to ≤5 (0 to 11 lb)	47.3	24.6
>5 to ≤10 (11 to 22 lb)	42.4	26.7
>10 to ≤15 (22 to 33 lb)	5.8	22
>15 to ≤20 (33 to 44 lb)	0.8	12.6
>20 to ≤25 (44 to 55 lb)	0.8	9.4
>25 to ≤30 (55 to 66 lb)	0	2.1
>30 to ≤35 (66 to 77 lb)	0	0
>35 to ≤40 (77 to 88 lb)	0	0
>40 (>88 lb)	0	0.5

5.7 Tardive Dyskinesia

5.8 Orthostatic Hypotension

₁[see Patient Counseling Information (17.7)]

[see Dosage and Administration (2)]





Caution [see Drug Interactions (7)]

5.9 Leukopenia, Neutropenia, and Agranulocytosis

Class Effect



³

5.10 Dysphagia

5.11 Seizures

5.12 Potential for Cognitive and Motor Impairment

[see Patient Counseling Information (17.8)]

5.13 Body Temperature Regulation

[see Patient Counseling Information (17.9)]

5.14 Use in Patients with Concomitant Illness

[see Clinical Pharmacology (12.3)]

in vitro

[see Boxed Warning, Warnings and Precautions (5.1), and Patient Counseling Information (17.2)]

[see Warnings and Precautions (5.8)]

5.15 Hyperprolactinemia

As with

Tissue culture in vitro[see Nonclinical Toxicology (13.1)]

In placebo^{1 2 3}

In placebo¹²³[see Use in Specific Populations (8.4)]

^1
2
3

5.16 Use in Combination with Fluoxetine, Lithium, or Valproate

[see Drug Interactions (7)]

5.17 Laboratory Tests

[see Warnings and Precautions (5.4, 5.5) and Patient Counseling Information (17.4, 17.5)]

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Clinical Trials in Adults













Incidence of Adverse Reactions in Short-Term, Placebo-Controlled and Combination Trials



Adverse Reactions Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials

Schizophrenia

Bipolar I Disorder (Manic or Mixed Episodes) Monotherapy

Adverse Reactions Associated with Discontinuation of Treatment in Short-Term Combination Trials

Bipolar I Disorder (Manic or Mixed Episodes), Olanzapine as Adjunct to Lithium or Valproate

Commonly Observed Adverse Reactions in Short-Term, Placebo-Controlled Trials

Table 9: Common Treatment-Emergent Adverse Reactions Associated with the Use of Oral Olanzapine in 6-Week Trials — SCHIZOPHRENIA

	Percentage of Patients Reporting Event
Adverse Reaction	Olanzapine (N=248)	Placebo (N=118)
Postural hypotension	5	2
Constipation	9	3
Weight gain	6	1
Dizziness	11	4
Personality disorderPersonality disorder is the COSTART term for designating nonaggressive objectionable behavior.	8	4
Akathisia	5	1

Table 10: Common Treatment-Emergent Adverse Reactions Associated with the Use of Oral Olanzapine in 3-Week and 4-Week Trials — Bipolar I Disorder (Manic or Mixed Episodes)

	Percentage of Patients Reporting Event
	Olanzapine	Placebo
Adverse Reaction	(N=125)	(N=129)
Asthenia	15	6
Dry mouth	22	7
Constipation	11	5
Dyspepsia	11	5
Increased appetite	6	3
Somnolence	35	13
Dizziness	18	6
Tremor	6	3

Adverse Reactions Occurring at an Incidence of 2% or More among Oral Olanzapine-Treated Patients in Short-Term, Placebo-Controlled Trials

Table 11: Treatment-Emergent Adverse Reactions: Incidence in Short-Term, Placebo-Controlled Clinical Trials with Oral Olanzapine

