Fetal/Neonatal adverse reactions Placental passage has been reported in published study reports; however, the placental passage ratio was highly variable ranging between 7% to 167% at birth following exposure during pregnancy. Adverse reactions in adolescent patients treated with oral olanzapine (doses 2.5 mg) reported with an incidence of 2% or more and greater than placebo are listed in Table 22. Indicated for acute/maintenance treatment of manic or mixed episodes associated with bipolar 1 disorder; may be used adjunctively to valproate or lithium in the treatment of manic or mixed episodes. How is olanzapine injection given? It is eliminated extensively by first pass metabolism, with approximately 40% of the dose metabolized before reaching the systemic circulation. Signs and symptoms of NMS include hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia) [see Warnings and Precautions ( 5.3)]. Following is a list of treatment-emergent adverse reactions reported by patients treated with intramuscular olanzapine for injection (at 1 or more doses 2.5 mg/injection) in clinical trials. Patients should also be advised to inform their healthcare providers if they are taking, plan to take, or have stopped taking any prescription or over-the-counter drugs, including herbal supplements, since there is a potential for interactions [see Drug Interactions ( 7)]. Digestive System Infrequent: abdominal distension, nausea and vomiting, tongue edema; Rare: ileus, intestinal obstruction, liver fatty deposit. Patients should be monitored regularly for worsening of glucose control. Patients should have their weight monitored regularly [see Warnings and Precautions ( 5.5)]. Olanzapine is not approved for the treatment of patients with Alzheimers disease. If agitation warranting additional intramuscular doses persists following the initial dose, subsequent doses up to 10 mg may be given. This adverse reaction was also dose related. A more gradual titration to the target dose should be considered if hypotension occurs. Dosage form: injection, powder, for solution Drug class: Atypical antipsychotics Medically reviewed by Drugs.com. Patients could receive up to 3 injections during the 24 hour IM treatment periods; however, patients could not receive the second injection until after the initial 2 hour period when the primary efficacy measure was assessed. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.4. In patients with schizophrenia, there was no indication of any different tolerability of olanzapine in the elderly compared to younger patients. (2) In a second placebo-controlled trial in agitated inpatients meeting DSM-IV criteria for schizophrenia (n=311), 1 fixed intramuscular olanzapine for injection dose of 10 mg was evaluated. Patients should be advised of the potential risk of hyperglycemia-related adverse reactions. Table 14 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred in 2% or more of patients treated with the combination of olanzapine (doses 5 mg/day) and lithium or valproate and with incidence greater than lithium or valproate alone who participated in the acute phase of placebo-controlled combination trials. Metabolism and Elimination Following a single oral dose of 14C labeled olanzapine, 7% of the dose of olanzapine was recovered in the urine as unchanged drug, indicating that olanzapine is highly metabolized. Olanzapine is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning and Patient Counseling Information ( 17)]. In placebo-controlled olanzapine monotherapy studies in adults, clinically significant ALT elevations (change from <3 times the upper limit of normal [ULN] at baseline to 3 times ULN) were observed in 5% (77/1426) of patients exposed to olanzapine compared to 1% (10/1187) of patients exposed to placebo. (5.5) Dyslipidemia:Undesirable alterations in lipids have been observed. Olanzapine Injection Prescribing Information, WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS, Dose Selection for Agitated Adult Patients with Schizophrenia and Bipolar I Mania, Intramuscular Dosing in Special Populations, Administration of olanzapine for injection, Directions for Preparation of olanzapine for injection IntraMuscular with Sterile Water for Injection, [see Boxed Warning, Use in Specific Populations (, Cerebrovascular Adverse Events (CVAE), Including Stroke, [see Boxed Warning and Patient Counseling Information (, Table 2: Changes in Fasting Glucose Levels from Adult Olanzapine Monotherapy Studies, Category Change (at least once) from Baseline, Table 4: Changes in Fasting Lipids Values from Adult Olanzapine Monotherapy Studies, Table 5: Changes in Fasting Lipids Values from Adolescent Olanzapine Monotherapy Studies, Table 7: Weight Gain with Olanzapine Use in Adolescents from 4 Placebo-Controlled Trials, Table 8: Weight Gain with Olanzapine Use in Adolescents, Incidence of Adverse Reactions in Short-Term, Placebo-Controlled and Combination Trials, Adverse Reactions Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials, Bipolar