Pronunciation:

(floo FEN a zeen)

U.S. Brand Names:

Synonyms:

Generic Available:

Canadian Brand Names:

Use:

Use - Unlabeled/Investigational:

Pregnancy Risk Factor:

Lactation:

Contraindications:

Warnings/Precautions:

Phenothiazines may cause anticholinergic effects (confusion, agitation, constipation, xerostomia, blurred vision, urinary retention). Therefore, they should be used with caution in patients with decreased gastrointestinal motility, urinary retention, BPH, xerostomia, or visual problems. Conditions which also may be exacerbated by cholinergic blockade include narrow-angle glaucoma (screening is recommended) and worsening of myasthenia gravis. Relative to other antipsychotics, fluphenazine has a low potency of cholinergic blockade.

May cause extrapyramidal symptoms, including pseudoparkinsonism, acute dystonic reactions, akathisia and tardive dyskinesia (risk of these reactions is high relative to other antipsychotics). May be associated with neuroleptic malignant syndrome (NMS) or pigmentary retinopathy.

Adverse Reactions:

Cardiovascular: Tachycardia, fluctuations in blood pressure, hyper-/hypotension, arrhythmia, edema

Central nervous system: Parkinsonian symptoms, akathisia, dystonias, tardive dyskinesia, dizziness, hyper-reflexia, headache, cerebral edema, drowsiness, lethargy, restlessness, excitement, bizarre dreams, EEG changes, depression, seizure, NMS, altered central temperature regulation

Dermatologic: Dermatitis, eczema, erythema, itching, photosensitivity, rash, seborrhea, skin pigmentation, urticaria

Endocrine & metabolic: Changes in menstrual cycle, breast pain, amenorrhea, galactorrhea, gynecomastia, libido (changes in), prolactin increased, SIADH

Gastrointestinal: Weight gain, loss of appetite, salivation, xerostomia, constipation, paralytic ileus, laryngeal edema

Genitourinary: Ejaculatory disturbances, impotence, polyuria, bladder paralysis, enuresis

Hematologic: Agranulocytosis, leukopenia, thrombocytopenia, nonthrombocytopenic purpura, eosinophilia, pancytopenia

Hepatic: Cholestatic jaundice, hepatotoxicity

Neuromuscular & skeletal: Trembling of fingers, SLE, facial hemispasm

Ocular: Pigmentary retinopathy, cornea and lens changes, blurred vision, glaucoma

Respiratory: Nasal congestion, asthma

Overdosage/Toxicology:

Drug Interactions:

Aluminum salts: May decrease the absorption of phenothiazines; monitor

Amphetamines: Efficacy may be diminished by antipsychotics; in addition, amphetamines may increase psychotic symptoms. Avoid concurrent use

Anticholinergics: May inhibit the therapeutic response to phenothiazines and excess anticholinergic effects may occur; includes benztropine, trihexyphenidyl, biperiden, and drugs with significant anticholinergic activity (TCAs, antihistamines, disopyramide)

Antihypertensives: Concurrent use of phenothiazines with an antihypertensive may produce additive hypotensive effects (particularly orthostasis)

Bromocriptine: Phenothiazines inhibit the ability of bromocriptine to lower serum prolactin concentrations

CNS depressants: Sedative effects may be additive with phenothiazines; monitor for increased effect; includes barbiturates, benzodiazepines, narcotic analgesics, ethanol, and other sedative agents

CYP2D6 inhibitors: May increase the levels/effects of fluphenazine. Example inhibitors include chlorpromazine, delavirdine, fluoxetine, miconazole, paroxetine, pergolide, quinidine, quinine, ritonavir, and ropinirole.

Epinephrine: Chlorpromazine (and possibly other low potency antipsychotics) may diminish the pressor effects of epinephrine

Guanethidine and guanadrel: Antihypertensive effects may be inhibited by phenothiazines

Levodopa: Phenothiazines may inhibit the antiparkinsonian effect of levodopa; avoid this combination

Lithium: Phenothiazines may produce neurotoxicity with lithium; this is a rare effect

Metoclopramide: May increase extrapyramidal symptoms (EPS) or risk.

