Zyprexa zydis olanzapine what is it

Learn More. Or in a crisis , text "NAMI" to Donate Now. All FDA black box warnings are at the end of this fact sheet. Please review before taking this medication. Olanzapine is a medication that works in the brain to treat schizophrenia. It is also known as a second generation antipsychotic SGA or atypical antipsychotic.

Olanzapine rebalances dopamine and serotonin to improve thinking, mood, and behavior. This medication sheet will focus primarily on schizophrenia. You can find more information about bipolar disorder and depression here. Olanzapine may also be helpful when prescribed "off-label" for prevention of chemotherapy-associated acute and delayed nausea or vomiting, chemotherapy-associated breakthrough nausea or vomiting, delirium, delusional parasitosis, post-traumatic stress disorder, Tourette syndrome, and other mental health conditions.

Your mental health provider should justify his or her thinking in recommending and "off-label" treatment. They should be clear about the limits of the research around that medication and if there are any other options.

Schizophrenia requires long-term treatment. Do not stop taking olanzapine, even when you feel better. With input from you, your health care provider will assess how long you will need to take the medicine. Do not stop taking olanzapine or change your dose without talking with your healthcare provider first. For olanzapine to work properly, it should be taken every day as ordered by your healthcare provider.

If you are planning on becoming pregnant, notify your healthcare provider to best manage your medications. People living with schizophrenia who wish to become pregnant face important decisions. This is a complex decision since untreated schizophrenia has risks to the fetus, as well as the mother. It is important to discuss the risks and benefits of treatment with your doctor and caregivers. Symptoms in the newborn may include agitation, feeding disorder, hypertonia, hypotonia, respiratory distress, somnolence, and tremor; these effects may be self-limiting or require hospitalization.

Caution is advised with breastfeeding since olanzapine does pass into breast milk. It is recommended that women receiving olanzapine should not breast-feed. Typically patients begin at a low dose of medicine and the dose is increased slowly over several weeks.

The oral dose usually ranges from 5 mg to 20 mg. The dose of the injection usually ranges from mg to mg. Only your healthcare provider can determine the correct dose for you. Olanzapine orally disintegrating tablets must remain in their original packaging. Open the package with clean dry hands before each dose. Autism and Autism Spectrum Disorders. Behaviour and Conduct Problems. Bipolar Disorders.

Dementia including Alzheimer's. Developmental, Intellectual Delay and Disabilities. Domestic Violence. Down syndrome. Eating Disorders including Anorexia and Bulimia. Elimination Disorders. Gender Identity Issues. Grief and Bereavement. Learning Disorders. Medication Treatment. Mental Health in General. Mood Disorders. Oppositional behaviours including oppositional defiant disorder ODD. Overweight and Obesity. Pandemic e. Physical Disabilities. Schizophrenia and Psychosis. School Refusal and School Phobia.

Self-harm including Self-cutting. Separation and Divorce. Sleep Problems and Disorders. Social Skills and Life Skills. Somatoform Disorders. Speech and Language. Tourette Syndrome and Tic Disorders. Suggest a Resource. Care Plan. There are currently no additional screening tools attached to this article. Clinical Practice Guidelines There are currently no practice guidelines attached to this article. School and Workplace Letters There are currently no letters attached to this article.

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Blood clots: This medication may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities. If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg.

Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision, or difficulty speaking, contact your doctor immediately. Body temperature: This medication, like other antipsychotic medications, can disrupt the body's ability to control body temperature.

If you exercise vigorously, are exposed to extreme heat, are dehydrated, or are taking anticholinergic medications e. Contact your doctor as soon as possible if you feel very hot and are unable to cool down while taking this medication. Cholesterol: Olanzapine can cause increased blood cholesterol levels.

If you are at risk of developing high cholesterol or you have high cholesterol levels before starting olanzapine, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Avoid drinking alcohol while taking this medication, as it may produce extreme drowsiness. Glaucoma: This medication may cause the symptoms of glaucoma increased pressure in the eye to develop or become worse.

