Olanzapine (Zyprexa)

Trade Name : Zyprexa

Eli Lilly and Company

TABLET

Strength 2.5 mg/1

OLANZAPINE Atypical Antipsychotic [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Olanzapine (Zyprexa) which is also known as Zyprexa and Manufactured by Eli Lilly and Company. It is available in strength of 2.5 mg/1 per ml. Read more

Olanzapine (Zyprexa) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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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. ZYPREXA (olanzapine) is not approved for the treatment of patients with dementia-related psychosis nn .
When using ZYPREXA and fluoxetine in combination, also refer to the Boxed Warning section of the package insert for Symbyax.
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
See full prescribing information for complete boxed warning.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ZYPREXA is not approved for the treatment of patients with dementia-related psychosis. (, , ) When using ZYPREXA and fluoxetine in combination, also refer to the Boxed Warning section of the package insert for Symbyax.

ZYPREXA (olanzapine) is an atypical antipsychotic indicated:n
As oral formulation for the:
As ZYPREXA IntraMuscular for the:
As ZYPREXA and Fluoxetine in Combination for the:

ZYPREXA and Fluoxetine in Combination:

The ZYPREXA 2.5u00a0mg, 5u00a0mg, 7.5u00a0mg, and 10u00a0mg tablets are white, round, and imprinted in blue ink with LILLY and tablet number. The 15u00a0mg tablets are elliptical, blue, and debossed with LILLY and tablet number. The 20u00a0mg tablets are elliptical, pink, and debossed with LILLY and tablet number. Tablets are not scored. The tablets are available as follows:n
ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) are yellow, round, and debossed with the tablet strength. Tablets are not scored. The tablets are available as follows:n
ZYPREXA IntraMuscular is available in 10u00a0mg vial (1s).n

Tablets (not scored): 2.5, 5, 7.5, 10, 15, 20u00a0mg. ()n
Orally Disintegrating Tablets (not scored): 5, 10, 15, 20u00a0mg. ()n
Intramuscular Injection: 10u00a0mg vial. ()n

No data

None with ZYPREXA monotherapy. ()n
When using ZYPREXA and fluoxetine in combination, also refer to the Contraindications section of the package insert for Symbyax. ()n
When using ZYPREXA in combination with lithium or valproate, refer to the Contraindications section of the package inserts for those products. ()n

When using ZYPREXA and fluoxetine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax.n
Increased Mortalityn
u2014 Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ZYPREXA is not approved for the treatment of patients with dementia-related psychosis .n
In placebo-controlled clinical trials of elderly patients with dementia-related psychosis, the incidence of death in olanzapine-treated patients was significantly greater than placebo-treated patients (3.5% vs 1.5%, respectively).n
Cerebrovascular Adverse Events (CVAE), Including Stroke
[see and Patient Counseling Information ()]

Elderly Patients with Dementia-Related Psychosis:
Suicide:
Neuroleptic Malignant Syndrome:
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS):
Metabolic Changes:
Tardive Dyskinesia:
Orthostatic Hypotension:
Leukopenia, Neutropenia, and Agranulocytosis:
Seizures:
Potential for Cognitive and Motor Impairment:
Hyperprolactinemia:
Use in Combination with Fluoxetine, Lithium or Valproate:
Laboratory Tests:

The possibility of a suicide attempt is inherent in schizophrenia and in bipolaru00a0I disorder, and close supervision of high-risk patients should accompany drug therapy. Prescriptions for olanzapine should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.n

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndromeu00a0(NMS) has been reported in association with administration of antipsychotic drugs, including 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). Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.n
The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to exclude cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptomsu00a0(EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system pathology.n
The management of NMS should include: 1)u00a0immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy; 2)u00a0intensive symptomatic treatment and medical monitoring; and 3)u00a0treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for NMS.n
If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported .n

ntttttttttDrug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with olanzapine exposure. DRESS may present with a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. DRESS is sometimes fatal. Discontinue olanzapine if DRESS is suspected .n

ntttttttttAtypical antipsychotic drugs have been associated with metabolic changes including hyperglycemia, dyslipidemia, and weight gain. Metabolic changes may be associated with increased cardiovascular/cerebrovascular risk. Olanzapine's specific metabolic profile is presented below.n

