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GEODON
Mood disorders
Psychosis
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Drug Name:

GEODON Rx

Generic Name and Formulations:
Ziprasidone (as HCl) 20mg, 40mg, 60mg, 80mg; caps.

Company:
Pfizer Inc.

Therapeutic Use:

Indications for GEODON:

Acute treatment of manic or mixed episodes in bipolar disorder as monotherapy; or as an adjunct to lithium or valproate for maintenance treatment.

Adult:

Take with food. Initially 40mg twice daily; may increase on day 2 to 60mg or 80mg twice daily; usual range 40–80mg twice daily. Elderly: consider lower initial dose, slower titration.

Children:

Not established.

Contraindications:

History of QT prolongation. Congenital long QT syndrome. Recent acute MI. Uncompensated heart failure. Concomitant drugs that cause QT prolongation, including dofetilide, sotalol, quinidine, other Class Ia and III antiarrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl, dolasetron, probucol, tacrolimus.

Warnings/Precautions:

Increased mortality in elderly with dementia-related psychosis (not approved use). Concomitant use of oral and IM forms: not recommended. Renal (IM form) or hepatic impairment (both forms). Discontinue if QTc >500 msec persists, neuroleptic malignant syndrome, unexplained rash occurs, or if severe skin reactions (eg, Stevens-Johnson syndrome or DRESS) are suspected; consider discontinuing if tardive dyskinesia occurs. Conditions that increase risk of torsade de pointes (eg, bradycardia, hypokalemia, hypomagnesemia). Monitor potassium, magnesium, others if risk of electrolyte disturbances (eg, diarrhea); correct imbalance before starting. Avoid in significant cardiovascular disease (eg, arrhythmias). Evaluate cardiac function if symptoms of torsade de pointes occur (eg, dizziness, palpitations, syncope). Cardio- or cerebrovascular disease. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Diabetes; monitor for hyperglycemia. Monitor weight. Risk of hypotension or seizures. History of breast cancer. Dysphagia. Exposure to extreme heat. Perform fall risk assessments when initiating and recurrently on long-term therapy. Reevaluate periodically. Write ℞ for smallest practical amount. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

See Contraindications. May potentiate CNS drugs, antihypertensives. May antagonize levodopa, dopamine agonists. Extent of absorption and/or plasma levels may be affected by CYP3A4 inducers (eg, carbamazepine) or inhibitors (eg, ketoconazole). Correct hypokalemia, hypomagnesemia due to diuretics.

Pharmacological Class:

Serotonin and dopamine antagonist.

Adverse Reactions:

Somnolence, extrapyramidal syndrome, respiratory disorder, dizziness, akathisia, abnormal vision, asthenia, vomiting, nausea, rash, dystonia, postural hypotension, QTc prolongation, headache, weight gain, hyperprolactinemia, dyslipidemia, hyperglycemia; rare: priapism, leukopenia, neutropenia, agranulocytosis (may be fatal).

How Supplied:

Caps—60

Indications for GEODON:

Schizophrenia.

Adult:

Take with food. Initially 20mg twice daily; may increase at intervals of at least 2 days; max 80mg twice daily. Elderly: consider lower initial dose, slower titration.

Children:

Not established.

Contraindications:

History of QT prolongation. Congenital long QT syndrome. Recent acute MI. Uncompensated heart failure. Concomitant drugs that cause QT prolongation, including dofetilide, sotalol, quinidine, other Class Ia and III antiarrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl, dolasetron, probucol, tacrolimus.

Warnings/Precautions:

Increased mortality in elderly with dementia-related psychosis (not approved use). Concomitant use of oral and IM forms: not recommended. Renal (IM form) or hepatic impairment (both forms). Discontinue if QTc >500 msec persists, neuroleptic malignant syndrome, unexplained rash occurs, or if severe skin reactions (eg, Stevens-Johnson syndrome or DRESS) are suspected; consider discontinuing if tardive dyskinesia occurs. Conditions that increase risk of torsade de pointes (eg, bradycardia, hypokalemia, hypomagnesemia). Monitor potassium, magnesium, others if risk of electrolyte disturbances (eg, diarrhea); correct imbalance before starting. Avoid in significant cardiovascular disease (eg, arrhythmias). Evaluate cardiac function if symptoms of torsade de pointes occur (eg, dizziness, palpitations, syncope). Cardio- or cerebrovascular disease. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Diabetes; monitor for hyperglycemia. Monitor weight. Risk of hypotension or seizures. History of breast cancer. Dysphagia. Exposure to extreme heat. Perform fall risk assessments when initiating and recurrently on long-term therapy. Reevaluate periodically. Write ℞ for smallest practical amount. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

See Contraindications. May potentiate CNS drugs, antihypertensives. May antagonize levodopa, dopamine agonists. Extent of absorption and/or plasma levels may be affected by CYP3A4 inducers (eg, carbamazepine) or inhibitors (eg, ketoconazole). Correct hypokalemia, hypomagnesemia due to diuretics.

See Also:

GEODON for INJECTION

Pharmacological Class:

Serotonin and dopamine antagonist.

Adverse Reactions:

Somnolence, extrapyramidal syndrome, respiratory disorder, dizziness, akathisia, abnormal vision, asthenia, vomiting, nausea, rash, dystonia, postural hypotension, QTc prolongation, headache, weight gain, inj site reactions, hyperprolactinemia, dyslipidemia, hyperglycemia; rare: priapism, leukopenia, neutropenia, agranulocytosis (may be fatal).

How Supplied:

Caps—60; Single-use vials—10

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