If you have glaucoma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Report any changes in vision to your doctor as soon as possible while you are taking this medication. High blood sugar: Olanzapine, in rare instances, may cause an increase in blood sugar levels. Your doctor will monitor you if you have diabetes or are at risk of developing diabetes. If you experience weakness, increased thirst, increased urination, and increased appetite while taking this medication, contact your doctor.

Hypersensitivity reactions: A severe allergic reaction called hypersensitivity syndrome has occurred for some people with the use of olanzapine. This reaction involves a number of organs in the body and may be fatal if not treated quickly. Stop taking the medication and get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering. Liver disease: Olanzapine can affect liver function and cause liver problems.

If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Your doctor may want to test your liver function regularly with blood tests while you are taking this medication. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Low blood pressure: Olanzapine may cause low blood pressure, especially when moving from a lying or sitting position to a standing position. If you have heart disease, cerebrovascular disease, or conditions that increase the risk of developing low blood pressure e. Neuroleptic malignant syndrome NMS : Olanzapine, like other antipsychotic medications, can cause a potentially fatal syndrome known as neuroleptic malignant syndrome NMS.

If you notice the symptoms of NMS such as high fever, confusion or loss of consciousness, racing or irregular heartbeat, muscle stiffness, or sweating, get immediate medical attention. Phenylketonuria: People with phenylketonuria an inherited disorder where the enzyme needed to break down phenylalanine is lacking should take the regular tablet forms of olanzapine and not the oral dissolving tablets ODT.

The ODT form of olanzapine contains aspartame, which is a source of phenylalanine. Prolonged erection: In rare cases, use of this medication by some men may cause them to develop priapism a prolonged and painful erection. If you have an erection that lasts for more than 4 hours, contact your doctor. Seizures: Olanzapine may increase the risk of seizures, especially if you have had seizures in the past. Race — In vivo studies have shown that exposures are similar among Japanese, Chinese and Caucasians, especially after normalization for body weight differences.

Dosage modifications for race are, therefore, not recommended. Combined Effects — The combined effects of age, smoking, and gender could lead to substantial pharmacokinetic differences in populations. The clearance in young smoking males, for example, may be 3 times higher than that in elderly nonsmoking females. Dosing modification may be necessary in patients who exhibit a combination of factors that may result in slower metabolism of olanzapine [see Dosage and Administration 2 ].

Adolescents ages 13 to 17 years — In clinical studies, most adolescents were nonsmokers and this population had a lower average body weight, which resulted in higher average olanzapine exposure compared to adults. Carcinogenesis — Oral carcinogenicity studies were conducted in mice and rats. Rats were dosed for 2 years at doses of 0. Antipsychotic drugs have been shown to chronically elevate prolactin levels in rodents.

Serum prolactin levels were not measured during the olanzapine carcinogenicity studies; however, measurements during subchronic toxicity studies showed that olanzapine elevated serum prolactin levels up to 4-fold in rats at the same doses used in the carcinogenicity study.

An increase in mammary gland neoplasms has been found in rodents after chronic administration of other antipsychotic drugs and is considered to be prolactin mediated. The relevance for human risk of the finding of prolactin mediated endocrine tumors in rodents is unknown [see Warnings and Precautions 5.

Mutagenesis — No evidence of genotoxic potential for olanzapine was found in the Ames reverse mutation test, in vivo micronucleus test in mice, the chromosomal aberration test in Chinese hamster ovary cells, unscheduled DNA synthesis test in rat hepatocytes, induction of forward mutation test in mouse lymphoma cells, or in vivo sister chromatid exchange test in bone marrow of Chinese hamsters.

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 Discontinuance of olanzapine treatment reversed the effects on male mating performance.

Diestrous was prolonged and estrous delayed at 1. Nonspecific lymphopenia, consistent with decreased body weight gain, occurred in rats receiving No evidence of bone marrow cytotoxicity was found in any of the species examined. Bone marrows were normocellular or hypercellular, indicating that the reductions in circulating blood cells were probably due to peripheral non-marrow factors.

