PROMETHAZINE HYDROCHLORIDE- promethazine hydrochloride tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Lake Erie Medical DBA Quality Care Products LLC

Designación común internacional (DCI):

PROMETHAZINE HYDROCHLORIDE

Composición:

PROMETHAZINE HYDROCHLORIDE 25 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

INDICATIONS AND USAGE 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. CONTRAINDICATIONS Promethazine hydrochloride t

Resumen del producto:

HOW SUPPLIED Promethazine Hydrochloride Tablets USP, 25 mg are scored, round, white tablets imprinted DAN DAN and 5307 supplied in bottles of 100 and 1000. Promethazine Hydrochloride Tablets USP, 50 mg are unscored, round, white tablets imprinted DAN and 5319 supplied in bottles of 100. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
REFERENCE LABEL SET ID: FF54560E-C905-4DF4-B101-1F19A87AF562
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PROMETHAZINE HYDROCHLORIDE 25 MG
DESCRIPTION
Promethazine hydrochloride is a racemic compound.
Promethazine hydrochloride, a phenothiazine derivative, is designated
chemically as 10_H_-
Phenothiazine-10-ethanamine, _N_,_N_,α-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 soluble in water and freely
soluble in alcohol.
Each tablet, for oral administration, contains 25 mg or 50 mg of
promethazine hydrochloride. In addition
each tablet contains the following inactive ingredients: dibasic
calcium phosphate, magnesium stearate,
microcrystalline cellulose, sodium starch glycolate and stearic acid.
Promethazine Hydrochloride Tablets USP, 50 mg also contain anhydrous
lactose.
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 appearing in the urine.
INDICATIONS AND USAGE
Promethazine hydrochloride tablets are useful for:
Perennial and seaso