Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494)
Sun Pharmaceutical Industries, 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 angiodema. 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. Promethazine hydrochloride tablets are contraindicated for use in pediat
Promethazine hydrochloride tablets, USP contains 12.5 mg, 25 mg or 50 mg as promethazine hydrochloride, USP and are supplied as follows: 12.5 mg : Light peach, round, biconvex, uncoated tablets, debossed “107” on one side and scored on the other side. NDC 57664-107-83 Bottles of 30 CRC NDC 57664-107-88 Bottles of 100 CRC NDC 57664-107-08 Bottles of 100 NDC 57664-107-13 Bottles of 500 NDC 57664-107-18 Bottles of 1000 25 mg : White to off-white, round, flat face bevel edge, uncoated tablets, debossed “108” on one side and scored on the other side. NDC 57664-108-83 Bottles of 30 CRC NDC 57664-108-88 Bottles of 100 CRC NDC 57664-108-08 Bottles of 100 NDC 57664-108-13 Bottles of 500 NDC 57664-108-18 Bottles of 1000 50 mg : Light pink, round, biconvex, uncoated tablets, debossed “109” on one side and plain on the other side. NDC 57664-109-83 Bottles of 30 CRC NDC 57664-109-88 Bottles of 100 CRC NDC 57664-109-08 Bottles of 100 NDC 57664-109-13 Bottles of 500 NDC 57664-109-18 Bottles of 1000 Store at 20° - 25°C (68° - 77°F). (See USP Controlled Room Temperature). Dispense in tight, light-resistant container. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 6044T04 Rev. 07/2014
Abbreviated New Drug Application
PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE TABLET SUN PHARMACEUTICAL INDUSTRIES, INC. ---------- DESCRIPTION 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 is a racemic compound; the molecular 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: hypromellose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The 12.5 mg contains FD&C Yellow No.6 aluminum lake. The 50 mg contains D&C Red Lake Blend No.27 aluminum lake and D & C Red No. 30 aluminum 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 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 rhin Lestu allt skjalið