Dyslipidemia
ntttttttttUndesirable alterations in lipids have been observed with olanzapine use. Clinical monitoring, including baseline and periodic follow-up lipid evaluations in patients using olanzapine, is recommended .n
ntttttttttClinically significant, and sometimes very high (>500u00a0mg/dL), elevations in triglyceride levels have been observed with olanzapine use. Modest mean increases in total cholesterol have also been seen with olanzapine use.n

Weight Gain
ntttttttttPotential consequences of weight gain should be considered prior to starting olanzapine. Patients receiving olanzapine should receive regular monitoring of weight .n

A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.n
The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses or may even arise after discontinuation of treatment.n
Array
Given these considerations, olanzapine should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients (1)u00a0who suffer from a chronic illness that is known to respond to antipsychotic drugs, and (2)u00a0for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.n
If signs and symptoms of tardive dyskinesia appear in a patient on olanzapine, drug discontinuation should be considered. However, some patients may require treatment with olanzapine despite the presence of the syndrome.n
For specific information about the warnings of lithium or valproate, refer to the Warnings section of the package inserts for these other products.n

Olanzapine may induce orthostatic hypotension associated with dizziness, tachycardia, bradycardia and, in some patients, syncope, especially during the initial dose-titration period, probably reflecting its u03b1-adrenergic antagonistic properties .n
ntttttttttFrom 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 u226520% (1277/6030) of patients.
For oral olanzapine therapy, the risk of orthostatic hypotension and syncope may be minimized by initiating therapy with 5u00a0mgu00a0QD . A more gradual titration to the target dose should be considered if hypotension occurs.n
Hypotension, bradycardia with or without hypotension, tachycardia, and syncope were also reported during the clinical trials with intramuscular olanzapine for injection. In an open-label clinical pharmacology study in nonagitated patients with schizophrenia in which the safety and tolerability of intramuscular olanzapine were evaluated under a maximal dosing regimen (three 10u00a0mg doses administered 4 hours apart), approximately one-third of these patients experienced a significant orthostatic decrease in systolic blood pressure (i.e., decrease u226530u00a0mmHg) . Syncope was reported in 0.6% (15/2500) of olanzapine-treated patients in phase 2-3 oral olanzapine studies and in 0.3% (2/722) of olanzapine-treated patients with agitation in the intramuscular olanzapine for injection studies. Three normal volunteers in phase 1 studies with intramuscular olanzapine experienced hypotension, bradycardia, and sinus pauses of up to 6 seconds that spontaneously resolved (in 2 cases the reactions occurred on intramuscular olanzapine, and in 1 case, on oral olanzapine). The risk for this sequence of hypotension, bradycardia, and sinus pause may be greater in nonpsychiatric patients compared to psychiatric patients who are possibly more adapted to certain effects of psychotropic drugs. For intramuscular olanzapine for injection therapy, patients should remain recumbent if drowsy or dizzy after injection until examination has indicated that they are not experiencing postural hypotension, bradycardia, and/or hypoventilation.n
Olanzapine should be used with particular caution in patients with known cardiovascular disease (history of myocardial infarction or ischemia, heart failure, or conduction abnormalities), cerebrovascular disease, and conditions which would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medications) where the occurrence of syncope, or hypotension and/or bradycardia might put the patient at increased medical risk.n
n Caution is necessary in patients who receive treatment with other drugs having effects that can induce hypotension, bradycardia, respiratory or central nervous system depression . Concomitant administration of intramuscular olanzapine and parenteral benzodiazepine is not recommended due to the potential for excessive sedation and cardiorespiratory depression.n

ntttttttttZYPREXA may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.n

Class Effect
n Possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC) and history of drug induced leukopenia/neutropenia. Patients with a history of a clinically significant low WBC or drug induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of ZYPREXA should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.n
n Patients with clinically significant neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Patients with severe neutropenia (absolute neutrophil count <1000/mm) should discontinue ZYPREXA and have their WBC followed until recovery.n

Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in patients with advanced Alzheimer's disease. Olanzapine is not approved for the treatment of patients with Alzheimer's disease.n

During premarketing testing, seizures occurred in 0.9% (22/2500) of olanzapine-treated patients. There were confounding factors that may have contributed to the occurrence of seizures in many of these cases. Olanzapine should be used cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold, e.g., Alzheimer's dementia. Olanzapine is not approved for the treatment of patients with Alzheimer's disease. Conditions that lower the seizure threshold may be more prevalent in a population of 65 years or older.n

