Updated May 30, 2026, 4:23 PM
Antipsychotic/neurolepticUS FDA Database Verified

fluPHENAZine decanoate (Rx)

Generic: FluPHENAZine decanoate

Brand: Modecate

(floo-fen'ah-zeen)

Pregnancy Category: C

Pharmacological Action

Depresses cerebral cortex, hypothalamus, limbic system, which control activity and aggression; blocks neurotransmission produced by dopamine at synapse; exhibits strong a-adrenergic and anticholinergic blocking action; mechanism for antipsychotic effects is unclear

Therapeutic outcome: Decreased signs and symptoms of psychosis

Uses

Schizophrenia

Contraindications

Hypersensitivity, blood dyscrasias, coma, bone marrow depression, closed-angle glaucoma

Precautions: Pregnancy C, breastfeeding, children ,12 yr, geriatric, seizure disorders, hypertension, hepatic/cardiac disease, abrupt discontinuation; accidental exposure, agranulocytosis, ambient temperature increase, angina, hypersensitivity to benzyl alcohol/parabens/sesame oil/tartrazine dye, QT prolongation, suicidal ideation, renal failure, Parkinson's disease, hypocalcemia, head trauma, prostatic hypertrophy, pulmonary disease, infection, ileus, chemotherapy, breast cancer

BLACK BOX WARNING: Increased mortality in elderly patients with dementia-related psychosis

Dosage & Routes

Decanoate Adult and child .12 yr: IM/SUBCUT 12.5-25 mg q1-3 wk, may increase slowly, max 100 mg/dose HCl

Adult: PO 2.5-10 mg, in divided doses q6-8 hr, max 40 mg/day; IM initially 1.25 mg then 2.5-10 mg in divided doses q6-8 hr

Available forms: decanoate: inj 25 mg/ml; elixir 2.5 mg/5 ml; oral sol 5 mg/ml;

HCl: tabs 1, 2.5, 5, 10 mg; inj 2.5 mg/ml

Implementation PO route - Give with food, milk, or a full glass of water to minimize gastric irritation - Oral concentrate: Give using a calibrated measuring device. Dilute just before use with 120-240 ml of water, saline, milk, 7-Up, carbonated orange beverage, or the following juices: apricot, orange, pineapple, prune, tomato or V-8. Do not mix with beverages containing caffeine (coffee, cola), tannics (tea), or pectinates (apple juice) or with other liquid medications. Avoid spilling the solution on the skin and clothing - Oral elixir: Give using a calibrated measuring device. Avoid spilling the solution on the skin and clothing Injectable routes - Visually inspect for particulate matter and discoloration prior to use; slight yellow to amber color does not alter potency, markedly discolored solutions should be discarded IM route (fluPHENAZine HCl only) - No dilution necessary, if irritation occurs, subsequent IM doses may be diluted with NS for injection or 2% procaine - Inject slowly and deeply into the upper, outer quadrant of the gluteal muscle using a dry syringe and needle; aspirate prior to injection - Keep patient in a recumbent position for at least 30 min following injection to minimize hypotensive effects - Rotate the site of injection to avoid irritation or sterile abscess formation with repeat use IM depot injection (fluPHENAZine decanoate or fluPHENAZine enanthate) - FluPHENAZine decanoate or enanthate injections are administered via IM or subcut; do not use IV - FluPHENAZine depot injections must be drawn up using a dry syringe and needle of at least 21-G; do not dilute - Inject slowly and deeply into the upper outer quadrant of the gluteal muscle, aspirate - Keep patient in a recumbent position for at least 30 min following the initial injection to minimize hypotensive effects; once dose-stabilized on depot formulation, this precaution may be modified - Rotate the site of injection to avoid irritation or sterile abscess formation with repeat administration Subcut injection route (fluPHENAZine decanoate or fluPHENAZine enanthate) - FluPHENAZine decanoate or enanthate injections are administered via IM or SC injection only; do not administer intravenously - FluPHENAZine depot injection solutions must be drawn up using a dry syringe and a needle of at least 21-G; do not dilute - Inject subcut taking care not to inject intradermally - Keep patient in a recumbent position for at least 30 min following the initial injection to minimize hypotensive effects. Once dose-stabilized on depot formulation, this precaution may be modified for ambulatory patients; rotate the injection sites

Adverse Effects

CNS: EPS, pseudoparkinsonism, akathisia, dystonia, tardive dyskinesia, drowsiness, headache, seizures, neuroleptic malignant syndrome, drowsiness

CV: Orthostatic hypotension, hypertension, cardiac arrest, ECG changes, tachycardia

EENT: Blurred vision, glaucoma, dry eyes, nasal congestion

GI: Dry mouth, nausea, vomiting, anorexia, constipation, diarrhea, jaundice, weight gain, paralytic ileus, hepatitis, cholecystic jaundice

GU: Urinary retention, urinary frequency, enuresis, impotence, amenorrhea, gynecomastia

HEMA: Anemia, leukopenia, leukocytosis, agranulocytosis, aplastic anemia, thrombocytopenia

INTEG: Rash, photosensitivity, dermatitis, hyperpigmentation (long-term use)

