ZYPREXA Tablet / Tablet, orally disintegrating / Powder for solution for injection (2020)
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Eli Lilly and Company
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1. Indications and Usage
1.1 Schizophrenia Oral ZYPREXA 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 ...
2. Dosage and Administration
2.1 Schizophrenia Adults <u>Dose Selection:</u> — 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 ...
3. Dosage Forms and Strengths
The ZYPREXA 2.5 mg, 5 mg, 7.5 mg, and 10 mg tablets are white, round, and imprinted in blue ink with LILLY and tablet number. The 15 mg tablets are elliptical, blue, and debossed with LILLY and tablet ...
4. Contraindications
None with ZYPREXA monotherapy. When using ZYPREXA and fluoxetine in combination, also refer to the Contraindications section of the package insert for Symbyax. For specific information about the contraindications ...
5. Warnings and Precautions
When using ZYPREXA and fluoxetine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax. 5.1 Elderly Patients with Dementia-Related Psychosis Increased Mortality ...
6. Adverse Reactions
When using ZYPREXA and fluoxetine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax.
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during post-approval use of ZYPREXA. Because these reactions are reported voluntarily from a population of uncertain size, it is difficult to reliably ...
7. Drug Interactions
The risks of using olanzapine in combination with other drugs have not been extensively evaluated in systematic studies. 7.1 Potential for Other Drugs to Affect Olanzapine Diazepam The co-administration ...
8. Use in Specific Populations
When using ZYPREXA and fluoxetine in combination, also refer to the Use in Specific Populations section of the package insert for Symbyax.
8.1. Pregnancy
Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including ZYPREXA, during pregnancy. Healthcare providers ...
8.2. Lactation
Risk Summary Olanzapine is present in human milk. There are reports of excess sedation, irritability, poor feeding and extrapyramidal symptoms (tremors and abnormal muscle movements) in infants exposed ...
8.3. Females and Males of Reproductive Potential
Infertility Females Based on the pharmacologic action of olanzapine (D<sub>2</sub> receptor antagonism), treatment with ZYPREXA may result in an increase in serum prolactin levels, which may lead to a ...
8.4. Pediatric Use
The safety and effectiveness of oral ZYPREXA in the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder were established in short-term studies in adolescents (ages ...
8.5. Geriatric Use
Of the 2500 patients in premarketing clinical studies with oral olanzapine, 11% (263) were 65 years of age or over. In patients with schizophrenia, there was no indication of any different tolerability ...
9.3. Dependence
In studies prospectively designed to assess abuse and dependence potential, olanzapine was shown to have acute depressive CNS effects but little or no potential of abuse or physical dependence in rats ...
10. Overdosage
10.1 Human Experience In premarketing trials involving more than 3100 patients and/or normal subjects, accidental or intentional acute overdosage of olanzapine was identified in 67 patients. In the patient ...
11. Description
ZYPREXA (olanzapine) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10<em>H</em>thieno[2,3<em>b</em>] [1,5]benzodiazepine. ...
12.1. Mechanism of Action
The mechanism of action of olanzapine, in the listed indications is unclear. However, the efficacy of olanzapine in schizophrenia could be mediated through a combination of dopamine and serotonin type ...
12.2. Pharmacodynamics
Olanzapine binds with high affinity to the following receptors: serotonin 5HT<sub>2A/2C</sub>, 5HT<sub>6</sub> (K<sub>i</sub>=4, 11, and 5 nM, respectively), dopamine D<sub>1-4</sub> (K<sub>i</sub>=11-31 ...
12.3. Pharmacokinetics
Oral Administration, Monotherapy Olanzapine is well absorbed and reaches peak concentrations in approximately 6 hours following an oral dose. It is eliminated extensively by first pass metabolism, with ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis Oral carcinogenicity studies were conducted in mice and rats. Olanzapine was administered to mice in two 78-week studies at doses of 3, 10, 30/20 mg/kg/day (equivalent to 0.8-5 times the ...
13.2. Animal Toxicology and/or Pharmacology
In animal studies with olanzapine, the principal hematologic findings were reversible peripheral cytopenias in individual dogs dosed at 10 mg/kg (17 times the daily oral MRHD based on mg/m² body surface ...
14. Clinical Studies
When using ZYPREXA and fluoxetine in combination, also refer to the Clinical Studies section of the package insert for Symbyax. 14.1 Schizophrenia Adults The efficacy of oral olanzapine in the treatment ...
16.1. How Supplied
The ZYPREXA 2.5 mg, 5 mg, 7.5 mg, and 10 mg tablets are white, round, and imprinted in blue ink with LILLY and tablet number. The 15 mg tablets are elliptical, blue, and debossed with LILLY and tablet ...
16.2. Storage and Handling
Store ZYPREXA tablets, ZYPREXA ZYDIS, and ZYPREXA IntraMuscular vials (before reconstitution) at controlled room temperature, 20° to 25°C (68° to 77°F) [<em>see</em> USP]. Reconstituted ZYPREXA IntraMuscular ...
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide) for the oral formulations. Patients should be advised of the following issues and asked to alert their prescriber if these ...
BOXED WARNING SECTION
<b>WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS</b> <b>Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of ...