patients treated with INSPRA than placebo were hyperkalemia (3.4% vs. 2.0%) and Side Effects. Symptoms of schizophrenia include unusual behavior, delusions, and hallucinations.Bipolar disorder (or manic depression) is a mental illness characterized by depression, mania, and severe mood swings. Call your doctor for medical advice about side effects. It is important to emphasize that, although the reactions occurred during treatment with olanzapine, they were not necessarily caused by it. Trihexyphenidyl oral tablet is a prescription medication used to treat all forms of parkinsonism, including Parkinson’s disease. adverse events were 47% with INSPRA and 45% with placebo. Although not all of these side effects may occur, if they do occur they may need medical attention. Side effects not requiring immediate medical attention. Higher daily doses of carbamazepine may cause an even greater increase in olanzapine clearance.Ethanol (45 mg/70 kg single dose) did not have an effect on olanzapine pharmacokinetics. Inspra (eplerenone) is an aldosterone receptor blocker, which is an antihypertensive, used to treat congestive heart failure after a heart attack, and is also used to treat high blood pressure (hypertension).Inspra is available in generic form. ... an increase in anticholinergic side effects may occur. Risk of death is increased in elderly patients with Along with its needed effects, olanzapine may cause some unwanted effects. Learn about side effects, warnings, dosage, and more. It is characterized by periods of deep, profound, and prolonged depression that alternate with periods of an excessively elevated or irritable mood known as mania. Call your doctor for medical advice about side effects. Learn more about the challenges of mental illness with the Schizophrenia Quiz.Schizophrenia is a disabling brain disorder that may cause hallucinations and delusions and affect a person's ability to communicate and pay attention. of patients administered INSPRA and for 4.9% of placebo-treated patients.Rates of hyperkalemia increased with decreasing renal treated group vs. placebo were increased in patients with proteinuria (16% vs In long-term studies of at least 48-weeks in adults, increased from baseline in mean fasting cholesterol, LDL, triglycerides were 5.6 mg/dL, 2.5 mg/dL, and 18.7 mg/dL, respectively. Onset of events ranged from soon after injection to greater than 3 hours later. We comply with the HONcode standard for trustworthy health information - The most common reasons for discontinuation of What is in this leaflet: 1. function.The rates of hyperkalemia in EPHESUS in the INSPRA Possible side effects 5. during postapproval use of INSPRA. The data were analyzed using the Cochran-Armitage test, excluding the placebo group, and the table includes only those adverse reactions for which there was a trend.In the bipolar I disorder (manic or mixed episodes) adjunct placebo-controlled trials, the most commonly observed adverse reactions associated with the combination of olanzapine and lithium or valproate (incidence of ≥5% and at least twice placebo) were:Table 14 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred in 2% or more of patients treated with the combination of olanzapine (doses ≥5 mg/day) and lithium or valproate and with incidence greater than lithium or valproate alone who participated in the acute phase of placebo-controlled combination trials.For specific information about the adverse reactions observed with lithium or valproate, refer to the Adverse Reactions section of the package inserts for these other products.Table 15 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred in 1% or more of patients treated with intramuscular olanzapine for injection (dose range of 2.5-10 mg/injection) and with incidence greater than placebo who participated in the short-term, placebo-controlled trials in agitated patients with schizophrenia or bipolar I mania.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.The following table enumerates the percentage of patients with treatment-emergent extrapyramidal symptoms as assessed by spontaneously reported adverse reactions during acute therapy in the same controlled clinical trial comparing olanzapine at 3 fixed doses with placebo in the treatment of schizophrenia in a 6-week trial.The following table enumerates the percentage of adolescent patients with treatment-emergent extrapyramidal symptoms as assessed by spontaneously reported adverse reactions during acute therapy (dose range: 2.5 to 20 mg/day).The following table enumerates the percentage of patients with treatment-emergent extrapyramidal symptoms as assessed by categorical analyses of formal rating scales during controlled clinical trials comparing fixed doses of intramuscular olanzapine for injection with placebo in agitation.Patients in each dose group could receive up to 3 injections during the trials.
The entire label should be read to gain a complete understanding of the safety profile of olanzapine.The following findings are based on premarketing trials ofOverall, there was no difference in the incidence of discontinuation due to adverse reactions (5% for oral olanzapine vs 6% for placebo).
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