PROMETHAZINE HYDROCHLORIDE tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Life Line Home Care Services, Inc.

INN（国際名）:

PROMETHAZINE HYDROCHLORIDE

構図:

PROMETHAZINE HYDROCHLORIDE 25 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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, 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 hydrochloride tablets are contraindicated for use in pe

製品概要:

Promethazine Hydrochloride Tablets, USP are available as follows: 12.5 mg: orange, round, scored tablet debossed "5138" on one side and debossed "V" on the reverse side, in bottles of 10, 100 and 1000. 25 mg: white, round, scored, flat-faced beveled edge tablet debossed "5137" on one side and debossed "V" on the reverse side, in bottles of 10, 100, 1000 and 2500. 50 mg: pink, round tablet debossed "5136" on one side and debossed "V" on the reverse side, in bottles of 10, 100 and 1000.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

PROMETHAZINE HYDROCHLORIDE - PROMETHAZINE HYDROCHLORIDE TABLET
LIFE LINE HOME CARE SERVICES, INC.
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PROMETHAZINE HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
Each tablet for oral administration contains 12.5 mg, 25 mg, or 50 mg
promethazine HCl. The inactive
ingredients present are colloidal silicon dioxide, disodium EDTA,
hypromellose, lactose monohydrate,
magnesium stearate, microcrystalline cellulose, saccharin sodium, and
sodium starch glycolate. 12.5 mg
also contains - FD&C Yellow No. 5 Aluminum Lake and FD&C Yellow No. 6
Aluminum Lake; 50 mg
also contains - FD&C Blue No. 2 Aluminum Lake and FD&C Red No. 40
Aluminum Lake.
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
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
17
20
2
1
promethazine and N-demethylpromethazine are the predominant
metabolites