PROMETHAZINE HYDROCHLORIDE- promethazine hydrochloride suppository

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Renaissance Pharma, Inc.

INN (nume internaţional):

Promethazine Hydrochloride

Compoziție:

Promethazine Hydrochloride 12.5 mg

Calea de administrare:

RECTAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Promethazine HCl Suppositories, USP 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. Promethazine HCl Suppositories are cont

Rezumat produs:

Promethazine HCl Rectal Suppositories, USP are available in boxes of 12 as follows: 12.5 mg, white, bullet-shaped suppository wrapped in silver foil.   Box of 12     NDC 40085-218-12 25 mg, white, bullet-shaped suppository wrapped in silver foil.      Box of 12     NDC 40085-219-12  Store refrigerated between 2°-8°C (36°-46°F). Dispense in well-closed container. Manufactured for: Renaissance Pharma, Inc. Newtown, PA 18940 By: G&W Laboratories, Inc. South Plainfield, NJ 07080 Rev: 06/2014 8-PROMGW7

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE SUPPOSITORY
RENAISSANCE PHARMA, INC.
----------
PROMETHAZINE HYDROCHLORIDE
SUPPOSITORIES, USP
RX ONLY
DESCRIPTION
Each rectal suppository contains 12.5 mg or 25 mg promethazine HCl
with ascorbyl palmitate, colloidal
silicon dioxide, white wax, hard fat, and glyceryl monostearate.
Promethazine HCl Suppositories,
USP are for rectal administration only.
Promethazine HCl is a racemic compound; the empirical 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
soluble in water and freely 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 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
Promethazine HCl Suppositories, USP are useful for:
Perennial and seasonal allergic rhinitis.
Vasomotor rhinitis.
Allergic conjunctivitis due to inhalant allergens and foods.
17
20
2
1
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