Fluphenazine

Trade Names:
Fluphenazine Hydrochloride
- Tablets 1 mg
- Tablets 2.5 mg
- Tablets 5 mg
- Tablets 10 mg
- Elixir 2.5 mg per 5 mL
- Injection 2.5 mg/mL

Trade Names:
Fluphenazine Decanoate
- Injection 25 mg/mL

Pharmacology

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Blocks dopamine receptor in CNS.

Indications and Usage

Management of psychotic disorders.

Long-acting parenteral depot products for long-term neuroleptic therapy.

Unlabeled Uses

Nausea/vomiting.

Contraindications

Allergy to any phenothiazine; comatose or severely depressed states; concurrent use of large doses of other CNS depressants; bone marrow depression or blood dyscrasias; liver damage; cerebral arteriosclerosis; coronary artery disease; severe hypotension or hypertension; subcortical brain damage; children younger than 12 years of age (decanoate).

Dosage and Administration

PO Initially, 2.5 to 10 mg/day in divided doses at 6 to 8 h intervals. When symptoms are controlled, gradually reduce dosage to 1 to 5 mg/day. IM Average starting dose 1.25 mg. Depending on severity and duration of symptoms, initial daily dose may range from 2.5 to 10 mg, divided and given at 6- to 8-h intervals.

PO Start with 1 to 2.5 mg daily, adjusted according to response.

IM / Subcutaneous

12.5 to 25 mg. Do not exceed 100 mg/dose.

1 to 4 wk and as long as 6 wk in some patients.

General Advice

• Oral tablets
• Administer tablets without regard to meals. Administer with food if GI upset occurs.

• Elixir
• Measure prescribed dose of elixir using calibrated dropper or dosing syringe.

• Injection
• Injection is for IM or subcutaneous administration only. Not for intradermal or IV administration.
• Use dry syringe and needle to withdraw and administer IM or subcutaneous dose of fluphenazine decanoate.
• Do not administer injection if particulate matter or marked discoloration is noted.

Storage/Stability

Store tablets, elixir, and injection at controlled room temperature (59° to 86°F). Protect from light. Do not freeze elixir or injection.

Drug Interactions

Increased CNS depression; may precipitate extrapyramidal reaction.

Reduced therapeutic effects and increased anticholinergic adverse reactions of fluphenazine; may lead to tardive dyskinesia.

Increased frequency and severity of neuromuscular excitation and hypotension.

Increased plasma levels of both drugs.

Effectiveness of bromocriptine may be reduced.

The risk of life-threatening cardiac arrhythmias, including torsades de pointes, may be increased.

Hypotensive action may be inhibited.

Increase or decrease in phenytoin levels.

May result in disorientation, unconsciousness, and extrapyramidal symptoms.

Increased seizure risk.

Plasma levels of fluphenazine may be elevated, increasing the risk of adverse reactions.

Laboratory Test Interactions

False-positive pregnancy tests may occur but are less likely with serum test. Increases in protein-bound iodine have been reported. Increased cephalin flocculation accompanied by altered LFTs has been reported with fluphenazine enanthate. Pink to red-brown urine discoloration.

Adverse Reactions

Cardiovascular

Orthostatic hypotension; hypertension; tachycardia; bradycardia; syncope; cardiac arrest; circulatory collapse; ECG changes; arrhythmias; CHF.

CNS

Pseudoparkinsonism; dyskinesia; motor restlessness; oculogyric crises; opisthotonos; hyperreflexia; tardive dyskinesia; headache; weakness; tremor; fatigue; slurring; insomnia; vertigo; seizures; drowsiness; hallucinations; lethargy; increased libido; lightheadedness; faintness; dizziness.

Dermatologic

Photosensitivity; skin pigmentation; dry skin; exfoliative dermatitis; urticarial rash; maculopapular hypersensitivity reaction; seborrhea; eczema; jaundice; perspiration; erythema.

EENT

Pigmentary retinopathy; glaucoma; photophobia; blurred vision; miosis; mydriasis; increased IOP; dry mouth or throat; nasal congestion.

GI

Nausea; dyspepsia; constipation; salivation; fecal impaction; paralytic ileus; adynamic ileus (may result in death).

Genitourinary

Menstrual irregularities; urinary hesitancy and retention; impotence; sexual dysfunction; bladder paralysis; abnormal lactation; dysmenorrhea; breast enlargement; galactorrhea.

