DESCRIPTION
id: 6743fada-5812-4824-9950-71371c9b45e7
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Promethazine hydrochloride is a racemic compound.
Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)-with the following structural formula:
C 17H20N2S• 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: 427c922b-4066-4113-b106-c886040c27fa
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: 4999f130-fd5a-462c-83c4-a703aa32215a
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 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.
CONTRAINDICATIONS
id: 007e4b76-4095-42d3-97a1-0f8d4e07d90a
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.
OVERDOSAGE
id: 2f9113c4-62d0-438f-bb91-244a37174250
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: 45c47c35-2236-4a7f-bb41-9dd17a123374
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: 303ed495-e7e1-4ff6-afeb-c3f0e1f1c595
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Promethazine Hydrochloride Tablets USP, 25 mg are scored, round, white tablets imprinted ZC02 .
They are supplied by State of Florida DOH Central Pharmacy as follows:
|
NDC
|
Strength
|
Quantity/Form
|
Color
|
Source Prod. Code
|
| 53808-0545-1 |
25 mg |
30 Tablets in a Blister Pack |
WHITE |
68382-0041 |
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.
Keep tightly closed.
Store at controlled room temperature 20 -25°C (68 -77°F). [See USP Controlled Room Temperature].
Protect from light.
Manufactured by:
Zydus Pharmaceuticals USA
Princeton, NJ 08540-6233
This Product was Repackaged By:
State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States
25mg Label
id: 4e60e7b2-89bb-4674-b861-601bd14cbe01
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
