stream Deep IM injection is the preferred route of administration. You could have more side effects. Stability at Room Temperature** FOR SPECIFIC INFORMATION, CONTACT MANUFACTURER. Promethazine Dosage must be individualized. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Promethazine Dosage Guide + Max Dose, Adjustments - Drugs.com Acidosis and electrolyte losses should be corrected. To determine the activation energy necessary by constructing an Arrhenius plot. and transmitted securely. you should know that this medication may make you drowsy. It is not known whether promethazine HCl is excreted in human milk. IV formulations should be diluted to a concentration of 25 mg/mL or less. this version. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. 20 N ) or by phone (1-800-332-1088). 03/2020 VC7409, Boxed Warnings, In the in vivo experiments, the plasma indomethacin levels after administration of suppositories stored at different temperatures were measured in conscious and anesthetized rats. Promethazine HCl Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function. (see Promethazine HCl Suppositories may cause marked drowsiness or impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Talk with the doctor. Disclaimer. www.fda.gov/medwatch. The first-order rate constant increased with increasing pH. to you and the baby. Store them away from light, heat, and moisture. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Administration of 12.5 to 25 mg promethazine HCl by rectal suppository at bedtime will provide sedation in children. Parenteral: 12.5 mg IM or IV once, and may be repeated within 2 hours if necessary Bioequivalence and pharmacokinetic profile of promethazine hydrochloride suppositories in humans. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. If you think there has been an overdose, call your poison control center or get medical care right away. Carcinogenicity Under the conditions of the National Toxicology Program (NTP) studies, there was no evidence of Allergic conjunctivitis due to inhalant allergens and foods. Other Angioneurotic edema. 0713-0526-12, Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. WebThe NDC Packaged Code 0713-0526-12 is assigned to a package of 12 suppository in 1 box of Promethegan, a human prescription drug labeled by Cosette Pharmaceuticals, Inc.. Unable to load your collection due to an error, Unable to load your delegates due to an error. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or An official website of the United States government. WARNINGSBlack Box Warning and Adjunctive therapy to epinephrine and other standard measures for anaphylactic reactions, after acute manifestations have been controlled, Parenteral: 6.25 to 12.5 mg IM or IV every 4 hours a day, Oral and Rectal: 12.5 to 25 mg orally or rectally 2 times a day. help if any of these side effects or any other side effects bother you or do not go away: These are not all of the side effects that may occur. All oral versions (tablets, syrup) of promethazine should be stored in the original, labeled container at room temperature. Promethazine HCl Suppositories are useful for: Perennial and seasonal allergic rhinitis. When promethazine is used to treat motion sickness, it is taken 30 to 60 Clipboard, Search History, and several other advanced features are temporarily unavailable. DOSAGE AND ADMINISTRATION Off-label information indicates unopened bottle stable when maintained at continuous room 2 years and older: Treatment: Oral or Rectal: 1.1 mg/kg orally or rectally every 4 to 6 hours as needed. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. suppository. Combination products containing promethazine and codeine should not be given to children younger than 16 years old. Vaginal Suppositories Allow suppository to reach room temperature just prior to administration. Promethazine HCl is a racemic compound; the empirical formula is C 1990 Apr;38(4):1027-31. doi: 10.1248/cpb.38.1027. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Use in Pediatric Patients). Prophylactic doses may be used to prevent nausea and vomiting during surgery and the postoperative period. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Dermographism. WebPromethazine HCl 25mg. endobj Before 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. Keep this medication in the carton or container it came in, tightly closed, and out of reach of children. Promethegan (promethazine hydrochloride) dose, indications, It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. Comments: 2 years and older: Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. If you have any of these health problems: If you have any of these health problems: Low blood cell count or poor bone marrow function. Box of 12 NDC 0713-0536-12 See the FDA's Safe Disposal of Medicines website ( We comply with the HONcode standard for trustworthy health information. Subcutaneous administration is contraindicated. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. 