displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate.
Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S HCl and its molecular weight is 320.88.
Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula.
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, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate.
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 Hydrochloride, is useful orally 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 hydrochloride tablets, USP are contraindicated for use in pediatric patients less than two years of age.
Promethazine hydrochloride tablets, USP are 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 hydrochloride 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 hydrochloride tablets, USP 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 tablets USP, 12.5 mg are white to off-white, round shape, biconvex, uncoated tablets debossed with the logo of “ZC”, “01” and bisect on one side and plain on the other side and are supplied as follows:
NDC 68382-040-01 in bottle of 100 tablets
NDC 68382-040-05 in bottle of 500 tablets
NDC 68382-040-10 in bottle of 1000 tablets
Promethazine hydrochloride tablets USP, 25 mg are white to off-white, round shape, biconvex, uncoated tablets debossed with the quadrisect and the logo of “Z”, “C”, “0” and “2” on one side and plain on the other side and are supplied as follows:
NDC 68382-041-01 in bottle of 100 tablets
NDC 68382-041-05 in bottle of 500 tablets
NDC 68382-041-10 in bottle of 1000 tablets
Promethazine hydrochloride tablets USP, 50 mg are white to off-white, round shape, biconvex, uncoated tablets debossed with the logo of “ZC03” on one side and plain on the other side and are supplied as follows:
NDC 68382-042-01 in bottle of 100 tablets
NDC 68382-042-05 in bottle of 500 tablets
NDC 68382-042-10 in bottle of 1000 tablets
Keep tightly closed.
Store at 20° – 25°C (68° – 77°F) [See USP Controlled Room Temperature].
Protect from light.
Dispense in light-resistant, tight container.
Principal Display Panel
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Promethazine Hydrochloride Tablets, USP 25mg