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Olanzapine
Overview
What is Olanzapine?
Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10-thieno[2,3-] [1,5]benzodiazepine. The molecular formula is CHNS, 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 orally disintegrating tablets, USP are intended for oral administration only.
Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contains the following inactive ingredients: aspartame, microcrystalline cellulose, low substituted hydroxypropyl cellulose, crospovidone and magnesium stearate. The drug product meets USP Disintegration Test 2.
What does Olanzapine look like?
What are the available doses of Olanzapine?
· Orally Disintegrating Tablets (not scored): 5, 10, 15, 20 mg ()
What should I talk to my health care provider before I take Olanzapine?
When using olanzapine and fluoxetine in combination, also refer to the Use in Specific Populations section of the package insert for Symbyax
How should I use Olanzapine?
Olanzapine orally disintegrating tablets 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. In adolescent patients with schizophrenia (ages 13 17), efficacy was established in one 6-week trial
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 dyslipidemia. 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 .
2.1 SchizophreniaAdults
Dose Selection
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
[see Warnings and Precautions (), Drug Interactions (), and Clinical Pharmacology ()]
Maintenance Treatment
[see Clinical Studies ()]
Dose Selection
The safety and effectiveness of doses above 20 mg/day have not been evaluated in clinical trials .
Maintenance Treatment
What interacts with Olanzapine?
Sorry No Records found
What are the warnings of Olanzapine?
Sorry No Records found
What are the precautions of Olanzapine?
Sorry No Records found
What are the side effects of Olanzapine?
Sorry No records found
What should I look out for while using Olanzapine?
• None with olanzapine orally disintegrating tablets monotherapy. • When using olanzapine orally disintegrating tablets 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.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Olanzapine is not approved for the treatment of patients with dementia-related psychosis
When using olanzapine and fluoxetine in combination, also refer to the Boxed Warning section of the package insert for Symbyax.
What might happen if I take too much Olanzapine?
How should I store and handle Olanzapine?
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.Product: 71335-0776NDC: 71335-0776-1 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 71335-0776-2 90 TABLET, EXTENDED RELEASE in a BOTTLENDC: 71335-0776-3 60 TABLET, EXTENDED RELEASE in a BOTTLENDC: 71335-0776-4 180 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 71335-0776NDC: 71335-0776-1 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 71335-0776-2 90 TABLET, EXTENDED RELEASE in a BOTTLENDC: 71335-0776-3 60 TABLET, EXTENDED RELEASE in a BOTTLENDC: 71335-0776-4 180 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 71335-0776NDC: 71335-0776-1 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 71335-0776-2 90 TABLET, EXTENDED RELEASE in a BOTTLENDC: 71335-0776-3 60 TABLET, EXTENDED RELEASE in a BOTTLENDC: 71335-0776-4 180 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 71335-0776NDC: 71335-0776-1 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 71335-0776-2 90 TABLET, EXTENDED RELEASE in a BOTTLENDC: 71335-0776-3 60 TABLET, EXTENDED RELEASE in a BOTTLENDC: 71335-0776-4 180 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 71335-0776NDC: 71335-0776-1 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 71335-0776-2 90 TABLET, EXTENDED RELEASE in a BOTTLENDC: 71335-0776-3 60 TABLET, EXTENDED RELEASE in a BOTTLENDC: 71335-0776-4 180 TABLET, EXTENDED RELEASE in a BOTTLE
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism of action of olanzapine, as with other drugs having efficacy in schizophrenia, is unknown. However, it has been proposed that this drug's efficacy in schizophrenia is mediated through a combination of dopamine and serotonin type 2 (5HT) antagonism. The mechanism of action of olanzapine in the treatment of acute manic or mixed episodes associated with bipolar I disorder is unknown.
Non-Clinical Toxicology
• None with olanzapine orally disintegrating tablets monotherapy. • When using olanzapine orally disintegrating tablets 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.Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Olanzapine is not approved for the treatment of patients with dementia-related psychosis When using olanzapine and fluoxetine in combination, also refer to the Boxed Warning section of the package insert for Symbyax.
When using olanzapine and fluoxetine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax.
When using olanzapine and fluoxetine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
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