Ziprasidone is an antipsychotic medicine.

Ziprasidone oral is used to treat schizophrenia and the manic symptoms of bipolar disorder (manic depression).

Ziprasidone injection is used to quickly treat agitation in people with schizophrenia.

Ziprasidone may also be used for purposes not listed in this medication guide.

You should not use ziprasidone if you have a heart rhythm disorder, long QT syndrome, uncontrolled heart failure, or if you have recently had a heart attack.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Stop taking ziprasidone and call your doctor right away if you have sudden dizziness, fast or pounding heartbeats, fluttering in your chest, shortness of breath, or a new or worsening skin rash with fever, or swollen glands.

Ziprasidone is not approved for use in older adults with dementia-related psychosis.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Ziprasidone oral is taken by mouth.

Ziprasidone injection is injected into a muscle. A healthcare provider will give you this injection if you are unable to take the medicine by mouth.

Take ziprasidone with food. Swallow the capsule whole.

You may need frequent medical tests.

If you are diabetic, check your blood sugar levels on a regular basis while you are taking ziprasidone.

It may take several weeks before your symptoms improve. Do not stop using ziprasidone suddenly, even if you feel fine. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture, light, and heat.

Usual Adult Dose for Schizophrenia:

Oral:
Initial dose: 20 mg orally twice a day
Maintenance dose: Adjust as clinically indicated at intervals of not less than 2 days
Maximum dose: 100 mg twice a day

Comments: A dose greater than 80 mg twice a day is generally not recommended.

Intramuscular:
Recommended dose: 10 to 20 mg IM; may repeat 10 mg IM every 2 hours or 20 mg IM every 4 hours up to maximum daily dose
Maximum dose: 40 mg IM per day
Duration of therapy: Use beyond 3 consecutive days has not been studied

Comments:
-Coadministration of IM ziprasidone to patient's already taking oral ziprasidone has not been studied and is not recommended.
-If long-term therapy is indicated, oral capsules should replace IM administration as soon as possible.

Uses:
-Treatment of schizophrenia (oral)
-Acute treatment of agitation in schizophrenia (IM)

Usual Adult Dose for Bipolar Disorder:

Acute Treatment of Manic or Mixed Episodes:
-Initial dose: 40 mg orally twice daily
-Increase dose to 60 mg or 80 mg twice daily on the second day; subsequently adjust dose based on tolerance and efficacy within the dose range of 40 to 80 mg orally twice a day
Maintenance Treatment (as adjunct to lithium or valproate):
-Once stabilized, continue on same dose within the range of 40 to 80 mg orally twice daily.

Comments:
-The mean ziprasidone dose administered in flexible-dose clinical trials was approximately 120 mg per day.
-Monotherapy has not been systematically evaluated for maintenance treatment of bipolar I disorder.

Uses:
-As monotherapy for the acute management of manic or mixed episodes associated with bipolar I disorder
-As adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder.

You should not use this medicine if you are allergic to ziprasidone, or if you have:

• a heart rhythm disorder;

• long QT syndrome (in you or a family member);

• uncontrolled or untreated heart failure; or

• if you have recently had a heart attack.

Ziprasidone can cause a serious heart problem. Your risk may be higher if you also use certain other medicines. Your doctor may change your treatment plan if you also use:

• an antidepressant;

• bronchodilator asthma medication;

• cancer medicine;

• certain medicines for infections;

• heart or blood pressure medication;

• medicine to treat or prevent malaria;

• medicine to prevent nausea or vomiting;

• medicine to treat a psychiatric disorder; or

• medicine to treat HIV or AIDS.

Ziprasidone may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Tell your doctor if you have ever had:

• any heart problems;

• a heart attack or stroke;

• fainting spells;

• breast cancer;

• low blood levels of potassium or magnesium;

• diabetes (ziprasidone may raise your blood sugar);

• seizures or epilepsy;

• suicidal thoughts;

• Alzheimer's disease;

• trouble swallowing;

• liver disease; or

• kidney disease.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. If you get pregnant, tell your doctor right away. Do not stop taking ziprasidone without your doctor's advice.

You should not breastfeed while using this medicine.

Older adults may be more sensitive to the effects of this medicine.

Ziprasidone is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature away from light and excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

While you are taking ziprasidone, you may be more sensitive to extreme temperatures, such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking ziprasidone.

Avoid driving or hazardous activity until you know how ziprasidone will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid drinking alcohol. Dangerous side effects could occur.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Ziprasidone may cause serious side effects. Stop using ziprasidone and call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

• any skin rash, no matter how mild;

• low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing;

• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or

• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, agitation.

Common side effects of ziprasidone may include:

• dizziness, drowsiness, weakness;

• headache;

• nausea, vomiting;

• trouble swallowing;

• weight gain;

• feeling restless or being unable to sit still;

• tremors, involuntary muscle movements;

• vision problems; or

• runny nose, new or worsening cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ziprasidone can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Using ziprasidone with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can affect ziprasidone, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to ziprasidone.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.