I Disorder (Manic or Mixed Episodes) Monotherapy, Adverse Reactions Associated with Discontinuation of Treatment in Short-Term Combination Trials, Bipolar I Disorder (Manic or Mixed Episodes), Olanzapine as Adjunct to Lithium or Valproate, Commonly Observed Adverse Reactions in Short-Term, Placebo-Controlled Trials, Table 9: Common Treatment-Emergent Adverse Reactions Associated with the Use of Oral Olanzapine in 6-Week Trials SCHIZOPHRENIA, Adverse Reactions Occurring at an Incidence of 2% or More among Oral Olanzapine-Treated Patients in Short- Term, Placebo-Controlled Trials, Table 11: Treatment-Emergent Adverse Reactions: Incidence in Short-Term, Placebo- Controlled Clinical Trials with Oral Olanzapine, Table 12: Percentage of Patients from a Schizophrenia Trial with Treatment-Emergent Adverse Reactions for the 3 Dose Range Groups and Placebo, Commonly Observed Adverse Reactions in Short-Term Trials of Oral Olanzapine as Adjunct to Lithium or Valproate, Table 13: Common Treatment-Emergent Adverse Reactions Associated with the Use of Oral Olanzapine in 6-Week Adjunct to Lithium or Valproate Trials Bipolar I Disorder (Manic or Mixed Episodes) Percentage of Patients Reporting Event, Adverse Reactions Occurring at an Incidence of 2% or More among Oral Olanzapine-Treated Patients in Short- Term Trials of Olanzapine as Adjunct to Lithium or Valproate, Table 14: Treatment-Emergent Adverse Reactions: Incidence in Short-Term, Placebo-Controlled Clinical Trials of Oral Olanzapine as Adjunct to Lithium or Valproate, Adverse Reactions Occurring at an Incidence of 1% or More among Intramuscular Olanzapine for Injection- Treated Patients in Short-Term, Placebo-Controlled Trials, Table 15: Treatment-Emergent Adverse Reactions: Incidence in Short-Term (24 Hour), Placebo-Controlled Clinical Trials with Intramuscular Olanzapine for Injection in Agitated Patients with Schizophrenia or Bipolar I Mania, Table 17: Treatment-Emergent Extrapyramidal Symptoms Assessed by Adverse Reactions Incidence in a Fixed Dosage Range, Placebo-Controlled Clinical Trial of Oral Olanzapine in Schizophrenia Acute Phase, Table 18: Treatment-Emergent Extrapyramidal Symptoms Assessed by Adverse Reactions Incidence in Placebo-Controlled Clinical Trials of Oral Olanzapine in Schizophrenia and Bipolar I Disorder Adolescents, Table 19: Treatment-Emergent Extrapyramidal Symptoms Assessed by Rating Scales Incidence in a Fixed Dose, Placebo-Controlled Clinical Trial of Intramuscular Olanzapine for Injection in Agitated Patients with Schizophrenia, Table 20: Treatment-Emergent Extrapyramidal Symptoms Assessed by Adverse Reactions Incidence in a Fixed Dose, Placebo-Controlled Clinical Trial of Intramuscular Olanzapine for Injection in Agitated Patients with Schizophrenia, Other Adverse Reactions Observed During the Clinical Trial Evaluation of Oral Olanzapine, Other Adverse Reactions Observed During the Clinical Trial Evaluation of Intramuscular Olanzapine for Injection, Clinical Trials in Adolescent Patients (age 13 to 17 years), Commonly Observed Adverse Reactions in Oral Olanzapine Short-Term, Placebo-Controlled Trials, Table 21: Treatment-Emergent Adverse Reactions of 5% Incidence among Adolescents (13 to 17 Years Old) with Schizophrenia or Bipolar I Disorder (Manic or Mixed Episodes), Adverse Reactions Occurring at an Incidence of 2% or More among Oral Olanzapine-Treated Patients in Short- Term (3 to 6 weeks), Placebo-Controlled Trials, Table 22: Treatment-Emergent Adverse Reactions of 2% Incidence among Adolescents (13 to 17 Years Old) (Combined Incidence from Short-Term, Placebo-Controlled Clinical Trials of Schizophrenia or Bipolar I Disorder [Manic or Mixed Episodes]), Inducers of CYP1A2 or Glucuronyl Transferase, Effect of Olanzapine on Drug Metabolizing Enzymes, [see Boxed Warning, Warnings and Precautions (. Dosage modifications for race are, therefore, not recommended. It is approved for maintenance treatment of schizophrenia in adults sufficiently stabilised during acute treatment with oral olanzapine. What happens if I overdose? Olanzapine-treated patients had a greater mean HbA1c increase from baseline of 0.04% (median exposure 21 days), compared to a mean HbA1c decrease of 0.06% in placebo-treated subjects (median exposure 17 days). Class Effect In clinical trial and/or postmarketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents, including olanzapine. Discontinuation due to weight gain occurred in 0.2% of olanzapine-treated patients and in 0% of placebo-treated patients. Table 17: Treatment-Emergent Extrapyramidal Symptoms Assessed by Adverse Reactions Incidence in a Fixed Dosage Range, Placebo-Controlled Clinical Trial of Oral Olanzapine in Schizophrenia Acute Phase. In premarketing trials involving more than 3100 patients and/or normal subjects, accidental or intentional acute overdosage of olanzapine was identified in 67 patients. Table 2 shows short-term and long-term changes in fasting glucose levels from adult olanzapine monotherapy studies. Caution