Body System/Adverse Reaction	Percentage of Patients Reporting Event
	Olanzapine (N=532)	Placebo (N=294)
Body as a Whole
Accidental injury	12	8
Asthenia	10	9
Fever	6	2
Back pain	5	2
Chest pain	3	1
Cardiovascular System
Postural hypotension	3	1
Tachycardia	3	1
Hypertension	2	1
Digestive System
Dry mouth	9	5
Constipation	9	4
Dyspepsia	7	5
Vomiting	4	3
Increased appetite	3	2
Hemic and Lymphatic System
Ecchymosis	5	3
Metabolic and Nutritional Disorders
Weight gain	5	3
Peripheral edema	3	1
Musculoskeletal System
Extremity pain (other than joint)	5	3
Joint pain	5	3
Nervous System
Somnolence	29	13
Insomnia	12	11
Dizziness	11	4
Abnormal gait	6	1
Tremor	4	3
Akathisia	3	2
Hypertonia	3	2
Articulation impairment	2	1
Respiratory System
Rhinitis	7	6
Cough increased	6	3
Pharyngitis	4	3
Special Senses
Amblyopia	3	2
Urogenital System
Urinary incontinence	2	1
Urinary tract infection	2	1

Commonly Observed Adverse Reactions in Short-Term Trials of Oral Olanzapine as Adjunct to Lithium or Valproate

Table 12: Common Treatment-Emergent Adverse Reactions Associated with the Use of Oral Olanzapine in 6-Week Adjunct to Lithium or Valproate Trials — Bipolar I Disorder (Manic or Mixed Episodes)

Adverse Reaction	Percentage of Patients Reporting Event
	Olanzapine with lithium or valproate (N=229)	Placebo with lithium or valproate (N=115)
Dry mouth	32	9
Weight gain	26	7
Increased appetite	24	8
Dizziness	14	7
Back pain	8	4
Constipation	8	4
Speech disorder	7	1
Increased salivation	6	2
Amnesia	5	2
Paresthesia	5	2

Adverse Reactions Occurring at an Incidence of 2% or More among Oral Olanzapine-Treated Patients in Short-Term Trials of Olanzapine as Adjunct to Lithium or Valproate

Table 13: Treatment-Emergent Adverse Reactions: Incidence in Short-Term, Placebo-Controlled Clinical Trials of Oral Olanzapine as Adjunct to Lithium or Valproate

	Percentage of Patients Reporting Event
Body System/Adverse Reaction	Olanzapine with lithium or valproate (N=229)	Placebo with lithium or valproate (N=115)
Body as a Whole
Asthenia	18	13
Back pain	8	4
Accidental injury	4	2
Chest pain	3	2
Cardiovascular System
Hypertension	2	1
Digestive System
Dry mouth	32	9
Increased appetite	24	8
Thirst	10	6
Constipation	8	4
Increased salivation	6	2
Metabolic and Nutritional Disorders
Weight gain	26	7
Peripheral edema	6	4
Edema	2	1
Nervous System
Somnolence	52	27
Tremor	23	13
Depression	18	17
Dizziness	14	7
Speech disorder	7	1
Amnesia	5	2
Paresthesia	5	2
Apathy	4	3
Confusion	4	1
Euphoria	3	2
Incoordination	2	0
Respiratory System
Pharyngitis	4	1
Dyspnea	3	1
Skin and Appendages
Sweating	3	1
Acne	2	0
Dry skin	2	0
Special Senses
Amblyopia	9	5
Abnormal vision	2	0
Urogenital System
DysmenorrheaDenominator used was for females only (olanzapine, N=128; placebo, N=51).	2	0
VaginitisDenominator used was for females only (olanzapine, N=128; placebo, N=51).	2	0

Additional Findings Observed in Clinical Trials

Dose Dependency of Adverse Reactions in Short-Term, Placebo-Controlled Trials

Extrapyramidal Symptoms:

Table 15: Treatment-Emergent Extrapyramidal Symptoms Assessed by Rating Scales Incidence in a Fixed Dosage Range, Placebo-Controlled Clinical Trial of Oral Olanzapine in Schizophrenia — Acute Phase

	Percentage of Patients Reporting Event
	Placebo	Olanzapine 5 ± 2.5 mg/day	Olanzapine 10 ± 2.5 mg/day	Olanzapine 15 ± 2.5 mg/day
ParkinsonismPercentage of patients with a Simpson-Angus Scale total score >3.	15	14	12	14
AkathisiaPercentage of patients with a Barnes Akathisia Scale global score ≥2.	23	16	19	27

Table 16: Treatment-Emergent Extrapyramidal Symptoms Assessed by Adverse Reactions Incidence in a Fixed Dosage Range, Placebo-Controlled Clinical Trial of Oral Olanzapine in Schizophrenia — Acute Phase

