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    DEA Class;  Rx

    Common Brand Names; Modecate, Modecate Concentrate, Moditen, Prolixin, RhoFluphenazine

    • Antipsychotics, 1st Generation; 
    • Antipsychotics, Phenothiazine
    Piperazine phenothiazine antipsychotic; 2 mg orally equivalent to 100 mg of oral chlorpromazine, the prototype antipsychotic; depot IM injections (i.e., fluphenazine decanoate or fluphenazine enanthate) available for chronic disorders; increased risk of death in elderly patients treated for dementia-related psychosis.

    Indicated for the treatment of schizophrenia

    For the treatment of acute agitation associated with psychotic disorders.
    For the treatment of severe behavioral or psychological symptoms of dementia (BPSD).

    Documented hypersensitivity

    Coma, severe hypotension, severe central nervous system (CNS) depression, concurrent use of large amounts of CNS depressants, subcortical brain damage, poorly controlled seizure disorder

    Blood dyscrasias, severe cardiovascular disease, coma, patients receiving large doses of hypnotics, children <12 years (decanoate dosage form only)


    Decreased gag reflex

    Extrapyramidal symptoms

    • Akathisia

    • Dystonia

    • Dyskinesia

    • Muscle stiffness

    • Neuroleptic malignant syndrome (NMS; infrequent but serious)

    • Parkinsonism

    • Tardive dyskinesia


    • Anticholinergic effects

    • Sedation

    • Weight gain

    • Erectile dysfunction

    • Oligomenorrhea or amenorrhea

    Less common

    • Orthostatic hypotension (after IM injection), tachycardia

    • Agitation, anxiety, cerebral edema, depression, dizziness, euphoria, headache, poikilothermia, restlessness, weakness

    • Anorexia, constipation, dyspepsia, ileus

    • Lens opacities (with prolonged use)


    • ECG changes

    • Photosensitivity

    • Pruritus

    • Diarrhea

    • Blood dyscrasia

    • Galactorrhea

    • Ejaculatory disorder


    • Seizure

    • Priapism

    • Cholestatic jaundice

    Use caution in glaucoma, prostatic hypertrophy, stenosing peptic ulcer disease (PUD), history of NMS, Parkinson disease, hypocalcemia, renal or hepatic impairment, history of severe reaction to insulin or electroconvulsive therapy (ECT), history of seizures, asthma, respiratory tract infections, cardiovascular disease

    May affect cardiac conduction, which may result in life-threatening arrhythmias

    Mild leukocytosis, leukopenia, and eosinophilia occasionally occur

    Antipsychotic use has been associated with aspiration and esophageal dysmotility; risk increases with age; use caution in patients at risk for aspiration pneumonia

    May be associated with neuroleptic malignant syndrome; monitor for fever, mental status changes, muscle rigidity, and /or autonomic instability

    Dermatologic reactions are common

    May cause pigmentary retinopathy, and lenticular and corneal deposits, especially in prolonged therapy

    May impair core body temperature regulation; caution with strenuous exercise, dehydration, heat exposure, and concomitant medication possessing anticholinergic effects

    CNS depression may impair physical or mental abilities; use caution operationg heavy machinery

    Watch for urinary retention, blurred vision, dry mouth, and constipation as result of anticholinergic effects

    Risk of extrapyramidal symptoms (EPS), NMS, hypotension; hypotension may be particularly severe in patients with pheochromocytoma or mitral insufficiency

    Pregnancy category: C

    Lactation: Drug enters breast milk; not recommended


    20 mg/day PO, with temporary use up to 40 mg/day in refractory patients; 100 mg/dose IM or subcutaneously of decanoate depot injection; 10 mg/day IM of the immediate-release injection.


    20 mg/day PO, with temporary use up to 40 mg/day in refractory patients; 100 mg/dose IM or subcutaneously of decanoate depot injection; 10 mg/day IM of the immediate-release injection.


    Safety and efficacy have not been established.


    Safety and efficacy have not been established.


    Not indicated.

    Fluphenazine hydrochloride


    • 1mg
    • 2.5mg
    • 5mg
    • 10mg


    • 2.5mg/5mL

    oral concentrate

    • 5mg/mL

    injectable solution

    • 2.5mg/mL (fluphenazine hydrochloride)
    • 25mg/mL (fluphenazine decanoate)