FULL PRESCRIBING INFORMATION: CONTENTS*
- PERPHENAZINE DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- PERPHENAZINE CONTRAINDICATIONS
- PERPHENAZINE ADVERSE REACTIONS
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
WARNINGIncreased 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 is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).
Parameter Perphenazine 7-Hydroxyperphenazine
INDICATIONS & USAGE
WARNINGSIncreased 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 is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING).
Information for PatientsandADVERSE REACTIONS.)
Neuroleptic Malignant Syndrome (NMS)
Usage in Pregnancy
PRECAUTIONSLeukopenia, Neutropenia and Agranulocytosis
Information for Patients
WARNINGS). Elderly patients taking psychotropic drugs may be at increased risk for falling and consequent hip fractures. Elderly patients should be started on lower doses and observed closely.
PERPHENAZINE ADVERSE REACTIONS
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.
urticaria, erythema, eczema, exfoliative dermatitis, pruritus, photosensitivity, asthma, fever, anaphylactoid reactions, laryngeal edema, and angioneurotic edema; contact dermatitis in nursing personnel administering the drug; and in extremely rare instances, individual idiosyncrasy or hypersensitivity to phenothiazines has resulted in cerebral edema, circulatory collapse, and death.
DOSAGE & ADMINISTRATION
Moderately disturbed nonhospitalized patients with schizophrenia
Hospitalized patients with schizophrenia
Severe nausea and vomiting in adults
2 mg: debossed GG 18 on one side and plain on the reverse side, supplied as:
4 mg:debossed GG 107 on one side and plain on the reverse side, supplied as:
8 mg:debossed GG 108 on one side and plain on the reverse side, supplied as:
16 mg:debossed GG 109 on one side and plain on the reverse side, supplied as:
STORAGE AND HANDLING
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
PERPHENAZINE TABLET, FILM COATED
PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!