RVP

Drug Catalog - Product Detail

PROMETHAZINE HCI TB 50MG 100

NDC Mfr Size Str Form
10702-0004-01 KVK TECH 100 50MG TABLET
Product Image

PACKAGE FILES

Package Image
Package Image
Package Image
Generic Name
Substance Name
Product Type
Route
Application Number
Description
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 C 17 H 20 N 2 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 ,_-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. Structure
How Supplied
HOW SUPPLIED Promethazine hydrochloride tablets, USP are available as follows: Promethazine hydrochloride tablets, USP 12.5 mg are supplied as orange colored, round shaped, biconvex tablets, debossed “K” on left and “2” on right of bisect, on one side and plain on the other side. Bottles of 100, NDC 10702-002-01 Bottles of 1000, NDC 10702-002-10 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 100, NDC 10702-003-01 Bottles of 1000, NDC 10702-003-10 Promethazine hydrochloride tablets, USP 50 mg are supplied as pink colored, round shaped, biconvex tablets, debossed “K 4” on one side and plain on the other side. Bottles of 100, NDC 10702-004-01 Bottles of 1000, NDC 10702-004-10 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 # 006025/02 07/14 Manufacturer’s Code: 10702 Logo
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Promethazine hydrochloride tablets, USP are contraindicated for children under 2 years of age (see WARNINGS - Black Box Warning and Use in Pediatric Patients ). Promethazine hydrochloride tablets, USP are for oral administration only. 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 mg 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 hydrochloride 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 8 to 12 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, USP 12.5 mg 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 hydrochloride tablets, USP for the active therapy of nausea and vomiting in children or adults is 25 mg. 12.5 to 25 mg doses may be repeated, as necessary, at 4 to 6 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 4 to 6 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 hydrochloride orally 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 hydrochloride tablets, USP 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 hydrochloride tablets, USP 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, USP are contraindicated for children under 2 years of age.