olanzapine tablet
1 INDICATIONS AND USAGE Olanzapine is an atypical antipsychotic indicated: As 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 ( ). Maintenance efficacy has not been systematically evaluated. 14.2 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*. 1.1 Schizophrenia olanzapine is indicated for the treatment of schizophrenia. Efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia. Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents . Oral [see Clinical Studies ( )] 14.1 . When [see Warnings and Precautions ( , )] 5.5 5.6 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. Information 1.2 Bipolar I Disorder (Manic or Mixed Episodes) — Oral olanzapine is indicated for the Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. Efficacy was established in three clinical trials in adult patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one monotherapy maintenance trial deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia. Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents . — Oral olanzapine is indicated for the treatment of manic or mixed episodes associated with bipolar I disorder as an adjunct to lithium or valproate. Efficacy was established in two 6-week clinical trials in adults. The effectiveness of adjunctive therapy for longer-term use has not been systematically evaluated in controlled trials . Monotherapy [see Clinical Studies ( )] 14.2 . When [see Warnings and Precautions ( , )] 5.5 5.6 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. Information Therapy to Lithium or Valproate Adjunctive [see Clinical Studies ( )] 14.2 1.3 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder 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. ion Informat 1.5 Olanzapine and Fluoxetine in Combination: Depressive Episodes Associated with Bipolar I Disorder Oral olanzapine and fluoxetine in combination is indicated for the treatment of depressive episodes associated with bipolar I disorder, based on clinical studies in adult patients. 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 depressive episodes associated with bipolar I disorder.
tya pharmaceuticals
OVAL YELLOW 15
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16 HOW SUPPLIED/STORAGE AND HANDLING NDC:64725-0555-1 in a BOTTLE of 30 TABLETS 16.1 How Supplied Olanzapine tablets are supplied as follows: 2.5 mg tablets: yellow, oval shaped uncoated tablets debossed with ‘2.5’ on one side and plain on other side. Bottles of 30’s with Child Resistant Cap …………….…………… NDC 62756-551-83 Bottles of 100’s with Child Resistant Cap …………………….….. NDC 62756-551-88 Bottles of 100’s with Non Child Resistant Cap ….……………….. NDC 62756-551-08 Bottles of 1000’s with Non Child Resistant Cap …………….…… NDC 62756-551-18 5 mg tablets: yellow, oval shaped uncoated tablets debossed with ‘5’ on one side and plain on other side. Bottles of 30’s with Child Resistant Cap …………….…………… NDC 62756-552-83 Bottles of 100’s with Child Resistant Cap …………………….….. NDC 62756-552-88 Bottles of 100’s with Non Child Resistant Cap….…………….….. NDC 62756-552-08 Bottles of 1000’s with Non Child Resistant Cap……………..…… NDC 62756-552-18 7.5 mg tablets: yellow, round shaped uncoated tablets debossed with ‘7.5’ on one side and plain on other side. Bottles of 30’s with Child Resistant Cap …………….…………… NDC 62756-553-83 Bottles of 100’s with Child Resistant Cap …………………….….. NDC 62756-553-88 Bottles of 100’s with Non Child Resistant Cap….……….……….. NDC 62756-553-08 Bottles of 1000’s with Non Child Resistant Cap……………..…… NDC 62756-553-18 10 mg tablets: yellow, oval shaped uncoated tablets debossed with ‘10’ on one side and plain on other side. Bottles of 30’s with Child Resistant Cap …………….…………… NDC 62756-554-83 Bottles of 100’s with Child Resistant Cap …………………….….. NDC 62756-554-88 Bottles of 100’s with Non Child Resistant Cap….…………….….. NDC 62756-554-08 Bottles of 1000’s with Non Child Resistant Cap……………..…… NDC 62756-554-18 15 mg tablets: yellow, oval shaped uncoated tablets debossed with ‘15’ on one side and plain on other side. Bottles of 30’s with Child Resistant Cap …………….…………… NDC 62756-555-83 Bottles of 100’s with Child Resistant Cap …………………….….. NDC 62756-555-88 Bottles of 100’s with Non Child Resistant Cap….………………... NDC 62756-555-08 Bottles of 1000’s with Non Child Resistant Cap……………..…… NDC 62756-555-18 20 mg tablets: yellow, oval shaped uncoated tablets debossed with ‘20’ on one side and plain on other side. Bottles of 30’s with Child Resistant Cap …………….…………… NDC 62756-556-83 Bottles of 100’s with Child Resistant Cap …………………….….. NDC 62756-556-88 Bottles of 100’s with Non Child Resistant Cap….…………….….. NDC 62756-556-08 Bottles of 1000’s with Non Child Resistant Cap……………..…… NDC 62756-556-18 16.2 Storage and Handling Store olanzapine tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. 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.
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