Dosing & Uses
Dosage Forms & Strengths
- 2.5mg/mL (fluphenazine hydrochloride)
- 25mg/mL (fluphenazine decanoate)
- 2.5-10 mg/day PO divided q6-8hr initially; maintenance: 1-5 mg PO/IM divided q6-8hr; not to exceed 40 mg/day
- 12.5-25 mg (25 mg/mL) IM/SC every 2-4 weeks
- Conversion from hydrochloride salt to decanoate: 10 mg/day PO HCl salt = ~12.5 mg IM/SC every 3 weeks of decanoate salt
Renal impairment: Use with caution; monitor
Hepatic impairment: Use with caution; monitor
Safety and efficacy not established
1-2.5 mg/day PO; dosage titrated according to response
Serious - Use Alternative
Significant - Monitor Closely
Frequency Not Defined
Decreased gag reflex
- Muscle stiffness
- Neuroleptic malignant syndrome (NMS; infrequent but serious)
- Tardive dyskinesia
- Anticholinergic effects
- Weight gain
- Erectile dysfunction
- Oligomenorrhea or amenorrhea
- 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
- Blood dyscrasia
- Ejaculatory disorder
- Cholestatic jaundice
Black Box Warnings
Patients with dementia-related psychosis who are treated with antipsychotic drugs are at increased risk for death, as shown in short-term controlled trials; deaths in these trials appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature
This drug is not approved for treatment of patients with dementia-related psychosis
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
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
Mild leukocytosis, leukopenia, and eosinophilia occasionally occur
Dermatologic reactions are common
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
May need anticholinergic antiparkinsonian agent to counter EPS; in case of severe hypotension, use norepinephrine or phenylepinephrine, and do not use epinephrine or dopamine
Depresses hypothalamic thermoregulatory mechanism; exposure to extreme temperatures may cause hypo- or hyperthermia
US Food and Drug Administration (FDA) warning regarding off-label use for dementia in elderly
Pregnancy & Lactation
Pregnancy category: C
Lactation: Drug enters breast milk; not recommended
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Phenothiazine; antagonizes dopaminergic D1 and D2 receptors; depresses release of hypothalamic and hypophyseal hormones
Bioavailability: Rapidly absorbed
Onset: Hydrochloride salt, 1 hr; decanoate, 24-72 hr
Duration: Hydrochloride salt, 6-8 hr; decanoate, 4 weeks
Peak plasma time: Hydrochloride salt, 2 hr; decanoate, 8-10 hr
Peak effect: Decanoate, 48-96 hr
Half-life: Hydrochloride salt, 14-16 hr; decanoate, 14 days
Excretion: Urine, feces
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