Oleanz Tablets (Generic Olanzapine Tablets)

1. Oleanz Tablets (Generic Olanzapine Tablets) © The Swiss Pharmacy

2. Oleanz Tablets (Generic Olanzapine Tablets) Oleanz (Generic Olanzapine Tablets) is used for the treatment of schizophrenia. This medicine may also be used alone or with other medicines (eg, Lithium or Valproate) for the acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. Olanzapine may also be used together with Fluoxetine to treat depression that is a part of bipolar disorder, and depression in patients who received other antidepressants that did not work well. © The Swiss Pharmacy

3. Oleanz Tablets (Generic Olanzapine Tablets) Oleanz Tablets are manufactured by SUN Pharmaceutical Industries Limited, India in the strengths of 2.5 mg, 5 mg, 7.5 mg, 10 mg and 20 mg. © The Swiss Pharmacy

4. Oleanz Tablets (Generic Olanzapine Tablets) Chemical Structure © The Swiss Pharmacy

5. Oleanz Tablets (Generic Olanzapine Tablets) The active ingredient contained in Oleanz tablets is Olanzapine. Each film coated Oleanz tablet contains 2.5 mg, 5 mg, 7.5 mg, 10 mg or 20 mg mg of Olanzapine. © The Swiss Pharmacy

6. Oleanz Tablets (Generic Olanzapine Tablets) Uses of Oleanz 2.5 mg, 5 mg, 7.5 mg, 10 mg and 20 mg Tablets: Oleanz (Olanzapine Tablets) is an antipsychotic medication that can treat several mental health conditions like schizophrenia and bipolar disorder. It balances the levels of dopamine and serotonin in your brain. Olanzapine tablets treats schizophrenia and bipolar disorder. It may also be used in combination with other medication to treat depression. This medication can help to decrease hallucinations and help you to think more clearly and positively about yourself, feel less agitated, and take a more active part in everyday life. It works by balancing the levels of dopamine and serotonin in your brain, substances that help regulate mood, behaviors, and thoughts. It belongs to a group of medications called antipsychotics. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9734_Olanzapine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9734_Olanzapine-Tablets.html © The Swiss Pharmacy

7. Oleanz Tablets (Generic Olanzapine Tablets) Recommended Adult Dosage For most patients, the starting dose of Oleanz tablets (Generic Olanzapine tablets) for the treatment of Schizophrenia is 5 mg to 10 mg a day. Oleanz should be administered on a once-a-day schedule without regard to meals, with a target dose of 10 mg/day within several days. Oleanz tablets URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9734_Olanzapine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9734_Olanzapine-Tablets.html © The Swiss Pharmacy

8. Oleanz Tablets (Generic Olanzapine Tablets) Recommended Adult Dosage The starting dose to treat adult patients for Bipolar I Disorder (Manic or Mixed Episodes) is 10 mg or 15 mg as monotherapy on a once-a-day schedule without regard to meals. Dosage adjustments, if indicated, should generally occur at intervals of not less than 24 hours, reflecting the procedures in the placebo-controlled trials. When dosage adjustments are necessary, dose increments/decrements of 5 mg per day are recommended. The starting dose to treat adult patients for Bipolar I Disorder (Manic or Mixed Episodes) with Lithium or Valproate is 10 mg once daily. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9734_Olanzapine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9734_Olanzapine-Tablets.html © The Swiss Pharmacy

9. Oleanz Tablets (Generic Olanzapine Tablets) Recommended Adult Dosage The starting dose to treat adult patients for: Depressive Episodes associated with Bipolar I Disorder in combination with Fluoxetine: Start at 5 mg of oral Olanzapine and 20 mg of Fluoxetine once daily. The starting dose to treat adult patients for: Treatment Resistant Depression in combination with Fluoxetine: Start at 5 mg of oral Olanzapine and 20 mg of Fluoxetine once daily. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9734_Olanzapine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9734_Olanzapine-Tablets.html © The Swiss Pharmacy

10. Oleanz Tablets (Generic Olanzapine Tablets) Contraindications ➔Oleanz is contraindicated in patients with a known hypersensitivity to Olanzapine or any component of the tablet. ➔When using Oleanz (Olanzapine Tablets) and Fluoxetine in combination, also refer to the Contraindications section of the package insert for Fluoxetine tablets. ➔For specific information about the contraindications of Lithium or Valproate, refer to the Contraindications section of the package inserts for these other products. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9734_Olanzapine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9734_Olanzapine-Tablets.html © The Swiss Pharmacy

11. Oleanz Tablets (Generic Olanzapine Tablets) Storage Instructions Oleanz Tablets (Generic Olanzapine Tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. © The Swiss Pharmacy

12. Oleanz Tablets (Generic Olanzapine Tablets) Warnings Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Olanzapine tablets (Oleanz) are not approved for the treatment of patients with dementia-related psychosis. The possibility of a suicide attempt is inherent in schizophrenia and in bipolar I disorder, and close supervision of high- risk patients should accompany drug therapy. A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic medicines, 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. © The Swiss Pharmacy

13. Oleanz Tablets (Generic Olanzapine Tablets) Warnings Drug 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 Oleanz tablets if DRESS is suspected. Atypical antipsychotic drugs have been associated with metabolic changes including hyperglycemia, dyslipidemia, and weight gain. Metabolic changes may be associated with increased cardiovascular/cerebrovascular risk. 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. © The Swiss Pharmacy

