Zyprexa tabletas de 5mg
Discuss the risks and benefits of treatment with your doctor. See also Notes section. Olanzapine may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. This medication may increase a certain natural substance prolactin made by your body. For males, it may result in decreased sexual ability, inability to produce sperm , or enlarged breasts.
If you develop any of these symptoms, tell your doctor right away. Get medical help right away if you have any very serious side effects, including: This medication may rarely cause a very serious condition called neuroleptic malignant syndrome NMS. Get medical help right away if you have any of the following symptoms: A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction , including: This is not a complete list of possible side effects.
If you notice other effects not listed above, contact your doctor or pharmacist. For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence at the same dose. If a new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued with dose optimisation as needed , with supplementary therapy to treat mood symptoms, as clinically indicated.
An increase to a dose greater than the recommended starting dose is advised only after appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours. Olanzapine can be given without regards for meals as absorption is not affected by food. Gradual tapering of the dose should be considered when discontinuing olanzapine.
In cases of moderate hepatic insufficiency cirrhosis, Child-Pugh Class A or B , the starting dose should be 5 mg and only increased with caution.
Smokers The starting dose and dose range need not be routinely altered for non-smokers relative to smokers. The metabolism of olanzapine may be induced by smoking. Clinical monitoring is recommended and an increase of olanzapine dose may be considered if necessary see section 4. When more than one factor is present which might result in slower metabolism female gender, geriatric age, non-smoking status , consideration should be given to decreasing the starting dose. Dose escalation, when indicated, should be conservative in such patients.
A greater magnitude of weight gain, lipid and prolactin alterations has been reported in short term studies of adolescent patients than in studies of adult patients see sections 4. Patients with known risk for narrow-angle glaucoma. Patients should be closely monitored during this period. The higher incidence of death was not associated with olanzapine dose mean daily dose 4.
However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors In the same clinical trials, cerebrovascular adverse events CVAE e. There was a 3-fold increase in CVAE in patients treated with olanzapine compared to patients treated with placebo 1.
All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors. The efficacy of olanzapine was not established in these trials. Parkinson's disease The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended. In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo see section 4.
In these trials, patients were initially required to be stable on the lowest effective dose of anti- Parkinsonian medicinal products dopamine agonist and to remain on the same anti-Parkinsonian medicinal products and dosages throughout the study. Olanzapine was started at 2. Rare cases reported as NMS have also been received in association with 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 creatine phosphokinase, myoglobinuria rhabdomyolysis , and acute renal failure. If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotic medicines, including olanzapine must be discontinued.
In some cases, a prior increase in body weight has been reported which may be a predisposing factor. Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines, e. Patients treated with any antipsychotic medicines, including olanzapine, should be observed for signs and symptoms of hyperglycaemia such as polydipsia, polyuria, polyphagia, and weakness and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
Weight should be monitored regularly, e. Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebocontrolled clinical trials see section 4. Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
Patients treated with any antipsychotic medicines, including olanzapine, should be monitored regularly for lipids in accordance with utilised antipsychotic guidelines, e. Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
However, as clinical experience with olanzapine in patients with concomitant illness is limited, caution is advised when prescribing for patients with prostatic hypertrophy, or paralytic ileus and related conditions. Hepatic function Transient, asymptomatic elevations of hepatic aminotransferases, ALT, AST have been seen commonly, especially in early treatment. In cases where hepatitis including hepatocellular, cholestatic or mixed liver injury has been diagnosed, olanzapine treatment should be discontinued.
Neutropenia has been reported commonly when olanzapine and valproate are used concomitantly see section 4. However, caution should be exercised when olanzapine is prescribed with medicines known to increase QTc interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia.
A causal relationship between the occurrence of venous thromboembolism and treatment with olanzapine has not been established. However, since patients with schizophrenia often present with acquired risk factors for venous thromboembolism all possible risk factors of VTE e. General CNS activity Given the primary CNS effects of olanzapine, caution should be used when it is taken in combination with other centrally acting medicines and alcohol. As it exhibits in vitro dopamine antagonism, olanzapine may antagonize the effects of direct and indirect dopamine agonists.
Seizures Olanzapine should be used cautiously in patients who have a history of seizures or are subject to factors which may lower the seizure threshold. Seizures have been reported to occur uncommonly in patients when treated with olanzapine.
In most of these cases, a history of seizures or risk factors for seizures were reported. Tardive Dyskinesia In comparator studies of one year or less duration, olanzapine was associated with a statistically significant lower incidence of treatment emergent dyskinesia.
Olanzapine
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Potential interactions affecting olanzapine Since olanzapine is metabolised by CYP1A2, substances that can specifically induce or inhibit this isoenzyme may affect the pharmacokinetics of olanzapine. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability irregular pulse or blood pressure, tachycardia, diaphoresis, zyprexa tabletas de 5mg, and 5mg dysrhythmia. The efficacy of olanzapine was not established in these trials. Parkinson's disease The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended. Excipient with known effect: This drug may also cause significant weight gain and a rise in your blood cholesterol or triglyceride levels, especially in teenagers. Dose escalation, zyprexa tabletas de 5mg, when indicated, should zyprexa conservative in such patients. Lactose Olanzapine Milpharm tablets contain lactose. A greater magnitude of weight gain, lipid and prolactin alterations has been reported in short term studies of adolescent patients than in studies of adult patients see sections 4. Lipid alterations Undesirable alterations in lipids have been observed in olanzapine-treated patients in placebocontrolled clinical trials see section 4. Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in terramycin drug description with risk factors for the development of lipids disorders. However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors In the same clinical trials, cerebrovascular adverse events CVAE e. General CNS activity Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression. Patients with rare hereditary problems of tabletas intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. In cases where hepatitis including hepatocellular, cholestatic or mixed liver injury has been diagnosed, olanzapine treatment should be discontinued. A decrease in the dose of olanzapine should be considered if treatment with an inhibitor of CYP1A2 is initiated.
ZYPREXA Olanzapine 10 mg twice daily
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