Geodon Capsules

GENERIC NAME: ZIPRASIDONE (zi-PRAS-i-done)

COMMON USES: This medicine is an antipsychotic used to treat mental and emotional disorders such as schizophrenia. It is also used alone or with other medicines (e.g., lithium, valproate) to treat bipolar disorder (manic-depression). It may also be used to treat conditions as determined by your doctor.

BEFORE USING THIS MEDICINE: WARNING: This medicine is an antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. This medicine is not approved treat mental problems caused by dementia. Talk with your doctor or pharmacist for more information. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking astemizole, cisapride, dofetilide, droperidol, halofantrine, levomethadyl, a macrolide immunosuppressive (e.g., tacrolimus), mefloquine, methadone, nilotidib, penandine, certain phenothiazines (e.g., thioridazine), pimozide, probucol, procainamide, quinidine, certain quinolone antibiotics (e.g., moxiflacin), a serotonin receptor antagonist antiemetic (e.g., dolasetron), sotalol, sparfloxatin, terfenadine, or tefrabenazine. QTc prolongation can infrequently result in serious, rarely fatal, irregular heartbeats. Consult your doctor or pharmacist for details about whether you need to stop any other OTc-prolonging medicines you may be using to minimize the risk of this effect. ADDITIONAL MONITORING OF YOU DOSE OR CONDITION may be needed if you are taking arsenic, bepridil, carbamazepine, chloroquine, class III antiarrhythmics (e.g., amiodarone), domperidone, haloperidol, IA and IC antiarrhythmics (e.g., flecainide, procainamide, propafenone), ketoconazole, kinaze inhibitors (e.g., lapatinib), macrolides and ketolides (e.g., azithromycin, erythromycin), maprotiline, streptogramins (e.g., mitomycin, pristinamycin), or tramadol. Inform your doctor of any other medical conditions including a history of heart problems (e.g., heart failure, slow or irregular heartbeat), low blood potassium or magnesium levels, low blood volume, low white blood cell counts, a drug-induced movement disorder, kidney or liver problems, stroke, heart attack, low blood pressure, seizures, difficulty swallowing, neuroleptic malignant syndrome (NMS), Alzheimer disease, dementia, or suicidal thoughts or actions; a personal or family history of diabetes; high blood prolactin levels or a history of certain types of cancer (e.g., breast, pancreas, pituitary), or if you are at risk for breast cancer; allergies; pregnancy; or breast-feeding. Tell your doctor if you are dehydrated, drink alcohol, or will be exposed to high temperatures; or if you have any problem with fainting or dizziness. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a history of QT prolongation, irregular heartbeat, recent heart attack, or severe heart failure. Use of this medicine in children is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.

HOW TO USE THIS MEDICINE: Follow the directions for using this medicine provided by your doctor. This medicine comes with a patient information leaflet. Ask your doctor, nurse or pharmacist any questions that you may have about this medicine. SWALLOW WHOLE. Do not break, crush, or chew before swallowing. TAKE THIS MEDICINE with food. STORE THIS MEDICINE at 77 degrees F (25 degrees C), in a tightly-closed container, away from heat, moisture and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. KEEP THIS MEDICINE out of the reach of children and away from pets. Take this medicine regularly to receive the most benefit from it. Taking this medicine at the same time each day will help you to remember. IT MAY TAKE SEVERAL WEEKS for you to notice the benefits of his medicine. CONTINUE TO TAKE THIS MEDICINE even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

CAUTIONS: DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or are allergic to any ingredient in this product. Do not stop using this medicine without checking with your doctor. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine. THIS MEDICINE MAY CAUSE DROWSINESS, DIZZINESS, lightheadedness, or fainting. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of these effects. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to this medicine. DO NOT DRINK ALCOHOL while you are taking this medicine. THIS MEDICINE WILL ADD TO THE EFFECTS of alcohol and other depressants. DO NOT BECOME OVERHEATED in hot weather or during exercise or other activities since risk of heatstroke may be increased. THIS MEDICINE MAY INCREASE YOUR RISK OF DEVELOPING DIABETES or increase blood sugar levels. High blood sugar levels can cause serious problems if left untreated. THIS MEDICINE MAY LOWER THE ABILITY OF YOUR BODY TO FIGHT INFECTION. Tell your doctor if you notice signs of infection like fever, sore throat rash, or chills. SEROTONIN SYNDROME and NEUROLEPTIC MALIGNANT SYNDROME (NMS) are possibly fatal syndromes that can be caused by this medicine. Your risk may be greater if you take this medicine with certain other medicines (e.g., "triptans", MAOls, antipsychotics). Symptoms may include blood pressure changes; agitation; confusion; hallucinations; other mental or mood changes; coma; fever; fast or irregular heartbeat; tremor excessive sweating; rigid muscles; and nausea, vomiting, or diarrhea. SOME PATIENT'S WHO TAKE THIS MEDICINE MAY DEVELOP MUSCLE MOVEMENTS that they cannot control. This is more likely to happen in elderly patients. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw, (e.g., tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking this medicine. THIS MEDICINE MAY RARELY CAUSE A PROLONGED, PAINFUL ERECTION. If this is not treated right away, it could lead to permanent sexual problems such as impotence. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. CAUTION IS ADVISED when using this medicine in the elderly because they may be more sensitive to the effects of this medicine. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. Using this medicine during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED in breast milk. DO NOT BREAST-FEED while taking this medicine. DIABETICS: THIS MEDICINE MAY AFFECT YOUR BLOOD SUGAR. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.

POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while taking this medicine include anxiety; constipation; diarrhea; dizziness; drowsiness; dry mouth; feeling unusually tired or sleepy; headache; increased cough or runny nose; loss of appetite; nausea; restlessness; upset stomach; vomiting; weakness, or weight gain. If they continue or are bothersome, check with your doctor. THIS MEDICINE MAY INCREASE THE AMOUNT OF A CERTAIN HORMONE (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms. CONTACT YOUR DOCTOR IMMEDIATELY if you experience abnormal thoughts; change in amount of urine produced; confusion; difficulty speaking or swallowing; fainting; fast, slow, or irregular heartbeat; fever, chills or persistent sore throat; inability to move; muscle rigidity; muscle spasms or twitching; pounding in the chest; prolonged or painful erection; seizures; shortness of breath; suicidal thoughts or attempts; sweating; symptoms of high blood sugar (increased thirst, increased urination, confusion, flushing, rapid breathing, or fruity breath odor); tremor; uncontrolled movements (e.g., arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual mood or mental changes; or vision changes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; or unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include slurring of speech, uncontrolled movement of the head and neck, seizure, irregular heartbeat, or fainting.

ADDITIONAL INFORMATION: DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.

The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.