should be exercised in patients with signs and symptoms of hepatic impairment, in patients with pre-existing conditions associated with limited hepatic functional reserve, and in patients who are being treated with potentially hepatotoxic drugs. Disruption of the bodys ability to reduce core body temperature has been attributed to antipsychotic agents. being unable to get an erection at any time. Patients taking olanzapine should be monitored regularly for worsening of glucose control. In addition, olanzapine is not removed by dialysis. Body Temperature Regulation Impairment of Fertility In an oral fertility and reproductive performance study in rats, male mating performance, but not fertility, was impaired at a dose of 22.4 mg/kg/day and female fertility was decreased at a dose of 3 mg/kg/day (11 and 1.5 times the daily oral MRHD based on mg/m 2 body surface area, respectively). Lower doses may be needed for patients over 65 years of age (5 mg per day for the tablets and 2.5 to 5 mg for the injection) and for patients who have reduced liver or kidney function (5 mg per day for both the tablets and injection). From an analysis of the vital sign data in an integrated database of 41 completed clinical studies in adult patients treated with oral olanzapine, orthostatic hypotension was recorded in 20% (1277/6030) of patients. Olanzapine binds with low affinity to GABA A, BZD, and -adrenergic receptors (K i>10 M). Skin and Appendages Infrequent: alopecia. Table 13: Common Treatment-Emergent Adverse Reactions Associated with the Use of Oral Olanzapine in 6-Week Adjunct to Lithium or Valproate Trials Bipolar I Disorder (Manic or Mixed Episodes) Percentage of Patients Reporting Event, Adverse Reactions Occurring at an Incidence of 2% or More among Oral Olanzapine-Treated Patients in Short- Term Trials of Olanzapine as Adjunct to Lithium or Valproate A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Table 22: Treatment-Emergent Adverse Reactions of 2% Incidence among Adolescents (13 to 17 Years Old) (Combined Incidence from Short-Term, Placebo-Controlled Clinical Trials of Schizophrenia or Bipolar I Disorder [Manic or Mixed Episodes]). It affects certain chemicals in the brain and helps in bringing about a change in thought and perception. In 1 case of death, the amount of acutely ingested olanzapine was reported to be possibly as low as 450 mg of oral olanzapine; however, in another case, a patient was reported to survive an acute olanzapine ingestion of approximately 2 g of oral olanzapine. b Percentage of patients with a Barnes Akathisia Scale global score 2. Table 9: Common Treatment-Emergent Adverse Reactions Associated with the Use of Oral Olanzapine in 6-Week Trials SCHIZOPHRENIA. Reconstituted olanzapine for injection may be stored at controlled room temperature, 20 to 25C (68 to 77F) [ see USP] for up to 1 hour if necessary. Risk Summary patients with schizophrenia or bipolar I mania. b Patients with the following MedDRA terms were counted in this category: abdominal pain, abdominal pain lower, abdominal pain upper. In analyses of patients who completed 9 to 12 months of olanzapine therapy, mean change in fasting and nonfasting glucose levels continued to increase over time. If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. Establish and maintain an airway and ensure adequate oxygenation and ventilation. 1 Stuttering was only studied in oral and long acting injection (LAI) formulations. Olanzapine Monotherapy in Adolescents: In placebo-controlled clinical trials of adolescent patients with schizophrenia or bipolar I disorder (manic or mixed episodes), greater frequencies for the following treatment-emergent findings, at anytime, were observed in laboratory analytes compared to placebo: elevated ALT (3X ULN in patients with ALT at baseline <3X ULN), (12% vs 2%); elevated AST (28% vs 4%); low total bilirubin (22% vs 7%); elevated GGT (10% vs 1%); and elevated prolactin (47% vs 7%). The incidence of mammary gland adenomas and adenocarcinomas was significantly increased in female mice dosed at 2 mg/kg/day and in female rats dosed at 4 mg/kg/day (0.5 and 2 times the daily oral MRHD based on mg/m 2 body surface area, respectively). Musculoskeletal System Rare: osteoporosis. Atypical antipsychotic drugs have been associated with metabolic changes including hyperglycemia, dyslipidemia, and weight gain. For specific information about the warnings of lithium or valproate, refer to the Warnings section of the package inserts for these other products. The following table enumerates the percentage of patients with treatment-emergent extrapyramidal symptoms as assessed by categorical analyses of formal rating scales during controlled clinical trials comparing fixed doses of intramuscular olanzapine for injection with placebo in agitation. Concomitant administration of intramuscular olanzapine and parenteral benzodiazepine is not recommended due to the potential for excessive sedation and cardiorespiratory depression. For fasting HDL cholesterol, no clinically meaningful differences were observed between olanzapine-treated patients and placebo-treated patients. In the patient taking the largest identified amount, 300 mg, the only symptoms reported were drowsiness and slurred speech. Smoking Status Olanzapine clearance is about 40% higher in smokers than in nonsmokers, although dosage modifications are not routinely recommended. Table 5: Changes in Fasting Lipids Values from Adolescent Olanzapine Monotherapy Studies. Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone density in both female and male subjects. aPatients with the following COSTART terms were counted in this category: dystonia, generalized spasm, neck rigidity, oculogyric crisis, opisthotonos, torticollis. d Patients with the following COSTART terms were counted in this category: buccoglossal syndrome, choreoathetosis, dyskinesia, tardive dyskinesia. Weight Gain Fasting blood glucose testing and lipid profile at the beginning of, and periodically during, treatment is recommended [see Warnings and Precautions ( 5.5) and Patient Counseling Information ( 17)]. Olanzapine is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning, Warnings and Precautions ( 5.1), and Patient Counseling Information ( 17)]. Table 2: Changes in Fasting Glucose Levels from Adult Olanzapine Monotherapy Studies. Cardiovascular System Infrequent: syncope. Package insert / product label Drowsiness, dose dependent. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of reactions into a smaller number of standardized reaction categories. Conditions that lower the seizure threshold may be more prevalent in a population of 65 years or older. High levels of triglycerides in the blood. In symptomatic patients, symptoms with 10% incidence included agitation/aggressiveness, dysarthria, tachycardia, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma. Table 15 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred in 1% or more of patients treated with intramuscular olanzapine for injection (dose range of 2.5 to 10 mg/injection) and with incidence greater than placebo who participated in the short-term, placebo-controlled trials in agitated patients with schizophrenia or bipolar I mania. However, discontinuations due to increases in ALT were considered to be drug related (2% for oral olanzapine vs 0% for placebo). In the limited number of patients who were evaluated in hospitals, including the patient taking 300 mg, there were no observations indicating an adverse change in laboratory analytes or ECG. Race In vivo studies have shown that exposures are similar among Japanese, Chinese and Caucasians, especially after normalization for body weight differences. Inducers of CYP1A2 or Glucuronyl Transferase Omeprazole and rifampin may cause an increase in olanzapine clearance. Olanzapine Monotherapy in Adolescents The safety and efficacy of olanzapine have not been established in patients under the age of 13 years. Administration of olanzapine once daily leads to steady-state concentrations in about 1 week that are approximately twice the concentrations after single doses. Table 20: Treatment-Emergent Extrapyramidal Symptoms Assessed by Adverse Reactions Incidence in a Fixed Dose, Placebo-Controlled Clinical Trial of Intramuscular Olanzapine for Injection in Agitated Patients with Schizophrenia. Inducers of CYP1A2 Carbamazepine therapy (200 mg bid) causes an approximately 50% increase in the clearance of olanzapine. Olanzapine Monotherapy in Adults: An assessment of the premarketing experience for olanzapine revealed an association with asymptomatic increases in ALT, AST, and GGT. Olanzapine is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) in adults and teenagers 13 years of age and older. Company has received reports of fatality in association with overdose of olanzapine alone. Olanzapine for injection IntraMuscular is indicated for the treatment of acute agitation associated with schizophrenia and bipolar I mania. Do not administer intravenously or subcutaneously. Adverse reactions with signs and symptoms consistent with olanzapine overdose, in particular, sedation (including coma) and/or delirium, have been reported following injections of olanzapine extended release (ER). Dose Selection for Agitated Adult Patients with Schizophrenia and Bipolar I Mania The efficacy of intramuscular olanzapine for injection in controlling agitation in these disorders was demonstrated in a dose range of 2.5 mg to 10 mg. It is important to emphasize that, although the reactions occurred during treatment with olanzapine, they were not necessarily caused by it. In an oral rabbit teratology study, fetal toxicity manifested as increased resorptions and decreased fetal weight, occurred at a maternally toxic dose of 30 mg/kg/day (30 times the daily oral MRHD based on mg/m 2 body surface area). A lower dose of 2.5 mg/injection should be considered for patients who otherwise might be debilitated, be predisposed to hypotensive reactions, or be more pharmacodynamically sensitive to olanzapine [see Warnings and Precautions ( 5.14), Drug Interactions ( 7), and Clinical Pharmacology ( 12.3)]. