BOX WARNING WARNING:
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.
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PHENADOZ SUMMARY
PHENADOZ®
Promethazine HCl
Suppositories USP
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.
Vasomotor 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.
Dermographism.
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.
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NEWS HIGHLIGHTS
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.
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.
Adjunct Sedatives in Procedures Involving Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP) [Recruiting]
The purpose of this study is to compare meperidine/midazolam with diphenhydramine,
meperidine/midazolam with promethazine, and meperidine/midazolam with placebo as sedation
methods. The investigators are interested to see whether adjunct sedatives (diphenhydramine
and promethazine) will improve sedation.
Evaluation of Treatment Satisfaction in Children With an Allergy and Who Received an Antihistamine [Not yet recruiting]
This is a non-interventional retrospective data collection study from children aged from 2 to
12 years old diagnosed with an allergy and who received a treatment consisting of an
H1-antihistamine. The period of last taken medication will be observed to evaluate the global
satisfaction of the parents and physician for this last treatment.
Diphenhydramine, Lorazepam, and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy in Young Patients With Newly Diagnosed Cancer [Recruiting]
RATIONALE: Diphenhydramine, lorazepam, and dexamethasone may help lessen or prevent nausea
and vomiting in patients treated with chemotherapy. It is not yet known whether
diphenhydramine, lorazepam, and dexamethasone are more effective than standard therapy in
treating nausea and vomiting caused by chemotherapy.
PURPOSE: This randomized phase II trial is studying diphenhydramine, lorazepam, and
dexamethasone to see how well they work compared with standard therapy in treating nausea and
vomiting caused by chemotherapy in young patients with newly diagnosed cancer.
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Page last updated: 2006-01-31
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