olanzapine/fluoxetine - oral, Symbyax (cont.)
PRECAUTIONS: Before taking olanzapine/fluoxetine, tell your doctor or pharmacist if you are allergic to olanzapine or fluoxetine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of suicide attempts, breast cancer, intestinal problems (e.g., paralytic ileus, chronic constipation), kidney disease, liver problems, low blood pressure, neuroleptic malignant syndrome, narrow-angle glaucoma, prostate problems, seizures, stomach/intestinal ulcers, brain problems (e.g., dementia, stroke), severe loss of body water (dehydration), low white blood cell count.Also tell your doctor or pharmacist if either you or a family member has a history of the following: diabetes, heart disease (e.g., chest pain, heart attack, heart failure, irregular heartbeat), high blood cholesterol/triglyceride levels, high blood pressure, obesity.This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position, especially when you first start taking this medication.Fluoxetine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using olanzapine/fluoxetine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using this medication safely.This medication can make it harder to control your body temperature. Avoid activities that might cause you to overheat (e.g., doing strenuous work, exercising in hot weather, or using hot tubs). Drink plenty of fluids to avoid becoming dehydrated.Teenagers may be more sensitive to the side effects of this drug, especially weight gain, and also increased amounts of cholesterol, triglycerides and prolactin. See also Side Effects section for more details.Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above), drowsiness, constipation, trouble urinating, confusion, or dizziness upon standing. Older adults may also be more likely to develop low sodium in the blood, especially if they are taking "water pills" (diuretics). Drowsiness, confusion, and dizziness can increase the risk of falling.During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Also, babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn anytime during their first month, tell the doctor right away.Since untreated depression can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss the benefits and risks of using this medication during pregnancy with your doctor.This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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