Somnolence was a commonly reported adverse reaction associated with olanzapine treatment, occurring at an incidence of 26% in olanzapine patients compared to 15% in placebo patients. This adverse reaction was also dose related. Somnolence led to discontinuation in 0.4% (9/2500) of patients in the premarketing database.n
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 .n

Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing olanzapine for patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration .n

Clinical experience with olanzapine in patients with certain concomitant systemic illnesses is limited .n
Olanzapine exhibits inu00a0vitro muscarinic receptor affinity. In premarketing clinical trials with olanzapine, olanzapine was associated with constipation, dry mouth, and tachycardia, all adverse reactions possibly related to cholinergic antagonism. Such adverse reactions were not often the basis for discontinuations from olanzapine, but olanzapine should be used with caution in patients with clinically significant prostatic hypertrophy, narrow angle glaucoma, or a history of paralytic ileus or related conditions.n
ntttttttttIn 5 placebo-controlled studies of olanzapine in elderly patients with dementia-related psychosis (n=1184), the following treatment-emergent adverse reactions were reported in olanzapine-treated patients at an incidence of at least 2% and significantly greater than placebo-treated patients: falls, somnolence, peripheral edema, abnormal gait, urinary incontinence, lethargy, increased weight, asthenia, pyrexia, pneumonia, dry mouth and visual hallucinations. The rate of discontinuation due to adverse reactions was greater with olanzapine than placebo (13% vs 7%). Elderly patients with dementia-related psychosis treated with olanzapine are at an increased risk of death compared to placebo. Olanzapine is not approved for the treatment of patients with dementia-related psychosis .n
Olanzapine has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Patients with these diagnoses were excluded from premarketing clinical studies. Because of the risk of orthostatic hypotension with olanzapine, caution should be observed in cardiac patients .n

n As with other drugs that antagonize dopamineu00a0D receptors, olanzapine elevates prolactin levels, and the elevation persists during chronic administration. Hyperprolactinemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion. This, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds. Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone density in both female and male subjects.n
n Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent inu00a0vitro, a factor of potential importance if the prescription of these drugs is contemplated in a patient with previously detected breast cancer. As is common with compounds which increase prolactin release, an increase in mammary gland neoplasia was observed in the olanzapine carcinogenicity studies conducted in mice and rats . Neither clinical studies nor epidemiologic studies conducted to date have shown an association between chronic administration of this class of drugs and tumorigenesis in humans; the available evidence is considered too limited to be conclusive at this time.n
n In placebo-controlled olanzapine clinical studies (up to 12 weeks), changes from normal to high in prolactin concentrations were observed in 30% of adults treated with olanzapine as compared to 10.5% of adults treated with placebo. In a pooled analysis from clinical studies including 8136 adults treated with olanzapine, potentially associated clinical manifestations included menstrual-related events (2% [49/3240] of females), sexual function-related events (2% [150/8136] of females and males), and breast-related events (0.7% [23/3240] of females, 0.2% [9/4896] of males).n
n 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. In a pooled analysis from clinical trials including 454 adolescents treated with olanzapine, potentially associated clinical manifestations included menstrual-related events (1% [2/168] of females), sexual function-related events (0.7% [3/454] of females and males), and breast-related events (2% [3/168] of females, 2% [7/286] of males) .n
ntttttttttDose group differences with respect to prolactin elevation have been observed. In a single 8-week randomized, double-blind, fixed-dose study comparing 10 (N=199), 20 (N=200) and 40 (N=200) mg/day of oral olanzapine in adult patients with schizophrenia or schizoaffective disorder, incidence of prolactin elevation >24.2 ng/mL (female) or >18.77 ng/mL (male) at any time during the trial (10u00a0mg/day: 31.2%; 20u00a0mg/day: 42.7%; 40u00a0mg/day: 61.1%) indicated significant differences between 10 vs 40u00a0mg/day and 20 vs 40u00a0mg/day.

ntttttttttWhen using ZYPREXA and fluoxetine in combination, the prescriber should also refer to the Warnings and Precautions section of the package insert for Symbyax. When using ZYPREXA in combination with lithium or valproate, the prescriber should refer to the Warnings and Precautions sections of the package inserts for lithium or valproate .n

ntttttttttFasting blood glucose testing and lipid profile at the beginning of, and periodically during, treatment is recommended .n

