Perphenazine (Perphenazine) - Indications and Dosage

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.

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. Optimal clinical effect or benefit may require lower doses for a longer duration. Dosing of perphenazine may occur before bedtime, if required.

HOW SUPPLIED

Perphenazine tablets, USP are round, unscored, film-coated white tablets available as:

2 mg: debossed GG 18 on one side and plain on the reverse side, supplied as:

NDC 0781-1046-01 bottles of 100 tablets

NDC 0781-1046-10 bottles of 1000 tablets

NDC 0781-1046-13 unit dose packages of 100 tablets

4 mg: debossed GG 107 on one side and plain on the reverse side, supplied as:

NDC 0781-1047-01 bottles of 100 tablets

NDC 0781-1047-05 bottles of 500 tablets

NDC 0781-1047-10 bottles of 1000 tablets

NDC 0781-1047-13 unit dose packages of 100 tablets

8 mg: debossed GG 108 on one side and plain on the reverse side, supplied as:

NDC 0781-1048-01 bottles of 100 tablets

NDC 0781-1048-05 bottles of 500 tablets

NDC 0781-1048-10 bottles of 1000 tablets

NDC 0781-1048-13 unit dose packages of 100 tablets

16 mg: debossed GG 109 on one side and plain on the reverse side, supplied as:

NDC 0781-1049-01 bottles of 100 tablets

NDC 0781-1049-10 bottles of 1000 tablets

NDC 0781-1049-13 unit dose packages of 100 tablets

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container.

11-2007M

7032

Sandoz Inc.

Princeton, NJ 08540