Avoid drinking alcohol while taking olanzapine. In clinical studies, changes in prolactin levels were found to be statistically significantly different based on dose, higher doses were associated with higher levels of prolactin. In a study of up to 12 weeks, plasma prolactin concentrations exceeded the upper limit of normal ULN in approximately 30% of patients who had normal baseline prolactin values. The majority of these elevations were mild, and remained below 2 x ULN. But now don't care as much when I go places. I noticed I am more calm and positive. This medicine makes me want to be more productive and happy. I am on my 2nd-3rd week of taking it. I don't have any side effects so far.
Oral carcinogenicity studies were conducted in mice and rats. While there is no body of evidence to answer the question of how long a patient treated with ZYPREXA and fluoxetine in combination should remain on it, it is generally accepted that bipolar I disorder, including the depressive episodes associated with bipolar I disorder, is a chronic illness requiring chronic treatment. The physician should periodically reexamine the need for continued pharmacotherapy. Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
CYP mediated oxidation are the primary metabolic pathways for olanzapine. Refer to the table at right to determine the final volume to inject. If you currently have, or have had any problems in the past with addictive drugs, including street drugs and medication, you should talk with your doctor before you take this medication. You should also mention any serious reactions you may have had to other similar medications. If you are taking other prescription drugs or supplements, you should check with your doctor or pharmacist before taking this drug.
In placebo-controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with oral olanzapine compared to patients treated with placebo. If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. In a study of patients who were already tolerating either lithium or valproate as monotherapy, discontinuation rates due to adverse reactions were 11% for the combination of oral olanzapine with lithium or valproate compared to 2% for patients who remained on lithium or valproate monotherapy. Discontinuations with the combination of oral olanzapine and lithium or valproate that occurred in more than 1 patient were: somnolence 3% weight gain 1% and peripheral edema 1%.
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. In the randomized phase, patients receiving continued olanzapine experienced a significantly longer time to relapse. Tell your surgeon or anesthesiologist that you are taking this medication if you plan to have any type of surgery, including oral surgery. Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. In general, the decision to use Zyprexa Relprevv in specific populations should be thoughtfully considered. For patients who have never taken oral olanzapine, tolerability should be established with oral olanzapine prior to initiating treatment with Zyprexa Relprevv. Patent and Trademark Office and certain other countries. 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. High fat levels in your blood cholesterol and triglycerides. High fat levels may happen in people treated with Zyprexa Relprevv, especially in teenagers 13 to 17 years old. Zyprexa Relprevv is not approved in patients less than 18 years old. You may not have any symptoms, so your doctor should do blood tests to check your cholesterol and triglyceride levels before you start taking Zyprexa Relprevv and during treatment. But this medicine helps more than anything to quiet those negative voices. Eli Lilly and Company has received reports of fatality in association with overdose of oral olanzapine alone. What should I do if I miss a dose?
What Is Olanzapine and How Does It Work? The rate of discontinuation due to adverse reactions was significantly greater with oral 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. These reactions were correlated with an unintentional rapid increase in serum olanzapine concentrations to supra-therapeutic ranges in some cases. While a rapid and greater than expected increase in serum olanzapine concentration has been observed in some patients with these reactions, the exact mechanism by which the drug was unintentionally introduced into the blood stream is not known. Clinical signs and symptoms included dizziness, confusion, disorientation, slurred speech, altered gait, difficulty ambulating, weakness, agitation, extrapyramidal symptoms, hypertension, convulsion, and reduced level of consciousness ranging from mild sedation to coma. Time after injection to event ranged from soon after injection to greater than 3 hours after injection. The majority of patients were hospitalized and some required supportive care, including intubation, in several cases. All patients had largely recovered by 72 hours. This list is not complete and other drugs may interact with olanzapine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Olanzapine can be taken with or without food. If you notice any of these symptoms in your especially during their first month, tell the doctor right away. olanzapine