	Percentage of Patients Reporting Event
	Placebo (N=68)	Olanzapine 5 ± 2.5 mg/day (N=65)	Olanzapine 10 ± 2.5 mg/day (N=64)	Olanzapine 15 ± 2.5 mg/day (N=69)
Dystonic eventsPatients with the following COSTART terms were counted in this category: dystonia, generalized spasm, neck rigidity, oculogyric crisis, opisthotonos, torticollis.	1	3	2	3
Parkinsonism eventsPatients with the following COSTART terms were counted in this category: akinesia, cogwheel rigidity, extrapyramidal syndrome, hypertonia, hypokinesia, masked facies, tremor.	10	8	14	20
Akathisia eventsPatients with the following COSTART terms were counted in this category: akathisia, hyperkinesia.	1	5	11	10
Dyskinetic eventsPatients with the following COSTART terms were counted in this category: buccoglossal syndrome, choreoathetosis, dyskinesia, tardive dyskinesia.	4	0	2	1
Residual eventsPatients with the following COSTART terms were counted in this category: movement disorder, myoclonus, twitching.	1	2	5	1
Any extrapyramidal event	16	15	25	32

Table 17: Treatment-Emergent Extrapyramidal Symptoms Assessed by Adverse Reactions Incidence in Placebo-Controlled Clinical Trials of Oral Olanzapine in Schizophrenia and Bipolar I Disorder — Adolescents

CategoriesCategories are based on Standard MedDRA Queries (SMQ) for extrapyramidal symptoms as defined in MedDRA version 12.0.	Percentage of Patients Reporting Event
	Placebo (N=89)		Olanzapine (N=179)
Dystonic events	0		1
Parkinsonism events		2	1
Akathisia events		4	6
Dyskinetic events		0	1
Nonspecific events		0	4
Any extrapyramidal event		6	10

Dystonia, Class Effect:

Other Adverse Reactions:

Table 20: Percentage of Patients from a Schizophrenia Trial with Treatment-Emergent Adverse Reactions for the 3 Dose Range Groups and Placebo

Adverse Reaction	Percentage of Patients Reporting Event
	Placebo (N=68)	Olanzapine 5 ± 2.5 mg/day (N=65)	Olanzapine 10 ± 2.5 mg/day (N=64)	Olanzapine 15 ± 2.5 mg/day (N=69)
Asthenia	15	8	9	20
Dry mouth	4	3	5	13
Nausea	9	0	2	9
Somnolence	16	20	30	39
Tremor	3	0	5	7

Differences among Fixed-Dose Groups Observed in Other Olanzapine Clinical Trials



Other Adverse Reactions Observed During the Clinical Trial Evaluation of Oral Olanzapine



Body as a Whole Infrequent: ¹Rare: ¹

Cardiovascular System Infrequent:

Digestive System Infrequent: Rare:

Hemic and Lymphatic System Infrequent:

Metabolic and Nutritional Disorders Infrequent:

Musculoskeletal System Rare:

Nervous System Infrequent: Rare:

Respiratory System Infrequent: Rare:

Skin and Appendages Infrequent:

Special Senses Infrequent: Rare:

Urogenital System Infrequent: <sup>222222

1
2</sup>



Commonly Observed Adverse Reactions in Oral Olanzapine Short-Term, Placebo-Controlled Trials

Table 21: Treatment-Emergent Adverse Reactions of ≥5% Incidence among Adolescents (13 to 17 Years Old) with Schizophrenia or Bipolar I Disorder (Manic or Mixed Episodes)

Adverse Reactions	Percentage of Patients Reporting Event
	6 Week Trial % Schizophrenia Patients		3 Week Trial % Bipolar Patients
	Olanzapine (N=72)	Placebo (N=35)	Olanzapine (N=107)	Placebo (N=54)
SedationPatients with the following MedDRA terms were counted in this category: hypersomnia, lethargy, sedation, somnolence.	39	9	48	9
Weight increased	31	9	29	4
Headache	17	6	17	17
Increased appetite	17	9	29	4
Dizziness	8	3	7	2
Abdominal painPatients with the following MedDRA terms were counted in this category: abdominal pain, abdominal pain lower, abdominal pain upper.	6	3	6	7
Pain in extremity	6	3	5	0
Fatigue	3	3	14	6
Dry mouth	4	0	7	0

Adverse Reactions Occurring at an Incidence of 2% or More among Oral Olanzapine-Treated Patients in Short-Term (3 to 6 weeks), Placebo-Controlled Trials

