"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
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.
- 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
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. The administration of promethazine HCl (promethazine hydrochloride) in 25-mg doses will control minor transfusion reactions of an allergic nature.
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, syrup, or rectal suppositories, 12.5 to 25 mg twice daily, may be administered.
Nausea and Vomiting
The average effective dose of promethazine hydrochloride 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 (cf. Promethazine Injection) or by rectal suppository. 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.
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 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 hydrochloride 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 (promethazine hydrochloride) 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.
Promethazine Hydrochloride Tablets USP, 25 mg are scored, round, white tablets imprinted DAN DAN and 5307 supplied in bottles of 100 and 1000.
Promethazine Hydrochloride Tablets USP, 50 mg are unscored, round, white tablets imprinted DAN and 5319 supplied in bottles of 100.
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. Keep tightly closed.
Store at controlled room temperature 20 -25°C (68 -77°F). [See USP Controlled Room Temperature]. Protect from light.
Watson Laboratories, Inc. Corona, CA 92880, USA. Revised: January 2005. FDA Rev date: 4/25/2001
Last reviewed on RxList: 6/13/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Promethazine HCl Information
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