Olanzapine appears to have a greater association than some other atypical antipsychotics for increasing glucose levels. Open the sachet and peel back the foil on the blister. Do not push the tablet through the foil. Bent or damaged needles can result in breakage or damage to the tissue or accidental needle puncture. Table 1 above demonstrates the appropriate individual component doses of Zyprexa and fluoxetine versus Symbyax. Dosage adjustments, if indicated, should be made with the individual components according to efficacy and tolerability. 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. The resulting solution should appear clear and yellow. Zyprexa IntraMuscular reconstituted with Sterile Water for Injection should be used immediately within 1 hour after reconstitution. Discard any unused portion. 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. What are the ingredients in Zyprexa? Based on a search of the following terms: anorgasmia, delayed ejaculation, erectile dysfunction, decreased libido, loss of libido, abnormal orgasm, and sexual dysfunction. Talk to the doctor about the risks and benefits of treatment especially when used in teenagers. After insertion of the needle into the muscle, aspirate for several seconds to ensure that no blood appears. If any blood is drawn into the syringe, discard the syringe and the dose and begin with a new convenience kit. The injection should be performed with steady, continuous pressure. What is Zyprexa used for? 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. Comparison of Zyprexa Relprevv and oral olanzapine, in a 24 week study, revealed no significant differences on ECG changes. NOT TO BE INJECTED INTRAVENOUSLY OR SUBCUTANEOUSLY. poci.info naproxen
This long-acting form of injection may cause serious side effects, including severe drowsiness, inability to wake up and confusion delirium after injection. Zyprexa Relprevv should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Talk with your doctor before you use medicines that may cause drowsiness eg, sleep aids, muscle relaxers while you are using Zyprexa Intramuscular; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. Do not drink alcohol while you are using Zyprexa Intramuscular. Do Not Reuse: Medical devices require specific material characteristics to perform as intended. These characteristics have been verified for single use only. Any attempt to re-process the device for subsequent re-use may adversely affect the integrity of the device or lead to deterioration in performance.
There are no adequate and well-controlled trials with olanzapine in pregnant females. Four pregnancies were observed during clinical trials with Zyprexa Relprevv, including 1 resulting in a normal birth and 3 therapeutic abortions. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. HCl is a fixed-dose combination of Zyprexa and fluoxetine. There is no specific antidote to olanzapine. Therefore, appropriate supportive measures should be initiated. Patients and caregivers should be advised that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. FOR DEEP INTRAMUSCULAR GLUTEAL INJECTION ONLY. When using Zyprexa and fluoxetine in combination, the prescriber should also refer to the Warnings and Precautions section of the package insert for Symbyax. Multiple doses of olanzapine did not influence the kinetics of biperiden. The pharmacokinetic characteristics of orally administered olanzapine were similar in patients with severe renal impairment and normal subjects, indicating that dosage adjustment based upon the degree of renal impairment is not required. In addition, olanzapine is not removed by dialysis. The effect of renal impairment on metabolite elimination has not been studied. Weight gain. Weight gain is very common in people who take Zyprexa Relprevv. Teenagers 13 to 17 years old are more likely to gain weight and to gain more weight than adults. Zyprexa Relprevv is not approved in patients less than 18 years old. Some people may gain a lot of weight while taking Zyprexa Relprevv, so you and your doctor should check your weight regularly. Talk to your doctor about ways to control weight gain, such as eating a healthy, balanced diet, and exercising. proventil stock purchase plan
How should I store Zyprexa? 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. Diagnosis was confirmed by the K-SADS-PL. When using Zyprexa and fluoxetine in combination, also refer to the Use in Specific Populations section of the package insert for Symbyax. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away. If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. Dispose of the vials, needles, and syringe appropriately after injection. The vial is for single-use only. HCl is a fixed-dose combination of ZYPREXA and fluoxetine. 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. 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. Drug Reaction with Eosinophilia and Systemic Symptoms DRESS has been reported with olanzapine exposure. In all studies, the effectiveness of Zyprexa was assessed using various symptom-rating scales. What benefit has Zyprexa shown during the studies? Hypodermic Needle-Pro needle with needle protection device. Co-administration of lorazepam does not significantly affect the pharmacokinetics of olanzapine, unconjugated lorazepam, or total lorazepam. However, this co-administration of lorazepam with olanzapine potentiated the somnolence observed with either drug alone. precose can i purchase payment
This medicine is available only with your doctor's prescription. 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. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including olanzapine. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse reactions in patients treated with the atypical antipsychotics. While relative risk estimates are inconsistent, the association between atypical antipsychotics and increases in glucose levels appears to fall on a continuum and olanzapine appears to have a greater association than some other atypical antipsychotics. 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. Concomitant administration of intramuscular olanzapine and parenteral benzodiazepine is not recommended due to the potential for excessive sedation and cardiorespiratory depression. Overall, there was no difference in the incidence of discontinuation due to adverse reactions 2% for oral olanzapine vs 2% for placebo. Dystonia, Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Some MEDICINES MAY INTERACT with Zyprexa Intramuscular. This effect continued until the patient's next scheduled exam, at approximately 20 days after initiation of therapy, at which point olanzapine was discontinued. Fecal incontinence resolved within approximately 24 hours. No organic cause for fecal incontinence was determined, rectal exam was negative, sigmoidoscopy results were normal, and lab tests were all within normal limits. All doses were statistically superior to placebo on the PANSS Excited Component at 2 hours post-injection. However, the effect was larger and more consistent for the 3 highest doses. Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist. 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. Zyprexa IntraMuscular results in rapid absorption with peak plasma concentrations occurring within 15 to 45 minutes. Fluvoxamine, a CYP1A2 inhibitor, decreases the clearance of olanzapine. This results in a mean increase in olanzapine Cmax following fluvoxamine of 54% in female nonsmokers and 77% in male smokers. The mean increase in olanzapine AUC is 52% and 108%, respectively. Lower doses of olanzapine should be considered in patients receiving concomitant treatment with fluvoxamine. Dosing modification may be necessary in patients who exhibit a combination of factors that may slow metabolism. When indicated, dose escalation should be performed with caution in these patients. For both oral ZYPREXA and Zyprexa Relprevv higher average plasma concentrations of olanzapine were observed in women than in men. There were, however, no apparent differences between men and women in effectiveness or adverse effects. Dosage modifications based on gender should not be needed. The following table demonstrates the appropriate individual component doses of Zyprexa and fluoxetine versus Symbyax. Dosage adjustments, if indicated, should be made with the individual components according to efficacy and tolerability. However, the efficacy of repeated doses of intramuscular olanzapine for injection in agitated patients has not been systematically evaluated in controlled clinical trials. If you are taking a combination of drugs, use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Onset of events ranged from soon after injection to greater than 3 hours later. The majority of patients were hospitalized and some required supportive care, including intubation. Two deaths have been reported occurring 3 to 4 days after receiving the appropriate dose of the extended-release IM suspension. In these patients, very high olanzapine blood levels were reported after death. A study undertaken to determine the cause of the elevated drug levels in these 2 deaths provides inconclusive results. As reported in a 3-23-2015 drug safety communication issued by the US Food and Drug Administration, a study in animals found much of the drug level increases could have occurred after death, but the possibility that the deaths were caused by a rapid, but delayed entry of the drug in to the bloodstream could not be ruled out. Zyprexa is a registered trademark of Eli Lilly and Company. B cirrhosis revealed little effect on the pharmacokinetics of orally administered olanzapine. lotriderm brand list
Omeprazole and rifampin may cause an increase in olanzapine clearance. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Zyprexa Intramuscular will be handled and stored by a health care provider. You will not store it at home. Keep all medicines out of the reach of children and away from pets. Clinically significant weight gain was observed across all baseline Body Mass Index BMI categories. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your or local waste disposal company. Disorders - Infrequent: creatine phosphokinase increased. Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. The drug product is olanzapine pamoate monohydrate, present as a yellow solid in a glass vial equivalent to 210, 300, or 405 mg olanzapine base per vial. When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential in adolescents as compared with adults for weight gain and dyslipidemia. The combined effects of age, smoking, and gender could lead to substantial pharmacokinetic differences in populations. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, swallow or take a sip of water. 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. Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. 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. People who take this drug may experience fainting if they stand up too quickly from a lying or sitting position. This is a condition known as orthostatic hypotension and is a common side effect among antipsychotic medications. To reduce the possibility of injury, put both feet on the floor and stand up slowly. There were confounding factors that may have contributed to the occurrence of seizures in many of these cases. purchase cheapest travatan payment uk
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of olanzapine in children. However, safety and efficacy of olanzapine in children younger than 13 years of age have not been established. Zyprexa Relprevv is a powder for suspension for intramuscular use only. The term abdominal pain upper was combined under abdominal pain. People taking this medication may overheat more easily and may have trouble cooling down after strenuous physical activity. Avoid dehydration, especially during hot weather or when exercising. DSM-IV or DSM-IV-TR criteria for schizophrenia. Patients should be advised to inform their physicians if they are taking, or plan to take, Symbyax. Seizures: Tell your doctor if you have a seizure during treatment with Zyprexa. Constipation; dizziness; drowsiness; dry mouth; light-headedness; pain, redness, or swelling at the injection site; weakness; weight gain. At first, 10 to 15 milligrams mg once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day. Adverse reactions during exposure were obtained by spontaneous report and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of reactions into a smaller number of standardized reaction categories. In the tables and tabulations that follow, MedDRA and COSTART Dictionary terminology has been used to classify reported adverse reactions.