Table 22: Treatment-Emergent Adverse Reactions of ≥2% Incidence among Adolescents (13 to 17 Years Old) (Combined Incidence from Short-Term, Placebo-Controlled Clinical Trials of Schizophrenia or Bipolar I Disorder [Manic or Mixed Episodes])

	Percentage of Patients Reporting Event
Adverse Reaction	Olanzapine (N=179)	Placebo (N=89)
SedationPatients with the following MedDRA terms were counted in this category: hypersomnia, lethargy, sedation, somnolence.	44	9
Weight increased	30	6
Increased appetite	24	6
Headache	17	12
Fatigue	9	4
Dizziness	7	2
Dry mouth	6	0
Pain in extremity	5	1
Constipation	4	0
Nasopharyngitis	4	2
Diarrhea	3	0
Restlessness	3	2
Liver enzymes increasedThe terms alanine aminotransferase (ALT), aspartate aminotransferase (AST), and hepatic enzyme were combined under liver enzymes.	8	1
Dyspepsia	3	1
Epistaxis	3	0
Respiratory tract infectionPatients with the following MedDRA terms were counted in this category: lower respiratory tract infection, respiratory tract infection, respiratory tract infection viral, upper respiratory tract infection, viral upper respiratory tract infection.	3	2
Sinusitis	3	0
Arthralgia	2	0
Musculoskeletal stiffness	2	0

6.2 Vital Signs and Laboratory Studies

Vital Sign Changes [see Warnings and Precautions (5)]

Laboratory Changes Olanzapine Monotherapy in Adults:







[see Warnings and Precautions (5.15)]

Olanzapine Monotherapy in Adolescents:



ECG Changes [see Warnings and Precautions (5.8)]

6.3 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Potential for Other Drugs to Affect Olanzapine

Diazepam [see Drug Interactions (7.2)]

Cimetidine and Antacids

Inducers of CYP1A2

Alcohol [see Drug Interactions (7.2)]

Inhibitors of CYP1A2

Fluvoxamine: _max

Inhibitors of CYP2D6

Fluoxetine:

Warfarin [see Drug Interactions (7.2)]

Inducers of CYP1A2 or Glucuronyl Transferase

Charcoal _max

7.2 Potential for Olanzapine to Affect Other Drugs

CNS Acting Drugs

Antihypertensive Agents

Levodopa and Dopamine Agonists

Lithium [see Warnings and Precautions (5.16)]

Valproate [see Warnings and Precautions (5.16)]

Effect of Olanzapine on Drug Metabolizing Enzymes In vitro

Imipramine

Warfarin [see Drug Interactions (7.1)]

Diazepam [see Drug Interactions (7.1)]

Alcohol [see Drug Interactions (7.1)]

Biperiden

Theophylline

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects, Pregnancy Category C ^{2 2 2 2}





Nonteratogenic Effects, Class Effect 

8.2 Labor and Delivery

8.3 Nursing Mothers

8.4 Pediatric Use

[see Warnings and Precautions (5.5, 5.6, 5.15, 5.17) and Adverse Reactions (6.2)]

[see Patient Counseling Information (17.13)]



Pediatric use information in pediatric patients with schizophrenia and bipolar I disorder is approved for Eli Lilly and Company’s olanzapine drug product labeling. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

8.5 Geriatric Use

[see Boxed Warning, Dosage and Administration (2.1), and Warnings and Precautions (5.1)]

9 DRUG ABUSE AND DEPENDENCE

9.3 Dependence

²

10 OVERDOSAGE

10.1 Human Experience

10.2 Management of Overdose

_max

11 DESCRIPTION

Hb₁₇₂₀₄

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

<sub>2A/2C6i1-4i1i1i3i1-5iAi

21-511</sub>

12.3 Pharmacokinetics

Oral Administration, Monotherapy





₁

Metabolism and Elimination ¹⁴

In vitroin vivo

Specific Populations

Renal Impairment

Hepatic Impairment

Geriatric [see Dosage and Administration (2)]

Gender

Smoking Status

Race In vivo

Combined Effects [see Dosage and Administration (2)]

Adolescents (ages 13 to 17 years)

Pharmacokinetic information in pediatric patients is approved for Eli Lilly and Company’s olanzapine drug product labeling. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis ^{2 2 2 2 2 2} [see Warnings and Precautions (5.15)]

