PROMETHAZINE HYDROCHLORIDE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

DIRECT RX

INN (Nome Internazionale):

PROMETHAZINE HYDROCHLORIDE

Composizione:

PROMETHAZINE HYDROCHLORIDE 25 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 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 are contraindicated for use in p

Dettagli prodotto:

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. Keep tightly closed. Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Protect from light. Manufactured By: Watson Pharma Private Ltd. Verna, Salcette Goa 403 722 INDIA Distributed By: Watson Pharma, Inc. Corona, CA 92880 USA Revised: June 2009 190824 0609B

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE TABLET
DIRECT RX
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PROMETHAZINE HYDROCHLORIDE
DESCRIPTION SECTION
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.
INDICATIONS & USAGE SECTION
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
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.
CONTRAINDICATIONS SECTION
Promethazine hydrochloride tablets are contraindicated for use in
pediatr