The efficacy of oral olanzapine in the treatment of schizophrenia was established in 2 short-term 6-week controlled trials of adult inpatients who met DSM III-R criteria for schizophrenia. A single haloperidol arm was included as a comparative treatment in 1 of the 2 trials, but this trial did not compare these 2 drugs on the full range of clinically relevant doses for both. Several instruments were used for assessing psychiatric signs and symptoms in these studies, among them the Brief Psychiatric Rating Scale BPRS , a multi-item inventory of general psychopathology traditionally used to evaluate the effects of drug treatment in schizophrenia.

The BPRS psychosis cluster conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content is considered a particularly useful subset for assessing actively psychotic schizophrenic patients. A second traditional assessment, the Clinical Global Impression CGI , reflects the impression of a skilled observer, fully familiar with the manifestations of schizophrenia, about the overall clinical state of the patient.

The results of the trials follow:. There was no clear advantage for the high-dose group over the medium-dose group. The follow-up period to observe patients for relapse, defined in terms of increases in BPRS positive symptoms or hospitalization, was planned for 12 months, however, criteria were met for stopping the trial early due to an excess of placebo relapses compared to olanzapine relapses, and olanzapine was superior to placebo on time to relapse, the primary outcome for this study.

Thus, olanzapine was more effective than placebo at maintaining efficacy in patients stabilized for approximately 8 weeks and followed for an observation period of up to 8 months. Examination of population subsets race and gender did not reveal any differential responsiveness on the basis of these subgroupings. In this flexible-dose trial, olanzapine 2.

While there is no body of evidence available to answer the question of how long the adolescent patient treated with ZYPREXA should be maintained, maintenance efficacy can be extrapolated from adult data along with comparisons of olanzapine pharmacokinetic parameters in adult and adolescent patients.

It is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Monotherapy — The efficacy of oral olanzapine in the treatment of manic or mixed episodes was established in 2 short-term one 3-week and one 4-week placebo-controlled trials in adult patients who met the DSM-IV criteria for bipolar I disorder with manic or mixed episodes.

These trials included patients with or without psychotic features and with or without a rapid-cycling course. The primary outcome in these trials was change from baseline in the Y-MRS total score. In an identically designed trial conducted simultaneously with the first trial, olanzapine demonstrated a similar treatment difference, but possibly due to sample size and site variability, was not shown to be superior to placebo on this outcome.

In the randomized phase, patients receiving continued olanzapine experienced a significantly longer time to relapse. Adjunct to Lithium or Valproate — The efficacy of oral olanzapine with concomitant lithium or valproate in the treatment of manic or mixed episodes was established in 2 controlled trials in patients who met the DSM-IV criteria for bipolar I disorder with manic or mixed episodes. The efficacy of intramuscular olanzapine for injection for the treatment of agitation was established in 3 short-term 24 hours of IM treatment placebo-controlled trials in agitated adult inpatients from 2 diagnostic groups: schizophrenia and bipolar I disorder manic or mixed episodes.

Each of the trials included a single active comparator treatment arm of either haloperidol injection schizophrenia studies or lorazepam injection bipolar I mania study. The primary efficacy measure used for assessing agitation signs and symptoms in these trials was the change from baseline in the PANSS Excited Component at 2 hours post-injection.

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.

However, the effect was larger and more consistent for the 3 highest doses. There were no significant pairwise differences for the 7. Examination of population subsets age, race, and gender did not reveal any differential responsiveness on the basis of these subgroupings.

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 occur while taking ZYPREXA as monotherapy or in combination with fluoxetine. Patients and caregivers should be advised that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Patients and caregivers should be advised that elderly patients with dementia-related psychosis treated with ZYPREXA had a significantly higher incidence of cerebrovascular adverse events e.

