Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494)
PD-Rx Pharmaceuticals, Inc.
PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE 50 mg
ORAL
PRESCRIPTION DRUG
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 apprehens
Promethazine Hydrochloride Tablets, USP for oral administration are available as: 50 mg: Pink color, biconvex, round tablets, debossed with “AN” above “522” on one side and plain on the other side are supplied as: Bottles of 4: NDC 43063-447-04 Store at 20º to 25°C (68° to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.
Abbreviated New Drug Application
PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE TABLET PD-RX 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 17 20 2 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 seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, Przeczytaj cały dokument