PROMETHAZINE HYDROCHLORIDE (Page 3 of 3)

Paradoxical Reactions

Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCl. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients.

OVERDOSAGE

Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex).

Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares.

Atropine-like signs and symptoms-dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms-may occur.

Treatment

Treatment of overdosage is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. Diazepam may be used to control convulsions. Acidosis and electrolyte losses should be corrected. Note that any depressant effects of promethazine HCl are not reversed by naloxone. Avoid analeptics which may cause convulsions.

The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. In the event that vasopressors are considered for the management of severe hypotension which does not respond to intravenous fluids and repositioning, the administration of norepinephrine or phenylephrine should be considered. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates. Oxygen may also be administered.

Limited experience with dialysis indicates that it is not helpful.

DOSAGE AND ADMINISTRATION

Promethazine Syrup is contraindicated for children under 2 years of age (see WARNINGS-Black Box Warning and Use in Pediatric Patients).

Allergy

The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The administration of promethazine HCl in 25-mg doses will control minor transfusion reactions of an allergic nature.

Motion Sickness

The average adult dose is 25 mg taken twice daily. The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later, if necessary. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. For children, Promethazine Syrup, 12.5 to 25 mg, twice daily, may be administered.

Nausea and Vomiting

Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS-Use in Pediatric Patients).

The average effective dose of Promethazine for the active therapy of nausea and vomiting in children or adults is 25 mg. When oral medication cannot be tolerated, the dose should be given parenterally (cf. Promethazine Injection) or by rectal suppository. 12.5- to 25-mg doses may be repeated, as necessary, at 4- to 6-hour intervals.

For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated.

For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose is 25 mg repeated at 4- to 6-hour intervals, as necessary.

Sedation

This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Administration of 12.5 to 25 mg Promethazine by the oral route will provide sedation in children. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation.

Pre- and Postoperative Use

Promethazine in 12.5- to 25-mg doses for children and 50-mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep.

For preoperative medication, children require doses of 0.5 mg per pound of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug. Usual adult dosage is 50 mg Promethazine with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid.

Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 to 25 mg in children and 25- to 50-mg doses in adults.

Promethazine Syrup is contraindicated for children under 2 years of age.

HOW SUPPLIED

Promethazine Syrup Plain 6.25 mg/5 mL is available in PET plastic bottles as follows:

NDC# 60432-608-16: Pint (473 mL)

STORAGE AND HANDLING

Keep tightly closed.

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

Dispense in light-resistant, tight container.

Rx Only

Product No.: 7608

Manufactured For:

Wockhardt USA, LLC.

Parsippany, NJ 07054

Manufactured By:

Morton Grove Pharmaceuticals, Inc

Morton Grove, IL 60053

A50-7608-16

REV. 07-18

PRINCIPAL DISPLAY PANEL — 473 mL Bottle Label

MGP

NDC 60432-608-16

PROMETHAZINE

SYRUP PLAIN

6.25 mg/5 mL

(Promethazine Hydrochloride

Syrup, USP)

Alcohol 7.0%

DO NOT USE IF INNER FOIL SEAL PRINTED “SEALED

FOR YOUR PROTECTION” IS BROKEN OR MISSING.

BULK CONTAINER —

NOT FOR HOUSEHOLD USE

Rx Only

NET: 1 Pint (473 mL)

Promethazine Syrup Plain Label

PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride syrup

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60432-608 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL

Inactive Ingredients Ingredient Name Strength WATER TRISODIUM CITRATE DIHYDRATE EDETATE DISODIUM SODIUM BENZOATE SACCHARIN SODIUM SODIUM PROPIONATE ASCORBIC ACID ANHYDROUS CITRIC ACID SUCROSE GLYCERIN ALCOHOL METHYLPARABEN FD&C RED NO. 40 D&C YELLOW NO. 10 FD&C BLUE NO. 1

Product Characteristics Color GREEN (clear green) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:60432-608-16 473 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA087953 11/15/1982

Labeler — Morton Grove Pharmaceuticals, Inc. (801897505)

Registrant — Morton Grove Pharmaceuticals, Inc. (801897505)

Establishment
Name	Address	ID/FEI	Operations
Morton Grove Pharmaceuticals, Inc.		801897505	ANALYSIS (60432-608), MANUFACTURE (60432-608), PACK (60432-608)

Revised: 11/2019 Morton Grove Pharmaceuticals, Inc.