Promethazine Hydrochloride and Dextromethorphan Hydrobromide (Page 3 of 3)

Geriatric Use

Clinical studies of promethazine hydrochloride and dextromethorphan hydrobromide syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Syrup and observed closely.

ADVERSE REACTIONS

Dextromethorphan

Dextromethorphan hydrobromide occasionally causes slight drowsiness, dizziness, and gastrointestinal disturbances.

Promethazine

Central Nervous System -Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported.

Cardiovascular — Increased or decreased blood pressure, tachycardia, bradycardia, faintness.

Dermatologic — Dermatitis, photosensitivity, urticaria.

Hematologic — Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.

Gastrointestinal — Dry mouth, nausea, vomiting, jaundice.

Respiratory-Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). (See WARNINGS-Promethazine; Respiratory Depression.)

Other-Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported. (See WARNINGS-Promethazine; Neuroleptic Malignant Syndrome.)

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.

DRUG ABUSE AND DEPENDENCE

According to the WHO Expert Committee on Drug Dependence, dextromethorphan could produce very slight psychic dependence but no physical dependence.

OVERDOSAGE

Dextromethorphan

Dextromethorphan may produce central excitement and mental confusion. Very high doses may produce respiratory depression. One case of toxic psychosis (hyperactivity, marked visual and auditory hallucinations) after ingestion of a single dose of 20 tablets (300 mg) of dextromethorphan has been reported.

Promethazine

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 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

The treatment of overdosage with promethazine and dextromethorphan 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. The antidotal efficacy of narcotic antagonists to dextromethorphan has not been established; note that any of the depressant effects of promethazine are not reversed by naloxone. Avoid analeptics, which may cause convulsions.

Severe hypotension usually responds to the administration of norepinephrine or phenylephrine. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockage may further lower the blood pressure.

Limited experience with dialysis indicates that it is not helpful.

DOSAGE AND ADMINISTRATION

Promethazine hydrochloride and dextromethorphan hydrobromide syrup is contraindicated for children under 2 years of age (see WARNINGS – Black Box Warning and Use in Pediatric Patients).

The average effective dose is given in the following table:

Adults
1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.
Children 6 years to under 12 years
½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours, not to exceed 20 mL in 24 hours.
Children 2 years to under 6 years
¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours, not to exceed 10 mL in 24 hours.

HOW SUPPLIED

This preparation is a clear, yellow colored syrup, containing Promethazine hydrochloride 6.25 mg/5 mL, dextromethorphan hydrobromide 15 mg/5 mL and alcohol 7 percent, and is available in one pint (473 mL) bottles (NDC 60432-604-16).

STORAGE AND HANDLING

Keep tightly closed. Protect from light.

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

Dispense in a tight, light-resistant container as defined in the USP.

Rx Only

Product No.: 7604

Manufactured For:

Wockhardt USA, LLC

Parsippany, NJ 07054

Manufactured By:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053

A50-7604-16

REV. 07-18

PRINCIPAL DISPLAY PANEL — 437 mL Bottle Label

MGP

NDC 60432-604-16

PROMETHAZINE

WITH

DEXTROMETHORPHAN

COUGH SYRUP

(Promethazine Hydrochloride

6.25 mg/5 mL & Dextromethorphan

Hydrobromide 15 mg/5 mL)

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 with DM Cough Syrup Label
(click image for full-size original)

Promethazine with DM Cough Syrup Label

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
promethazine hydrochloride and dextromethorphan hydrobromide syrup
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60432-604
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg in 5 mL
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 YELLOW NO. 6
D&C YELLOW NO. 10
Product Characteristics
Color YELLOW (clear yellow colored) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60432-604-16 473 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088864 01/04/1985
Labeler — Morton Grove Pharmaceuticals, Inc. (801897505)
Registrant — Morton Grove Pharmaceuticals, Inc. (801897505)
Establishment
Name Address ID/FEI Operations
Morton Grove Pharmaceuticals, Inc. 801897505 ANALYSIS (60432-604), LABEL (60432-604), MANUFACTURE (60432-604), PACK (60432-604)

Revised: 01/2021 Morton Grove Pharmaceuticals, Inc.

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