Zyprexa may not be right for you. DRESS is sometimes fatal. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor. The information below for Zyprexa Relprevv is derived primarily from a clinical trial database consisting of 2058 patients with approximately 1948 patient years of exposure to Zyprexa Relprevv. This database includes safety data from 6 open-label studies and 2 double-blind comparator studies, conducted in patients with schizophrenia or schizoaffective disorder. Additionally, data obtained from patients treated with oral olanzapine are also presented below. Adverse reactions were assessed by the collection of adverse reactions, vital signs, weights, laboratory analytes, ECGs, and the results of physical and ophthalmologic examinations. In the tables and tabulations that follow for Zyprexa Relprevv, the MedDRA terminology has been used to classify reported adverse reactions. Data obtained from oral olanzapine studies was reported using the COSTART and MedDRA dictionaries. Discontinuance of olanzapine treatment reversed the effects on male mating performance. While there is no body of evidence to answer the question of how long a patient treated with Zyprexa and fluoxetine in combination should remain on it, it is generally accepted that treatment resistant depression major depressive disorder in adult patients who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode is a chronic illness requiring chronic treatment. The physician should periodically reexamine the need for continued pharmacotherapy. Olanzapine may also be used for purposes not listed in this medication guide. Consult your doctor before -feeding. 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. What is olanzapine Zyprexa, Zyprexa Zydis? Mean increase in weight in adolescents was greater than in adults. In 4 placebo-controlled trials, discontinuation due to weight gain occurred in 1% of olanzapine-treated patients, compared to 0% of placebo-treated patients. Oral olanzapine was associated with orthostatic hypotension and tachycardia in clinical trials. vidalta
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Do not stop taking any medications without consulting your healthcare provider. Before administering the injection, confirm there will be someone to accompany the patient after the 3-hour observation period. If this cannot be confirmed, do not give the injection. The drug product is suspended in the diluent for Zyprexa Relprevv to a target concentration of 150 mg olanzapine per mL prior to intramuscular injection. Food and Drug Administration. WebMD does not endorse any specific product, service, or treatment. Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
In an analysis of patients who completed 12 months of therapy, the mean nonfasting total cholesterol did not increase further after approximately 4-6 months. The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. When you leave the clinic, someone must be with you. Olanzapine for injection was statistically superior to placebo on the PANSS Excited Component at 2 hours post-injection.
This section provides information on the proper use of a number of products that contain olanzapine. It may not be specific to Zyprexa. Please read with care. 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. Your doctor can tell you if it is safe to take Zyprexa with your other medicines. Do not start or stop any medicine while taking Zyprexa without talking to your doctor first. Oral Zyprexa and fluoxetine in combination is indicated for the treatment of treatment resistant depression major depressive disorder in patients who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode based on clinical studies in adult patients. When using Zyprexa and fluoxetine in combination, refer to the Clinical Studies section of the package insert for Symbyax.
The term tension headache was combined under headache. See FDA-approved Medication Guide for the oral formulations. Compared to patients from adult clinical trials, adolescents treated with oral ZYPREXA were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic aminotransferase levels. Luer slip or Luer lock syringe.