Increased Mortality in Elderly Patients with Dementia-Related Psychosis:
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Fluphenazine decanoate injection is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).
Each 1ml Solution contains 25mg Fluphenazine decanoate.
Benzyl alcohol, Dermarol CCT
Mechanism of action:
Fluphenazine decanoate is the decanoate ester of a trifluoromethyl phenothiazine derivative. It is a highly potent behavior modifier with a markedly extended duration of effect.
Fluphenazine Decanoate Injection is a long-acting parenteral antipsychotic drug intended for use in the management of patients requiring prolonged parenteral neuroleptic therapy (e.g., chronic schizophrenics).
Fluphenazine Decanoate Injection has not been shown effective in the management of behavioral complications in patients with mental retardation.
Dosage & Method of administration:
- Fluphenazine Decanoate Injection may be given IM or SC.
- For most patients, a dose of 12.5 to 25 mg may be given to initiate therapy. The onset of action generally appears between 24 and 72 hours after injection and the effects of the drug on psychotic symptoms becomes significant within 48 to 96 hours.
- Subsequent injections and the dosage interval are determined in accordance with the patient's response.
- When administered as maintenance therapy, a single injection may be effective in controlling schizophrenic symptoms up to four weeks or longer.
- It may be advisable that patients who have no history of taking phenothiazines should be treated initially with a shorter-acting form of fluphenazine before administering the decanoate to determine the patient's response to fluphenazine and to establish appropriate dosage.
- Severely agitated patients may be treated initially with a rapid-acting phenothiazine compound such as Fluphenazine Hydrochloride Injection.
When acute symptoms have subsided, 25 mg of Fluphenazine Decanoate Injection maybe administered; subsequent dosage is adjusted as necessary.
- Poor risk" patients (those with known hypersensitivity to phenothiazines, or with disorders that predispose to undue reactions): Therapy may be initiated cautiously with oral or parenteral fluphenazine
Hydrochloride. When the pharmacologic effects and an appropriate dosage are apparent, an equivalent dose of fluphenazine decanoate may be administered. Subsequent dosage adjustments are made in accordance with the response of the patient.
- Dosage should not exceed 100 mg. If doses greater than 50 mg are deemed necessary, the next dose and succeeding doses should be increased cautiously in increments of 12.5mg.
Use During Pregnancy:
The safety for the use of this drug during pregnancy has not been established.
Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates.
These complications have varied in severity; while in some cases symptoms have been self- limited, in other cases neonates have required intensive care unit support and prolonged hospitalization.
Fluphenazine Decanoate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.