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Promethazine HCl Syrup
(promethazine HCl) Syrup Plain
Each teaspoon (5 mL) of Promethazine HCl Syrup Plain contains 6.25 mg promethazine HCl in a flavored syrup base with a pH between 4.7 and 5.2. Alcohol 7%. The inactive ingredients present are artificial and natural flavors, citric acid, D&C Red 33, D&C Yellow 10, FD&C Blue 1, FD&C Yellow 6, glycerin, saccharin sodium, sodium benzoate, sodium citrate, sodium propionate, water, and other ingredients.
Promethazine HCl is a racemic compound; the empirical formula is C17H20N2S•HCl and its molecular weight is 320.88.
Promethazine HCl, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10 ethanamine, N,N, α-trimethyl-, monohydrochloride, (±)-
Promethazine HCl 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.
Promethazine HCl Syrup (promethazine hydrochloride syrup plain) Plain is useful for:
Perennial and seasonal allergic 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 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
It is important that Promethazine HCl Syrup (promethazine hydrochloride syrup plain) Plain is measured with an accurate measuring device (see PRECAUTIONS-Information for Patients). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose.
Promethazine HCl Syrup (promethazine hydrochloride syrup plain) Plain is contraindicated for children under 2 years of age (see WARNINGS – Boxed Warning and Use in Pediatric Patients).
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 taken on arising and again before the evening meal. For children, 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 Syrup (promethazine hydrochloride syrup plain) Plain 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 Hydrochloride 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 HCl Syrup (promethazine hydrochloride syrup plain) Plain by the oral route 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 Syrup (promethazine hydrochloride syrup plain) Plain 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 Syrup (promethazine hydrochloride syrup plain) Plain 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 HCl Syrup (promethazine hydrochloride syrup plain) Plain is contraindicated for children under 2 years of age.
Promethazine HCl Syrup (promethazine hydrochloride syrup plain) Plain is a clear, green solution supplied as follows:
NDC 62559-7481-4 – bottle of 4 fl. oz. (118 mL)
NDC 62559-7481-6 – bottle of 16 fl. oz. (473 mL)
Keep bottles tightly closed.
Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature.]
Protect from light.
Dispense in tight, light-resistant container (USP/NF) with a child-resistant closure.