Usual Adult Dose for Psychosis

Oral:

• Initial dose: 2.5 to 10 mg orally in divided doses every 6 to 8 hours
• Maintenance dose: 1 to 5 mg/day
• Maximum dose: Up to 40 mg/day

• Maintenance doses may be given as single daily doses.
• Many patients achieve therapeutic effect with doses of less than 20 mg. Patients who are severely disturbed or inadequately controlled may require a dose of up to 40 mg/day.

• Initial dose: 12.5 to 25 mg deep IM injection into the gluteal region
• Maintenance dose: 12.5 to 100 mg IM, usually every 3 to 4 weeks
• Maximum dose: 100 mg/injection

• Initial dose: 2.5 to 10 mg IM, given as divided doses every 6 to 8 hours
• Maximum dose: Up to 10 mg/day

• Patients may switch from Fluphenazine HCl for Injection to oral formulations when symptoms are controlled. The dose of an oral formulation is approximately 2 to 3 times the dose of fluphenazine HCl for injection.

• Fluphenazine decanoate for injection may be given subcutaneously.

• Management of manifestations of schizophrenia
• Management of patients requiring prolonged parenteral neuroleptic therapy (e.g., patients with chronic schizophrenia)

Usual Geriatric Dose for Psychosis

Oral:

• Initial dose: 1 to 2.5 mg orally, given in divided doses every 6 to 8 hours
• Maintenance dose: 1 to 5 mg/day
• Maximum dose: Up to 40 mg

• Maintenance doses may be given as a single dose.
• Many patients achieve therapeutic effect with doses less than 20 mg. Patients who are severely disturbed or inadequately controlled may require a dose of up to 40 mg/day.

Renal Dose Adjustments

Renal insufficiency: Use with caution.
Abnormal BUN: Discontinue treatment

Liver Dose Adjustments

Liver damage: Contraindicated
Development of cholestatic jaundice during treatment: Discontinue use

Dose Adjustments

• Severe neutropenia (absolute neutrophil count less than 1000 mm3): Discontinue treatment and follow WBC counts until recovery occurs

Precautions

US BOXED WARNING:

• INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS: This drug has an increased risk of mortality when administered to elderly patients with dementia-related psychosis. Elderly patients with dementia-related psychosis treated with antipsychotic drugs have an increased risk of death. This drug is not approved for use in patients with dementia-related psychosis.

Dialysis

Data not available

Other Comments

Administration advice:

• Decanoate formulations: Dry needles and syringes should be used to prevent cloudiness observed when wet needles and/or syringes are used. The dose should be given as a deep IM injection into the gluteal region.
• Oral solution formulations: The oral solution should be diluted in at least 60 mL (2 fluid ounces) of tomato/fruit juice, milk, and/or uncaffeinated soft drinks prior to administration. Dilution with caffeinated beverages, tannics (e.g., tea), and pectinates (e.g., apple juice) should be avoided.

• See manufacturer product information.

• See manufacturer product information.

• See manufacturer product information.

• This drug should not be used in non-psychotic disorders.
• Treatment has not been effective in managing behavioral complications in patients with mental disabilities.
• Patients should be started on a short-acting formulation before administering long-acting parenteral formulations.

• ECG monitoring for patients at risk of QT prolongation or with/with a family history of cardiovascular disease
• Periodic WBC with differential tests, especially in patients with signs/symptoms of infection/sore throat, at increased risk of blood dyscrasias, and/or with a history of low WBCs or drug-induced neutropenia/leukopenia
• Periodic liver function tests
• Blood pressure, especially in patients with impaired cardiovascular systems
• Eye examinations, especially in patients on prolonged treatment with moderate to high doses
• Heart rate, especially in patients with arrhythmias and/or taking QT prolonging drugs concurrently
• Periodic renal function tests, especially in patients on prolonged treatment

• Patients should be warned to avoid abrupt discontinuation of this drug.
• Patients should be instructed to immediately report any signs/symptoms of neutropenia/leukopenia, neuroleptic malignant syndrome, or tardive dyskinesia.
• Patients should be warned about extrapyramidal reaction signs/symptoms before beginning treatment.
• Patients should be advised to speak to a healthcare provider if they are pregnant, intend to become pregnant, or are breastfeeding.
• Inform patients that this drug may cause drowsiness, and they should avoid driving or operating machinery until the full effects of the drug are seen.