displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Each rectal suppository contains 12.5 mg or 25 mg promethazine HCl with ascorbyl palmitate, silicon dioxide, white wax, and cocoa butter. Promethazine hydrochloride suppositories are for rectal administration only.
Promethazine HCl is a racemic compound; the empirical formula is C17H20N7S•HCl and its molecular weight is 320.88.
Promethazine HCl, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-,monohydrochloride, (±)- with the following structural formula:
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-demethylpromethazine are the predominant metabolites appearing in the urine.
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Promethazine HCl suppositories, are 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 post-operative 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 suppositories are contraindicated for use in pediatric patients less than two years of age.
Promethazine HCl suppositories are contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenolhiazines. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma.
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
Promethazine HCl suppositories are contraindicated for children under 2 years of age (see WARNINGS-Black Box Warning
Use in Pediatric Patients ).
Promethazine HCl suppositories are for rectal administration only.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Promethazine HCl rectal suppositories are available in boxes of 12 as follows:
25 mg, ivory, torpedo-shaped suppository wrapped in aluminum foil.
Principal Display Panel
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4