To determine the activation energy necessary by constructing an Arrhenius plot. (see Cardiovascular Increased or decreased blood pressure, tachycardia, bradycardia, faintness. The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later, if necessary. with your doctor, nurse, pharmacist, or other health care provider. 2SHCl and its molecular weight is 320.88. can do this. WARNING: PROMETHAZINE HCL SUPPOSITORIES SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. Perennial and seasonal allergic rhinitis. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. Store promethazine suppositories in the refrigerator. www.fda.gov/medwatch. If you are taking any drugs that can stop your bone marrow from making some of the cells that your body needs. Unauthorized use of these marks is strictly prohibited. Room-temperature storage of medications labeled for & Articles, All Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Lie down on your left side and raise your right knee to your chest. 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 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. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. When promethazine is used to treat or prevent nausea and vomiting it is usually taken every 4 to 6 hours as needed. It may be given to you for other reasons. The average parenteral dose given during established labor is 50 mg. Do not freeze. Use of Promethazine HCl Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Information is also available online at SEVERE TISSUE INJURY, INCLUDING GANGRENE: Parenteral formulations can cause severe chemical irritation and damage to tissues regardless of the route of administration. Federal government websites often end in .gov or .mil. 65 years and older: Elderly patients should be given lower initial doses and should be closely monitored for adverse events. Convulsions may rarely occur. Carcinogenicity Under the conditions of the National Toxicology Program (NTP) studies, there was no evidence of The .gov means its official. All Rights Reserved. you should know that this medication may make you drowsy. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold. PRECAUTIONSDrug Interactions). The site is secure. The stability of aqueous solutions of promethazine hydrochloride as a function of pH. Get Label RSS Feed, Promethazine HCl 12.5mg. Allergic conjunctivitis due to inhalant allergens and foods. WebPromethazine HCl 25mg. Also tell the child's doctor if the child has not been drinking normally, has had excessive vomiting or diarrhea, or appears dehydrated. Biochemical Data Summary. Respiratory Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). <> 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. Uses of Promethazine Suppositories: It is used to ease allergy signs. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. 1987 Jun;76(6):441-5. doi: 10.1002/jps.2600760606. Stay informed and get access to the latest news, 4500 East-West Highway, 1984 Jun;7(6):392-9. doi: 10.1248/bpb1978.7.392. Promethazine should not be given to babies or children who are younger than 2 years old and should be given with caution to children who are 2 years of age or older. Box of 12 NDC 0713-0526-12 The effect of drug concentration on the thermal (dark) degradation of promethazin hydrochloride in aqueous solution. Do not share your drugs with others and do not take anyone else's drugs. Call your doctor for medical Patients should be told to report any involuntary muscle movements. promethazine 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. This may lead to a higher chance of getting an. Nakajima T, Takashima Y, Furuya A, Ozawa Y, Kawashima Y. Chem Pharm Bull (Tokyo). Dispense in well-closed container. Unauthorized use of these marks is strictly prohibited. In the event that vasopressors are considered for the management of severe hypotension that does not respond to intravenous fluids and repositioning, the administration of norepinephrine or phenylephrine should be considered. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. 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. Subsequent doses on succeeding days of travel should be given on rising and again before the evening meal. tablet. pharmacist if you have questions about the best way to throw out drugs. Teratogenic Effects - Pregnancy Category C 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. Stability WARNINGSCNS Depression and FROZEN Drugs 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. Promethazine HCl Suppositories may lower seizure threshold. Keep this medication in the carton or container it came in, tightly closed, and out of reach of children. Control) Pramlintide injection (Symlin) Promethazine suppositories (Promethegan) Proparacaine ophthalmic. Information (Quality. Active and prophylactic treatment of motion sickness. WARNING: Antiemetic therapy in postoperative patients. any drug without checking with your doctor. For children, Promethazine HCl Rectal Suppositories, 12.5 to 25 mg, twice daily, may be administered. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. 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. Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions. 20 N 4 0 obj Refrigerator settings should be mid-range at +5C (41F) to allow the highest There are many drugs that This site needs JavaScript to work properly. Parenteral or rectal formulations may be used when patients cannot tolerate oral formulations. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Promethazine HCl Suppositories,USPare for rectal administration only. When promethazine is used to relieve cold symptoms, it is usually taken every 4 to 6 hours as needed. Methods: During a 12-month period ending in June 2021, the prescribing information and published Monoamine Oxidase Inhibitors (MAOI) Check with your pharmacist. PROMETHEGAN- promethazine hydrochloride suppository, 0713-0526-10, Promethazine HCl Rectal Suppositories, USP are available in boxes of 12 and 1000 as follows: 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. Do not take more or less of it or take it more often than prescribed by your doctor. Keep containers out of reach of children and pets. Other Angioneurotic edema. Ask your doctor or pharmacist if you do not know if a medication you are allergic to is a phenothiazine. Vials stored at room temperature should not be returned to the refrigerator. Hallucinations (seeing or hearing things that are not there). 30 days. hUV?Rr$F/~H>d'K[U[\6 n=>r,+wk2rP#hqB8&\,d `S6XGfRFLm1b%Ux/w4 *uU=pk6M;]-I%d.@TdzJ]C//RbU=8q]W0,75ni. Motion Sickness Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 PRECAUTIONS- Information for Patients and Drug Interactions). MeSH Promethazine HCl Suppositories may lower seizure threshold. RxNorm, Please enable it to take advantage of the complete set of features! This site complies with the HONcode standard for trustworthy health information: verify here. It is also important information to carry with you in case of emergencies. Promethazine All Rights Reserved. Influence of storage temperature on indomethacin release from 0713-0526-12, Administration of 12.5 to 25 mg promethazine HCl by rectal suppository at bedtime will provide sedation in children. 