Mutagenesis in vivoin vivo

Impairment of Fertility ^{2 2 2}

13.2 Animal Toxicology and/or Pharmacology

^{2 2 2 2}

14 CLINICAL STUDIES

14.1 Schizophrenia

Adults













Adolescents

Clinical trial information in pediatric patients with schizophrenia is approved for Eli Lilly and Company’s olanzapine drug product labeling. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

14.2 Bipolar I Disorder (Manic or Mixed Episodes)

Adults

Monotherapy









Adjunct to Lithium or Valproate





Adolescents

Clinical trial information in pediatric patients with bipolar I disorder is approved for Eli Lilly and Company’s olanzapine drug product labeling. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

16.2 Storage and Handling

17 PATIENT COUNSELING INFORMATION

See FDA-approved Medication Guide for the oral formulations.
 

17.1 Information on Medication Guide

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

[see Boxed Warning and Warnings and Precautions (5.1)]

17.3 Neuroleptic Malignant Syndrome (NMS)

[see Warnings and Precautions (5.3)]

17.4 Hyperglycemia

[see Warnings and Precautions (5.4)]

17.5 Hyperlipidemia

[see Warnings and Precautions (5.5)]

17.6 Weight Gain

[see Warnings and Precautions (5.6)]

17.7 Orthostatic Hypotension

[see Warnings and Precautions (5.8) and Drug Interactions (7)]

17.8 Potential for Cognitive and Motor Impairment

[see Warnings and Precautions (5.12)]

17.9 Body Temperature Regulation

[see Warnings and Precautions (5.13)]

17.10 Concomitant Medication

[see Drug Interactions (7)]

17.11 Alcohol

[see Drug Interactions (7)]

17.13 Use in Specific Populations

Pregnancy [see Use in Specific Populations (8.1)]

Nursing Mothers [see Use in Specific Populations (8.3)]

Pediatric Use [see Warnings and Precautions (5.5, 5.6) and Use in Specific Populations (8.4)]

Pediatric use information in pediatric patients with schizophrenia and bipolar I disorder is approved for Eli Lilly and Company’s olanzapine drug product labeling. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

17.14 Need for Comprehensive Treatment Program in Pediatric Patients

Pediatric use information in pediatric patients with schizophrenia and bipolar I disorder is approved for Eli Lilly and Company’s olanzapine drug product labeling. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Medication Guide

Olanzapine Tablets



What is the most important information I should know about olanzapine tablets?
 
Olanzapine tablets may cause serious side effects, including:

• Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis).
• High blood sugar (hyperglycemia).
• High fat levels in your blood (increased cholesterol and triglycerides), especially in teenagers age 13 to 17.
• Weight gain, especially in teenagers age 13 to 17.

These serious side effects are described below.
 
1. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis).

2. High blood sugar (hyperglycemia).

• a build up of acid in your blood due to ketones (ketoacidosis)
• coma
• death

Call your doctor

• feel very thirsty
• need to urinate more than usual
• feel very hungry
• feel weak or tired
• feel sick to your stomach
• feel confused or your breath smells fruity

3. High fat levels in your blood (cholesterol and triglycerides).

4. Weight gain.

What are olanzapine tablets?

Olanzapine tablets are prescription medicines used to treat:

• schizophrenia.
• bipolar disorder, including:
  • manic or mixed episodes that happen with bipolar I disorder.
  • manic or mixed episodes that happen with bipolar I disorder, when used with the medicine lithium or valproate, in adults.
  • long-term treatment of bipolar I disorder in adults.
• episodes of depression that happen with bipolar I disorder, when used with the medicine fluoxetine (Prozac^®*), in adults.

Pediatric use information is approved for Eli Lilly and Company’s olanzapine drug product labeling. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

What should I tell my doctor before taking olanzapine tablets?

• heart problems
• seizures
• diabetes or high blood sugar levels (hyperglycemia)
• high cholesterol or triglyceride levels in your blood
• liver problems
• low or high blood pressure
• strokes or “mini-strokes” also called transient ischemic attacks (TIAs)
• Alzheimer’s disease
• narrow-angle glaucoma
• enlarged prostate in men
• bowel obstruction
• breast cancer
• thoughts of suicide or hurting yourself
• any other medical condition
• are pregnant or plan to become pregnant. It is not known if olanzapine tablets will harm your unborn baby.
• are breast-feeding or plan to breast-feed. Olanzapine can pass into your breast milk and may harm your baby. You should not breast-feed while taking olanzapine tablets. Talk to your doctor about the best way to feed your baby if you take olanzapine tablets.

thoughts of suicide

Tell your doctor about all the medicines that you take,

How should I take olanzapine tablets?