14. Oleanz Tablets (Generic Olanzapine Tablets) Warnings Olanzapine (Oleanz tablets) could induce orthostatic hypotension associated with dizziness, tachycardia, bradycardia and, in some patients, syncope, especially during the initial dose-titration period, probably reflecting its alpha1-adrenergic antagonistic properties. Olanzapine may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. During clinical trial and/or postmarketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents, including Olanzapine tablets. Agranulocytosis has also been reported. Possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC) and history of drug induced leukopenia/neutropenia. © The Swiss Pharmacy

15. Oleanz Tablets (Generic Olanzapine Tablets) Warnings 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 tablets are not approved for the treatment of patients with Alzheimer’s disease. 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. 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. Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing Oleanz tablets for patients who will be experiencing conditions which may contribute to an elevation in core body temperature. © The Swiss Pharmacy

16. Oleanz Tablets (Generic Olanzapine Tablets) Warnings Olanzapine exhibits in vitro muscarinic receptor affinity. During premarketing clinical trials, Olanzapine (Oleanz tablets) 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, but olanzapine should be used with caution in patients with a current diagnosis or prior history of urinary retention, clinically significant prostatic hypertrophy, constipation, or a history of paralytic ileus or related conditions. As with other medicines that antagonize dopamine D2 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. © The Swiss Pharmacy

17. Oleanz Tablets (Generic Olanzapine Tablets) Warnings When using Olanzapine tablets and Fluoxetine in combination, the prescriber should also refer to the warnings and precautions section of the package insert for Fluoxetine tablets. When using Olanzapine in combination with lithium or valproate, the prescriber should refer to the Warnings and Precautions sections of the package inserts for Lithium or Valproate. Fasting blood glucose testing and lipid profile at the beginning of, and periodically during treatment with this medicine is recommended. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9734_Olanzapine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9734_Olanzapine-Tablets.html © The Swiss Pharmacy

18. Oleanz Tablets (Generic Olanzapine Tablets) Possible Side Effects Most common Olanzapine (Oleanz tablets) side effects with an incidence rate of greater than or equal to 5% and at least twice that for placebo observed during clinical trials for Schizophrenia in adults were sedation, weight increased, headache, increased appetite, dizziness, abdominal pain, pain in extremity, fatigue, dry mouth. Most common Olanzapine (Oleanz tablets) side effects with an incidence rate of greater than or equal to 5% and at least twice that for placebo observed during clinical trials for Manic or Mixed Episodes, Bipolar I Disorder in adults were asthenia, dry mouth, constipation, increased appetite, somnolence, dizziness, tremor. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9734_Olanzapine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9734_Olanzapine-Tablets.html © The Swiss Pharmacy

19. Oleanz Tablets (Generic Olanzapine Tablets) Oleanz Tablets Overdosage During premarketing trials involving more than 3100 patients and/or normal subjects, accidental or intentional acute overdosage of Olanzapine tablets (Oleanz tablets) was identified in 67 patients. In the patient taking the largest identified amount, 300 mg, the only symptoms reported were drowsiness and slurred speech. In postmarketing reports of overdose with Olanzapine (Oleanz tablets) alone, symptoms have been reported in the majority of cases. In symptomatic patients, symptoms with 10% or greater incidence included agitation/aggressiveness, dysarthria, tachycardia, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma. Among less commonly reported symptoms were the following potentially medically serious reactions: aspiration, cardiopulmonary arrest, cardiac arrhythmias, delirium, possible neuroleptic malignant syndrome, respiratory depression/arrest, convulsion, hypertension, and hypotension. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9734_Olanzapine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9734_Olanzapine-Tablets.html © The Swiss Pharmacy

20. Oleanz Tablets (Generic Olanzapine Tablets) Treatment of Oleanz Tablets Overdosage The possibility of multiple drug involvement should be considered. In case of acute overdosage, establish and maintain an airway and ensure adequate oxygenation and ventilation, which may include intubation. Gastric lavage (after intubation, if patient is unconscious) and administration of activated charcoal together with a laxative should be considered. As peak Olanzapine levels are not typically obtained until about 6 hours after dosing, charcoal may be a useful treatment for Olanzapine (Oleanz tablets) overdose. The possibility of obtundation, seizures, or dystonic reaction of the head and neck following overdose may create a risk of aspiration with induced emesis. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias. There is no specific antidote to Olanzapine (Oleanz tablets). Therefore, appropriate supportive measures should be initiated. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9734_Olanzapine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9734_Olanzapine-Tablets.html © The Swiss Pharmacy

21. Oleanz Tablets (Generic Olanzapine Tablets) Oleanz Tablets During Pregnancy Olanzapine (Oleanz tablets) has been classified by the US FDA as Pregnancy Category C. Neonates exposed to antipsychotic drugs, including Oleanz, during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Olanzapine was not teratogenic when administered orally to pregnant rats and rabbits at doses that are 9- and 30-times the daily oral maximum recommended human dose (MRHD), based on mg/m2 body surface area;some fetal toxicities were observed at these doses. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9734_Olanzapine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9734_Olanzapine-Tablets.html © The Swiss Pharmacy

22. Oleanz Tablets (Generic Olanzapine Tablets) Oleanz Tablets Oleanz Tablets (Generic Olanzapine Tablets) are manufactured by Sun Pharmaceutical Industries Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9734_Olanzapine-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9734_Olanzapine-Tablets.html © The Swiss Pharmacy