Careers. sharing sensitive information, make sure youre on a federal 2SHCl and its molecular weight is 320.88. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Refrigerator settings should be mid-range at +5C (41F) to allow the highest Minor transfusion and/or amelioration of allergic reactions may be controlled with 12.5 mg doses. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. Promethazine is a phenothiazine derivative, which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. Signs of an allergic reaction, like rash; Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking. IV: Treatment should be injected into a large vein, avoiding sites in the hand/wrist if possible. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. This possibility should be considered with Promethazine HCl Suppositories. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. Sedative doses may be given the night before surgery. The https:// ensures that you are connecting to the Ask your doctor or pharmacist if you are not sure. Throw away unused or expired drugs. Promethazine helps control symptoms, but will not treat the cause of the symptoms or speed recovery. Hallucinations (seeing or hearing things that are not there). Box of 1000 NDC 0713-0526-10 1989 Nov;37(11):3145-7. doi: 10.1248/cpb.37.3145. 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. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. National Library of Medicine Nonteratogenic Effects Promethazine HCl 800-349-8919 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. Hargoli S, Farid J, Azarmi SH, Ghanbarzadeh S, Zakeri-Milani P. Indian J Pharm Sci. Promethazine is also used to prevent and treat motion sickness. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Promethazine Suppositories Description Each rectal suppository contains 12.5 mg or 25 mg promethazine HCl with ascorbyl palmitate, cocoa butter, colloidal silicon dioxide, and white wax. Promethazine Hydrochloride Suppositories are for rectal administration only. Parenteral: 25 mg IM or IV once, and may be repeated within 2 hours if necessary <> 17H If you think there has been an overdose, call your poison control center or get medical care right away. The site is secure. 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. Inform patients that this drug may cause drowsiness, and they should avoid driving or operating machinery until the full effects of the drug are seen. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery, Antiemetic therapy in postoperative patients. 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. Promethazine is used to relieve the symptoms of allergic reactions such as allergic rhinitis (runny nose and watery eyes caused by allergy to pollen, mold or dust), allergic conjunctivitis (red, watery eyes caused by allergies), allergic skin reactions, and allergic reactions to blood or plasma products. 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. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. Parenteral or rectal formulations may be used when patients cannot tolerate oral formulations. Alcohol can make the side effects of promethazine worse. However, many people have no side effects or only have minor side effects. The concomitant use of alcohol or other central nervous system depressants, including narcotic analgesics, sedatives, hypnotics, and tranquilizers, may have an additive effect and should be avoided or their dosage reduced. Do not freeze the oral liquid. Promethazine HCl in 12.5- to 25-mg doses for children and 50-mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep. Active and prophylactic treatment of motion sickness, Oral and Rectal: 25 mg orally every 4 to 6 hours as needed. However, you should not flush this medication down the toilet. Remove the wrapper. FOIA PRECAUTIONS- Information for Patients and Drug Interactions). Drug classes: Antihistamines, Phenothiazine antiemetics. Patient should remain supine for South Plainfield, NJ 07080 This report on medications is for your information only, and is not considered individual patient advice. , 4500 East-West Highway, Suite 900, Bethesda, Maryland. . Avoid sun, sunlamps, and tanning beds. 301-657-3000. Tell your Promethazine FDA Warning 2 SHCl and its molecular weight is 320.88. Select one or more newsletters to continue. 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. WARNINGS Use in Pediatric Patients). A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later, if necessary. You must check Low white blood cell counts have happened with this medicine (promethazine suppositories). Convulsions may rarely occur. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. Rectal suppositories Never take suppositories by mouth. This possibility should be considered with Promethazine HCl Suppositories. Avoid prolonged exposure to the sun. If you become pregnant while taking promethazine, call your doctor. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. Promethazine HCl Suppositories, USP are for rectal administration only. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients. Updated Promethazine HCl Suppositories are for rectal administration only. J Pharm Sci. You may get sunburned more easily. Limited experience with dialysis indicates that it is not helpful. Accessibility Once warmed, remove from wrapper and insert high into the posterior vaginal fornix. Box of 12 NDC 0713-0536-12 Clipboard, Search History, and several other advanced features are temporarily unavailable. 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.. 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 Unauthorized use of these marks is strictly prohibited. Use of Promethazine HCl Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. 25 mg, white, bullet-shaped suppository wrapped in silver foil. 1990 Apr;38(4):1027-31. doi: 10.1248/cpb.38.1027. prednisone, trazodone, hydroxyzine, ondansetron, montelukast, fluticasone nasal, lorazepam, loratadine, cetirizine, diazepam. Do not try to test for pregnancy at home. Do not take a double dose to make up for a missed one. 