PROMETHAZINE HYDROCHLORIDE solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Akorn

INN (Nome Internazionale):

PROMETHAZINE HYDROCHLORIDE

Composizione:

PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Promethazine is useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated 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 is contraindicated for use in pediatric patients less than two years of age. Promethazin

Dettagli prodotto:

Promethazine Hydrochloride Oral Solution, USP is supplied as follows: bottle of 4 oz (118 mL) bottle of 8 oz (237 mL) bottle of 16 oz (473 mL) Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in light-resistant, tight container. Distributed by: Akorn Operating Company LLC Gurnee, IL 60031 Rev. 801:07 07/22

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE SOLUTION
AKORN
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PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION USP
DESCRIPTION
Each 5 mL (teaspoonful) of Promethazine Hydrochloride Oral Solution,
USP contains:
6.25 mg of Promethazine HCl.
The inactive ingredients present are alcohol 7%, ascorbic acid, citric
acid, D&C Red No.
33, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6,
methylparaben, natural
cherry flavor, propylene glycol, propylparaben, purified water,
saccharin sodium, sodium
benzoate, sodium citrate, and sucrose syrup. Citric acid or sodium
citrate is used to
adjust the pH to 4.6 to 5.0.
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
10_H_-Phenothiazine-10-ethanamine,_N,N_,á-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 promethazine and N-
17
20
2
1
demethylpromethazine are the predominant meta