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Drug Catalog - Product Detail

PROMETHAZINE HCL 50MG TB 100CT

NDC Mfr Size Str Form
57664-0109-88 SUN PHARMACEUTICALS 100 50MG TABLET
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Description
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 17 H 20 N 2 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. Structure
How Supplied
HOW SUPPLIED 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
Indications & Usage
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, 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Promethazine hydrochloride tablets are contraindicated for children under 2 years of age (see WARNINGS: Black Box Warning and Use in Pediatric Patients ). Allergy The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Single 25 mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The administration of promethazine HCl in 25 mg doses will control minor transfusion reactions of an allergic nature. Motion Sickness The average adult dose is 25 mg taken twice daily. The initial dose should be taken one-half to one hour before anticipated travel and be repeated eight to twelve hours later, if necessary. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. For children, promethazine hydrochloride tablets 12.5 to 25 mg, twice daily, may be administered. Nausea and Vomiting Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS: Use in Pediatric Patients ). The average effective dose of promethazine HCl for the active therapy of nausea and vomiting in children or adults is 25 mg. When oral medication cannot be tolerated, the dose should be given parenterally (promethazine injection) or by rectal suppository. 12.5 mg to 25 mg doses may be repeated, as necessary, at four-to six-hour intervals. For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated. For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose is 25 mg repeated at four-to-six hour intervals, as necessary. Sedation This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Administration of 12.5 to 25 mg promethazine HCl by the oral route or by rectal suppository at bedtime will provide sedation in children. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. Pre- and Postoperative Use Promethazine HCl in 12.5 to 25 mg doses for children and 50 mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep. For preoperative medication, children require doses of 0.5 mg per pound of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug. Usual adult dosage is 50 mg promethazine HCl with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid. Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 to 25 mg in children and 25 to 50 mg doses in adults. Promethazine hydrochloride tablets are contraindicated for children under 2 years of age.