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About Geodon

About GEODON

 
 

What is GEODON?

GEODON® (ziprasidone HCl) is a type of prescription medicine called a psychotropic, also known as an atypical antipsychotic. GEODON can be used to treat symptoms of schizophrenia and acute manic or mixed episodes associated with bipolar disorder. GEODON can also be used as maintenance treatment of bipolar disorder when added to lithium or valproate (Depakote®).

If you have bipolar disorder or schizophrenia, ask your doctor if GEODON might be right for you.

Who should not take GEODON?

  • Elderly patients with a diagnosis of psychosis related to dementia. GEODON is not approved for the treatment of these patients
  • Patients who have certain heart diseases such as long QT syndrome, a recent heart attack, severe heart failure, or certain irregularities of heart rhythm
  • Patients who are currently taking medicines that should not be taken in combination with GEODON. For a list of medicines that should not be taken with GEODON, read the GEODON Patient Information

What are the possible side effects with GEODON?

Contact your doctor IMMEDIATELY if you experience the following symptoms, because these problems could mean you’re having a heart rhythm abnormality:

  • Faint or lose consciousness
  • Feel a change in the way your heart beats (palpitations)

What are the common side effects of GEODON?

  • Feeling unusually tired or sleepy
  • Nausea or upset stomach
  • Constipation
  • Dizziness
  • Restlessness
  • Abnormal muscle movements, including tremor, shuffling, and uncontrolled involuntary movements
  • Diarrhea
  • Rash
  • Increased cough/runny nose

If you develop any side effects that concern you, talk with your doctor. It is particularly important to tell your doctor if you have diarrhea, vomiting, or another illness that can cause you to lose fluids. Your doctor may want to check your blood to make sure that you have the right amount of important salts after such illnesses.

GEODON Important Safety Information

Elderly patients with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) treated with this type of medicine are at an increased risk of death, compared to placebo (sugar pill). GEODON® (ziprasidone HCl) is not approved for treating these patients.

GEODON ® (ziprasidone HCl) may increase the risk of changes to your heart rhythm. You should not take GEODON if you have certain kinds of heart conditions that change your heart rhythm, a recent heart attack, heart failure, or take certain medicines known to change heart rhythm. It is important to talk to your doctor about this possible side effect. Call your doctor right away if you faint, pass out, or feel a change in your heartbeat.

If you experience a high fever, stiff muscles, shaking, confusion, sweating, or increased heart rate or blood pressure, tell your doctor right away. These can be signs of a rare but potentially fatal condition called neuroleptic malignant syndrome (NMS).

Delayed-onset drug reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) can occur with ziprasidone. Signs of DRESS may include rash, fever, and swollen lymph nodes. Other severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome can occur with ziprasidone. Signs of Stevens-Johnson syndrome may include rash with blisters which could include ulcers in mouth, skin shedding, fever, and target-like spots in the skin. SCAR and DRESS are sometimes fatal; therefore call your health care professional(s) and seek immediate care if you develop any of these signs or symptoms.

If you experience abnormal or uncontrollable facial or body movements, notify your doctor. These could be a sign of tardive dyskinesia (TD), a potentially permanent condition whose risk increases with the length of treatment, but which can also occur after brief periods at low doses.

If you have diabetes or have risk factors or symptoms of diabetes, your blood sugar should be monitored. Symptoms include excessive thirst, urination, appetite, and weakness. High blood sugar has been reported with GEODON and medicines like it. In some cases, extreme high blood sugar can lead to coma or death. Increases in cholesterol and weight gain have also been reported with medicines like GEODON.

Tell your doctor if you are pregnant or intend to become pregnant. Breast feeding is not recommended.

If you experience a rash, lightheadedness upon standing, or seizures, tell your doctor. Also tell your doctor if you have thoughts of suicide.

Other risks may include decreases in white blood cells (which can be serious), trouble swallowing, high prolactin levels, and impairment in judgment or motor skills. Until you know how GEODON affects you, you should not drive or operate machinery.

Do not drink alcohol while taking GEODON. Avoid becoming overheated or dehydrated. Common side effects of GEODON include:

  • Feeling unusually tired or sleepy
  • Nausea or upset stomach
  • Constipation
  • Dizziness
  • Restlessness
  • Abnormal muscle movements, including tremor, shuffling, and uncontrolled involuntary movements
  • Diarrhea
  • Rash
  • Increased cough/runny nose

In short-term bipolar mania clinical studies, 4.9% of GEODON-treated patients gained significant weight (7% or more of body weight) vs 3.3% for placebo.

In a long-term bipolar maintenance clinical study, patients who tolerated GEODON plus lithium or valproate (Depakote®) for 10-16 weeks were either continued on GEODON or switched to placebo for up to 6 months. During these six months, 5.6% of patients in both groups gained significant weight. These results do not include patients who did not complete the study.

In short-term schizophrenia clinical studies, 10% of GEODON-treated patients gained significant weight vs 4% for placebo.

Since there is no experience regarding the safety of administering GEODON for Injection to schizophrenic patients already taking oral GEODON, the practice of coadministration is not recommended.

GEODON Indications

GEODON ® (ziprasidone HCl) is a prescription medicine. It is used to treat acute manic or mixed episodes associated with bipolar disorder and to treat symptoms of schizophrenia. GEODON is also used as maintenance treatment of bipolar disorder when added to lithium or valproate (Depakote). For full symptoms and diagnostic criteria, see the 
DSM-IV-TR® (2000). GEODON may increase the risk of changes to your heart rhythm. In some cases these types of changes can be fatal though it is unknown whether this is the case with GEODON. It is important to talk to your doctor about this potential side effect, as your doctor may consider a different medicine first.

Patients should always ask their doctors for medical advice about adverse events.

You may report an adverse event related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where health care professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch or call 1-800-FDA-1088.

Please see Full Prescribing Information, including BOXED WARNING and Patient Information.

 

*Terms and conditions apply. Card will be accepted only at participating pharmacies. Card is not health insurance. No membership fee. For more information call 1-800-725-9655 or write to Pfizer Inc, 235 E. 42nd Street, New York, NY 10017.

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