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Olanzapine (Olanzapine)

Trade Name : Olanzapine

Teva Pharmaceuticals USA, Inc.

TABLET, ORALLY DISINTEGRATING

Strength 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 (Olanzapine) which is also known as Olanzapine and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 5 mg/1 per ml. Read more

Olanzapine (Olanzapine) 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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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Olanzapine is not approved for the treatment of patients with dementia-related psychosis n
  • When using olanzapine 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. Olanzapine is not approved for the treatment of patients with dementia-related psychosis.n- Array
  • When using olanzapine and fluoxetine in combination, also refer to the Boxed Warning section of the package insert for Symbyax.
  • Warnings and Precautions ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 10/2019
  • Olanzapine orally disintegrating tablets are an atypical antipsychotic indicated:
  • As oral formulation for the:
  • As Olanzapine Orally Disintegrating Tablets and Fluoxetine in Combination for the:
  • Olanzapine and Fluoxetine in Combination:
  • Olanzapine Orally Disintegrating Tablets USP are available as:
  • Orally Disintegrating Tablets (not scored): 5, 10, 15, 20 mg ()
  • No data
  • None with olanzapine monotherapy.u00a0()
  • When using olanzapine and fluoxetine in combination, also refer to the Contraindications section of the package insert for Symbyax. ()
  • When using olanzapine in combination with lithium or valproate, refer to the Contraindications section of the package inserts for those products. ()
  • When using olanzapine and fluoxetine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax.
  • 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:
  • When using olanzapine and fluoxetine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax.
  • Most common adverse reactions (u22655% and at least twice that for placebo) associated with:
  • Oral Olanzapine Monotherapy:
  • Combination of Olanzapine and Lithium or Valproate:
  • Olanzapine and Fluoxetine in Combination:
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • The risks of using olanzapine in combination with other drugs have not been extensively evaluated in systematic studies.
  • Diazepam
  • Alcohol
  • Carbamazepine
  • Fluvoxamine
  • Olanzapine and Fluoxetine in Combination:
  • CNS Acting Drugs
  • Antihypertensive Agents
  • Levodopa and Dopamine Agonists
  • Other Concomitant Drug Therapy
  • When using olanzapine and fluoxetine in combination, also refer to the Use in Specific Populations section of the package insert for Symbyax.
  • 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 (20 mg) and rhesus monkeys administered oral doses up to 8 times the daily oral MRHD based on mg/m body surface area.
  • 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).
  • No data
  • Olanzapine Orally Disintegrating Tablets USP are 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 and has the following chemical structure:
  • CHNS M.W. 312.44
  • Olanzapine, USP is a yellow crystalline powder, which is practically insoluble in water.
  • Olanzapine Orally Disintegrating Tablets USP are intended for oral administration only.
  • Each orally disintegrating tablet contains olanzapine, USP equivalent to 5 mg (16 micromol), 10 mg (32 micromol), 15 mg (48 micromol) or 20 mg (64 micromol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine Orally Disintegrating Tablets USP also contain the following inactive ingredients: aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, sodium stearyl fumarate, strawberry flavor and xylitol.
  • No data
  • No data
  • When using olanzapine and fluoxetine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking olanzapine 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 olanzapine, call your doctor. When using olanzapine and fluoxetine in combination, also refer to the Patient Counseling Information section of the package insert for Symbyax.
  • 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 olanzapine had a significantly higher incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) compared with placebo.
  • Olanzapine 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 olanzapine. 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 doctoru2019s instructions about how often to check their blood sugar while taking olanzapine n
  • Dyslipidemia
  • Patients should be counseled that dyslipidemia has occurred during treatment with olanzapine. Patients should have their lipid profile monitored regularly n
  • Weight Gain
  • Patients should be counseled that weight gain has occurred during treatment with olanzapine. 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 olanzapine, 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.
  • Potential for Cognitive and Motor Impairment
  • Because 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 .
  • 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 olanzapine n
  • Phenylketonurics
