"The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflam"...
(Generic versions may still be available.)
Phenergan (promethazine) , either orally or by suppository, is useful for:
Perennial and seasonal allergic rhinitis.
Allergic conjunctivitis due to inhalant allergens and foods.
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.
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
Phenergan (promethazine) Tablets and Phenergan (promethazine) Rectal Suppositories are contraindicated for children under 2 years of age (see WARNINGS-Black Box Warning and Use in Pediatric Patients).
Phenergan (promethazine) Suppositories are for rectal administration only.
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.
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, Phenergan (promethazine) Tablets, Syrup, or Rectal Suppositories, 12.5 to 25 mg, twice daily, may be administered.
Nausea and Vomiting
The average effective dose of Phenergan (promethazine) 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. Phenergan (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 Phenergan (promethazine) 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
Phenergan (promethazine) 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 Phenergan (promethazine) 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.
Phenergan (promethazine) Tablets and Phenergan (promethazine) Rectal Suppositories are contraindicated for children under 2 years of age.
Phenergan® (promethazine HCl) Tablets are available as follows:
12.5 mg, orange tablet with "WYETH" on one side and "19" on the scored reverse side.
NDC 0008-0019-01, bottle of 100 tablets.
25 mg, white tablet with "WYETH" and "27" on one side and scored on the reverse side.
NDC 0008-0027-02, bottle of 100 tablets.
NDC 0008-0027-07, Redipak® carton of 100 tablets (10 blister strips of 10).
50 mg, pink tablet with "WYETH" on one side and "227" on the other side.
NDC 0008-0227-01, bottle of 100 tablets.
Keep tightly closed.
Store at controlled room temperature 20º to 25ºC (68º to 77ºF).
Protect from light.
Dispense in light-resistant, tight container.
Use carton to protect contents from light.
Phenergan® (promethazine HCl) Rectal Suppositories are available in boxes of 12 as follows:
12.5 mg, ivory, torpedo-shaped suppository wrapped in copper-colored foil,
25 mg, ivory, torpedo-shaped suppository wrapped in light-green foil, NDC 0008-0212-01.
50 mg, ivory, torpedo-shaped suppository wrapped in blue foil, NDC 0008-0229-01.
Store refrigerated between 2°-8°C (36°-46°F).
Dispense in well-closed container.
Wyeth Pharmaceuticals Inc.,Philadelphia, PA 19101
FDA rev date: 11/8/2004
Last reviewed on RxList: 6/21/2007
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