Perphenazine (Page 4 of 5)

OVERDOSAGE

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.

Manifestations

The toxic effects of perphenazine are typically mild to moderate with death occurring in cases involving a large overdose. Overdosage of perphenazine primarily involves the extrapyramidal mechanism and produces the same side effects described under ADVERSE REACTIONS, but to a more marked degree. It is usually evidenced by stupor or coma; children may have convulsive seizures. Signs of arousal may not occur for 48 hours. The primary effects of medical concern are cardiac in origin including tachycardia, prolongation of the QRS or QTc intervals, atrioventricular block, torsade de pointes, ventricular dysrhythmia, hypotension or cardiac arrest, which indicate serious poisoning. Deaths by deliberate or accidental overdosage have occurred with this class of drugs.

Treatment

Treatment is symptomatic and supportive. Induction of emesis is not recommended because of the possibility of a seizure, CNS depression, or dystonic reaction of the head or neck and subsequent aspiration. Gastric lavage (after intubation, if the patient is unconscious) and administration of activated charcoal together with a laxative should be considered. There is no specific antidote.

Standard measures (oxygen, intravenous fluids, corticosteroids) should be used to manage circulatory shock or metabolic acidosis. An open airway and adequate fluid intake should be maintained. Body temperature should be regulated. Hypothermia is expected, but severe hyperthermia may occur and must be treated vigorously (see CONTRAINDICATIONS).

An electrocardiogram should be taken and close monitoring of cardiac function instituted if there is any sign of abnormality. Close monitoring of cardiac function is advisable for not less than five days. Vasopressors such as norepinephrine may be used to treat hypotension, but epinephrine should NOT be used.

Hemodialysis and peritoneal dialysis are of no value because of low plasma concentrations of the drug.

Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase.

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 available as:

4 mg: gray, round, bi-convex, film-coated tablets debossed “4941” on one side and debossed “V” on the reverse side. Available as follows:
   Unit dose packages of 100 (10 x 10) NDC 68084-602-01

8 mg: gray, round, bi-convex, film-coated tablets debossed “4942” on one side and debossed “V” on the reverse side. Available as follows:
   Unit dose packages of 100 (10 x 10) NDC 68084-607-01

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Par Pharmaceutical as follows:
(4 mg / 100 UD) NDC 68084-602-01 packaged from NDC 0603-5061
(8 mg / 100 UD) NDC 68084-607-01 packaged from NDC 0603-5062

Distributed by:
American Health Packaging Columbus, OH 43217

8260201/0821

Package/Label Display Panel – Carton – 4 mg

4 mg Perphenazine Tablets Carton
(click image for full-size original)

NDC 68084- 602 -01

Perphenazine
Tablets, USP

4 mg

100 Tablets (10 × 10)               Rx Only

Each Tablet Contains:
Perphenazine, USP ……………………………………………………….4 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20º to 25ºC (68º to 77ºF); excursions permitted
between 15º to 30ºC (59º to 86ºF) [see USP Controlled Room
Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or
broken.

The drug product contained in this package is from
NDC # 0603-5061, Par Pharmaceutical.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

060201 0260201/0320

Package/Label Display Panel – Blister – 4 mg

4 mg Perphenazine Tablet Blister
(click image for full-size original)

Perphenazine Tablet, USP

4 mg

Package/Label Display Panel – Carton – 8 mg

8 mg Perphenazine Tablets Carton
(click image for full-size original)

NDC 68084- 607 -01

Perphenazine
Tablets, USP

8 mg

100 Tablets (10 × 10)               Rx Only

Each Tablet Contains:
Perphenazine, USP ……………………………………………..8 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20º to 25ºC (68º to 77ºF); excursions permitted
between 15º to 30ºC (59º to 86ºF) [see USP Controlled
Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or
broken.

The drug product contained in this package is from

NDC # 0603-5062, Par Pharmaceutical.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

160701 0260701/0320

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.