Prochlorperazine Edisylate (Page 4 of 4)

DOSAGE AND ADMINISTRATION

NOTE ON INJECTION: For intramuscular administration, inject deeply into the upper, outer quadrant of the buttock.

Subcutaneous administration is not advisable because of local irritation.

Stability

This solution should be protected from light. Slight yellowish discoloration will not alter potency. If markedly discolored, solution should be discarded.

Compatibility

It is recommended that Prochlorperazine Edisylate Injection not be mixed with other agents in the syringe.

Adults

(For children’s dosage and administration, see below.) Dosage should be increased more gradually in debilitated or emaciated patients.

ELDERLY PATIENTS

In general, dosages in the lower range are sufficient for most elderly patients. Since they appear to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely. Dosage should be tailored to the individual, response carefully monitored, and dosage adjusted accordingly. Dosage should be increased more gradually in elderly patients.

TO CONTROL SEVERE NAUSEA AND VOMITING

Adjust dosage to the response of the individual. Begin with lowest recommended dosage.

IM Dosage

Initially 5 mg to 10 mg (1 to 2 mL) injected deeply into the upper, outer quadrant of the buttock. If necessary, repeat every 3 or 4 hours. Total IM dosage should not exceed 40 mg per day.

IV Dosage

2.5 mg to 10 mg (0.5 to 2 mL) by slow IV injection or infusion at a rate not to exceed 5 mg per minute. Prochlorperazine Edisylate Injection may be administered either undiluted or diluted in isotonic solution. A single dose of the drug should not exceed 10 mg; total IV dosage should not exceed 40 mg per day. When administered IV, do not use bolus injection. Hypotension is a possibility if the drug is given by IV injection or infusion.

Subcutaneous administration is not advisable because of local irritation.

ADULT SURGERY (FOR SEVERE NAUSEA AND VOMITING)

Total parenteral dosage should not exceed 40 mg per day. Hypotension is a possibility if the drug is given by IV injection or infusion.

IM Dosage

5 mg to 10 mg (1 to 2 mL) 1 to 2 hours before induction of anesthesia (repeat once in 30 minutes, if necessary), or to control acute symptoms during and after surgery (repeat once if necessary).

IV Dosage

5 mg to 10 mg (1 to 2 mL) as a slow IV injection or infusion 15 to 30 minutes before induction of anesthesia, or to control acute symptoms during or after surgery. Repeat once if necessary. Prochlorperazine may be administered either undiluted or diluted in isotonic solution, but a single dose of the drug should not exceed 10 mg. The rate of administration should not exceed 5 mg per minute. When administered IV, do not use bolus injection.

IN ADULT PSYCHIATRIC DISORDERS

Adjust dosage to the response of the individual and according to the severity of the condition. Begin with the lowest recommended dose. Although response ordinarily is seen within a day or two, longer treatment is usually required before maximal improvement is seen.

IM Dosage

For immediate control of adult schizophrenic patients with severe symptomatology, inject an initial dose of 10 mg to 20 mg (2 to 4 mL) deeply into the upper, outer quadrant of the buttock. Many patients respond shortly after the first injection. If necessary, however, repeat the initial dose every 2 to 4 hours (or, in resistant cases, every hour) to gain control of the patient. More than 3 or 4 doses are seldom necessary. After control is achieved, switch patient to an oral form of the drug at the same dosage level or higher. If, in rare cases, parenteral therapy is needed for a prolonged period, give 10 mg to 20 mg (2 to 4 mL) every 4 to 6 hours. Pain and irritation at the site of injection have seldom occurred.

Subcutaneous administration is not advisable because of local irritation.

Children

DO NOT USE IN PEDIATRIC SURGERY

Children seem more prone to develop extrapyramidal reactions, even on moderate doses. Therefore, use lowest effective dosage. Tell parents not to exceed prescribed dosage, since the possibility of adverse reactions increases as dosage rises.

Occasionally the patient may react to the drug with signs of restlessness and excitement; if this occurs, do not administer additional doses. Take particular precaution in administering the drug to children with acute illnesses or dehydration (see under PRECAUTIONS and Dystonia).

SEVERE NAUSEA AND VOMITING IN CHILDREN

Prochlorperazine should not be used in pediatric patients under 20 pounds in weight or two years of age. It should not be used in conditions for which children’s dosages have not been established. Dosage and frequency of administration should be adjusted according to the severity of the symptoms and the response of the patient. The duration of activity following intramuscular administration may last up to 12 hours. Subsequent doses may be given by the same route if necessary.

IM Dosage

Calculate each dose on the basis of 0.06 mg of the drug per lb of body weight; give by deep IM injection. Control is usually obtained with one dose.

CHILDREN WITH SCHIZOPHRENIA

IM Dosage

For ages under 12, calculate each dose on the basis of 0.06 mg of prochlorperazine per lb of body weight; give by deep IM injection.

Control is usually obtained with one dose. After control is achieved, switch the patient to an oral form of the drug at the same dosage level or higher.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

Prochlorperazine Edisylate Injection, USP 5 mg/mL

2 mL (10 mg) vial, packaged in 10’s (NDC 14789-700-02)

Storage

PROTECT FROM LIGHT. Store in the box until ready to use. Discard if markedly discolored.

Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

The container closure is not made with natural rubber latex.

To report SUSPECTED ADVERSE REACTIONS contact Lambda Therapeutics Limited (Toll Free Number: 1-855-642-2594 or by email: safety.nexuspharma@lambda-cro.com) or the FDA (Toll Free Number: 1-800-FDA-1088 or by the MedWatch website at www.fda.gov/safety/MedWatch/).

Manufactured for:
Nexus Pharmaceuticals, Inc.
Lincolnshire, IL 60069

Made in Germany

NEXUS
PHARMACEUTICALS
Revised: 09/2021

PROPIR002

Principal Display Panel – Carton Label

NEXUS
PHARMACEUTICALS

NDC 14789-700-02

Prochlorperazine Edisylate Injection, USP

10 mg/2 mL (5 mg/mL)

FOR DEEP INTRAMUSCULAR OR INTAVENOUS USE.

NOT FOR SUBCUTANEOUS USE. PROTECT FROM LIGHT

Rx only

10 x 2 mL Vials

Keep Covered in Carton until time of use.

Discard contents if markedly discolored.

Principal Display Panel – Carton Label
(click image for full-size original)

Principal Display Panel – Vial Label

NDC 14789-700-07

Prochlorperazine Edisylate Injection, USP

10 mg per 2 mL (5 mg/mL)

2 mL Amber Vial

FOR DEEP IM OR IV USE ONLY

NOT FOR SC USE

Rx Only

PRO5-2LBLR001

Principal Display Panel – Vial Label
(click image for full-size original)
PROCHLORPERAZINE EDISYLATE
prochlorperazine edisylate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:14789-700
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Prochlorperazine Edisylate (Prochlorperazine) Prochlorperazine 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
SODIUM TARTRATE
SACCHARIN SODIUM
BENZYL ALCOHOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:14789-700-02 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (14789-700-07)
1 NDC:14789-700-07 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (14789-700-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204860 02/25/2019
Labeler — Nexus Pharmaceuticals Inc. (620714787)
Establishment
Name Address ID/FEI Operations
Haupt Pharma Wolfratshausen GmbH 314715889 MANUFACTURE (14789-700)

Revised: 09/2021 Nexus Pharmaceuticals Inc.

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