PROMETHAZINE HYDROCHLORIDE syrup

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

Promethazine Hydrochloride (UNII: R61ZEH7I1I) (Promethazine - UNII:FF28EJQ494)

Disponibbli minn:

Proficient Rx LP

INN (Isem Internazzjonali):

Promethazine Hydrochloride

Kompożizzjoni:

Promethazine Hydrochloride 6.25 mg in 5 mL

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Promethazine 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 Syrup is contraindicated for use in pediatric patients less than two years of

Sommarju tal-prodott:

Promethazine Syrup Plain 6.25 mg/5 mL is available as follows: 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.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE SYRUP
PROFICIENT RX LP
----------
PROMETHAZINE SYRUP PLAIN 6.25 MG/5 ML
(PROMETHAZINE HYDROCHLORIDE SYRUP, USP)
RX ONLY
DESCRIPTION
Each 5 mL (teaspoonful) of Promethazine contains 6.25 mg of
promethazine HCl. The inactive
ingredients present are artificial banana flavor, artificial fruit
flavor, artificial strawberry flavor,
ascorbic acid, citric acid anhydrous, dehydrated alcohol, D&C Yellow
No. 10, edetate disodium,
FD&C Blue No. 1, FD&C Red No. 40, glycerin, liquid sugar,
methylparaben, purified water, saccharin
sodium, sodium benzoate, sodium citrate dihydrate, and sodium
propionate.
Promethazine HCl is a racemic compound; the molecular formula is C
H N S•HCl and its molecular
weight is 320.88.
Promethazine HCl, a phenothiazine derivative, is designated chemically
as 10_H_-Phenothiazine-10-
ethanamine, _N,N,_ α-trimethyl-, monohydrochloride, (±)- with the
following structural formula:
Promethazine HCl 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-demethylpromethazine are the predominant
metabolites appe