When using ZYPREXA and fluoxetine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax.n
Most common adverse reactions (u22655% and at least twice that for placebo) associated with:n
Oral Olanzapine Monotherapy:
Combination of ZYPREXA and Lithium or Valproate:
ZYPREXA and Fluoxetine in Combination:
ZYPREXA IntraMuscular for Injection:
To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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 estimate their frequency or evaluate a causal relationship to drug exposure.n
Adverse reactions reported since market introduction that were temporally (but not necessarily causally) related to ZYPREXA therapy include the following: allergic reaction (e.g., anaphylactoid reaction, angioedema, pruritus or urticaria), cholestatic or mixed liver injury, diabetic coma, diabetic ketoacidosis, discontinuation reaction (diaphoresis, nausea or vomiting), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), hepatitis, jaundice, neutropenia, pancreatitis, priapism, rash, restless legs syndrome, rhabdomyolysis, salivary hypersecretion, stuttering, and venous thromboembolic events (including pulmonary embolism and deep venous thrombosis). Random cholesterol levels of u2265240u00a0mg/dL and random triglyceride levels of u22651000u00a0mg/dL have been reported.n

The risks of using olanzapine in combination with other drugs have not been extensively evaluated in systematic studies.n

Diazepam:
Alcohol:
Carbamazepine:
Fluvoxamine:
ZYPREXA and Fluoxetine in Combination:
CNS Acting Drugs:
Antihypertensive Agents:
Levodopa and Dopamine Agonists:
Lorazepam (IM):
Other Concomitant Drug Therapy:

When using ZYPREXA and fluoxetine in combination, also refer to the Use in Specific Populations section of the package insert for Symbyax.n

Pregnancy:
Pediatric Use:

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 administered oral doses up to 15 times the daily oral MRHD (20u00a0mg) and rhesus monkeys administered oral doses up to 8 times the daily oral MRHD based on mg/m body surface area.n
Olanzapine has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic, and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of olanzapine (e.g., development of tolerance, increases in dose, drug-seeking behavior).n

No data

ZYPREXA (olanzapine) 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:n
Olanzapine is a yellow crystalline solid, which is practically insoluble in water.n
ZYPREXA tablets are intended for oral administration only.n
Each tablet contains olanzapine equivalent to 2.5u00a0mg (8u00a0u03bcmol), 5u00a0mg (16u00a0u03bcmol), 7.5u00a0mg (24u00a0u03bcmol), 10u00a0mg (32u00a0u03bcmol), 15u00a0mg (48u00a0u03bcmol), or 20u00a0mg (64u00a0u03bcmol). Inactive ingredients are carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No.u00a02 Aluminum Lake (15u00a0mg), or Synthetic Red Iron Oxide (20u00a0mg). The 2.5, 5, 7.5, and 10u00a0mg tablets are imprinted with edible ink which contains FD&C Blue No.u00a02 Aluminum Lake.n
ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) is intended for oral administration only.n
Each orally disintegrating tablet contains olanzapine equivalent to 5u00a0mg (16u00a0u03bcmol), 10u00a0mg (32u00a0u03bcmol), 15u00a0mg (48u00a0u03bcmol) or 20u00a0mg (64u00a0u03bcmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) also contains the following inactive ingredients: gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propyl paraben.n
ZYPREXA IntraMuscular (olanzapine for injection) is intended for intramuscular use only.n
Each vial provides for the administration of 10u00a0mg (32u00a0u03bcmol) olanzapine with inactive ingredients 50u00a0mg lactose monohydrate and 3.5u00a0mg tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH.n

No data

No data

When using ZYPREXA and fluoxetine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.n