Phenytoin: May reduce serum levels of phenothiazines; phenothiazines may increase phenytoin serum levels

Propranolol: Serum concentrations of phenothiazines may be increased; propranolol also increases phenothiazine concentrations

Polypeptide antibiotics: Rare cases of respiratory paralysis have been reported with concurrent use of phenothiazines

QTc-prolonging agents: Effects on QTc interval may be additive with phenothiazines, increasing the risk of malignant arrhythmias; includes type Ia antiarrhythmics, TCAs, and some quinolone antibiotics (sparfloxacin, moxifloxacin and gatifloxacin)

Sulfadoxine-pyrimethamine: May increase phenothiazine concentrations

Tricyclic antidepressants: Concurrent use may produce increased toxicity or altered therapeutic response

Trazodone: Phenothiazines and trazodone may produce additive hypotensive effects

Valproic acid: Serum levels may be increased by phenothiazines

Ethanol/Nutrition/Herb Interactions:

Ethanol: Avoid ethanol (may increase CNS depression).

Herb/Nutraceutical: Avoid dong quai, St John's wort (may also cause photosensitization). Avoid kava kava, gotu kola, valerian, St John's wort (may increase CNS depression).

Stability:

Compatibility:

Mechanism of Action:

Pharmacodynamics/Kinetics:

Onset of action: I.M., SubQ (derivative dependent): Hydrochloride salt: ~1 hour

Peak effect: Neuroleptic: Decanoate: 48-96 hours

Duration: Hydrochloride salt: 6-8 hours; Decanoate: 24-72 hours

Absorption: Oral: Erratic and variable

Distribution: Crosses placenta; enters breast milk

Protein binding: 91% and 99%

Metabolism: Hepatic

Half-life elimination (derivative dependent): Hydrochloride: 33 hours; Decanoate: 163-232 hours

Excretion: Urine (as metabolites)

Dosage:

Children: Oral: Childhood-onset pervasive developmental disorder (unlabeled use): 0.04 mg/kg/day

Adults: Psychoses:

Oral: 0.5-10 mg/day in divided doses at 6- to 8-hour intervals; some patients may require up to 40 mg/day

I.M.: 2.5-10 mg/day in divided doses at 6- to 8-hour intervals (parenteral dose is ¹/3 to ¹/2 the oral dose for the hydrochloride salts)

I.M. (decanoate): 12.5 mg every 2 weeks

Conversion from hydrochloride to decanoate I.M. 0.5 mL (12.5 mg) decanoate every 3 weeks is approximately equivalent to 10 mg hydrochloride/day

Hemodialysis: Not dialyzable (0% to 5%)

Administration:

Monitoring Parameters:

Reference Range:

Patient Education:

Additional Information:

Anesthesia and Critical Care Concerns/Other Considerations:

Dental Health: Effects on Dental Treatment:

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

Mental Health: Child/Adolescent Considerations:

Joshi PT, Capozzoli JA, and Coyle JT, "Low-Dose Neuroleptic Therapy for Children With Childhood-Onset Pervasive Developmental Disorder,"Am J Psychiatry, 1988, 145(3):335-8.

Dosage Forms:

Elixir, as hydrochloride (Prolixin®): 2.5 mg/5 mL (60 mL) [contains alcohol 14% and sodium benzoate] [DSC]

Injection, oil, as decanoate: 25 mg/mL (5 mL) [may contain benzyl alcohol, sesame oil]

Prolixin Decanoate®: 25 mg/mL (5 mL) [contains benzyl alcohol, sesame oil]

Injection, solution, as hydrochloride (Prolixin® [DSC]): 2.5 mg/mL (10 mL)

Solution, oral concentrate, as hydrochloride (Prolixin®): 5 mg/mL (120 mL) [contains alcohol 14%] [DSC]

Tablet, as hydrochloride: 1 mg, 2.5 mg, 5 mg, 10 mg

Prolixin®: 1 mg, 2.5 mg, 5 mg [contains tartrazine], 10 mg [DSC]

International Brand Names: