Fluphenazine decanoate
Looking up MedlinePlus…
From MedlinePlus, U.S. National Library of Medicine
Boxed warning
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. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group.
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 ).
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
Prepare this dose
Your numbers for fluphenazine decanoate. Take vial strength, diluent, and limits from the label below.
Enter a dose to see draw volume, final concentration, and rates.
DOSAGE AND ADMINISTRATION Fluphenazine Decanoate Injection may be given IM or SC. A dry syringe and needle of at least 21 gauge should be used. Use of a wet needle or syringe may cause the solution to become cloudy. To begin therapy with Fluphenazine Decanoate Injection, the following regimens are suggested: For most patients , a dose of 12.5 to 25 mg (0.5 to 1 mL) may be given to initiate therapy.
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 12.5 mg. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Contraindications
Phenothiazines are contraindicated in patients with suspected or established subcortical brain damage. Phenothiazine compounds should not be used in patients receiving large doses of hypnotics. Fluphenazine Decanoate Injection is contraindicated in comatose or severely depressed states. The presence of blood dyscrasia or liver damage precludes the use of fluphenazine decanoate. Fluphenazine Decanoate Injection is not intended for use in children under 12 years of age. Fluphenazine Decanoate Injection is contraindicated in patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may occur.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
CLikelihood score C: Probable cause of clinically apparent liver injury.
Fluphenazine is a phenothiazine and antipsychotic agent which is no longer in common use. Fluphenazine can cause mild and transient serum enzyme elevations and has been linked to rare instances of clinically apparent cholestatic liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
Pregnancy Non-teratogenic Effects 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.
Breastfeeding (LactMed)
There is no published experience with fluphenazine during breastfeeding. Very limited long-term follow-up data indicate no adverse developmental effects when other phenothiazines are used alone. Because of the lack of published experience with fluphenazine during breastfeeding, other antipsychotic agents may be preferred, especially while nursing a newborn or preterm infant. Monitor the infant for drowsiness and developmental milestones, especially if other antipsychotics are used concurrently.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.