PROMETHAZINE HYDROCHLORIDE syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494)

Available from:

ATLANTIC BIOLOGICALS CORP

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Promethazine Hydrochloride Syrup (Promethazine Hydrochloride Oral Solution, USP) is 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. Promethazine Hydrochlor

Product summary:

Promethazine Hydrochloride Syrup (Promethazine Hydrochloride Oral Solution, USP) is a clear, green colored solution with a strawberry banana fruit punch flavor. It is supplied in cups of:  PROMETHAZINE 6.25MG/5ML - 5 ML CUP 72 ct UD   NDC 17856-0059-01 Store at 25°C (77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. DISTRIBUTED BY: ATLANTIC BIOLOGICALS CORP. MIAMI, FL 33179

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE SYRUP
ATLANTIC BIOLOGICALS CORP
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PROMETHAZINE HCL SYRUP
DESCRIPTION
Each teaspoonful (5 mL) of Promethazine Hydrochloride Syrup
(Promethazine
Hydrochloride Oral Solution, USP) contains 6.25 mg promethazine HCl in
a flavored
syrup base with a pH between 4.9 and 5.4. Alcohol 8%(v/v). The
inactive ingredients
present are: anhydrous citric acid, ascorbic acid, D&C yellow No. 10,
edetate disodium,
FD&C blue No. 1 powder, FD&C red No. 40, glycerin, methylparaben,
natural and artificial
strawberry banana flavor, natural fruit punch flavor, purified water,
sodium benzoate,
sodium citrate, sodium propionate, sodium saccharin, and sucrose.
Promethazine hydrochloride is a racemic compound; the empirical
formula is
C
H
N S•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 and soluble in alcohol.
CLINICAL PHARMACOLOGY
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 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