GEODON (Ziprasidone)

What is Geodon and how is it used?

Geodon is a prescription medicine used to treat the symptoms of Schizophrenia, acute agitation with Schizophrenia and Bipolar I Disorder. Geodon may be used alone or with other medications.

Geodon belongs to a class of medications called antipsychotics.

It is not known if Geodon is safe and effective in children.

What are possible side effects of Geodon?

Geodon may cause serious side effects, including:

• fast or pounding heartbeats,
• fluttering in your chest,
• shortness of breath,
• sudden dizziness,
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement),
• any skin rash,
• fever,
• mouth sores,
• skin sores,
• sore throat,
• cough,
• trouble breathing,
• increased thirst,
• increased urination
• dry mouth,
• fruity breath odor,
• very stiff muscles,
• high fever,
• sweating,
• agitation, and
• confusion

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Geodon include:

• dizziness,
• drowsiness,
• weakness,
• nausea,
• vomiting,
• trouble swallowing,
• feeling restless,
• tremors,
• vision problems,
• runny nose, and
• new or worsening cough

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Prometrium. For more information, ask your doctor or pharmacist.

DOSAGE AND ADMINISTRATION

Schizophrenia

Dose Selection

GEODON Capsules should be administered at an initial daily dose of 20 mg twice daily with food. In some patients, daily dosage may subsequently be adjusted on the basis of individual clinical status up to 80 mg twice daily. Dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state is achieved within 1 to 3 days. In order to ensure use of the lowest effective dose, patients should ordinarily be observed for improvement for several weeks before upward dosage adjustment.

Efficacy in schizophrenia was demonstrated in a dose range of 20 mg to 100 mg twice daily in short-term, placebo-controlled clinical trials. There were trends toward dose response within the range of 20 mg to 80 mg twice daily, but results were not consistent. An increase to a dose greater than 80 mg twice daily is not generally recommended. The safety of doses above 100 mg twice daily has not been systematically evaluated in clinical trials.

Maintenance Treatment

While there is no body of evidence available to answer the question of how long a patient treated with ziprasidone should remain on it, a maintenance study in patients who had been symptomatically stable and then randomized to continue ziprasidone or switch to placebo demonstrated a delay in time to relapse for patients receiving GEODON . No additional benefit was demonstrated for doses above 20 mg twice daily. Patients should be periodically reassessed to determine the need for maintenance treatment.

Bipolar I Disorder (Acute Mixed Or Manic Episodes And Maintenance Treatment As An Adjunct To Lithium Or Valproate)

Acute Treatment Of Manic Or Mixed Episodes

Dose Selection-Oral ziprasidone should be administered at an initial daily dose of 40 mg twice daily with food. The dose may then be increased to 60 mg or 80 mg twice daily on the second day of treatment and subsequently adjusted on the basis of tolerance and efficacy within the range 40 mg–80 mg twice daily. In the flexible-dose clinical trials, the mean daily dose administered was approximately 120 mg [see Clinical Studies].

Maintenance Treatment (as an adjunct to lithium or valproate)

Continue treatment at the same dose on which the patient was initially stabilized, within the range of 40 mg–80 mg twice daily with food. Patients should be periodically reassessed to determine the need for maintenance treatment

Acute Treatment Of Agitation In Schizophrenia

Intramuscular Dosing

The recommended dose is 10 mg to 20 mg administered as required up to a maximum dose of 40 mg per day. Doses of 10 mg may be administered every two hours; doses of 20 mg may be administered every four hours up to a maximum of 40 mg/day. Intramuscular administration of ziprasidone for more than three consecutive days has not been studied.

If long-term therapy is indicated, oral ziprasidone hydrochloride capsules should replace the intramuscular administration as soon as possible.

Since there is no experience regarding the safety of administering ziprasidone intramuscular to schizophrenic patients already taking oral ziprasidone, the practice of co-administration is not recommended.

Ziprasidone intramuscular is intended for intramuscular use only and should not be administered intravenously.

Intramuscular Preparation For Administration

GEODON for Injection (ziprasidone mesylate) should only be administered by intramuscular injection and should not be administered intravenously. Single-dose vials require reconstitution prior to administration.

Add 1.2 mL of Sterile Water for Injection to the vial and shake vigorously until all the drug is dissolved. Each mL of reconstituted solution contains 20 mg ziprasidone. To administer a 10 mg dose, draw up 0.5 mL of the reconstituted solution. To administer a 20 mg dose, draw up 1.0 mL of the reconstituted solution. Any unused portion should be discarded. Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparation of the final solution. This medicinal product must not be mixed with other medicinal products or solvents other than Sterile Water for Injection. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.