RESP: Laryngospasm, dyspnea, respiratory depression

Pharmacokinetics

Absorption: Well absorbed (PO, IM)

Distribution: Widely absorbed, crosses blood-brain barrier, placenta

Metabolism: Liver, extensively, not dialyzable

Excretion: Kidneys (metabolites)

Half-life: HCl-4.7-15.3 hr, enanthate 3½-4 days, decanoate 6.8-14.3 days

Pharmacodynamics

PO/IM

HCl: Onset 1 hr, Peak 1½-2 hr, Duration 6-8 hr IM

Enanthate: Onset 1-2 days, Peak 2-3 days, Duration 1-3 wk IM

Decanoate: Onset 1-3 days, Peak 1-2 days, Duration .4 wk

Interactions

Individual drugs Alcohol, haloperidol, metyrosine, risperidone: increased effects of both products, oversedation Amiodarone, ARIPiprazole, arsenic trioxide, astemizole, dasatinib, disopyramide, dofetilide, droperidol, erythromycin, flecainide, gatifloxacin, haloperidol, ibutilide, levomethadyl, lurasidone, ondansetron, paliperidone, palonosetron, pimozide, procainamide probucol, ranolazine, quiNIDine, sotalol, sparfloxacin, saquinavir, SUNItinib, vorinostat, ziprasidone: increased QT prolongation, torsades de pointes (at higher doses)

EPINEPHrine: increased toxicity

Levodopa: decreased antiparkinson activity

Lithium: decreased effects of lithium

Drug classifications

Anticholinergics: increased anticholinergic effects

Barbiturates: decreased effect of fluphenazine, oversedation CNS depressants: oversedation

Smoking: decreased effects of fluphenazine

Drug/herb Betel palm, kava: increased EPS Cola tree, hops, kava, nettle, nutmeg: possible increased action Henbane leaf: increased anticholinergic effect

Drug/lab test

Increased: liver function tests, cardiac enzymes, cholesterol, blood glucose, prolactin, bilirubin, cholinesterase

Decreased: hormones (blood and urine) False positive: pregnancy tests, PKU, urinary steroids, 17-OHCS

Nursing Considerations

Assessment - SSRIs, SNRIs, serotonin-receptor agonists: increased serotonin syndrome, malignant neuroleptic syndrome

BLACK BOX WARNING: Increased mortality in elderly patients with dementia-related psychosis; not approved for this use - Serotonin syndrome, neuroleptic malignant syndrome: severe EPS, increased CPK, altered mental state, sinus tachycardia, change in B/P; sweating often occurs in young men; heat stress, physical exhaustion, dehydration, organic brain disease - QT prolongation, torsades de pointes: ECG for changes - Assess mental status: orientation, mood, behavior, presence and type of hallucinations before initial administration and monthly; this product should significantly reduce psychotic behavior - Monitor bilirubin, CBC, liver function tests monthly; ophthalmic exams periodically - Assess affect, orientation, LOC, reflexes, gait, coordination, sleep pattern disturbances - Monitor B/P with patient sitting, standing, and lying down; take pulse and respirations q4 hr during initial treatment; establish baseline before starting treatment; report drops of 30 mm Hg; obtain baseline ECG, Q-wave and T-wave changes - Check for dizziness, faintness, palpitations, tachycardia on rising; severe orthostatic hypotension is common - Assess for EPS including akathisia (inability to sit still, no pattern to movements), tardive dyskinesia (bizarre movements of the jaw, mouth, tongue, extremities), pseudoparkinsonism (rigidity, tremors, pill rolling, shuffling gait); an antiparkinson product should be prescribed - Assess for constipation, urinary retention daily; if these occur, increase bulk, water in diet

Patient/family education - Caution patient to avoid hazardous activities until product response is determined; dizziness, blurred vision may occur - Inform patient that orthostatic hypotension occurs often and to rise from sitting or lying position gradually; tell patient to avoid hot tubs, hot showers, tub baths because hypotension may occur; tell patient that in hot weather, heat stroke may occur; extra precautions are necessary to stay cool - Instruct patient to avoid abrupt withdrawal of this product, or EPS may result; product should be withdrawn slowly - Advise patient that follow-up lab and ophthalmic exams are needed - Teach patient to avoid OTC preparations (cough, hay fever, cold) unless approved by physician because serious product interactions may occur; avoid use with alcohol, CNS depressants; increased drowsiness may occur - Instruct patient to use a sunscreen and sunglasses to prevent burns - Teach patient about EPS and necessity of meticulous oral hygiene because oral candidiasis may occur - Instruct patient to take antacids 2 hr before or after this product - Advise patient to report sore throat, malaise, fever, bleeding, mouth sores; if these occur, CBC should be performed and product discontinued

Evaluation

Positive therapeutic outcome: Decrease in emotional excitement, hallucinations, delusions, paranoia; Reorganization of patterns of thought, speech TREATMENT OF

OVERDOSE: Lavage if orally ingested; provide airway; do not induce vomiting or use EPINEPHrine

Reference

Mosby's Drug Guide; Davis Drug Guide

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