PROMETHAZINE HYDROCHLORIDE- promethazine hydrochloride tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

NuCare Pharmaceuticals, Inc.

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Promethazine Hydrochloride Tablets 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 and 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 sicknes

Tóm tắt sản phẩm:

Promethazine Hydrochloride Tablets, USP for oral administration are available as: 25 mg: White to off-white, flat-faced, beveled edge, round, uncoated tablets, debossed with “AN” above “521” with single line bisect separating them on one side and plain on the other side are supplied as: Bottles of 6 NDC 68071-3233-6 Bottles of 7 NDC 68071-3233-7 Store at 20º to 25°C (68° to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev. 10-2015-00

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE TABLET
NUCARE PHARMACEUTICALS, INC.
----------
PROMETHAZINE HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Promethazine hydrochloride, a phenothiazine derivative, is designated
chemically as 10- [2-
(Dimethylamino)propyl]phenothiazine monohydrochloride and has the
following structural formula:
Promethazine hydrochloride is a racemic compound; the empirical
formula is C
H
N
S HCl and its
molecular weight is 320.88.
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.
Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg
promethazine hydrochloride, USP.
The inactive ingredients include: lactose anhydrous, magnesium
stearate, and microcrystalline
cellulose. The 50 MG also contains D&C Red # 27 Lake.
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 N-demethylpromethazine are the predominant
metabolites appearing in the urine.
INDICATIONS AND USAGE
Promethazine Hydrochloride Tablets are useful for:
17
20
2
Perennial and seasonal allergic rhinitis.
Vasomotor rhinitis.
Allergic conjunctivitis due to inhalant allergens and foods.
Mild