displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Each 5 mL (teaspoonful) contains:
Promethazine Hydrochloride, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.25 mg
(In a flavored syrup base with a pH between 4.7 and 5.2)
Alcohol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.0%
In addition, the following inactive ingredients are present: artificial banana flavor, artificial fruit flavor, artificial strawberry flavor, ascorbic acid, USP, citric acid anhydrous, USP, D&C Yellow No. 10, edetate disodium, USP, FD&C Blue No. 1, FD&C Red No. 40, glycerin, USP, liquid sugar, methylparaben, NF, purified water, USP, saccharin sodium, USP, sodium benzoate, NF, sodium citrate dihydrate, USP, and sodium propionate, NF.
Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S•HCl and its molecular weight is 320.89.
Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as 10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Its structural formula is:
Promethazine hydrochloride 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 dopaminergic Central Nervous System (CNS) action.
Promethazine is an H1 receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. In therapeutic dosage, promethazine produces no significant effects on the cardiovascular system.
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-demethylpromethazine are the predominant metabolites appearing in the urine.
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Promethazine 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 products are contraindicated for use in pediatric patients less than two years of age.
Promethazine is contraindicated 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
CNS–Sedation, sleepiness, occasional blurred vision, dryness of mouth, dizziness; rarely confusion, disorientation and extrapyramidal symptoms such as oculogyric crisis, torticollis and tongue protrusion (usually in association with parenteral injection or excessive dosage).
Cardiovascular–Increased or decreased blood pressure.
Dermatologic–Rash, rarely photosensitivity.
Hematologic–Rarely leukopenia, thrombocytopenia; agranulocytosis (1 case).
Gastrointestinal–Nausea and vomiting.
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Signs and symptoms of overdosage with promethazine range from mild depression of the CNS and cardiovascular system to profound hypotension, respiratory depression and unconsciousness.
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.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Promethazine products are contraindicated for children under 2 years of age (see
WARNINGS-Black Box Warning
Use in Pediatric Patients
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Promethazine Hydrochloride Syrup, USP 6.25 mg/5 mL NDC 21695-703-04 is supplied as a clear, green syrup. Available in 4 fl oz (118 mL) Bottles.
Principal Display Panel
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4