PROMETHAZINE HYDROCHLORIDE- promethazine solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals LLC

INN (International Name):

PROMETHAZINE HYDROCHLORIDE

Composition:

PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Promethazine HCl Oral Solution 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 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. Promethazine HCl Oral Solution is contraindicated for use in pediatric p

Product summary:

Promethazine HCl Oral Solution USP, 6.25 mg/5 mL , is a clear, green colored solution. It is available as follows: 4 fl oz (118 mL)          NDC 65162-678-86 16 fl oz (473 mL)        NDC 65162-678-90 KEEP TIGHTLY CLOSED.   Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT. Dispense in tight, light-resistant container as defined in the USP, with a child-resistant closure. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 12-2019-00

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE SOLUTION
AMNEAL PHARMACEUTICALS LLC
----------
PROMETHAZINE HCL ORAL SOLUTION, USP
6.25 MG/5 ML
RX ONLY
DESCRIPTION
Each teaspoonful (5 mL) of Promethazine HCl Oral Solution, USP
contains 6.25 mg of
promethazine HCl, USP in a flavored syrup base with a pH between 4.7
and 5.2. Alcohol
7%. The inactive ingredients present are alcohol, ascorbic acid,
citric acid, D&C Yellow #
10, edetate disodium, FD&C Blue # 1, glycerin, methylparaben, natural
and artificial
banana flavor, natural and artificial fruit flavor, saccharin sodium,
sodium benzoate,
sodium citrate, and sucrose.
Promethazine HCl, USP is a racemic compound; the molecular formula is
C
H
N S•HCl
and its molecular weight is 320.88.
Promethazine HCl USP, a phenothiazine derivative, is designated
chemically as 10_H_-
Phenothiazine-10-ethanamine, _N,N_, α-trimethyl-, monohydrochloride,
(±)- with the
following structural formula:
Promethazine HCl, USP 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
17
20
2
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 promethazine and N-
demethylpromethazine are the predominant metabolites appearing in t