Hematologic

Agranulocytosis; eosinophilia; leukopenia; hemolytic anemia; thrombocytopenic purpura; nonthrombocytopenic purpura; pancytopenia.

Hepatic

Jaundice.

Metabolic

Decreased cholesterol; weight change.

Respiratory

Laryngospasm; bronchospasm; dyspnea; acute fulminating pneumonia or pneumonitis.

Miscellaneous

Increases in appetite and weight; polydipsia; increased prolactin levels; NMS; loss of appetite; peripheral edema; sudden unexpected and unexplained death.

Precautions

Pregnancy

Pregnancy category undetermined.

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

More susceptible to effects; consider reduced dose.

Special Risk Patients

Use with caution in patients with CV disease or mitral insufficiency, pheochromocytoma, history of glaucoma, EEG abnormalities or seizure disorders, prior brain damage, hepatic or renal function impairment, and patients exposed to extreme heat or phosphorous insecticides.

Abrupt withdrawal

Although this drug is not known to cause psychological or physical dependence, abrupt discontinuation of high-dose therapy has been associated with withdrawal symptoms (eg, nausea, vomiting, dizziness, headache, tachycardia, insomnia, tremulousness).

Adolescents

More susceptible to effects; consider reduced dose.

Debilitated patients

More susceptible to effects; consider reduced dose.

Hepatic effects

Jaundice usually occurs between 2nd and 4th weeks of treatment; considered hypersensitivity reaction. Usually reversible.

Hyperprolactinemia

Patients treated with antipsychotic agents often have elevation in prolactin levels; however, there is no evidence of increased breast tumor risk.

Myelography

Ensure that medication is discontinued at least 48 h before myelography and not resumed until at least 24 h after procedure to reduce chance of seizures occurring.

NMS

Potentially fatal condition that has occurred, most often with fluphenazine decanoate. Signs and symptoms include hyperpyrexia, muscle rigidity, altered mental status, irregular pulse, fluctuating BP, tachycardia, and diaphoresis.

Pulmonary effects

Cases of bronchopneumonia, some fatal, have occurred.

Sudden death

Has been reported; predisposing factors may be seizures or previous brain damage. Flare-up of psychotic behavior may precede death.

Tardive dyskinesia

Syndrome of potentially irreversible, involuntary body and facial movements may develop. Prevalence highest in elderly, especially women. Use smallest effective doses for shortest possible time period.

Overdosage

Symptoms

Somnolence, coma, extrapyramidal symptoms, cardiac arrhythmias, fever, hypotension, seizures.

Patient Information

• Explain the risk of developing tardive dyskinesia.
• Advise patient receiving injection that medication will be prepared and administered by health care provider in a medical setting.
• Advise patient, family, or caregiver that dose will be adjusted periodically until max benefit has been obtained.
• Advise patient, family, or caregiver not to change the dose or stop taking unless advised by health care provider.
• Instruct patient, family, or caregiver to measure prescribed dose of elixir using calibrated dropper or dosing syringe.
• Instruct patient not to stop taking fluphenazine when feeling better.
• Instruct patient, family, or caregiver to immediately report fainting or loss of consciousness, palpitations, dizziness, high fever, muscle rigidity or unusual muscle movements, altered mental status, irregular pulse, sore throat or other signs of infection, bleeding or unusual bruising, or yellowing of the skin or eyes.
• Advise patient, family, or caregiver to notify health care provider of the following: excessive drowsiness, increased agitation or anxiety, involuntary body or facial movements.
• Advise patient to avoid strenuous activity during periods of high temperature or humidity.
• Instruct patient to avoid alcoholic beverages and other depressants while taking this medication.
• Instruct patient to get up slowly from a lying or sitting position and to avoid sudden position changes to prevent postural hypotension. Advise patient to report dizziness with position changes to health care provider. Caution patient that hot tubs and hot showers or baths may make dizziness worse.
• Advise patient to take sips of water, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs.
• Advise patient that drug may cause drowsiness and impaired judgment or thinking skills and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
• Caution patient that medication may cause sensitivity to sunlight and to avoid unnecessary exposure to UV light (sunlight, tanning booths), use sunscreen, and wear protective clothing when exposed to UV light until tolerance is determined.

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