Olanzapine And Fluoxetine
Generic Name: olanzapine and fluoxetine
Brand Names:
Olanzapine And Fluoxetine
11 DESCRIPTION Olanzapine and Fluoxetine Capsules USP combine an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine, USP (the active ingredient in Zyprexa ® , and Zyprexa ® Zydis ® ) and fluoxetine hydrochloride, USP (the active ingredient in Prozac ® , Prozac ® Weekly ™ , and Sarafem ® ). Olanzapine, USP 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.
Overview
11 DESCRIPTION Olanzapine and Fluoxetine Capsules USP combine an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine, USP (the active ingredient in Zyprexa ® , and Zyprexa ® Zydis ® ) and fluoxetine hydrochloride, USP (the active ingredient in Prozac ® , Prozac ® Weekly ™ , and Sarafem ® ). Olanzapine, USP 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.
Uses
1 INDICATIONS AND USAGE Olanzapine and fluoxetine capsules are indicated for the treatment of: Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1) ]. Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2) ]. Olanzapine and fluoxetine capsules combine olanzapine, an atypical antipsychotic and fluoxetine, a selective serotonin reuptake inhibitor, indicated for treatment of: Acute Depressive Episodes Associated with Bipolar I Disorder (1) Treatment Resistant Depression (1)
Dosage
2 DOSAGE AND ADMINISTRATION Adult Starting Dose: 6 mg olanzapine with 25 mg fluoxetine (6 mg/25 mg, once daily in the evening) (2.1 , 2.2 ) Adult Maximum Dose: 12 mg/50 mg once daily (2.1 , 2.2 ). Pediatric Bipolar Depression Starting Dose: 3 mg/25 mg once daily (for ages 10 to 17 years) (2.1) . Pediatric Bipolar Depression Maximum Dose: 12 mg/50 mg (2.1) Starting dose in patients predisposed to hypotensive reactions, hepatic impairment, or with potential for slowed metabolism: 3 mg/25 mg to 6 mg/25 mg. Escalate dose cautiously (2.3) 2.1 Depressive Episodes Associated with Bipolar I Disorder Adults – Administer olanzapine and fluoxetine capsules once daily in the evening, generally beginning with the 6 mg/25 mg (mg olanzapine/mg equivalent fluoxetine) capsule.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions (5.1) ] Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions (5.2) ] Neuroleptic Malignant syndrome (NMS) [see Warnings and Precautions (5.3) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.4) ] Hyperglycemia [see Warnings and Precautions (5.5) ] Dyslipidemia [see Warnings and Precautions (5.5) ] Weight Gain [see Warnings and Precautions (5.5) ] Serotonin Syndrome [see Warnings and Precautions (5.6) ] Angle-Closure Glaucoma [see Warnings and Precautions (5.7)...
Interactions
7 DRUG INTERACTIONS The risks of using olanzapine and fluoxetine capsules in combination with other drugs have not been extensively evaluated in systematic studies. The drug-drug interactions sections of fluoxetine and olanzapine are applicable to olanzapine and fluoxetine capsules. As with all drugs, the potential for interaction by a variety of mechanisms (e.g., pharmacodynamic, pharmacokinetic drug inhibition or enhancement, etc.) is a possibility. In evaluating individual cases, consideration should be given to using lower initial doses of the concomitantly administered drugs, using conservative titration schedules, and monitoring of clinical status [see Clinical Pharmacology (12.3) ].
Warnings
WARNINGS: SUICIDAL THOUGHTS AND BEHAVIORS; AND INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Suicidal Thoughts and Behaviors — Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. 5 WARNINGS AND PRECAUTIONS Neuroleptic Malignant Syndrome : Manage with immediate discontinuation and close monitoring (5.3) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) : Discontinue if DRESS is suspected (5.4) Metabolic Changes : Atypical antipsychotic drugs have been associated with metabolic changes including hyperglycemia, dyslipidemia, and weight gain (5.5) Hyperglycemia and Diabetes Mellitus : In some cases extreme and associated with ketoacidosis or hyperosmolar coma or death. Monitor for symptoms of hyperglycemia. Perform fasting blood glucose testing before beginning, and periodically during treatment. 4 CONTRAINDICATIONS Monoamine Oxidase Inhibitors (MAOI) : Because of the risk of serotonin syndrome, do not use MAOIs intended to treat psychiatric disorders with olanzapine and fluoxetine capsules or within 5 weeks of stopping treatment with olanzapine and fluoxetine capsules.
Pregnancy
8.1 Pregnancy Pregnancy Category C Risk Summary There are no adequate and well-controlled clinical studies with olanzapine and fluoxetine capsules or their components (olanzapine and fluoxetine) in pregnant women. A number of published epidemiological studies assessing the risk of fluoxetine exposure during the first trimester of pregnancy have demonstrated inconsistent results.
Storage
16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Keep container tightly closed. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Frequently Asked Questions
What is Olanzapine And Fluoxetine used for?▼
1 INDICATIONS AND USAGE Olanzapine and fluoxetine capsules are indicated for the treatment of: Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1) ]. Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2) ]. Olanzapine and fluoxetine capsules combine olanzapine, an atypical antipsychotic and fluoxetine, a selective serotonin reuptake inhibitor, indicated for treatment of: Acute Depressive Episodes Associated with Bipolar I Disorder (1) Treatment Resistant Depression (1)
What are the side effects of Olanzapine And Fluoxetine?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions (5.1) ] Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions (5.2) ] Neuroleptic Malignant syndrome (NMS) [see Warnings and Precautions (5.3) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.4) ] Hyperglycemia [see Warnings and Precautions (5.5) ] Dyslipidemia [see Warnings and Precautions (5.5) ] Weight Gain [see Warnings and Precautions (5.5) ] Serotonin Syndrome [see Warnings and Precautions (5.6) ] Angle-Closure Glaucoma [see Warnings and Precautions (5.7)...
Can I take Olanzapine And Fluoxetine during pregnancy?▼
8.1 Pregnancy Pregnancy Category C Risk Summary There are no adequate and well-controlled clinical studies with olanzapine and fluoxetine capsules or their components (olanzapine and fluoxetine) in pregnant women. A number of published epidemiological studies assessing the risk of fluoxetine exposure during the first trimester of pregnancy have demonstrated inconsistent results.
What are the important warnings for Olanzapine And Fluoxetine?▼
WARNINGS: SUICIDAL THOUGHTS AND BEHAVIORS; AND INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Suicidal Thoughts and Behaviors — Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. 5 WARNINGS AND PRECAUTIONS Neuroleptic Malignant Syndrome : Manage with immediate discontinuation and close monitoring (5.3) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) : Discontinue if DRESS is suspected (5.4) Metabolic Changes : Atypical antipsychotic drugs have been associated with metabolic changes including hyperglycemia, dyslipidemia, and weight gain (5.5) Hyperglycemia and Diabetes Mellitus : In some cases extreme and associated with ketoacidosis or hyperosmolar coma or death. Monitor for symptoms of hyperglycemia. Perform fasting blood glucose testing before beginning, and periodically during treatment. 4 CONTRAINDICATIONS Monoamine Oxidase Inhibitors (MAOI) : Because of the risk of serotonin syndrome, do not use MAOIs intended to treat psychiatric disorders with olanzapine and fluoxetine capsules or within 5 weeks of stopping treatment with olanzapine and fluoxetine capsules.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.