Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494)
Liberty Pharmaceuticals, Inc.
PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE 25 mg
ORAL
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
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 Lesen Sie das vollständige Dokument