• Take olanzapine tablets exactly as prescribed. Your doctor may need to change (adjust) the dose of olanzapine tablets until it is right for you.
• If you miss a dose of olanzapine tablets, take the missed dose as soon as you remember. If it is almost time for the next dose, just skip the missed dose and take your next dose at the regular time. Do not take two doses of olanzapine tablets at the same time.
• To prevent serious side effects, do not stop taking olanzapine tablets suddenly. If you need to stop taking olanzapine tablets, your doctor can tell you how to safely stop taking it.
• If you take too many olanzapine tablets, call your doctor or poison control center at 1-800-222-1222 right away, or get emergency treatment.
• Olanzapine tablets can be taken with or without food.
• Olanzapine tablets are usually taken one time each day.
• Call your doctor if you do not think you are getting better or have any concerns about your condition while taking olanzapine tablets.

What should I avoid while taking olanzapine tablets?

• Olanzapine tablets can cause sleepiness and may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how olanzapine tablets affect you.
• Avoid drinking alcohol while taking olanzapine tablets. Drinking alcohol while you take olanzapine tablets may make you sleepier than if you take olanzapine tablets alone.

What are the possible side effects of olanzapine tablets?

Serious side effects may happen when you take olanzapine tablets, including:

• See “What is the most important information I should know about olanzapine tablets?”, which describes the increased risk of death in elderly people with dementia-related psychosis and the risks of high blood sugar, high cholesterol and triglyceride levels, and weight gain.
• Increased incidence of stroke or “mini-strokes” called transient ischemic attacks (TIAs) in elderly people with dementia-related psychosis (elderly people who have lost touch with reality due to confusion and memory loss). Olanzapine tablets are not approved for these patients.
• Neuroleptic Malignant Syndrome (NMS): NMS is a rare but very serious condition that can happen in people who take antipsychotic medicines, including olanzapine tablets. NMS can cause death and must be treated in a hospital. Call your doctor right away if you become severely ill and have any of these symptoms:
  • high fever
  • excessive sweating
  • rigid muscles
  • confusion
  • changes in your breathing, heartbeat, and blood pressure.
• Tardive Dyskinesia: This condition causes body movements that keep happening and that you can not control. These movements usually affect the face and tongue. Tardive dyskinesia may not go away, even if you stop taking olanzapine tablets. It may also start after you stop taking olanzapine tablets. Tell your doctor if you get any body movements that you can not control.
• Decreased blood pressure when you change positions, with symptoms of dizziness, fast or slow heartbeat, or fainting.
• Difficulty swallowing, that can cause food or liquid to get into your lungs.
• Seizures: Tell your doctor if you have a seizure during treatment with olanzapine tablets.
• Problems with control of body temperature: You could become very hot, for instance when you exercise a lot or stay in an area that is very hot. It is important for you to drink water to avoid dehydration. Call your doctor right away if you become severely ill and have any of these symptoms of dehydration:
  • sweating too much or not at all
  • dry mouth
  • feeling very hot
  • feeling thirsty
  • not able to produce urine.

Common side effects of olanzapine tablets include:

Other common side effects in teenagers (13 to 17 years old) include:





Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store olanzapine tablets?

• Store olanzapine tablets at room temperature, at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). 
• Keep olanzapine tablets away from light.
• Keep olanzapine tablets dry and away from moisture.

Keep olanzapine tablets and all medicines out of the reach of children.

General information about olanzapine tablets
 




What are the ingredients in olanzapine tablets?

Active ingredient:

Inactive ingredients:

Olanzapine Tablets

This Medication Guide has been approved by the U.S. Food and Drug Administration.


 

 

Caraco Pharmaceutical Laboratories, Ltd.

 

Sun Pharmaceutical Industries Ltd.