  • Olanzapine orally disintegrating tablets contain phenylalanine (1, 2, 3, or 4 mg per 5, 10, 15, or 20 mg tablet, respectively) n
  • Use in Specific Populations
  • Pregnancyn- [see Use in Specific Populations ()].
  • Lactation u2014 Advise breastfeeding women using olanzapine 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 .
  • Infertility u2014 Advise females of reproductive potential that olanzapine may impair fertility due to an increase in serum prolactin levels. The effects on fertility are reversible n
  • Pediatric Usen- [see Indications and Usage (, )].n- [see Warnings and Precautions () and Use in Specific Populations ()].
  • Need for Comprehensive Treatment Program in Pediatric Patients
  • Olanzapine 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 olanzapine 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 provideru2019s assessment of the chronicity and severity of the patientu2019s symptoms n
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
  • Teva Pharmaceuticals USA, Inc.n
  • Rev. G 10/2019
  • Olanzapine (oh LAN za peen)
  • Orally Disintegrating Tablets
  • Read the Medication Guide that comes with olanzapine orally disintegrating tablets before you start taking them 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 olanzapine orally disintegrating tablets.
  • What is the most important information I should know about olanzapine orally disintegrating tablets?
  • Olanzapine orally disintegrating tablets may cause serious side effects, including:
  • These serious side effects are described below.
  • Your doctor should do tests to check your blood sugar before you start taking olanzapine orally disintegrating tablets and during treatment. In people who do not have diabetes, sometimes high blood sugar goes away when olanzapine orally disintegrating tablets are stopped. People with diabetes and some people who did not have diabetes before taking olanzapine orally disintegrating tablets need to take medicine for high blood sugar even after they stop taking olanzapine orally disintegrating tablets.
  • If you have diabetes, follow your doctoru2019s instructions about how often to check your blood sugar while taking olanzapine orally disintegrating tablets.
  • Call your doctor
  • 3. High fat levels in your blood (cholesterol and triglycerides).
  • 4. Weight gain.
  • What are olanzapine orally disintegrating tablets?
  • Olanzapine orally disintegrating tablets are a prescription medicine used to treat:
  • Olanzapine orally disintegrating tablets have not been approved for use in children under 13 years of age. Olanzapine orally disintegrating tablets in combination with fluoxetine have not been approved for use in children under 10 years of age.
  • 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.
  • What should I tell my doctor before taking olanzapine orally disintegrating tablets?
  • Olanzapine orally disintegrating tablets may not be right for you. Before starting olanzapine orally disintegrating tablets, tell your doctor if you have or had:
  • Tell your doctor if you exercise a lot or are in hot places often.
  • The symptoms of bipolar I disorder 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.
  • Tell your doctor about all the medicines that you take,
  • How should I take olanzapine orally disintegrating tablets?
  • What should I avoid while taking olanzapine orally disintegrating tablets?
  • What are the possible side effects of olanzapine orally disintegrating tablets?
  • Serious side effects may happen when you take olanzapine orally disintegrating tablets, including:
  • Common side effects of olanzapine orally disintegrating tablets include:
  • Other common side effects in teenagers (13 to 17 years old) include:
  • Tell your doctor about any side effect that bothers you or that does not go away.
  • These are not all the possible side effects with olanzapine orally disintegrating tablets. For more information, ask your doctor or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store olanzapine orally disintegrating tablets?
  • Keep olanzapine orally disintegrating tablets and all medicines out of the reach of children.
  • General information about olanzapine orally disintegrating tablets
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use olanzapine orally disintegrating tablets for a condition for which they were not prescribed. Do not give olanzapine orally disintegrating tablets to other people, even if they have the same condition. They may harm them.
  • This Medication Guide summarizes the most important information about olanzapine orally disintegrating tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about olanzapine orally disintegrating tablets that was written for healthcare professionals. For more information about olanzapine orally disintegrating tablets call Teva Pharmaceuticals at 1-888-838-2872.
  • What are the ingredients in olanzapine orally disintegrating tablets?
  • Active ingredient:
  • Inactive ingredients:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
  • Teva Pharmaceuticals USA, Inc.
  • Rev. F 10/2019
  • No data
  • No data
  • No data
  • No data

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