Ozapez Special Precautions

When olanzapine is used in combination with fluoxetine, the usual contraindications associated with fluoxetine must be considered.
When olanzapine is used as adjunctive therapy with lithium or valproate, should be advised clinicians to refer to prescribing information for those other drugs.
Seizures: Seizures occurred in about 0.9%. Olanzapine should be administered with caution to patients with a history of seizures, patients with conditions known to lower the seizure threshold (e.g. dementia of the Alzheimer's type), and during concurrent therapy with drugs that may lower the seizure threshold.
ECG Changes: Olanzapine-treated patients experience potentially important ECG changes, including QT, QT_c (Fridericia corrected), and PR intervals. The higher dosage of the drug may increase the risk of QT_c internal prolongation; however, the clinical relevance of these findings remains to be established.
Chest Pain: In short-term trials, chest pain occurred in approximately 3% of patients.
Venous thromboembolic effects: Venous thromboembolic effects including pulmonary embolism and deep venous thrombosis, have been reported in patients receiving Olanzapine during post-marketing surveillance.
Hepatic Effect: Olanzapine therapy was associated with asymptomatic elevations in serum aminotransferase (transaminase) concentrations, including elevations in serum concentrations of ALT (SGPT), AST (SGOT), and γ-glutamyltransferase (GGT).
Olanzapine should be used with caution in patients with signs and symptoms of hepatic impairment, in patients pre-existing conditions associated with limited hepatic functional reserve, and in patients who are being treated concurrently with potentially hepatotoxic drugs.
Weight Gain: Olanzapine have been associated with metabolic changes, including weight gain. Such metabolic changes may be associated with increased cardiovascular and cerebrovascular risk.
Dyslipidemia: Olanzapine has been associated with undesirable changes in serum lipid parameters, including elevations in serum triglyceride and cholesterol concentrations.
Endocrine and Metabolic: Olanzapine has been reported associated with peripheral edema in approximately 3%. Olanzapine increased bilirubin serum alkaline phosphatase concentrations and decreased proteinemia, which have been reported in at least 1% in short term treatment.
Laboratory Test Monitoring: Recommends fasting blood glucose testing and lipid profile determinations at the beginning of Olanzapine therapy and periodically during treatment with the drug.
Hyperprolactinemia: Olanzapine can cause elevated serum prolactin concentrations, which may persist during chronic use of the drug. Clinical disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been associated with prolactin-elevating drugs. In addition, chronic hyperprolactinemia associated with hypogonadism may lead to decrease bone density.
If Olanzapine therapy is considered in a patient with previously detected breast cancer, that approximately one-third of human breast cancers are prolactin-dependent in vitro.
Drug Reaction with Eosinophilia and Systemic Symptoms: Drug reaction with eosinophilia and systemic symptoms (dermatologic and sensitivity reaction) has been reported.
Dysphagia: Esophageal dysmotility and aspiration have been associated with the use of antipsychotic agents. Aspiration pneumonia is a common cause of morbidity and mortality in patients with advance Alzheimer's disease. Olanzapine is not approved for the treatment of Alzheimer's disease.
Patients with Concomitant Illness: Olanzapine has demonstrated anticholinergic activity in vitro and constipation, dryness of the mouth, and tachycardia, possibly related to the drug's anticholinergic effects, have occurred. Olanzapine should be used with caution in patients with clinically important prostatic hypertrophy, angle-closure glaucoma, or a history of paralytic ileus or related conditions.
Concomitant Medication or Alcohol Use: Recommends that patients be advised to avoid herbal supplement or alcohol while receiving the Olanzapine.
Tardive Dyskinesia: Olanzapine should be prescribed in a manner that is most likely to minimize the occurrence of the tardive dyskinesia that is potentially irreversible, involuntary, dyskinetic movements.
Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia, neutropenia, and agranulocytosis temporally related to Olanzapine treatment that have been reported.
Orthostatic Hypotension: Orthostatic hypotension associated with dizziness, tachycardia, bradycardia, and/or syncope, particular during the initial dosage has been reported. Should be used with particular caution in patients with known cardiovascular disease (e.g., history of myocardial infraction or ischemia, heart failure, conduction abnormalities), cerebrovascular disease, and/or other conditions that would predispose patients to hypotension (e.g., dehydration, hypovolemia, concomitant antihypertensive therapy).
Hyperglycemia and Diabetes Mellitus: Hyperglycemia, sometimes severe and associated with ketoacidosis, hyperosmolar coma, or death, has been reported.
Neuroleptic Malignant Syndrome (NMS): A potentially fatal syndrome requiring immediate discontinuance of the drug and intensive symptomatic treatment has been reported.
Suicide: Possibility of a suicide attempt is inherent in patients with schizophrenia and bipolar disorder, close supervision of high risk patients is recommended during olanzapine therapy.
Use in the Elderly: Geriatric Patients with Dementia-Related Psychosis: Olanzapine is not approved for the treatment of patients with dementia-related psychosis.