PERPHENAZINE- perphenazine tablet, film coated
Wilshire Pharmaceuticals, Inc.
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 is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).
Perphenazine (4-[3-(2-chlorophenothiazin-10-yl) propyl]-1-piperazineethanol), a piperazinyl phenothiazine, having the chemical formula, C21 H26 CIN3 OS. It is available as oral tablets containing 2 mg, 4 mg, 8 mg, and 16 mg of perphenazine.
Inactive ingredients: lactose (monohydrate), hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch (corn), talc, titanium dioxide, and polysorbate 80
Perphenazine Indications and Usage
Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults.
Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.
DOSAGE AND ADMINISTRATION
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 to 8 mg t.i.d. initially; reduce as soon as possible to minimum effective dosage.
Hospitalized patients with schizophrenia
8 to 16 mg b.i.d. to q.i.d.; avoid dosages in excess of 64 mg daily.
Severe nausea and vomiting in adults
8 to 16 mg daily in divided doses; 24 mg occasionally may be necessary; early dosage reduction is desirable.
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. Optimal clinical effect or benefit may require lower doses for a longer duration. Dosing of perphenazine may occur before bedtime, if required.
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.