Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. Bent or damaged needles can result in breakage or damage to the tissue or accidental needle puncture. 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 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 deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. Zyprexa Relprevv may not be right for you.
Tell your doctor if your condition persists or worsens. Dispose of the vials, needles, and syringe appropriately after injection. The vial is for single-use only. It includes a needle and needle safety sheath.
Some teens who take this medication report weight gain, high levels of fat in the blood, liver problems, breast enlargement, and breast discharge. For best results, teens taking Zyprexa should consider using this medication as part of an overall treatment plan that includes therapy. Teens are more likely to experience side effects from this medication than adults. There were confounding factors that may have contributed to the occurrence of seizures in many of these cases. Placental transfer of olanzapine occurred in rat pups. Comparison of Zyprexa Relprevv and oral olanzapine, in a 24 week study, revealed no significant differences on ECG changes.
CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A. Thus, olanzapine is unlikely to cause clinically important drug interactions mediated by these enzymes. The extended-release injection should only be used if you have already taken olanzapine by without any serious side effects. Common side effects of Zyprexa Relprevv include: headache, sleepiness or drowsiness, weight gain, dry mouth, diarrhea, nausea, common cold, eating more increased appetite vomiting, cough, back pain, or pain at the injection site. There is no specific antidote to olanzapine. Therefore, appropriate supportive measures should be initiated. Omeprazole and rifampin may cause an increase in olanzapine clearance.
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. 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. What should I avoid while receiving Zyprexa Relprevv? Olanzapine helps you to think more clearly, feel less nervous, and take part in everyday life. The most common side effects with Zyprexa seen in more than 1 patient in 10 are somnolence sleepiness weight gain, orthostatic hypotension sudden drop in blood pressure on standing up and raised levels of prolactin a hormone. For the full list of all side effects reported with Zyprexa, see the package leaflet. Slow dissolution of Zyprexa Relprevv, a practically insoluble salt, after a deep intramuscular gluteal injection of a dose of Zyprexa Relprevv results in prolonged systemic olanzapine plasma concentrations that are sustained over a period of weeks to months. An injection every 2 or 4 weeks provides olanzapine plasma concentrations that are similar to those achieved by daily doses of oral olanzapine. Fluoxetine caused a small decrease in olanzapine clearance leading to a minimal change in olanzapine steady-state concentrations and, therefore dose modification is not routinely recommended.
Olanzapine may also be used for purposes not listed in this medication guide. Scholey, A. Herbal medicine for depression, anxiety and insomnia: a review of psychopharmacology and clinical evidence. Eur. 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. Oral olanzapine should be administered in combination with fluoxetine once daily in the evening, without regard to meals, generally beginning with 5 mg of oral olanzapine and 20 mg of fluoxetine. Store at room temperature away from light and moisture. not store in the bathroom. Keep all away from children and pets. Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit. What is the most important information I should know about Zyprexa Relprevv? Before using olanzapine, tell your doctor if you regularly use other medicines that can make you sleepy or slow your breathing such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety. They can add to the side effects of olanzapine. The terms alanine aminotransferase ALT aspartate aminotransferase AST and hepatic enzyme were combined under liver enzymes. Tell your doctor if you smoke tobacco. You might need a different amount of this medicine if you smoke. What happens if I miss a dose Zyprexa, Zyprexa Zydis?
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Your doctor should do tests to check your blood sugar before you start taking Zyprexa and during treatment. In people who do not have diabetes, sometimes high blood sugar goes away when Zyprexa is stopped. People with diabetes and some people who did not have diabetes before taking Zyprexa need to take medicine for high blood sugar even after they stop taking Zyprexa. Dosage is based on your medical condition and response to treatment. It is recommended that gloves are used when reconstituting, as Zyprexa Relprevv may be irritating to the skin. Flush with water if contact is made with skin. The studies also showed an increased risk of among elderly patients with dementia using Zyprexa. Prescribing information for the drug was updated in January 2004 to include information on this risk. 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. Zyprexa Intramuscular may cause dizziness, drowsiness, or decreased vision. These effects may be worse if you take it with alcohol or certain medicines. Use Zyprexa Intramuscular with caution. When using Zyprexa and fluoxetine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax.
This drug may also cause significant gain and a rise in your or levels, especially in teenagers. 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. The term sinus congestion was combined under nasal congestion. 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. May cause side effects to become worse. Olanzapine is indicated for the treatment of moderate to severe manic episode. Zyprexa Relprevv must be administered in a registered healthcare facility such as a hospital, clinic, residential treatment center, or community healthcare center with ready access to emergency response services. F that are experienced in pharmacies, hospitals, and warehouses. Tay lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills. Zyprexa Relprevv 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. Zyprexa Relprevv is a long-acting prescription medicine given by injection and used to treat schizophrenia in adults.
