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Drug Catalog - Product Detail

OLANZAPINE TB 10MG 30

NDC Mfr Size Str Form
65862-0564-30 AUROBINDO PHARMA 30 10MG TABLET
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Description
Description Section Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H -thieno[2,3- b ] [1,5]benzodiazepine. The molecular formula is C 17 H 20 N 4 S, which corresponds to a molecular weight of 312.44. The chemical structure is: Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, and magnesium stearate. MM1
How Supplied
How Supplied Section 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. Bottles of 30 NDC 65862-561-30 Bottles of 100 NDC 65862-561-01 Bottles of 1000 NDC 65862-561-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-561-10 Olanzapine Tablets USP, 5 mg are yellow colored, circular, biconvex uncoated tablets, debossed with ‘C’ on one side and ‘46’ on the other side. Bottles of 30 NDC 65862-562-30 Bottles of 100 NDC 65862-562-01 Bottles of 1000 NDC 65862-562-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-562-10 Olanzapine Tablets USP, 7.5 mg are yellow colored, circular, biconvex uncoated tablets, debossed with ‘C’ on one side and ‘47’ on the other side. Bottles of 30 NDC 65862-563-30 Bottles of 100 NDC 65862-563-01 Bottles of 1000 NDC 65862-563-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-563-10 Olanzapine Tablets USP, 10 mg are yellow colored, circular, biconvex uncoated tablets, debossed with ‘C’ on one side and ‘48’ on the other side. Bottles of 30 NDC 65862-564-30 Bottles of 100 NDC 65862-564-01 Bottles of 1000 NDC 65862-564-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-564-10 Olanzapine Tablets USP, 15 mg are yellow colored, circular, biconvex uncoated tablets, debossed with ‘C’ on one side and ‘49’ on the other side. Bottles of 30 NDC 65862-565-30 Bottles of 100 NDC 65862-565-01 Bottles of 1000 NDC 65862-565-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-565-10 Olanzapine Tablets USP, 20 mg are yellow colored, circular, biconvex uncoated tablets, debossed with ‘C’ on one side and ‘50’ on the other side. Bottles of 30 NDC 65862-566-30 Bottles of 100 NDC 65862-566-01 Bottles of 1000 NDC 65862-566-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-566-10 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.
Indications & Usage
Indications & Usage Section 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 (14.2) . Maintenance efficacy has not been systematically evaluated. As Olanzapine Tablets, USP 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. Oral olanzapine tablets, USP are 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 [see Clinical Studies (14.1) ] . When 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 [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. Monotherapy — Oral olanzapine tablets, USP are 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 [see Clinical Studies (14.2) ] . When 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 [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 — Oral olanzapine tablets, USP are 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 [see Clinical Studies (14.2) ] . Information on treating 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. Oral olanzapine tablets, USP 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 tablets, USP and fluoxetine in combination, refer to the Clinical Studies section of the package insert for Symbyax. Olanzapine tablets, USP monotherapy is not indicated for the treatment of depressive episodes associated with bipolar I disorder.
