PROMETHAZINE HYDROCHLORIDE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Liberty Pharmaceuticals, Inc.

INN (International Adı):

PROMETHAZINE HYDROCHLORIDE

Kompozisyon:

PROMETHAZINE HYDROCHLORIDE 25 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Promethazine hydrochloride tablets, 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 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 hydrochloride tablets, USP are contraindicated fo

Ürün özeti:

Promethazine hydrochloride tablets, USP are available as follows: Promethazine hydrochloride tablets, USP 25 mg are supplied as white colored, round shaped, flat face bevel edge tablets, debossed “K 3” on one side and quadrisected on the other side. Bottles of 12, NDC 00440-8195-12 Store at 20° to 25°C with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured by: KVK-TECH, INC. 110 Terry Drive Newtown, PA 18940-1850 Item ID # 006025/01 05/07 Manufacturer’s Code: 10702 Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE TABLET
LIBERTY PHARMACEUTICALS, INC.
----------
UNKNOWN TITLE
DESCRIPTION
Each 12.5 mg promethazine hydrochloride tablet for oral administration
contains 12.5 mg promethazine
hydrochloride.
Each 25 mg promethazine hydrochloride tablet for oral administration
contains 25 mg promethazine
hydrochloride.
Each 50 mg promethazine hydrochloride tablet for oral administration
contains 50 mg promethazine
hydrochloride.
Each tablet contains the following inactive ingredients: lactose
monohydrate, magnesium stearate, and
methylcellulose.
In addition, 50 mg tablet contains FD&C Red #40 and 12.5 mg tablet
contains FD&C Yellow #6.
Promethazine hydrochloride is a racemic compound; the empirical
formula is
C17H20N2S•HCl and its molecular weight is 320.88.
Promethazine hydrochloride, a phenothiazine derivative, is designated
chemically as
10_H_-Phenothiazine-10-ethanamine, _N,N_,_-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 H1 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