DESCRIPTION
id: 4f59c2d3-a766-41f2-8850-b8d10ed15aef
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Promethazine hydrochloride is a racemic compound.
Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine-10-ethanamine, N, N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula:
C17H20N2S•HCl M.W. 320.88
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 soluble in water and freely soluble in alcohol.
Each tablet, for oral administration, contains 25 mg or 50 mg of promethazine hydrochloride. In addition each tablet contains the following inactive ingredients: dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and stearic acid.
Promethazine Hydrochloride Tablets USP, 50 mg also contain anhydrous lactose.
CLINICAL PHARMACOLOGY
id: 4e7bdb96-4969-4b4a-a671-4e6da25c01f5
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
id: 9f21370d-a79b-46ea-97aa-04fb9e3cca2f
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Promethazine hydrochloride tablets are useful for:
Perennial and seasonal allergic rhinitis.
Vasomotor 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.
Dermographism.
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.
CONTRAINDICATIONS
id: 3516957e-c857-4b9d-9bfa-6227892d8829
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Promethazine hydrochloride tablets are contraindicated for use in pediatric patients less than two years of age.
Promethazine hydrochloride tablets 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.
WARNINGS
id: 590eee2c-311f-42c1-9427-019eab2f1b9d
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
PROMETHAZINE HYDROCHLORIDE TABLETS USP SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION.
POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HYDROCHLORIDE IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HYDROCHLORIDE BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.
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OVERDOSAGE
id: 7e0172f5-9a7c-4268-b737-5c0770b467fe
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
id: 0c332045-f87f-4a41-a4ca-585ad1fcd2f8
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
and
Use in Pediatric Patients
).
HOW SUPPLIED
id: 5a19d03b-0f1f-4d62-9739-2e1e4564d600
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Promethazine Hydrochloride Tablets USP, 25 mg are scored, round, white tablets imprinted DAN DAN and 5307 supplied in:
Bottles of 10 NDC # 16590-191-10
Bottles of 15 NDC # 16590-191-15
Bottles of 20 NDC # 16590-191-20
Bottles of 28 NDC # 16590-191-28
Bottles of 30 NDC # 16590-191-30
Bottles of 45 NDC # 16590-191-45
Bottles of 56 NDC # 16590-191-56
Bottles of 60 NDC # 16590-191-60
Bottles of 120 NDC # 16590-191-72
Bottles of 112 NDC # 16590-191-73
Bottles of 75 NDC # 16590-191-75
Bottles of 90 NDC # 16590-191-90
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.
Keep tightly closed.
Store at 20-25°C (68-77°F). [See USP controlled room temperature.]
Protect from light.
Manufactured By:
Watson Pharma Private Ltd.
Verna, Salcette Goa 403 722 INDIA
Distributed By:
Watson Pharma, Inc.
Corona, CA 92880 USA
Revised: June 2009
190824
0609B
Relabeling and Repackaging by:
STAT Rx USA LLC
Gainesville, GA. 30501
PACKAGE LABEL – PROMETHAZINE 25 MG TABLETS
id: b821c042-41ea-429b-9108-dbd9e48f29da
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