Dosage and Administration
Dosage & Administration Section Schizophrenia in adults (2.1) Oral: Start at 5 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 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 Tablets 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) Adults Dose Selection — Oral olanzapine should be administered on a once-a-day schedule without regard to meals, generally beginning with 5 to 10 mg initially, with a target dose of 10 mg/day within several days. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week, since steady state for olanzapine would not be achieved for approximately 1 week in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended. Efficacy in schizophrenia was demonstrated in a dose range of 10 to 15 mg/day in clinical trials. However, doses above 10 mg/day were not demonstrated to be more efficacious than the 10 mg/day dose. An increase to a dose greater than the target dose of 10 mg/day (i.e., to a dose of 15 mg/day or greater) is recommended only after clinical assessment. Olanzapine is not indicated for use in doses above 20 mg/day. Dosing in Special Populations — The recommended starting dose is 5 mg in patients who are debilitated, who have a predisposition to hypotensive reactions, who otherwise exhibit a combination of factors that may result in slower metabolism of olanzapine (e.g., nonsmoking female patients ≥65 years of age), or who may be more pharmacodynamically sensitive to olanzapine [see Warnings and Precautions (5.14) , Drug Interactions (7) , and Clinical Pharmacology (12.3) ] . When indicated, dose escalation should be performed with caution in these patients. Maintenance Treatment — The effectiveness of oral olanzapine, 10 mg/day to 20 mg/day, in maintaining treatment response in schizophrenic patients who had been stable on olanzapine tablets for approximately 8 weeks and were then followed for relapse has been demonstrated in a placebo-controlled trial [see Clinical Studies (14.1) ] . The physician who elects to use olanzapine tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient. 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. Adults Dose Selection for Monotherapy — Oral olanzapine should be administered on a once-a-day schedule without regard to meals, generally beginning with 10 or 15 mg. Dosage adjustments, if indicated, should generally occur at intervals of not less than 24 hours, reflecting the procedures in the placebo-controlled trials. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended. Short-term (3 to 4 weeks) antimanic efficacy was demonstrated in a dose range of 5 mg to 20 mg/day in clinical trials. The safety of doses above 20 mg/day has not been evaluated in clinical trials [see Clinical Studies (14.2) ] . Maintenance Monotherapy — The benefit of maintaining bipolar I patients on monotherapy with oral olanzapine tablets at a dose of 5 to 20 mg/day, after achieving a responder status for an average duration of 2 weeks, was demonstrated in a controlled trial [see Clinical Studies (14.2) ] . The physician who elects to use olanzapine tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient. Dose Selection for Adjunctive Treatment — When administered as adjunctive treatment to lithium or valproate, oral olanzapine dosing should generally begin with 10 mg once-a-day without regard to meals. Antimanic efficacy was demonstrated in a dose range of 5 mg to 20 mg/day in clinical trials [see Clinical Studies (14.2) ] . The safety of doses above 20 mg/day has not been evaluated in clinical trials. 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. When using olanzapine tablets and fluoxetine in combination, also refer to the Clinical Studies section of the package insert for Symbyax. Oral olanzapine should be administered in combination with fluoxetine once daily in the evening, without regard to meals, generally beginning with 5 mg of oral olanzapine and 20 mg of fluoxetine. Dosage adjustments, if indicated, can be made according to efficacy and tolerability within dose ranges of oral olanzapine 5 to 12.5 mg and fluoxetine 20 to 50 mg. Antidepressant efficacy was demonstrated with olanzapine tablets and fluoxetine in combination in adult patients with a dose range of olanzapine 6 to 12 mg and fluoxetine 25 to 50 mg. Safety and efficacy of olanzapine tablets and fluoxetine in combination was determined in clinical trials supporting approval of Symbyax (fixed dose combination of olanzapine tablets and fluoxetine). Symbyax is dosed between 3 mg/25 mg (olanzapine/fluoxetine) per day and 12 mg/50 mg (olanzapine/fluoxetine) per day. The following table demonstrates the appropriate individual component doses of olanzapine tablets and fluoxetine versus Symbyax. Dosage adjustments, if indicated, should be made with the individual components according to efficacy and tolerability. Table 1: Approximate Dose Correspondence Between Symbyaxa and the Combination of Olanzapine Tablets and Fluoxetine For Symbyax (mg/day) Use in Combination Olanzapine Tablets(mg/day) Fluoxetine (mg/day) 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 While there is no body of evidence to answer the question of how long a patient treated with olanzapine tablets and fluoxetine in combination should remain on it, it is generally accepted that bipolar I disorder, including the depressive episodes associated with bipolar I disorder, is a chronic illness requiring chronic treatment. The physician should periodically reexamine the need for continued pharmacotherapy. Safety of coadministration of doses above 18 mg olanzapine with 75 mg fluoxetine has not been evaluated in clinical studies. Olanzapine tablets monotherapy is not indicated for the treatment of depressive episodes associated with bipolar I disorder. The starting dose of oral olanzapine 2.5 to 5 mg with fluoxetine 20 mg should be used for patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of olanzapine or fluoxetine in combination (female gender, geriatric age, nonsmoking status), or those patients who may be pharmacodynamically sensitive to olanzapine. Dosing modification may be necessary in patients who exhibit a combination of factors that may slow metabolism. When indicated, dose escalation should be performed with caution in these patients. Olanzapine tablets and fluoxetine in combination have not been systematically studied in patients over 65 years of age or in patients <18 years of age [see Warnings and Precautions (5.14) , Drug Interactions (7) , and Clinical Pharmacology (12.3) ] .