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Related to Prolixin: Prolixin Decanoate
Modecate Concentrate(trade name),
Prolixin Decanoate(trade name)
Pregnancy Category: C
Acute and chronic psychoses.
Alters the effects of dopamine in the CNS.
Has anticholinergic and alpha-adrenergic blocking activity.
Diminished signs and symptoms of psychoses.
Absorption: Well absorbed after PO/IM administration. Decanoate salt in sesame oil has delayed onset and prolonged action because of delayed release from oil vehicle and subsequent delayed release from fatty tissues.
Distribution: Widely distributed. Crosses the blood-brain barrier. Crosses the placenta; enters breast milk.
Protein Binding: ≥90%.
Metabolism and Excretion: Highly metabolized by the liver; undergo enterohepatic recirculation.
Half-life: Fluphenazine hydrochloride—33 hr; fluphenazine decanoate—6.8–9.6 days.
Time/action profile (antipsychotic activity)
|PO hydrochloride||1 hr||unknown||6–8 hr|
|IM decanoate||24–72 hr||48–96 hr||≥4 wk|
Contraindicated in: Hypersensitivity; Cross-sensitivity with other phenothiazines may exist; Subcortical brain damage; Severe CNS depression; Coma; Bone marrow depression; Liver disease; Hypersensitivity to sesame oil (decanoate salt); Some products contain alcohol or tartrazine and should be avoided in patients with known intolerance; Concurrent use of drugs that prolong the QT interval; Pediatric: Children <6 mo (safety not established).
Use Cautiously in: Cardiovascular disease; Parkinson's disease; Angle-closure glaucoma; Myasthenia gravis; Prostatic hypertrophy; Seizure disorders; Obstetric: Use only if potential benefit justifies potential risk to fetus; Lactation: Enters breast milk, not recommended; Geriatric: Initial dose ↓ may be necessary in geriatric or debilitated patients; ↑ risk of mortality in elderly patients treated for dementia-related psychosis.
Adverse Reactions/Side Effects
Central nervous system
- neuroleptic malignant syndrome (life-threatening)
- extrapyramidal reactions (most frequent)
- tardive dyskinesia
Ear, Eye, Nose, Throat
- blurred vision
- dry eyes
- drug-induced hepatitis
- dry mouth
- weight gain
- urinary retention
- photosensitivity (most frequent)
- pigment changes
- agranulocytosis (life-threatening)
- allergic reactions
Drug-Drug interactionConcurrent use with drugs that prolong the QT interval, including antiarrhythmics, pimozide, erythromycin, clarithromycin, fluoroquinolones, methadone, and tricyclic antidepressants may ↑ the risk for arrhythmias; concurrent use should be avoided.Additive hypotension with antihypertensives.Additive CNS depression with other CNS depressants, including alcohol, antidepressants, antihistamines, opioids, sedative/hypnotics, or general anesthetics.Effects may be ↓ by phenobarbital.May ↑ the risk of lithium toxicity.Oral absorption may be ↓ by aluminum-containing antacids.May ↓ anti-Parkinson activity of levodopa and bromocriptine.May ↓ the vasopressor response to epinephrine and norepinephrine.Effects may be ↑ by beta blockers, chlorpromazine, chloroquine, delavirdine, fluoxetine, paroxetine, quinidine, quinine, ritonavir, and ropinirole.↑ risk of anticholinergic effects with other agents having anticholinergic properties, including antihistamines, tricyclicantidepressants, disopyramide, or quinidine.Metoclopramide may ↑ the risk of extrapyramidal reactions.
Intramuscular (Adults) 12.5–25 mg initially; may be repeated q 3 wk. Dose may be slowly ↑ as needed (not to exceed 100 mg/dose).
Oral (Adults) 0.5–10 mg/day in divided doses q 6–8 hr (maximum dose = 40 mg/day).
Oral (Geriatric Patients or Debilitated Patients) 1–2.5 mg/day initially; ↑ dose every 4–7 days by 1–2.5 mg/day as needed (max dose = 20 mg/day).
Intramuscular (Adults) 1.25–2.5 mg q 6–8 hr.
Availability (generic available)
Fluphenazine decanoate injection: 25 mg/mL, 100 mg/mL
Fluphenazine hydrochloride tablets: 1 mg, 2.5 mg, 5 mg, 10 mg
Fluphenazine hydrochloride elixirorange flavor: 2.5 mg/5 mL
Fluphenazine hydrochloride concentrate: 5 mg/mL
Fluphenazine hydrochloride injection: 2.5 mg/mL
- Assess mental status (orientation, mood, behavior) before and periodically during therapy.
- Monitor BP (sitting, standing, lying), ECG, pulse, and respiratory rate before and frequently during the period of dose adjustment. May cause Q-wave and T-wave changes in ECG.
