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 Hydrochloride Tablets USP are 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 hydrochloride tablets, syrup, or rectal suppositories, 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 hydrochloride 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 hydrochloride by the oral route or by rectal suppository at bedtime will provide sedation in children. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation.

Pre- and Postoperative Use

Promethazine hydrochloride 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 HCl 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 hydrochloride tablets are contraindicated for children under 2 years of age.

HOW SUPPLIED

Promethazine Hydrochloride Tablets USP, 25 mg are scored, round, white tablets imprinted DAN DAN and 5307 supplied in bottles of 100 and 1000.

Promethazine Hydrochloride Tablets USP, 50 mg are unscored, round, white tablets imprinted DAN and 5319 supplied in bottles of 100.

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

Keep tightly closed.

Store at 20-25°C (68-77°F). [See USP controlled room temperature.]

Protect from light.

Manufactured by:
Watson Pharma Private Ltd.
Verna, Salcette Goa 403 722 INDIA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Revised: December 2016
190824-1

PRINCIPAL DISPLAY PANEL

NDC 0591-5307-01
Promethazine
Hydrochloride
Tablets USP
25 mg
Actavis 100 Tablets Rx only

1
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0591-5319-01
Promethazine
Hydrochloride
Tablets USP
50 mgActavis 100 Tablets Rx only

1
(click image for full-size original)
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-5307
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) PROMETHAZINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code DAN;DAN;5307
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-5307-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:0591-5307-10 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA083426 09/19/1973
PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-5319
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) PROMETHAZINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
ANHYDROUS LACTOSE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code DAN;5319
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-5319-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA083711 09/21/1973
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 12/2016 Actavis Pharma, Inc.

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