Patients and caregivers should be counseled that a potentially fatal symptom complex sometimes referred to as NMS has been reported in association with administration of antipsychotic drugs, including ZYPREXA. 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. Patients should be advised to report to their health care provider at the earliest onset of any signs and symptoms that may be associated with Drug Reaction with Eosinophilia and Systemic Symptoms DRESS [see Warnings and Precautions 5.

Patients should be advised of the potential risk of hyperglycemia-related adverse reactions. Patients should be monitored regularly for worsening of glucose control. Patients should have their lipid profile monitored regularly [see Warnings and Precautions 5. Patients should have their weight monitored regularly [see Warnings and Precautions 5. Patients should be advised of the risk of orthostatic hypotension, especially during the period of initial dose titration and in association with the use of concomitant drugs that may potentiate the orthostatic effect of ZYPREXA, e.

Patients should be advised to change positions carefully to help prevent orthostatic hypotension, and to lie down if they feel dizzy or faint, until they feel better. Patients should be advised to call their doctor if they experience any of the following signs and symptoms associated with orthostatic hypotension: dizziness, fast or slow heartbeat, or fainting. Because ZYPREXA 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 ZYPREXA therapy does not affect them adversely [see Warnings and Precautions 5.

Patients should be advised regarding appropriate care in avoiding overheating and dehydration. Patients should be advised to call their doctor right away if they become severely ill and have some or all of these symptoms of dehydration: sweating too much or not at all, dry mouth, feeling very hot, feeling thirsty, not able to produce urine [see Warnings and Precautions 5.

Patients should be advised to inform their healthcare providers if they are taking, or plan to take, Symbyax. 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 ].

Lactation — Advise breastfeeding women using ZYPREXA 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. The effects on fertility are reversible [see Use in Specific Populations 8. Pediatric Use — ZYPREXA is indicated for treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents 13 to 17 years of age.

Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin, and hepatic aminotransferase levels. Patients should be counseled about the potential long-term risks associated with ZYPREXA and advised that these risks may lead them to consider other drugs first [see Indications and Usage 1.

Safety and efficacy of ZYPREXA and fluoxetine in combination in patients 10 to 17 years of age have been established for the acute treatment of depressive episodes associated with bipolar I disorder. ZYPREXA is indicated as an integral part of a total treatment program for pediatric patients with schizophrenia and bipolar disorder that may include other measures psychological, educational, social for patients with the disorder.

Appropriate educational placement is essential and psychosocial intervention is often helpful. The decision to prescribe atypical antipsychotic medication will depend upon the healthcare provider's assessment of the chronicity and severity of the patient's symptoms [see Indications and Usage 1.

There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.

The symptoms of schizophrenia include hearing voices, seeing things that are not there, having beliefs that are not true, and being suspicious or withdrawn. The symptoms of bipolar I disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior, and a decreased need for sleep. The symptoms of treatment resistant depression include decreased mood, decreased interest, increased guilty feelings, decreased energy, decreased concentration, changes in appetite, and suicidal thoughts or behavior.

Some of your symptoms may improve with treatment. If you do not think you are getting better, call your doctor. The symptoms of bipolar I disorder, treatment resistant depression, or schizophrenia may include thoughts of suicide or of hurting yourself or others.

If you have these thoughts at any time, tell your doctor or go to an emergency room right away. Tell your doctor about all the medicines that you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. ZYPREXA and some medicines may interact with each other and may not work as well, or cause possible serious side effects. Common side effects of ZYPREXA include: lack of energy, dry mouth, increased appetite, sleepiness, tremor shakes , having hard or infrequent stools, dizziness, changes in behavior, or restlessness.

Other common side effects in teenagers years old include: headache, stomach-area abdominal pain, pain in your arms or legs, or tiredness. Teenagers experienced greater increases in prolactin, liver enzymes, and sleepiness, as compared with adults.

For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. It may harm them. If you would like more information, talk with your doctor. Tablets — carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients.

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Approval: The increased potential in adolescents compared with adults for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. Maintenance efficacy has not been systematically evaluated.

