pharmacopeia
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/api/v1/drug/fluphenazine

Boxed warning

Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Fluphenazine Hydrochloride Oral Solution USP (Concentrate) is not approved for the treatment of patients with dementia-related psychosis ( see WARNINGS ).

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Adrenergic alpha-Antagonists; Dopamine Antagonists; Unknown Cellular or Molecular Interaction.

Dopamine

Indications

Sourced from openFDA
  • Fluphenazine hydrochloride is indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.

Contraindications

Sourced from openFDA
  • Phenothiazines are contraindicated in patients with suspected or established subcortical brain damage, in patients receiving large doses of hypnotics, and in comatose or severely depressed states. The presence of blood dyscrasia or liver damage precludes the use of fluphenazine hydrochloride.contraindicated

Dosage & administration

Sourced from openFDA

Depending on the severity and duration of symptoms, total daily dosage for adult psychotic patients may range initially from 2.5 to 10 mg and should be divided and given at six- to eight- hour intervals. The smallest amount that will produce the desired results must be carefully determined for each individual, since optimal dosage levels of this potent drug may vary from patient to patient. In general, the oral dose has been found to be approximately two to three times the parenteral dose of fluphenazine. Treatment is best instituted with a low initial dosage, which may be increased, if necessary, until the desired clinical effects are achieved. Therapeutic effect is often achieved with doses under 20 mg daily. Patients remaining severely disturbed or inadequately controlled may require upward titration of dosage. Daily doses up to 40 mg may be necessary; controlled clinical studies have not been performed to demonstrate safety of prolonged administration of such doses. When symptoms are controlled, dosage can generally be reduced gradually to daily maintenance doses of 1 to 5 mg, often given as a single daily dose. Continued treatment is needed to achieve maximum therapeutic benefits; further adjustments in dosage may be necessary during the course of therapy to meet the patient's requirements.

Warnings & precautions

Sourced from openFDA

Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Fluphenazine Hydrochloride Oral Solution USP (Concentrate) is not approved for the treatment of patients with dementia-related psychosis ( see BOXED WARNING ). Tardive Dyskinesia Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with neuroleptic (antipsychotic) drugs. Although the prevalence of the syndrome appears to be the highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of neuroleptic treatment, which patients are likely to develop the syndrome. Whether neuroleptic drug products differ in their potential to cause tardive dyskinesia is unknown. Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of neuroleptic drugs administered to the patient increase. However, the syndrome can develop although much less commonly, after relatively brief treatment periods at low doses. There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if neuroleptic treatment is withdrawn.

Adverse reactions

Sourced from openFDA

Central Nervous System The side effects most frequently reported with phenothiazine compounds are extrapyramidal symptoms including pseudoparkinsonism, dystonia, dyskinesia, akathisia, oculogyric crises, opisthotonos, and hyperreflexia. Most often these extrapyramidal symptoms are reversible; however, they may be persistent (see below). With any given phenothiazine derivative, the incidence and severity of such reactions depend more on individual patient sensitivity than on other factors, but dosage level and patient age are also determinants. Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups. Extrapyramidal reactions may be alarming, and the patient should be forewarned and reassured. These reactions can usually be controlled by administration of antiparkinsonian drugs such as Benztropine Mesylate or Intravenous Caffeine and Sodium Benzoate Injection, and by subsequent reduction in dosage. Tardive Dyskinesia (See WARNINGS ) .

Use in specific populations

Sourced from openFDA

Usage In Pregnancy Non-teratogenic Effects Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. Fluphenazine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The safety for the use of this drug during pregnancy has not been established; therefore, the possible hazards should be weighed against the potential benefits when administering this drug to pregnant patients.

Approval history

Sourced from openFDA
  • Apr 16, 1987ANDAANDA089556Fresenius Kabi Usa
  • Jul 14, 1987ANDAANDA071413Fresenius Kabi Usa
  • Aug 25, 1988ANDAANDA089743Lannett Co Inc
  • Aug 21, 1996ANDAANDA040146Pharm Assoc
  • Aug 30, 1996ANDAANDA074531Hikma
  • Sep 16, 1996ANDAANDA074725Pharm Assoc
  • Aug 17, 2001ANDAANDA075918Mylan Labs Ltd
  • Jul 3, 2014ANDAANDA203732Ph Health

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
530 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective6612%
  2. 2Sedation5510%
  3. 3Neuroleptic Malignant Syndrome448.3%
  4. 4Parkinsonism407.5%
  5. 5Akathisia387.2%
  6. 6Drug Interaction387.2%
  7. 7Weight Increased346.4%
  8. 8Dystonia326.0%
  9. 9Suicide Attempt315.8%
  10. 10Dyskinesia295.5%
  11. 11Delusion285.3%
  12. 12Hypercholesterolaemia264.9%
  13. 13Abnormal Behaviour254.7%
  14. 14Anxiety254.7%
  15. 15Constipation254.7%

Literature

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Recent PubMed references pinned to Fluphenazine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 18 ClinicalTrials.gov registrations naming Fluphenazine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Fluphenazine work?
Mechanism-of-action classes: Adrenergic alpha-Antagonists; Dopamine Antagonists; Unknown Cellular or Molecular Interaction.
What is Fluphenazine used for?
According to FDA labeling, Fluphenazine carries indications including: Fluphenazine hydrochloride is indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Fluphenazine?
Fluphenazine is classified as Phenothiazines with piperazine structure, Phenothiazine, Adrenergic alpha-Antagonists, Dopamine Antagonists, Unknown Cellular or Molecular Interaction, Decreased Central Nervous System Organized Electrical Activity, Decreased Dopamine Activity, Decreased Histamine Activity, Decreased Norepinephrine Activity, Decreased Serotonin Activity, Hypothalamic Endocrine Activity Alteration.
What are the contraindications for Fluphenazine?
Fluphenazine labeling lists contraindications including: Phenothiazines are contraindicated in patients with suspected or established subcortical brain damage, in patients receiving large doses of hypnotics, and in comatose or severely depressed states. The presence of blood dyscrasia or liver damage precludes the use of fluphenazine hydrochloride.. Always consult the full prescribing information and a clinician.
Note. Data for fluphenazine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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