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. ZYPREXA RELPREVV provides a dose of 150, 210, 300, or 405 mg olanzapine. Elderly patients with dementia-related psychosis treated with olanzapine are at an increased risk of death compared to placebo. Last updated on Apr 19, 2023. Diazepam The co-administration of diazepam with olanzapine potentiated the orthostatic hypotension observed with olanzapine [see Drug Interactions ( 7.2)]. The proportion of patients who had changes (at least once) in total cholesterol, LDL cholesterol or triglycerides from normal or borderline to high, or changes in HDL cholesterol from normal or borderline to low, was greater in longterm studies (at least 48 weeks) as compared with short-term studies. Lactation Advise breastfeeding women using olanzapine for injection to monitor infants for excess sedation, irritability, poor feeding and extrapyramidal symptoms (tremors and abnormal muscle movements) and to seek medical care if they notice these signs [see Use in Specific Populations ( 8.3)]. In the bipolar I disorder (manic or mixed episodes) adjunct placebo-controlled trials, the most commonly observed adverse reactions associated with the combination of olanzapine and lithium or valproate (incidence of 5% and at least twice placebo) were: The relevance for human risk of the finding of prolactin mediated endocrine tumors in rodents is unknown [see Warnings and Precautions ( 5.15)]. ZYPREXA (olanzapine) is an atypical antipsychotic indicated: As oral formulation for the: Treatment of schizophrenia. Patients in each dose group could receive up to 3 injections during the trials [see Clinical Studies (14.3)]. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. High cholesterol. The following table addresses dose relatedness for other adverse reactions using data from a schizophrenia trial involving fixed dosage ranges of oral olanzapine. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Since olanzapine has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that olanzapine therapy does not affect them adversely [see Patient Counseling Information ( 17)]. In placebo-controlled olanzapine monotherapy studies in adolescents, clinically significant ALT elevations (change from <3 times ULN at baseline to 3 times ULN) were observed in 12% (22/192) of patients exposed to olanzapine compared to 2% (2/109) of patients exposed to placebo. Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system pathology. These tumors were not increased in another mouse study in females dosed up to 2 to 5 times the daily oral MRHD based on mg/m 2 body surface area; in this study, there was a high incidence of early mortalities in males of the 30/20 mg/kg/day group. (1.1) Adults: Efficacy was established in three clinical trials in patients with. Other Adverse Reactions Observed During the Clinical Trial Evaluation of Oral Olanzapine Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Each of the trials included a single active comparator treatment arm of either haloperidol injection (schizophrenia studies) or lorazepam injection (bipolar I mania study). Body as a Whole Infrequent: chills, face edema, photosensitivity reaction, suicide attempt 1; Rare: chills and fever, hangover effect, sudden death 1. Hyperprolactinemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion. Dose group differences with respect to prolactin elevation have been observed. Adverse reactions were assessed by collecting adverse reactions, results of physical examinations, vital signs, weights, laboratory analytes, ECGs, chest x-rays, and results of ophthalmologic examinations. Two currently available short-acting IM SGAs are olanzapine and ziprasidone. Among adolescent patients, mean weight gain by baseline BMI category was 11.5 kg (25.3 lb), 12.1 kg (26.6 lb), and 12.7 kg (27.9 lb), respectively, for normal (N=106), overweight (N=26) and obese (N=17). The magnitude of the impact of this factor is small in comparison to the overall variability between individuals, and therefore dose modification is not routinely recommended. a Percentage of patients with a Simpson-Angus Scale total score >3. In placebo-controlled olanzapine monotherapy studies in adolescent patients (up to 6 weeks) with schizophrenia or bipolar I disorder (manic or mixed episodes), changes from normal to high in prolactin concentrations were observed in 47% of olanzapine-treated patients compared to 7% of placebo-treated patients. Patients should have their lipid profile monitored regularly [see Warnings and Precautions ( 5.5)]. Olanzapine for injection IntraMuscular should not be combined in a syringe with diazepam injection because precipitation occurs when these products are mixed. And slurred speech decreased bone density in both female olanzapine injection dose levitra male subjects pain, abdominal pain abdominal. 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