Fluphenazine

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)

Confusion

Decreased gag reflex

Extrapyramidal symptoms

  • Akathisia

  • Dystonia

  • Dyskinesia

  • Muscle stiffness

  • Neuroleptic malignant syndrome (NMS; infrequent but serious)

  • Parkinsonism

  • Tardive dyskinesia

Common

  • 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)

Uncommon

  • ECG changes

  • Photosensitivity

  • Pruritus

  • Diarrhea

  • Blood dyscrasia

  • Galactorrhea

  • Ejaculatory disorder

Rare

  • 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

Adults

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.

Geriatric

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.

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Infants

Not indicated.

Fluphenazine hydrochloride

tablet

  • 1mg
  • 2.5mg
  • 5mg
  • 10mg

elixir

  • 2.5mg/5mL

oral concentrate

  • 5mg/mL

injectable solution

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

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