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. Distributedby: Cosette Pharmaceuticals, Inc. In the in vitro release test using a dialysis cell method, much lower amounts of indomethacin were released from the suppositories stored at a high temperature than from those stored at a low temperature. Ask the doctor or pharmacist if you are not sure. Phenergan, Promethegan, Antinaus 50, Phenadoz. Promethazine may make your skin sensitive to sunlight. Protect the medication from light. Promethazine HCl 12.5mg. All Rights Reserved. FROZEN Drugs Pregnancy Tests Purpose: The aim of this review was to build upon previous literature describing the maximum duration for which refrigerated medications can tolerate room temperature excursions while maintaining stability and potency. This site needs JavaScript to work properly. Remove the wrapper. If you will be giving promethazine to a child, also tell the child's doctor if the child has any of the following symptoms before he or she receives the medication: vomiting, listlessness, drowsiness, confusion, aggression, seizures, yellowing of the skin or eyes, weakness, or flu-like symptoms. RESPIRATORY DEPRESSION (PEDIATRIC PATIENTS): This drug should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. View NDC Code(s)NEW! government site. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. PROMETHEGAN- promethazine hydrochloride suppository, 0713-0526-10, ), More about getting RSS News & Updates from DailyMed, 12 in 1 BOX; Type 0: Not a Combination Product, 1000 in 1 BOX; Type 0: Not a Combination Product, Cosette Pharmaceuticals NC Laboratories, LLC, analysis(0713-0526, 0713-0536) , label(0713-0526, 0713-0536) , manufacture(0713-0526, 0713-0536) , pack(0713-0526, 0713-0536), 6 The information is not a substitute for medical care. WebPromethazine is an H1 receptor blocking agent. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Note that any depressant effects of promethazine HCl are not reversed by naloxone. 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. Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Webstore at a room temperature not to exceed 77F (25C) for up to 6 weeks. Promethazine HCl Suppositories, USP are useful for: Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Preoperative, postoperative, or obstetric sedation. <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> Stored in a warmer box to prevent crystallization If you are giving promethazine to a child, watch the child to be sure he or she does not get hurt while riding a bike or participating in other activities that could be dangerous. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. If you are taking any drugs that can stop your bone marrow from making some of the cells that your body needs. Disclaimer. Promethazine helps control symptoms, but will not treat the cause of the symptoms or speed recovery. Labels, All Index WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Promethazine should not routinely be used to treat vomiting in children; it should only be used in specific cases when a doctor decides that it is needed. If you experience any of the following symptoms, call your doctor immediately: If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Oxidative degradation of pharmaceutically important phenothiazines III: Kinetics and mechanism of promethazine oxidation. Many times this medicine (promethazine suppositories) is taken on an as needed basis. Kinetic studies were performed to determine the photolytic and thermal degradation rates of promethazine hydrochloride as a function of pH. WebPROMETHAZINE (proe METH a zeen) prevents and treats the symptoms of an allergic reaction. Accessibility The site is secure. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Manufacturer Contact Information (Quality Control) InterMune, Inc. 888 The administration of promethazine hydrochloride in 25-mg doses will control minor transfusion reactions of an allergic nature. Salmonella test system of Ames. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. You will need to talk about the benefits and risks WARNINGS Use in Pediatric Patients). Medication Storage Flashcards | Quizlet sharing sensitive information, make sure youre on a federal Methods: During a 12-month period ending in June 2021, the prescribing information and published Treatment Drug classes: Antihistamines, Phenothiazine antiemetics. Shakiness, trouble moving around, or stiffness. Study on absorption of indomethacin from sustained-release suppositories containing hydrogenated soybean lecithin in rabbits. Pediatric patients should be supervised to avoid potential harm in bike riding or other hazardous activities. Promethazine HCl Suppositories may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Promethazine Suppositories Information - Drugs.com 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. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. Call your doctor or get medical PROMETHEGAN (Cosette Pharmaceuticals, Inc.): FDA Package Limited data suggest that use of promethazine HCl during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. WARNING: Stavchansky S, Wallace JE, Geary R, Hecht G, Robb CA, Wu P. J Pharm Sci. Tell your doctor or pharmacist about all the medications your child is taking, especially barbiturates such as phenobarbital (Luminal), medications for anxiety, narcotic medications for pain, sedatives, sleeping pills, and tranquilizers. Active and prophylactic treatment of motion sickness. Call your child's doctor immediately and get emergency medical treatment if your child has difficulty breathing, wheezes, slows or pauses in breathing, or stops breathing. Dermographism. The initial dose should be given 30 to 60 minutes before anticipated travel, and may be repeated in 8 to 12 hours as needed. Promethazine HCl is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Sedative doses may be given the night before surgery. Promethazine HCl 50mg. The site is secure. 