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. with your doctor, nurse, pharmacist, or other health care provider. Be sure to mention any of the following: antidepressants ('mood elevators') such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); antihistamines; azathioprine (Imuran);barbiturates such as phenobarbital (Luminal); cancer chemotherapy; epinephrine (Epipen); ipratropium (Atrovent)medications for anxiety, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems; monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), and selegiline (Eldepryl, Emsam, Zelapar); narcotics and other pain medication; sedatives; sleeping pills;and tranquilizers. Oral solution: The oral solution should be measured with an accurate measuring device to decrease the risk of overdosage. Biochemical Data Summary. The product's dosage form is suppository and is administered via rectal form. 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. Indomethacin sustained-release suppositories containing sugar ester in polyethylene glycol base. <> For children, Promethazine HCl Rectal Suppositories, 12.5 to 25 mg, twice daily, may be administered. The stability of aqueous solutions of promethazine hydrochloride as a function of pH. We comply with the HONcode standard for trustworthy health information. Promethazine HCl Rectal Suppositories, USPare available in boxes of 12 and 1000 as follows: A wide range of weight-based doses have resulted in respiratory depression in these patients. Absorption and bioavailability of calcium and magnesium salts of indomethacin from rectal suppositories. 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. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 8600 Rockville Pike When promethazine is used to treat motion sickness, it is taken 30 to 60 2 years and older: Treatment: Oral or Rectal: 1.1 mg/kg orally or rectally every 4 to 6 hours as needed. When promethazine is used to relieve cold symptoms, it is usually taken every 4 to 6 hours as needed. The American Society of Health-System Pharmacists Where do I get this medication? WebPromethazine HCl Suppositories are for rectal administration only. It is soluble in water and freely soluble in alcohol. There are no adequate and well-controlled studies of Promethazine HCl Suppositories in pregnant women. WebIn conscious rats, the plasma indomethacin levels attained after the intrarectal administration of suppositories stored at a high temperature were slightly lower than Webtype of IVPB solution will be stored at room temperature (21C), 4C, and 37C in the dark. Bookshelf The average adult dose is 25 mg taken twice daily. 03/2020 VC7409, Boxed Warnings, (A left-handed person should lie on the right side and raise the left knee.). J Pharm Pharmacol. Minor transfusion and/or amelioration of allergic reactions may be controlled with 25 mg doses. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Oxidative degradation of pharmaceutically important phenothiazines III: Kinetics and mechanism of promethazine oxidation. http://goo.gl/c4Rm4p Citations, PRECAUTIONS- Information for Patients and Drug Interactions, Carcinogenesis, Mutagenesis, Impairment of Fertility, Report Adverse 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. Patients should be told to report any involuntary muscle movements. 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. The effect of drug concentration on the thermal (dark) degradation of promethazin hydrochloride in aqueous solution. Patient Medication Information. Store promethazine tablets and liquid at room temperature and away from excess heat and moisture (not in the bathroom). 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. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Manufacturer Contact. Unable to load your collection due to an error, Unable to load your delegates due to an error. Put suppository into the rectum with gentle pressure, pointed end first. When promethazine is used to treat or prevent nausea and vomiting it is usually taken every 4 to 6 hours as needed. PROMETHEGAN- promethazine hydrochloride suppository, 0713-0526-10, Administration of 12.5 to 25 mg promethazine HCl by rectal suppository at bedtime will provide sedation in children. <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. Labels, All Index A stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. Federal government websites often end in .gov or .mil. You may report side effects to the FDA at 1-800-332-1088. Instead, the best way to dispose of your medication is through a medicine take-back program. Do not try to swallow the suppositories or insert in any other part of your body. Do not take more often than told by the doctor. 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. Promethazine is used with other medications to treat anaphylaxis (sudden, severe allergic reactions) and the symptoms of the common cold such as sneezing, cough, and runny nose. 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 ( This site complies with the HONcode standard for trustworthy health information: verify here. Webafter 24 hours of storage at room- temperature, when stored in a cool place (815 C), and when stored at room-temperature (1530 C). Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. Insert the suppository Promethazine HCl is a racemic compound; the empirical formula is C17H20N2SHCl and its molecular weight is Off-label information indicates unopened bottle stable when maintained at continuous room View NDC Code(s)NEW! and transmitted securely. Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see government site. Vasomotor rhinitis. Parenteral formulations: Store ampoules in the carton until ready to use. Usual Pediatric Dose for Nausea/Vomiting. Do not take 2 doses at the same time or extra doses. The administration of promethazine hydrochloride in 25-mg doses will control minor transfusion reactions of an allergic nature. This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. Avoid analeptics, which may cause convulsions. Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking promethazine. Before Disclaimer. https://medlibrary.org/lib/rx/meds/promethegan-5/. Files, All Mapping Stay informed and get access to the latest news, 4500 East-West Highway, stream N,N -trimethyl-, monohydrochloride, ()- with the following structural formula: WebPromethazine Suppositories Insulin Formulations Latanoprost Ophthalmic Drops Etonogestrel/Ethinyl Estradiol Vaginal Rings Name common medications stored at room temperature Antibiotic powders for reconstitution How is mannitol stored? All oral versions (tablets, syrup) of promethazine should be stored in the original, labeled container at room temperature. Promethazine HCl is a racemic compound; the empirical formula is C WebPhenadoz Suppositories are for rectal administration only. If you are taking any drugs that can stop your bone marrow from making some of the cells that your body needs. Hallucinations have also been reported. Ask your doctor or pharmacist if you do not know if a medication you are allergic to is a phenothiazine. any drug without checking with your doctor. you should know that this medication may make you drowsy. Also tell the child's doctor if the child has not been drinking normally, has had excessive vomiting or diarrhea, or appears dehydrated. The impairment may be amplified by concomitant use 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 either be eliminated or given in reduced dosage in the presence of promethazine HCl (see Bioequivalence and pharmacokinetic profile of promethazine hydrochloride suppositories in humans. When promethazine is used to treat motion sickness, it is taken 30 to 60 minutes before travel and again after 8 to 12 hours if needed. Unable to load your collection due to an error, Unable to load your delegates due to an error. Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCl. The https:// ensures that you are connecting to the Unauthorized use of these marks is strictly prohibited. PMC Talk with the doctor. Careers. How long does promethazine stay in your system? R)EU4u:/uug83YR/^dL P?062v*6>As5>) ,]'bHK80Ume4xWTJy$yI p7[I?ruO[P8kW,]6-tg4IE&()LV l=-V4{d]|O You could have more side effects. For all patients taking this medicine (promethazine suppositories): This is not a list of all drugs or health problems that interact with this medicine (promethazine suppositories). Medically reviewed by Drugs.com. 20N ask your doctor about the safe use of alcohol while you are taking this medication. Active and prophylactic treatment of motion sickness. Once treatment begins, the dose should be reduced to the smallest effective amount needed to control symptoms. Before is this? ). Antiemetic therapy in postoperative patients. Vaginal Suppositories Allow suppository to reach room temperature just prior to administration. Stability at Room Temperature** FOR SPECIFIC INFORMATION, CONTACT MANUFACTURER. 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. MeSH Duplication for commercial use must be authorized by ASHP. Keep containers out of reach of children and pets. Store promethazine suppositories in the refrigerator. 25 mg, white, bullet-shaped suppository wrapped in silver foil. This method is capable of distinguishing the intact drug from its thermal and photodegradation products. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Promethazine HCl Rectal Suppositories are not recommended for children under 2 years of age. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. The release of indomethacin from fatty-base suppositories, which had been stored at a low (4 degrees C) and a high (25-30 degrees C) temperature for about one month, was examined in vitro and in vivo. 2013 Mar;75(2):143-8. Clipboard, Search History, and several other advanced features are temporarily unavailable. solution. For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose is 25 mg repeated at 4- to 6-hour intervals, as necessary. WARNINGSRespiratory Depression). Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. Oral or Rectal: 1.1 mg/kg orally or rectally every 4 to 6 hours as needed, 2 years and older: Stored in a warmer box to prevent crystallization 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. Perennial and seasonal allergic rhinitis. A linear relationship between peak height ratio (promethazine-promazine) and promethazine concentration is found up to a concentration of 600 micrograms/ml. Pediatric patients should be supervised to avoid potential harm in bike riding or other hazardous activities. Preoperative, postoperative, or obstetric sedation. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Epinephrine Because of the potential for promethazine HCl to reverse epinephrines vasopressor effect, epinephrine should NOT be used to treat hypotension associated with Promethazine HCl Suppositories overdose. The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. Preoperative doses should be given with appropriate doses of an analgesic/hypnotic and an atropine-like agent. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. (current), promethazine HCl 12.5 MG Rectal Suppository, promethazine hydrochloride 12.5 MG Rectal Suppository, promethazine hydrochloride 12.5 MG Rectal Suppository [Promethegan], promethazine HCl 25 MG Rectal Suppository, promethazine hydrochloride 25 MG Rectal Suppository, promethazine hydrochloride 25 MG Rectal Suppository [Promethegan]. Store refrigerated between 2-8C (36-46F). Do not let anyone else take your medication. Webexplain the stability of the product at room temperature. This medicine may cause very bad and sometimes deadly breathing problems. Using your finger, insert the suppository into the rectum, about 1/2 to 1 inch (1.25 to 2.5 centimeters) in children who are 2 years of age older and 1 inch (2.5 centimeters) in adults. Promethazine HCl Suppositories may lower seizure threshold. Before your child takes this medicine (promethazine suppositories), tell the doctor if your child is taking any drugs that can cause breathing problems. WARNINGSBlack Box Warning and Kinetic studies were performed to determine the photolytic and thermal degradation rates of promethazine hydrochloride as a function of pH.

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