No data

ntttttttAdvise the patient to read the FDA-approved patient labeling (Medication Guide) for the oral formulations.ntttttt
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. If you do not think you are getting better or have any concerns about your condition while taking ZYPREXA, call your doctor. When using ZYPREXA and fluoxetine in combination, also refer to the Patient Counseling Information section of the package insert for Symbyax.n
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. 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.g., stroke, transient ischemic attack) compared with placebo.n
ZYPREXA is not approved for elderly patients with dementia-related psychosis .n
Neuroleptic Malignant Syndrome (NMS)
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) .n
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
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) .n
Hyperglycemia and Diabetes Mellitus
Patients should be advised of the potential risk of hyperglycemia-related adverse reactions. Patients should be monitored regularly for worsening of glucose control. Patients who have diabetes should follow their doctor's instructions about how often to check their blood sugar while taking ZYPREXA .n
Dyslipidemia
Patients should be counseled that dyslipidemia has occurred during treatment with ZYPREXA. Patients should have their lipid profile monitored regularly .n
Weight Gain
Patients should be counseled that weight gain has occurred during treatment with ZYPREXA. Patients should have their weight monitored regularly .n
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.g., diazepam or alcohol . 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.n
Potential for Cognitive and Motor Impairment
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 .n
Body Temperature Regulation
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 .n
Concomitant Medication
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 .n
Alcohol
Patients should be advised to avoid alcohol while taking ZYPREXA .n
Phenylketonurics
ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) contains phenylalanine (0.34, 0.45, 0.67, or 0.90u00a0mg per 5, 10, 15, or 20u00a0mg tablet, respectively) .n
Use in Specific Populations
Pregnancyn- [see Use in Specific Populations ()]
Lactationn- [see Use in Specific Populations ()]
Infertilityn- [see Use in Specific Populations ()]
Pediatric Usen- [see Indications and Usage (, )]n- [see Warnings and Precautions () and Use in Specific Populations ()]
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. Effectiveness and safety of ZYPREXA have not been established in pediatric patients less than 13 years of age. Atypical antipsychotics are not intended for use in the pediatric patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders. 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 .n
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USAn
Copyright u00a9 1997, 2019, Eli Lilly and Company. All rights reserved.n
ZYP-0008-USPI-201910n

Medication Guide
ZYPREXA (zy-PREX-a)
(olanzapine)
Tablet
ZYPREXA ZYDIS (zy-PREX-a ZY-dis)
(olanzapine)
Tablet, Orally Disintegrating
Read the Medication Guide that comes with ZYPREXA before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. Talk with your doctor or pharmacist if there is something you do not understand or you want to learn more about ZYPREXA.n
What is the most important information I should know about ZYPREXA?
ZYPREXA may cause serious side effects, including:
These serious side effects are described below.
What is ZYPREXA?
ZYPREXA is a prescription medicine used to treat:
ZYPREXA has not been approved for use in children under 13 years of age. ZYPREXA in combination with fluoxetine has not been approved for use in children under 10 years of age.n
The symptoms of schizophrenia include hearing voices, seeing things that are not there, having beliefs that are not true, and being suspicious or withdrawn.n
The symptoms of bipolaru00a0I 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.n
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.n
Some of your symptoms may improve with treatment. If you do not think you are getting better, call your doctor.n
What should I tell my doctor before taking ZYPREXA?
ZYPREXA may not be right for you. Before starting ZYPREXA, tell your doctor if you have or had:n
Tell your doctor if you exercise a lot or are in hot places often.n
The symptoms of bipolaru00a0I disorder, treatment resistant depression, or schizophrenia may include 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.n
Tell your doctor about all the medicines that you take,
How should I take ZYPREXA?
What should I avoid while taking ZYPREXA?
What are the possible side effects of ZYPREXA?
Serious side effects may happen when you take ZYPREXA, including:
Common side effects of ZYPREXA include:
Other common side effects in teenagers (13-17 years old) include:
Tell your doctor about any side effect that bothers you or that does not go away.n
These are not all the possible side effects with ZYPREXA. For more information, ask your doctor or pharmacist.n
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.n
How should I store ZYPREXA?
Keep ZYPREXA and all medicines out of the reach of children.
General information about ZYPREXA
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ZYPREXA for a condition for which it was not prescribed. Do not give ZYPREXA to other people, even if they have the same condition. It may harm them.n
This Medication Guide summarizes the most important information about ZYPREXA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ZYPREXA that was written for healthcare professionals. For more information about ZYPREXA call 1-800-Lilly-Rx (1-800-545-5979).n
What are the ingredients in ZYPREXA?
Active ingredient:
Inactive ingredients:
Tablets
ZYDIS
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Medication Guide revised October 22, 2019n
Marketed by: Lilly USA, LLCIndianapolis, IN 46285, USA
Copyright u00a9 2009, 2019, Eli Lilly and Company. All rights reserved.n
ZYP-0002-MG-20191022n

PACKAGE LABEL - ZYPREXA 2.5 mg tablet, bottle of 30
NDC 0002-4112-30n
30 Tabletsn
No. 4112n
ZYPREXAn
Olanzapine Tabletsn
2.5 mgn
Rx onlyn
Medication Guide is to be dispensed to patients.n
Lillyn

