Classes
DEA Class; Rx
Common Brand Names; Modecate, Modecate Concentrate, Moditen, Prolixin, RhoFluphenazine
- Antipsychotics, 1st Generation;
- Antipsychotics, Phenothiazine
Description
Indications
Indicated for the treatment of schizophrenia
Contraindications
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)
Adverse Effects
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
Warnings
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 and Lactation
Pregnancy category: C
Lactation: Drug enters breast milk; not recommended
Maximum Dosage
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.
How supplied
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)