PJPI0378B

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 2.5MG

NDC 62756-551-88
Olanzapine Tablets
2.5 mg
Rx only
100 TABLETS
SUN PHARMA
PHARMACIST: Dispense the Medication Guide provided separately to each patient.
 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 5MG

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 7.5MG

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 10MG

NDC 62756-554-88
Olanzapine Tablets
10 mg
Rx only
100 TABLETS
SUN PHARMA
PHARMACIST: Dispense the Medication Guide provided separately to each patient.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 15MG

NDC 62756-555-88
Olanzapine Tablets
15 mg
Rx only
100 TABLETS
SUN PHARMA
PHARMACIST: Dispense the Medication Guide provided separately to each patient.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 20MG

NDC 62756-556-88
Olanzapine Tablets
20 mg
Rx only
100 TABLETS
SUN PHARMA 
PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Olanzapine Olanzapine TABLET Product Information Product Type Human prescription drug label Item Code (Source) NDC:62756-551 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLANZAPINE OLANZAPINE 2.5 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE cellulose, microcrystalline CROSPOVIDONE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED MAGNESIUM STEARATE SILICON DIOXIDE Product Characteristics Color Size Imprint Code Shape YELLOW 6 mm 2;5 OVAL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62756-551-83 30 in 1 BOTTLE 2 NDC:62756-551-88 100 in 1 BOTTLE 3 NDC:62756-551-08 100 in 1 BOTTLE 4 NDC:62756-551-18 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091038 2012-04-23

Olanzapine Olanzapine TABLET Product Information Product Type Human prescription drug label Item Code (Source) NDC:62756-552 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLANZAPINE OLANZAPINE 5 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE cellulose, microcrystalline CROSPOVIDONE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED MAGNESIUM STEARATE SILICON DIOXIDE Product Characteristics Color Size Imprint Code Shape YELLOW 9 mm 5 OVAL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62756-552-83 30 in 1 BOTTLE 2 NDC:62756-552-88 100 in 1 BOTTLE 3 NDC:62756-552-08 100 in 1 BOTTLE 4 NDC:62756-552-18 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091038 2012-04-23

Olanzapine Olanzapine TABLET Product Information Product Type Human prescription drug label Item Code (Source) NDC:62756-553 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLANZAPINE OLANZAPINE 7.5 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE cellulose, microcrystalline CROSPOVIDONE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED MAGNESIUM STEARATE SILICON DIOXIDE Product Characteristics Color Size Imprint Code Shape YELLOW 7 mm 7;5 ROUND Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62756-553-83 30 in 1 BOTTLE 2 NDC:62756-553-88 100 in 1 BOTTLE 3 NDC:62756-553-08 100 in 1 BOTTLE 4 NDC:62756-553-18 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091038 2012-04-23

Olanzapine Olanzapine TABLET Product Information Product Type Human prescription drug label Item Code (Source) NDC:62756-554 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLANZAPINE OLANZAPINE 10 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE cellulose, microcrystalline CROSPOVIDONE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED MAGNESIUM STEARATE SILICON DIOXIDE Product Characteristics Color Size Imprint Code Shape YELLOW 12 mm 10 OVAL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62756-554-83 30 in 1 BOTTLE 2 NDC:62756-554-88 100 in 1 BOTTLE 3 NDC:62756-554-08 100 in 1 BOTTLE 4 NDC:62756-554-18 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091038 2012-04-23

Olanzapine Olanzapine TABLET Product Information Product Type Human prescription drug label Item Code (Source) NDC:62756-555 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLANZAPINE OLANZAPINE 15 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE cellulose, microcrystalline CROSPOVIDONE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED MAGNESIUM STEARATE SILICON DIOXIDE Product Characteristics Color Size Imprint Code Shape YELLOW 13 mm 15 OVAL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62756-555-83 30 in 1 BOTTLE 2 NDC:62756-555-88 100 in 1 BOTTLE 3 NDC:62756-555-08 100 in 1 BOTTLE 4 NDC:62756-555-18 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091038 2012-04-23

Olanzapine Olanzapine TABLET Product Information Product Type Human prescription drug label Item Code (Source) NDC:62756-556 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLANZAPINE OLANZAPINE 20 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE cellulose, microcrystalline CROSPOVIDONE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED MAGNESIUM STEARATE SILICON DIOXIDE Product Characteristics Color Size Imprint Code Shape YELLOW 15 mm 20 OVAL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62756-556-83 30 in 1 BOTTLE 2 NDC:62756-556-88 100 in 1 BOTTLE 3 NDC:62756-556-08 100 in 1 BOTTLE 4 NDC:62756-556-18 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091038 2012-04-23