Treatment of treatment resistant depression. Patients taking olanzapine should be monitored for symptoms of hyperglycemia and undergo fasting blood glucose testing at the beginning of, and periodically during, treatment. Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodically during, treatment.

Patients should receive regular monitoring of weight. Use caution in patients with cardiovascular disease, cerebrovascular disease, and those conditions that could affect hemodynamic responses. Use caution when operating machinery. Adults 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.

Children and Adolescents years of age Oral olanzapine should be administered in combination with fluoxetine once daily in the evening, without regard to meals, generally beginning with 2. For specific information about the contraindications of lithium or valproate, refer to the Contraindications section of the package inserts for these other products.

Clinical Trials in Adults The information below for olanzapine is derived from a clinical trial database for olanzapine consisting of 10, adult patients with approximately patient-years of exposure to olanzapine plus patients with exposure to intramuscular olanzapine for injection. Incidence of Adverse Reactions in Short-Term, Placebo-Controlled and Combination Trials The following findings are based on premarketing trials of 1 oral olanzapine for schizophrenia, bipolar I disorder manic or mixed episodes , a subsequent trial of patients having various psychiatric symptoms in association with Alzheimer's disease, and premarketing combination trials, and 2 intramuscular olanzapine for injection in agitated patients with schizophrenia or bipolar I mania.

Extrapyramidal Symptoms The following table enumerates the percentage of patients with treatment-emergent extrapyramidal symptoms as assessed by categorical analyses of formal rating scales during acute therapy in a controlled clinical trial comparing oral olanzapine at 3 fixed doses with placebo in the treatment of schizophrenia in a 6-week trial. Vital Signs and Laboratory Studies Vital Sign Changes — Oral olanzapine was associated with orthostatic hypotension and tachycardia in clinical trials.

Clinical Considerations Infants exposed to ZYPREXA should be monitored for excess sedation, irritability, poor feeding, and extrapyramidal symptoms tremors and abnormal muscle movements. Specific Populations. Elderly Patients with Dementia-Related Psychosis: Increased Mortality and Cerebrovascular Adverse Events CVAE , Including Stroke Patients and caregivers should be advised that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

Hyperglycemia and Diabetes Mellitus Patients should be advised of the potential risk of hyperglycemia-related adverse reactions. Orthostatic Hypotension Patients should be advised of the risk of orthostatic hypotension, especially during the period of initial dose titration and in association with the use of concomitant drugs that may potentiate the orthostatic effect of ZYPREXA, e.

Body Temperature Regulation Patients should be advised regarding appropriate care in avoiding overheating and dehydration. Concomitant Medication Patients should be advised to inform their healthcare providers if they are taking, or plan to take, Symbyax.

Need for Comprehensive Treatment Program in Pediatric Patients ZYPREXA is indicated as an integral part of a total treatment program for pediatric patients with schizophrenia and bipolar disorder that may include other measures psychological, educational, social for patients with the disorder.

All rights reserved. ZYPREXA may cause serious side effects, including: Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality dementia-related psychosis. High blood sugar hyperglycemia. High fat levels in your blood increased cholesterol and triglycerides , especially in teenagers age 13 to 17 or when used in combination with fluoxetine in children age 10 to Weight gain, especially in teenagers age 13 to 17 or when used in combination with fluoxetine in children age 10 to These serious side effects are described below.

Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality dementia-related psychosis. High blood sugar can happen if you have diabetes already or if you have never had diabetes. High blood sugar could lead to: a build up of acid in your blood due to ketones ketoacidosis coma death Your doctor should do tests to check your blood sugar before you start taking ZYPREXA and during treatment. Call your doctor if you have any of these symptoms of high blood sugar hyperglycemia while taking ZYPREXA: feel very thirsty need to urinate more than usual feel very hungry feel weak or tired feel sick to your stomach feel confused or your breath smells fruity High fat levels in your blood cholesterol and triglycerides.

High fat levels may happen in people treated with ZYPREXA, especially in teenagers 13 to 17 years old , or when used in combination with fluoxetine in children 10 to 17 years old.