- Observe carefully when administering oral medication to ensure that medication is actually taken and not hoarded.
- Assess fluid intake and bowel function. Increased bulk and fluids in the diet help minimize constipation.
- Monitor for onset of akathisia (restlessness or desire to keep moving) and extrapyramidal side effects (parkinsonian—difficulty speaking or swallowing, loss of balance control, pill rolling, mask-like face, shuffling gait, rigidity, tremors; dystonic—muscle spasms, twisting motions, twitching, inability to move eyes, weakness of arms or legs) every 2 mo during therapy and 8–12 wk after therapy has been discontinued. Reduction in dose or discontinuation of medication may be necessary. Benztropine or diphenhydramine may be used to control these symptoms.
- Monitor for tardive dyskinesia (uncontrolled rhythmic movement of mouth, face, and extremities; lip smacking or puckering; puffing of cheeks; uncontrolled chewing; rapid or worm-like movements of tongue). Report immediately; may be irreversible.
- Monitor for development of neuroleptic malignant syndrome (fever, respiratory distress, tachycardia, seizures, diaphoresis, arrhythmias, hypertension or hypotension, pallor, tiredness, severe muscle stiffness, loss of bladder control). Report immediately.
- Lab Test Considerations: Evaluate CBC, liver function tests, and ocular examinations periodically during therapy. May cause ↓ hematocrit, hemoglobin, leukocytes, granulocytes, and platelets. May cause ↑ bilirubin, AST, ALT, and alkaline phosphatase. Agranulocytosis may occur after 4–10 wk of therapy with recovery 1–2 wk after discontinuation. May recur if medication is restarted. Liver function abnormalities may require discontinuation of therapy.
Potential Nursing DiagnosesDisturbed thought process (Indications)
Noncompliance (Patient/Family Teaching)
- Do not confuse fluphenazine with fluvoxamine.
- Slight yellow to amber color does not alter potency.
- To prevent contact dermatitis, avoid getting liquid preparations on hands and wash hands thoroughly if spillage occurs.
- Injectable forms must be drawn up with a dry syringe and dry 21-gauge needle to prevent clouding of the solution.
- Oral: Dilute concentrate just before administration in 120–240 mL of water, milk, carbonated beverage, soup, or tomato or fruit juice. Do not mix with beverages containing caffeine (cola, coffee), tannics (tea), or pectinates (apple juice).
- Subcutaneous: Fluphenazine decanoate is dissolved in sesame oil for long duration of action. It may be administered subcut or IM. 12.5 mg of fluphenazine decanoate given every 3 wk is approximately equivalent to 10 mg/day orally of fluphenazine hydrochloride.
- Intramuscular: IM dose of fluphenazine hydrochloride is usually 30–50% of oral dose. Because fluphenazine hydrochloride has a shorter duration of action, it is used initially to determine the patient’s response to the drug and to treat the acutely agitated patient.
- Administer deep IM, using a dry syringe and 21-gauge needle, into dorsal gluteal site. Instruct patient to remain recumbent for 30 min to prevent hypotension.
- Syringe Compatibility: Fluphenazine hydrocholride is compatible in syringe with.benztropine, diphenhydramine, hydroxyzine
- Advise patient to take medication as directed and not to skip doses or double up on missed doses. If a dose is missed, take within 1 hr or skip dose and return to regular schedule if taking more than 1 dose/day; take as soon as possible unless almost time for next dose if taking 1 dose/day. Abrupt withdrawal may lead to gastritis, nausea, vomiting, dizziness, headache, tachycardia, and insomnia.
- Inform patient of possibility of extrapyramidal symptoms and tardive dyskinesia. Caution patient to report these symptoms immediately to health care professional.
- Advise patient to change positions slowly to minimize orthostatic hypotension.
- Medication may cause drowsiness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
- Caution patient to avoid taking alcohol or other CNS depressants concurrently with this medication.
- Advise patient to use sunscreen and protective clothing when exposed to the sun. Exposed surfaces may develop a blue-gray pigmentation, which may fade after discontinuation of the medication. Extremes of temperature should also be avoided because this drug impairs body temperature regulation.
- Advise patient that good oral hygiene, frequent rinsing of mouth with water, and sugarless gum or candy may help relieve dry mouth. Health care professional should be notified if dry mouth persists beyond 2 wk.
- Instruct patient to notify health care professional promptly if sore throat, fever, unusual bleeding or bruising, rash, weakness, tremors, visual disturbances, dark-colored urine, or clay-colored stools occur.
- Advise patient to notify health care professional of medication regimen before treatment or surgery.
- Emphasize the importance of routine follow-up exams, including ocular exams, with long-term therapy and continued participation in psychotherapy.
- Decrease in excitable, paranoiac, or withdrawn behavior.