pharmacopeia
GET
/api/v1/drug/perphenazine

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. Perphenazine tablets, USP are 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.

Dopamine

Indications

Sourced from openFDA
  • Perphenazine tablets, USP are indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine tablets, USP have not been shown effective for the management of behavioral complications in patients with mental retardation.ICD-10: F20.9, R11.2

Contraindications

Sourced from openFDA
  • Perphenazine products are contraindicated in comatose or greatly obtunded patients and in patients receiving large doses of central nervous system depressants (barbiturates, alcohol, narcotics, analgesics, or antihistamines); in the presence of existing blood dyscrasias, bone marrow depression, or liver damage; and in patients who have shown hypersensitivity to perphenazine products, their components, or related compounds. Perphenazine products are also contraindicated in patients with suspected or established subcortical brain damage, with or without hypothalamic damage, since a hyperthermic reaction with temperatures in excess of 104°F may occur in such patients, sometimes not until 14 to 16 hours after drug administration.contraindicated

Dosage & administration

Sourced from openFDA

Dosage must be individualized and adjusted according to the severity of the condition and the response obtained. As with all potent drugs, the best dose is the lowest dose that will produce the desired clinical effect. Since extrapyramidal symptoms increase in frequency and severity with increased dosage, it is important to employ the lowest effective dose. These symptoms have disappeared upon reduction of dosage, withdrawal of the drug, or administration of an antiparkinsonian agent. Prolonged administration of doses exceeding 24 mg daily should be reserved for hospitalized patients or patients under continued observation for early detection and management of adverse reactions. An antiparkinsonian agent, such as trihexyphenidyl hydrochloride or benztropine mesylate, is valuable in controlling drug-induced extrapyramidal symptoms. Suggested dosages for various conditions follow: Moderately disturbed nonhospitalized patients with schizophrenia 4 mg to 8 mg three times daily initially; reduce as soon as possible to minimum effective dosage. Hospitalized patients with schizophrenia 8 mg to 16 mg two times daily to four times daily; avoid dosages in excess of 64 mg daily. Severe nausea and vomiting in adults 8 mg to 16 mg daily in divided doses; 24 mg occasionally may be necessary; early dosage reduction is desirable. Elderly Patients With increasing age, plasma concentrations of perphenazine per daily ingested dose increase. Geriatric dosages of perphenazine preparations have not been established, but initiation of lower dosages is recommended.

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. Perphenazine tablets, USP are not approved for the treatment of patients with dementia-related psychosis ( see BOXED WARNING ). Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs. Older patients are at increased risk for development of tardive dyskinesia. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic 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 antipsychotic 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 antipsychotic treatment is withdrawn.

Adverse reactions

Sourced from openFDA

Not all of the following adverse reactions have been reported with this specific drug; however, pharmacological similarities among various phenothiazine derivatives require that each be considered. With the piperazine group (of which perphenazine is an example), the extrapyramidal symptoms are more common, and others (e.g., sedative effects, jaundice, and blood dyscrasias) are less frequently seen. CNS Effects Extrapyramidal Reactions opisthotonus, trismus, torticollis, retrocollis, aching and numbness of the limbs, motor restlessness, oculogyric crisis, hyperreflexia, dystonia, including protrusion, discoloration, aching and rounding of the tongue, tonic spasm of the masticatory muscles, tight feeling in the throat, slurred speech, dysphagia, akathisia, dyskinesia, parkinsonism, and ataxia. Their incidence and severity usually increase with an increase in dosage, but there is considerable individual variation in the tendency to develop such symptoms. Extrapyramidal symptoms can usually be controlled by the concomitant use of effective antiparkinsonian drugs, such as benztropine mesylate, and/or by reduction in dosage. In some instances, however, these extrapyramidal reactions may persist after discontinuation of treatment with perphenazine. Dystonia Class effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment.

Pharmacokinetics

Sourced from openFDA
Metabolism
Following oral administration of perphenazine tablets, mean peak plasma perphenazine concentrations were observed between 1 to 3 hours. The plasma elimination half-life of perphenazine was independent of dose and ranged between 9 and 12 hours.

Overdosage

Sourced from openFDA

In the event of overdosage, emergency treatment should be started immediately. Consultation with a poison center should be considered. All patients suspected of having taken an overdose should be hospitalized as soon as possible.

Approval history

Sourced from openFDA
  • Nov 10, 1988ANDAANDA071443Mylan
  • Dec 8, 1988ANDAANDA089685Sandoz
  • Dec 31, 1998ANDAANDA040226Ph Health
  • Dec 17, 2015ANDAANDA205973Wilshire Pharms Inc
  • Oct 17, 2016ANDAANDA207582Watson Labs Inc
  • Mar 1, 2019ANDAANDA205056Rising
  • Apr 6, 2020ANDAANDA205232Zydus Pharms
  • May 18, 2022ANDAANDA210163Appco

FAERS reports

View JSON
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.
2,067 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 Ineffective37118%
  2. 2Toxicity To Various Agents28714%
  3. 3Weight Increased22511%
  4. 4Akathisia1869.0%
  5. 5Off Label Use1859.0%
  6. 6Suicide Attempt1818.8%
  7. 7Obsessive-compulsive Disorder1647.9%
  8. 8Increased Appetite1577.6%
  9. 9Product Use In Unapproved Indication1567.5%
  10. 10Euphoric Mood1547.5%
  11. 11Antipsychotic Drug Level Below Therapeutic1507.3%
  12. 12Disinhibition1497.2%
  13. 13Drug Interaction1436.9%
  14. 14Therapeutic Product Effect Incomplete1436.9%
  15. 15Therapeutic Product Effect Variable1416.8%

Literature

View JSON

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

Clinical trials

View JSON

The 10 most recently updated of 34 ClinicalTrials.gov registrations naming Perphenazine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

View JSON

CPIC-curated drug–gene pairs for Perphenazine. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • CYP2D6CPIC B/C (provisional)FDA label: Informative PGx

Frequently asked questions

How does Perphenazine work?
Mechanism-of-action classes: Adrenergic alpha-Antagonists; Dopamine Antagonists.
What is Perphenazine used for?
According to FDA labeling, Perphenazine carries indications including: Perphenazine tablets, USP are indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine tablets, USP have not been shown effective for 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 Perphenazine?
Perphenazine is classified as Phenothiazines with piperazine structure, Phenothiazine, Adrenergic alpha-Antagonists, Dopamine Antagonists, Central Nervous System Depression, Decreased Dopamine Activity, Decreased Norepinephrine Activity, Hypothalamic Endocrine Activity Alteration.
What are the contraindications for Perphenazine?
Perphenazine labeling lists contraindications including: Perphenazine products are contraindicated in comatose or greatly obtunded patients and in patients receiving large doses of central nervous system depressants (barbiturates, alcohol, narcotics, analgesics, or antihistamines); in the presence of existing blood dyscrasias, bone marrow depression, or liver damage; and in patients who have shown hypersensitivity to perphenazine products, their components, or related compounds. Perphenazine products are also contraindicated in patients with suspected or established subcortical brain damage, with or without hypothalamic damage, since a hyperthermic reaction with temperatures in excess of 104°F may occur in such patients, sometimes not until 14 to 16 hours after drug administration.. Always consult the full prescribing information and a clinician.
Note. Data for perphenazine 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.

Search pharmacopeia

Search drugs, classes, and ingredients