PROMETHAZINE HCL SUPPOSITORIES, USP SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION.
POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HCL SUPPOSITORIES, USP IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCL SUPPOSITORIES, USP HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.
CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HCL BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.
Each rectal suppository of Phenadoz contains 12.5 mg or 25 mg promethazine HCl with ascorbyl palmitate, colloidal silicon dioxide, white wax, and cocoa butter. Phenadoz Suppositories are for rectal administration only.
PHENADOZ (promethazine RECTAL) is indicated for the following:
Phenadoz is useful for:
Perennial and seasonal allergic rhinitis.
Allergic conjuctivitis 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.
Published Studies Related to Phenadoz (Promethazine Rectal)
Pharmacokinetics of promethazine hydrochloride after administration of rectal suppositories and oral syrup to healthy subjects. [2000.08.15]
The pharmacokinetics of promethazine hydrochloride after administration of rectal suppositories at three dosage strengths and oral syrup were studied... All formulations were comparable in terms of dose-normalized AUC and t1/2, and the three suppository treatments were comparable in terms of dose-normalized Cmax.
Rectal thiopental compared with intramuscular meperidine, promethazine, and chlorpromazine for pediatric sedation. [1991.06]
STUDY OBJECTIVES: We studied the hypothesis that rectal thiopental is an effective agent for emergency department pediatric sedation and may have advantages over a more traditional regimen... CONCLUSION: Rectal thiopental is superior to this drug combination for pediatric sedation because it can be administered painlessly, has a more rapid onset and offset of action, and is of equal safety and efficacy at the dosage studied.
Promethazine toxicity in a seven-month-old Doberman pinscher. [1995.06]
A 7-mo-old female Doberman Pinscher undergoing antibiotic treatment for tonsillitis was presented in near collapse with markedly low blood pressure, tachycardia, dilatation of pupils (non-responsive to light), and gastrointestinal distress. Since the owner could provide no history of significant toxin exposure, general supportive and non-specific toxicologic treatment protocols were initiated...
Clinical Trials Related to Phenadoz (Promethazine Rectal)
Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine [Active, not recruiting]
Diphenhydramine for Acute Migraine [Completed]
Parenteral diphenhydramine is commonly used as adjuvant therapy for acute migraine despite
the fact that data supporting this practice do not exist. The investigators propose a
randomized double blind study to test the hypothesis that 50mg of intravenous
diphenhydramine, when added to standard migraine therapy, will result in a greater rate of
sustained headache relief than standard migraine therapy alone. For this study, standard
migraine therapy will be 10mg of intravenous metoclopramide. Sustained headache relief is
defined as achieving a headache level of "mild" or "none" within two hours and maintaining a
level of "mild" or "none" for 48 hours. Patients who present to the Montefiore emergency
room (Bronx, NY) with an acute migraine will be approached for participation. They will be
screened for medication contra-indications and non-migraine etiologies of headache. The
study will be randomized. Assignment will be concealed. Participants and researchers will be
blinded. Efficacy outcomes and adverse events will be assessed every half hour for two hours
in the ED and by telephone 48 hours after medication administration. A sample size
calculation, based on pilot data, revealed the need for 374 participants. An interim
analysis will be performed after 200 participants have been enrolled with the goal of
assessing for lack of conditional power.
Study of Promethazine for Treatment of Diabetic Gastroparesis [Recruiting]
Adult diabetic patients (ages 18-65) with gastric emptying scintigraphy-confirmed delayed
gastric emptying will be recruited to participate in the study. Using double-blinded
methodology, study participants will be randomly assigned to one of two treatment arms:
promethazine 12. 5 mg three times daily for 28 days or placebo three times daily for 28 days.
The primary outcome will be the change in gastroparesis symptom severity, as measured by
the Gastroparesis Cardinal Symptom Index (GCSI) at four weeks compared to baseline.
Participants will be seen for a clinic evaluation at weeks 0, 2 and 4, during which symptom
scores, adverse events and treatment compliance will be assessed. It is hypothesized
promethazine treatment will be superior to placebo in improving symptoms of gastroparesis.
Antitussive Effect of a Naturally Flavored Syrup Containing Diphenhydramine, Compared With Dextromethorphan and Placebo [Completed]
The purpose of this study is to evaluate the antitussive (cough-suppressing) effects of two
liquid medications: a combination of diphenhydramine and phenylephrine in a naturally cocoa
flavoring, and, dextromethorphan syrup, compared with placebo.
Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fed Condition [Completed]
Page last updated: 2006-02-01