PACKAGE LABEL - ZYPREXA 5 mg tablet, bottle of 30
NDC 0002-4115-30n
30 Tabletsn
No. 4115n
ZYPREXAn
Olanzapine Tabletsn
5 mgn
Rx onlyn
Medication Guide is to be dispensed to patients.n
Lillyn

PACKAGE LABEL - ZYPREXA 7.5 mg tablet, bottle of 30
NDC 0002-4116-30n
30 Tabletsn
No. 4116n
ZYPREXAn
Olanzapine Tabletsn
7.5 mgn
Rx onlyn
Medication Guide is to be dispensed to patients.n
Lillyn

PACKAGE LABEL - ZYPREXA 10 mg tablet, bottle of 30
NDC 0002-4117-30n
30 Tabletsn
No. 4117n
ZYPREXAn
Olanzapine Tabletsn
10 mgn
Rx onlyn
Medication Guide is to be dispensed to patients.n
Lillyn

PACKAGE LABEL - ZYPREXA 15 mg tablet, bottle of 30
NDC 0002-4415-30n
30 Tabletsn
No. 4415n
ZYPREXAn
Olanzapine Tabletsn
15 mgn
Rx onlyn
Medication Guide is to be dispensed to patients.n
Lillyn

PACKAGE LABEL - ZYPREXA 20 mg tablet, bottle of 30
NDC 0002-4420-30n
30 Tabletsn
No. 4420n
ZYPREXAn
Olanzapine Tabletsn
20 mgn
Rx onlyn
Medication Guide is to be dispensed to patients.n
Lillyn

PACKAGE LABEL - ZYPREXA ZYDIS 5 mg tablet, 30 sachets
5 mg orally disintegrating tabletsn
30 Sachets, No. 4453n
NDC 0002-4453-85n
Rx onlyn
Medication Guide is to be dispensed to patients.n
ZYPREXA ZYDISn
Olanzapine Orally Disintegrating Tabletsn
5 mgn
Phenylketonurics: Contains phenylalanine 0.34 mg per tablet.n
DO NOT OPEN POUCH UNTIL IMMEDIATELY PRIOR TO USE.n
Lillyn

PACKAGE LABEL - ZYPREXA ZYDIS 10 mg tablet, 30 sachets
10 mg orally disintegrating tabletsn
30 Sachets, No. 4454n
NDC 0002-4454-85n
Rx onlyn
Medication Guide is to be dispensed to patients.n
ZYPREXA ZYDISn
Olanzapine Orally Disintegrating Tabletsn
10 mgn
Phenylketonurics: Contains phenylalanine 0.45 mg per tablet.n
DO NOT OPEN POUCH UNTIL IMMEDIATELY PRIOR TO USE.n
Lillyn

PACKAGE LABEL - ZYPREXA ZYDIS 15 mg tablet, 30 sachets
15 mg orally disintegrating tabletsn
30 Sachets, No. 4455n
NDC 0002-4455-85n
Rx onlyn
Medication Guide is to be dispensed to patients.n
ZYPREXA ZYDISn
Olanzapine Orally Disintegrating Tabletsn
15 mgn
Phenylketonurics: Contains phenylalanine 0.67 mg per tablet.n
DO NOT OPEN POUCH UNTIL IMMEDIATELY PRIOR TO USE.n
Lillyn

PACKAGE LABEL - ZYPREXA ZYDIS 20 mg tablet, 30 sachets
20 mg orally disintegrating tabletsn
30 Sachets, No. 4456n
NDC 0002-4456-85n
Rx onlyn
Medication Guide is to be dispensed to patients.n
ZYPREXA ZYDISn
Olanzapine Orally Disintegrating Tabletsn
20 mgn
Phenylketonurics: Contains phenylalanine 0.90 mg per tablet.n
DO NOT OPEN POUCH UNTIL IMMEDIATELY PRIOR TO USE.n
Lillyn

PACKAGE LABEL - ZYPREXA INTRAMUSCULAR 10 mg/vial
NDC 0002-7597-01n
1 Vialn
No. VL7597n
ZYPREXA IntraMuscularn
Olanzapine for Injectionn
Sterile Single Use Vialn
Rx onlyn
For intramuscular use only.n
10 mg/vialn
Lillyn

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Olanzapine (Zyprexa)

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