WARNINGS
WARNING:
PHENERGAN (PROMETHAZINE HCL SUPPOSITORIES 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 IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCL SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.
CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO 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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PHENERGAN SUMMARY
Each rectal suppository contains 12.5 mg or 25 mg promethazine HCl with ascorbyl palmitate, colloidal silicon dioxide, white wax, hard fat, and glyceryl monostearate. Phenergan (Promethazine HCl) Suppositories, USP are for rectal administration only.
PHENERGAN (Promethazine) is indicated for the following:
Phenergan (Promethazine HCl) Suppositories, USP are useful for:
Perennial and seasonal allergic rhinitis.
Vasomotor 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.
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 postoperative 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 Phenergan (Promethazine)
Intravenous promethazine versus lorazepam for the treatment of peripheral vertigo
in the emergency department: A double blind, randomized clinical trial of
efficacy and safety. [2014]
vertigo reduction compared with lorazepam in ED patients... CONCLUSION: Our study demonstrated the evidence that promethazine is superior to
Effects of single therapeutic doses of promethazine, fexofenadine and olopatadine
on psychomotor function and histamine-induced wheal- and flare-responses: a
randomized double-blind, placebo-controlled study in healthy volunteers. [2012]
Since most first-generation antihistamines have undesirable sedative effects on
the central nervous systems (CNS), newer (second-generation) antihistamines have
been developed to improve patients' quality of life. However, there are few
reports that directly compare the antihistaminic efficacy and impairment of
psychomotor functions...
Low-dose adrenaline, promethazine, and hydrocortisone in the prevention of acute adverse reactions to antivenom following snakebite: a randomised, double-blind, placebo-controlled trial. [2011.05]
CONCLUSIONS: Pretreatment with low-dose adrenaline was safe and reduced the risk of acute severe reactions to snake antivenom. This may be of particular importance in countries where adverse reactions to antivenom are common, although the need to improve the quality of available antivenom cannot be overemphasized.
A randomized, placebo-controlled trial of ondansetron, metoclopramide, and promethazine in adults. [2011.03]
OBJECTIVES: The objective of the study was to assess whether ondansetron has superior nausea reduction compared with metoclopramide, promethazine, or saline placebo in emergency department (ED) adults... CONCLUSIONS: Our study shows no evidence that ondansetron is superior to metoclopramide and promethazine in reducing nausea in ED adults. Early study termination may have limited detection of ondansetron's superior nausea reduction over saline. Copyright (c) 2011 Elsevier Inc. All rights reserved.
Promethazine compared with metoclopramide for hyperemesis gravidarum: a randomized controlled trial. [2010.05]
OBJECTIVE: To compare the effects of promethazine with those of metoclopramide for hyperemesis gravidarum... CONCLUSION: Promethazine and metoclopramide have similar therapeutic effects in patients who are hospitalized for hyperemesis gravidarum. The adverse effects profile was better with metoclopramide.
Clinical Trials Related to Phenergan (Promethazine)
Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine [Active, not recruiting]
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.
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.
Morphine Versus Morphine-promethazine Combination for Acute Low Back Pain Relief in the Adult Emergency Department [Not yet recruiting]
Acute low back pain is a common cause for emergency department visits. Controversy remains
regarding the optimal medication for acute low back pain relief. The investigators
hypothesized that administration of pharmacological anxiolysis in addition to analgesia will
improve pain relief and patient management in the emergency department.
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.
Reports of Suspected Phenergan (Promethazine) Side Effects
Hypersensitivity (13),
Pruritus (10),
Constipation (10),
Insomnia (10),
Drug Ineffective (9),
Infection (8),
Eczema (8),
Rash Pruritic (8),
Cerebrovascular Accident (8),
Eosinophilia (8), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Phenergan has an overall score of 5.50. The effectiveness score is 9 and the side effect score is 5. The scores are on ten point scale: 10 - best, 1 - worst.
| | Phenergan review by 42 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Highly Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | Nausea |
| Dosage & duration: | | 1 tablet by mouth every 6 hours taken once every other week for the period of 2 years |
| Other conditions: | | Upset stomach |
| Other drugs taken: | | Prilosec | | |
Reported Results |
| Benefits: | | The medication ease the nausea and my stomach was at ease for at more than a week. The medication relaxed the muscles in my stomach and released the gas trapped. |
| Side effects: | | The medication made you very tired. Soon after taking the medication you fell asleep. After waking up, you feel groggy and tired. The feeling is like you didn't get enough sleep and you will feel this way all day. |
| Comments: | | I was being treated for nausea cause by trapped gas in the stomach and intestines. |
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| | Phenergan review by 42 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | nausea |
| Dosage & duration: | | 1 pill taken once for the period of just once |
| Other conditions: | | cancer |
| Other drugs taken: | | procrit/epogen | | |
Reported Results |
| Benefits: | | Phenergan was given to combat nausea due to chemotherapy. Was given one pill in the ER to try and stop vomiting. It did ease the nausea a bit. |
| Side effects: | | It made me feel like I couldn't sit still even though I was very weak from constant vomiting. I felt like I had bugs crawling all over my legs. I also had to keep moving my legs. |
| Comments: | | One pill was given by mouth with water to ease nausea and vomiting. After about 20 minutes the side effects started. |
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Page last updated: 2014-11-30
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