Auro Ziprasidone

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Auro Ziprasidone.

Abnormal heart rhythms: Auro Ziprasidone can cause abnormal heart rhythms. Certain medications (e.g., sotalol, quinidine, thioridazine, chlorpromazine, pimozide, moxifloxacin, mefloquine, pentamidine, arsenic trioxide, probucol, tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with ziprasidone. You are more at risk for this type of abnormal heart rhythm and its complications if you:

• are female
• are older than 65 years of age
• have a family history of sudden cardiac death
• have a history of heart disease or abnormal heart rhythms
• have a slow heart rate
• have congenital prolongation of the QT interval
• have Diabetes
• have had a stroke
• have low potassium, magnesium, or calcium levels
• have nutritional deficiencies

If you have any of these risk factors, discuss with your doctor how Auro Ziprasidone may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Auro Ziprasidone, and whether any special monitoring is needed.

Blood Clots: Ziprasidone may increase the risk of blood clots, especially in the lower leg. Talk to your doctor or pharmacist if you have risk factors for developing blood clots (e.g., a family history of blood clots, recent major surgery, immobility due to air travel, or other reason).

Blood sugar: Auro Ziprasidone may cause high blood sugar levels and a loss of blood glucose control. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Auro Ziprasidone. If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Auro Ziprasidone may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Auro Ziprasidone, and whether any special monitoring is needed. If you experience weakness, increased thirst, increased urination, and increased appetite while taking Auro Ziprasidone, contact your doctor.

Body temperature: Auro Ziprasidone, like other antipsychotic medications, can disrupt the body's ability to control body temperature. People who exercise vigorously, who are exposed to extreme heat, are dehydrated, or are taking anticholinergic medications (e.g., Benztropine, Oxybutynin) are more at risk. Contact your doctor as soon as possible if you feel very hot and are unable to cool down while taking Auro Ziprasidone.

Drowsiness/reduced alertness: Ziprasidone may interfere with activities requiring mental alertness. Avoid driving or potentially hazardous activities until you know how Auro Ziprasidone affects you.

Lactose: Auro Ziprasidone contains lactose. If you have hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption discuss the appropriateness of Auro Ziprasidone with your doctor.

Liver function: Liver disease or reduced liver function may cause Auro Ziprasidone to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Auro Ziprasidone may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Auro Ziprasidone, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Auro Ziprasidone.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Low Blood Pressure: Ziprasidone may cause low blood pressure when rising from a sitting or lying down position. If you feel dizzy, lightheaded, feel your pulse racing, or if you faint, call your doctor. While you are taking Auro Ziprasidone, get up slowly after you have been sitting or lying down.

Neuroleptic malignant syndrome (NMS): Ziprasidone, like other antipsychotic medications, can cause a potentially fatal syndrome known as neuroleptic malignant syndrome (NMS). If you notice the symptoms of NMS such as high fever, muscle stiffness, confusion or loss of consciousness, sweating, racing or irregular heartbeat, or fainting, get immediate medical attention.

Prolactin levels: As with other antipsychotics, ziprasidone can elevate levels of the hormone prolactin. This may lead to symptoms such as spontaneous flow of milk from the breast, irregular menstruation, breast enlargement in males, diminished sexual function in males, and decreased bone strength. If you experience any of these symptoms, contact your doctor.

Seizures: Ziprasidone may increase the risk of seizures, especially in people who have had seizures in the past. If you have a seizure disorders or a history of seizures, discuss with your doctor how Auro Ziprasidone may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Auro Ziprasidone, and whether any special monitoring is needed.

Serotonin syndrome: Severe reactions are possible when ziprasidone is combined with other medications that act on serotonin, such as tricyclic antidepressants and serotonin reuptake inhibitors, which are used to treat Depression. These combinations must be avoided. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, and changes in mental state including delirium and agitation. Coma and death are possible.

If you are taking antidepressants, discuss with your doctor how Auro Ziprasidone may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Auro Ziprasidone, and whether any special monitoring is needed.

Suicidal behaviour: People with mental illness may experience feelings of wanting to hurt themselves or others. If you experience these side effects or notice them in a family member who is taking Auro Ziprasidone, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking Auro Ziprasidone.

Tardive dyskinesia (TD): Ziprasidone, like some other antipsychotic medications may cause tardive dyskinesia (TD) to develop. TD is a potentially irreversible syndrome of involuntary, repetitive movements of the face and tongue muscles. Although TD appears most commonly in seniors, especially women, it is impossible to predict who will develop TD. The risk of developing TD increases with higher doses and long-term treatment. If you experience muscle twitching or abnormal movements of the face or tongue, contact your doctor as soon as possible.

White blood cells: As with other antipsychotics, ziprasidone can lower the number of infection-fighting white blood cells in your blood. This can increase your risk of infections. If you experience frequent colds or other infections, contact your doctor. Your doctor will monitor your white blood cell levels with blood tests during treatment with ziprasidone.

Pregnancy: Auro Ziprasidone should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Auro Ziprasidone, contact your doctor immediately.

Babies born to mothers who take Auro Ziprasidone in the last 3 months of pregnancy may experience withdrawal symptoms after they are born, including breathing problems, difficulty feeding or irritability. If you have been taking Auro Ziprasidone during pregnancy, make sure you tell everyone involved in caring for you and your baby.

Breast-feeding: It is not known if ziprasidone passes into breast milk. If you are a breast-feeding mother and are taking Auro Ziprasidone, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Auro Ziprasidone have not been established for children less than 18 years of age.

Seniors: The safety of using Auro Ziprasidone has not been established for adults 65 years of age or older. The increased risk of liver, kidney, and heart conditions increases the risk of side effects with the use of ziprasidone.

There may be a higher risk of strokes, heart attacks, and deaths associated with the use of ziprasidone by seniors with Dementia. Seek medical attention immediately if you notice the signs and symptoms of a stroke (e.g., sudden weakness or numbness, speech problems, vision problems, dizziness, confusion, sudden severe headache) or a heart attack (e.g., discomfort or pain in the chest, back, neck, jaw, arms; sweating; shortness of breath; nausea; lightheadedness) or infection (e.g., pneumonia). Ziprasidone should not be used by seniors with dementia.