displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Each rectal suppository of Phenadoz contains 12.5 mg or 25 mg promethazine HCl with ascorbyl palmitate, colloidal silicon dioxide, white wax, hard fat, and glyceryl monostearate. Phenadoz Suppositories are for rectal administration only.
Promethazine HCl is a racemic compound; the empirical formula is C
2S•HCl and its molecular weight is 320.88.
Promethazine HCl, a phenothiazine derivative, is designated chemically as 10
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 soluble in water and freely 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 H
1 receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects.
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
Phenadoz 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
Phenadoz is contraindicated for use in pediatric patients less than two years of age.
Phenadoz 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: 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, and 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 Rectal Suppositories, USP are contraindicated for children under 2 years of age (see
WARNINGS–Black Box Warning
Use in Pediatric Patients).
Phenadoz 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:
12.5 mg, white, bullet-shaped suppository wrapped in silver foil. Bottle of 2 NDC 43063-376-02
Store refrigerated between 2°-8°C (36°-46°F).
Dispense in well-closed container.
PRINCIPAL DISPLAY PANEL – 12.5 mg Suppository
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Promethazine HCl Suppositories, USP
12.5 mg For Rectal Administration