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. Instead, the best way to dispose of your medication is through a medicine take-back program. Comments: Oral or Rectal: 25 to 50 mg orally or rectally once Pediatric patients should be supervised to avoid potential harm in bike riding or other hazardous activities. Convulsions may rarely occur. Drowsiness is the most prominent CNS effect of this drug. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Careers. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. Available for Android and iOS devices. https://www.poisonhelp.org/help The melting point of suppositories stored at a high temperature was higher by approximately 2 degrees C than those stored at a low temperature. Refrigerator settings should be mid-range at +5C (41F) to allow the highest Unauthorized use of these marks is strictly prohibited. Promethazine HCl is a racemic compound; the empirical formula is C Stand up after about 15 minutes. Promethazine hydrochloride Oral / IV / Suppository CNS Depressants Promethazine HCl Suppositories may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. Use. Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see Tell your doctor if any of these symptoms are severe or do not go away: Some side effects can be serious. 8600 Rockville Pike Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Promethazine HCl is a racemic compound; the empirical formula is C17H20N2SHCl and its molecular weight is tablet. 65 years and older: Elderly patients should be given lower initial doses and should be closely monitored for adverse events. Parenteral formulations: Store ampoules in the carton until ready to use. Tell your Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. The stability of aqueous solutions of promethazine hydrochloride as a function of pH. Antiemetic therapy in postoperative patients. & Articles, All Presence in Breast Milk, Medline Plus, How to classify reactions as zero, first, and second order reactions and their corresponding reactions rates. N,N -trimethyl-, monohydrochloride, ()- with the following structural formula: Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. Medically reviewed by Drugs.com. Promethazine is also used to prevent and treat motion sickness. The average adult dose is 25 mg taken twice daily. 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. Follow all instructions closely. Promethazine Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. Antiemetic therapy in postoperative patients. The syrup version of promethazine should be in a light-protected bottle with the lid tightly closed at all times. WebIndomethacin suppositories are contraindicated in patients with a history of proctitis or recent rectal bleeding. official website and that any information you provide is encrypted Indomethacin (Rectal Route) Proper Use - Mayo Clinic Promethazine is a phenothiazine derivative, which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. The use of alcohol or other central-nervous-system depressants such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers, may enhance impairment Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. Promethazine FDA Warning promethazine This includes your doctors, nurses, pharmacists, and dentists. Also tell the child's doctor if the child has not been drinking normally, has had excessive vomiting or diarrhea, or appears dehydrated. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. In anesthetized rats, the plasma indomethacin levels were markedly lower than those in conscious rats, and the influence of the storage temperature on the plasma indomethacin levels was clearly observed. Promethazine suppositories are for rectal use only. WARNINGS Use in Pediatric Patients). It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. J Pharmacobiodyn. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Copy the URL below and paste it into your RSS Reader application. FOIA If the suppository feels soft, hold it under cold, running water for 1 minute. Promethazine HCl Suppositories may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Please enable it to take advantage of the complete set of features! Do not take more often than told by the doctor. Remove the foil wrapper and insert the suppository high into the posterior vaginal fornix. 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. taken, how much, and when it happened. After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. Alcohol can make the side effects of promethazine worse. Unable to load your collection due to an error, Unable to load your delegates due to an error. On longer trips, promethazine is usually taken in the morning and before the evening meal on each day of travel. Do not You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. Rectally administered indomethacin should be used with caution in patients with hemorrhoids, anal, or rectal inflammation. http://goo.gl/c4Rm4p Bethesda, MD 20894, Web Policies In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. endobj tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. SEVERE TISSUE INJURY, INCLUDING GANGRENE: Parenteral formulations can cause severe chemical irritation and damage to tissues regardless of the route of administration. When given concomitantly with Promethazine HCl Suppositories, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Once treatment begins, the dose should be reduced to the smallest effective amount needed to control symptoms.