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)
To Determine if Diphenhydramine Works for Nasal Congestion at Two Different Doses [Completed]
The study was to determine if the drug worked to relieve nasal congestion experienced by
people with seasonal allergies.
A Dose Ranging Effect of Preoperative Diphenhydramine on Postoperative Quality of Recovery After Ambulatory Surgery [Recruiting]
Pain after ambulatory surgery remains an unsolved problem in The United States and Europe.
It is associated with delayed hospital discharge and it can result to an increased opioid
consumption with adverse side effects. The concept of multimodal analgesic technique was
introduced more than 15 years ago and several techniques have been studied over the years
including non steroidal antiinflammatory drugs (NSAIDs), acetaminophen, gabapentoids,
ketamine, local and regional anesthetic techniques. Histamine can have effects on polymodal
nociceptors and C-fibers, producing pain which is further increased by neurogenically
mediated release of substance P from afferent pain fibers. Several non-selective or H1
- selective histamine receptors antagonists have been demonstrated in animal models and
clinical pain. Chia et al demonstrated that preoperative promethazine had opioid sparing
properties without adverse sedative effects in patients undergoing abdominal hysterectomy.
Diphenhydramine is an anti-histamine drug who has been found to be effective in reducing
postoperative nausea and vomiting after ambulatory surgery but its effects on postoperative
pain and other important outcomes after ambulatory surgery such as time to meet discharge
criteria have not being studied.
The MQOR 40 is a validated instrument that was specifically design to evaluate patient
recovery after anesthesia and surgery. This instrument can be particularly valid to examine
interventions which affect different spheres of patient recovery as is the case of
diphenhydramine. The objective of this study is to determine a dose response effect of
preoperative diphenhydramine on postoperative quality of recovery after ambulatory surgery.
The use of preoperative diphenhydramine can improve patient's quality of recovery, decrease
postoperative pain, opioid consumption and opioid related side effects after ambulatory
The research question: Does a preoperative dose of diphenhydramine improve postoperative
quality of recovery after ambulatory surgery? The hypothesis of this study is that
preoperative diphenhydramine will improve postoperative pain, Postoperative nausea and
vomiting (PONV), sleep which will translate in a better overall quality of recovery.
Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Patients With Nausea [Recruiting]
This randomized clinical trial studies lorazepam, diphenhydramine hydrochloride, and
haloperidol gel in patients with nausea. Lorazepam, diphenhydramine hydrochloride, and
haloperidol gel, when absorbed into the skin, may be an effective treatment for nausea and
Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride [Completed]
The purpose of this study is to determine if two formulations of diphenhydramine
hydrochloride are bioequivalent.
Aprepitant Versus Ondansetron in Preoperative Triple-therapy Treatment of Nausea and Vomiting [Recruiting]
This study is being done to determine the efficacies of two preventative drug combinations
for postoperative nausea and vomiting in patients undergoing neurosurgery. The aim of this
study is to compare the efficacy of using aprepitant instead of ondansetron in combination
with dexamethasone and promethazine for post-operative nausea and vomiting prophylaxis. By
completing this comparison study investigators will determine the most efficacious drug
combination which will allow us to enhance the overall comfort and satisfaction of
neurosurgical patients in the immediate postoperative period.
Page last updated: 2006-02-01