displayName: Description Section
FDA Article Code: 34089-3
Each teaspoonful (5 mL) of Promethazine HCl Oral Solution contains 6.25 mg promethazine HCl in a flavored syrup base with a pH between 4.7 and 5.2. Alcohol 7%. The inactive ingredients present are ascorbic acid, citric acid, D&C Yellow No. 10, edetate disodium, ethyl alcohol, FD&C Blue No. 1, FD&C Red No. 40, glycerin, methylparaben, pineapple flavor, purified water, sodium benzoate, sodium citrate, sucralose, and sucrose.
Promethazine HCl is a racemic compound; the molecular formula is C17H20N2S•HCl and its molecular weight is 320.89. Promethazine HCl, a phenothiazine derivative, is chemically designated as 10-[2- (Dimethylamino)propyl] phenothiazine monohydrochloride. Its structural formula is:
Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol.
displayName: Clinical Pharmacology Section
FDA Article Code: 34090-1
Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties.
Promethazine is an H1 receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects.
Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-desmethylpromethazine are the predominant metabolites appearing in the urine.
INDICATIONS AND USAGE
displayName: Indications & Usage Section
FDA Article Code: 34067-9
Promethazine HCl Oral Solution is useful for:
Perennial and seasonal allergic rhinitis.
Allergic conjunctivitis due to inhalant allergens and foods.
Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.
Amelioration of allergic reactions to blood or plasma.
Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled.
Preoperative, postoperative, or obstetric sedation.
Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
Therapy adjunctive to meperidine or other analgesics for control of postoperative pain.
Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.
Active and prophylactic treatment of motion sickness.
Antiemetic therapy in postoperative patients.
displayName: Contraindications Section
FDA Article Code: 34070-3
Promethazine HCl Oral Solution is contraindicated for use in pediatric patients less than two years of age.
Promethazine HCl Oral Solution is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines.
Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma.
displayName: Adverse Reactions Section
FDA Article Code: 34084-4
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
Other– Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported. (See
WARNINGS-Neuroleptic Malignant Syndrome.)
displayName: Overdosage Section
FDA Article Code: 34088-5
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.
DOSAGE AND ADMINISTRATION
displayName: Dosage & Administration Section
FDA Article Code: 34068-7
It is important that Promethazine HCl Oral Solution is measured with an accurate measuring device (see
PRECAUTIONS-Information for Patients
). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose.
Promethazine HCl Oral Solution is contraindicated for children under 2 years of age (see
WARNINGS – Boxed Warning
Use in Pediatric Patients).
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.
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 taken on arising and again before the evening meal. For children, 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 HCl Oral Solution 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 Hydrochloride 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.
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 HCl Oral Solution by the oral route 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 HCl Oral Solution 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 Oral Solution 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 HCl Oral Solution is contraindicated for children under 2 years of age.
displayName: How Supplied Section
FDA Article Code: 34069-5
Promethazine Hydrochloride Oral Solution, USP, 6.25 mg/5 mL, is a clear, green oral solution supplied as follows:
NDC 70408-146-31 Bottle of 4 fl. oz. (118 mL)
NDC 70408-146-34 Bottle of 16 fl. oz. (473 mL)
Keep bottles tightly closed.
Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]
Protect from light.
Dispense in a tight, light-resistant container (USP/NF) with a child-resistant closure.
PATIENT INFORMATION LEAFLET
displayName: SPL Medguide Section
FDA Article Code: 42231-1
PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, 6.25 mg per 5 mL)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 70408 -146 -34
Promethazine Hydrochloride Oral Solution, USP
6.25 mg/5 mL
(Promethazine Hydrochloride Syrup, 6.25 mg per 5 mL)
Alcohol 7% v/v
16 fl oz (473 mL)