Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494)
Heritage Pharmaceuticals Inc.
PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE 12.5 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, 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
Promethazine Hydrochloride Tablets USP, 12.5 mg are available for oral administration as orange colored, round shaped, biconvex tablets debossed "HP bisect 67"on one side and "Plain" other side and are supplied as: Bottles of 100: NDC 23155-067-01 Promethazine Hydrochloride Tablets USP, 25 mg are available for oral administration as white, round, flat faced tablets debossed "HP 68" on one side and scored on the other side and are supplied as: Bottles of 100: NDC 23155-068-01 Bottles of 1000: NDC 23155-068-10 Promethazine Hydrochloride Tablets USP, 50 mg are available for oral administration as pink colored, round shaped, biconvex tablets debossed "HP 69" on one side and plain other side and are supplied as: Bottles of 100: NDC 23155-069-01 Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Keep tightly closed. Protect from light. Dispense in a tight, light-resistant container as defined in the USP. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 1.866.901. DRUG (3784) 51U000000123US01 Revised: 09/2015
Abbreviated New Drug Application
PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE TABLET HERITAGE PHARMACEUTICALS INC. ---------- RX ONLY DESCRIPTION Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg of promethazine hydrochloride, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate and methylcellulose. 12.5 mg also contain FD and C Yellow No. 6 aluminum lake; 50 mg also contains FD and C Red No. 40 aluminum lake. Promethazine hydrochloride is a racemic compound; the empirical formula is C H N S • HCl and its molecular weight is 320.88. 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 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 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 d Διαβάστε το πλήρες έγγραφο