Our Zyprexa Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. 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. Oral olanzapine was associated with orthostatic hypotension and tachycardia in clinical trials. Zyprexa Relprevv can cause sleepiness and may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how Zyprexa Relprevv affects you. You should not drive or operate heavy machinery for the rest of the day after each injection. Avoid using alcohol with this medication. Alcohol may increase the intensity and frequency of side effects. 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 Relprevv includes a vial of the drug product and a vial of the sterile diluent for Zyprexa Relprevv. Dose group differences with respect to prolactin elevation have been observed in some studies. Olanzapine for injection was statistically superior to placebo on the PANSS Excited Component at 2 hours post-injection. Some medical conditions may interact with Zyprexa Intramuscular. Patients with the following MedDRA terms were counted in this category: abdominal pain, abdominal pain lower, abdominal pain upper. Somnolence was reported in 8% of patients receiving IM extended-release suspension. Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco. Olanzapine exhibits in vitro muscarinic receptor affinity. In premarketing clinical trials with oral 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. Severe allergic reactions rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness; abnormal thoughts; chest pain; confusion; decreased urination; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; increased saliva production or drooling; increased sweating; memory loss; menstrual changes; muscle pain, weakness, or stiffness; new or worsening mental or mood changes eg, depression, hallucinations; one-sided weakness; seizures; severe or prolonged dizziness or headache; shortness of breath; suicidal thoughts or actions; swelling of the hands, legs, or feet; symptoms of high blood sugar eg, increased thirst, hunger, or urination; unusual weakness; symptoms of high prolactin levels eg, enlarged breast size, decreased sexual ability, missed menstrual period, nipple discharge; tremor; trouble concentrating, speaking, or swallowing; trouble sitting still; trouble walking or standing; uncontrolled muscle movements eg, arm or leg movements, twitching of the face or tongue, jerking or twisting; unusual bruising; vision changes; yellowing of the skin or eyes. 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.
Single doses of olanzapine did not affect the pharmacokinetics of imipramine or its active metabolite desipramine. Patient and caregivers should be advised that after each Zyprexa Relprevv injection, patients must be observed at the healthcare facility for at least 3 hours and must be accompanied to their destination upon leaving the facility. The Medication Guide should be distributed each time patients receive an injection. Call your doctor or contact a poison control center immediately. Do not induce vomiting unless advised to do so by a trained medical professional. When using Zyprexa and fluoxetine in combination, the prescriber should also refer to the Warnings and Precautions section of the package insert for Symbyax. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect or predict the rates observed in practice. 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. If you have diabetes, follow your doctor's instructions about how often to check your blood sugar while taking Zyprexa. TD and are considered the drugs of choice in patients being treated for psychosis. Shake the vial vigorously until the suspension appears smooth and is consistent in color and texture. Visually confirm that the needle is fully engaged into the needle protection sheath. Olanzapine Monotherapy in Adults: An assessment of the premarketing experience for oral olanzapine revealed an association with asymptomatic increases in ALT, AST, and GGT.
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III-R criteria for schizophrenia. A single haloperidol arm was included as a comparative treatment in 1 of the 2 trials, but this trial did not compare these 2 drugs on the full range of clinically relevant doses for both. 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%.
However, the efficacy of repeated doses of intramuscular olanzapine for injection in agitated patients has not been systematically evaluated in controlled clinical trials. The European Commission granted a marketing authorisation valid throughout the European Union for Zyprexa on 27 September 1996. Store at room temperature away from moisture, heat, and light.
After opening sachet, peel back foil on blister. Do not push tablet through foil. Immediately upon opening the blister, using dry hands, remove tablet and place entire Zyprexa ZYDIS in the mouth. Tablet disintegration occurs rapidly in saliva so it can be easily swallowed with or without liquid. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. When using Zyprexa and fluoxetine in combination, also refer to the Contraindications section of the package insert for Symbyax.
Respiratory support, including ventilation, may be required. Close medical supervision and monitoring should continue until the patient recovers. Zyprexa. Agranulocytosis has also been reported. Eli Lilly and Company has received reports of fatality in association with overdose of oral olanzapine alone. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Based on a search of the following terms: amenorrhea, hypomenorrhea, menstruation delayed, and oligomenorrhea.