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. A very bad and sometimes deadly health problem called. FOIA Promethazine HCl Suppositories administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. PHARMACEUTICAL STABILITY OF PROMETHAZINE IN IV 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 what signs you had. drugs that can do this. Stand up after about 15 minutes. Active and prophylactic treatment of motion sickness, Oral and Rectal: 25 mg orally every 4 to 6 hours as needed. Patients should be advised to report any involuntary muscle movements. WebPromethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. If suppository is soft, chill in a refrigerator or run cold water over it. PRECAUTIONS- Information for Patients and Drug Interactions, Cosette Pharmaceuticals, Inc. product information by RSS, Additional medications in the Prescription Medications section by. government site. Chem Pharm Bull (Tokyo). In the in vivo experiments, the plasma indomethacin levels after administration of suppositories stored at different temperatures were measured in conscious and anesthetized rats. National Library of Medicine On longer trips, promethazine is usually taken in the morning and before the evening meal on each day of travel. Promethazine HCl is a racemic compound; the empirical formula is C17H20N2SHCl and its molecular weight is Promethazine HCl 25mg. (see Promethazine HCl Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Minor transfusion and/or amelioration of allergic reactions may be controlled with 12.5 mg doses. Patients should Before EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. <> Rectally administered indomethacin should be used with caution in patients with hemorrhoids, anal, or rectal inflammation. National Library of Medicine H-Phenothiazine, 10-ethanamine, Do not give this medicine (promethazine suppositories) to a child younger than 2 years of age. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients. government site. Where do I get this medication? Do not flush down a toilet or pour down a drain unless you are told to do so. Patient should remain supine for Privacy Policy | Copyright 2023. 0713-0526-12 Promethegan Suppository IV: Treatment should be injected into a large vein, avoiding sites in the hand/wrist if possible. Wash your hands thoroughly and resume your normal activities. Hematologic Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. https://medlibrary.org/lib/rx/meds/promethegan-5/. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. If you have any questions about this medicine (promethazine suppositories), please talk Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. (See 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? Phenergan Suppositories Dosage Files, Presentations (See also 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. Older adults should not usually take promethazine because it is not as safe as other medications that can be used to treat the same conditions. Citations, PRECAUTIONS- Information for Patients and Drug Interactions, Carcinogenesis, Mutagenesis, Impairment of Fertility, Report Adverse You must check 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. 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. Dinoprostone WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. 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 HCl occurs as a white to faint yellow, practically odorless, crystalline powder, which slowly oxidizes and turns blue on prolonged exposure to air. Do not take a double dose to make up for a missed one. Prophylactic doses may be used to prevent nausea and vomiting during surgery and the postoperative period. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. is this? doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: All drugs may cause side effects. Follow all instructions closely. 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. Vasomotor rhinitis. If you are a consumer or patient please visit Drowsiness is the most prominent CNS effect of this drug. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold. Do not give this medicine (promethazine suppositories) to a child who is throwing up for an unknown reason. 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 The activation energies at pH 2.98, 3.94, and 5.12 were obtained from linear Arrhenius plots and were found to be 6601, 5888, 5570 cal/mole, respectively. Indomethacin sustained-release suppositories containing sugar ester. Do not freeze the oral liquid. Avoid driving and doing other tasks or actions that call for you to be. Oral or Rectal: 6.25 to 12.5 mg orally or rectally before meals and at bedtime, if necessary, OR 25 mg orally or rectally once a day at bedtime Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. Updated This drug should be administered at a rate no greater than 25 mg/min. Do not and transmitted securely. <> Comments: 2 years and older: Use. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine. PROMETHAZINE HCL SUPPOSITORIES SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. Nausea and Vomiting Last updated on Jan 28, 2022. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. Insert the suppository Unable to load your collection due to an error, Unable to load your delegates due to an error. Parenteral formulations of this drug may cause severe chemical irritation and tissue damage regardless of the route. Is NDC 0713-0526 included in the NDC Directory? Vasomotor rhinitis. 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. Rectal suppositories Never take suppositories by mouth. Labels, All Index Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. If you think there has been an overdose, call your poison control center or get medical care right away. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Last updated on Apr 10, 2023. Throw away unused or expired drugs. In conscious rats, the plasma indomethacin levels attained after the intrarectal administration of suppositories stored at a high temperature were slightly lower than those after the animals were given suppositories stored at a low temperature, but the difference was significant only 30 min after administration. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Disclaimer. The following laboratory tests may be affected in patients who are receiving therapy with promethazine HCl: Store promethazine rectal suppositories in a refrigerator between 36 - 46F. Talk with the doctor. continuous twisting movements of the hands and feet, wide pupils (black circles in the middle of the eyes), difficulty falling asleep or staying asleep, hallucinations (seeing things or hearing voices that do not exist), overwhelming or unmanageable fear or emotion, uncontrollable shaking of a part of the body, sore throat, fever, chills, and other signs of infection, inability to respond to people around you, swelling of the face, eyes, lips, tongue, throat, arms, hands, feet, ankles, or lower legs. Gastrointestinal Dry mouth, nausea, vomiting, jaundice. If the suppository feels soft, hold it under cold, running water for 1 minute. After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. WebIndomethacin suppositories are contraindicated in patients with a history of proctitis or recent rectal bleeding. Keep all drugs out of the reach of children and pets. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. Preparation and In vitro Evaluation of Naproxen Suppositories. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times. Clipboard, Search History, and several other advanced features are temporarily unavailable. Pre- and Postoperative Use N,N -trimethyl-, monohydrochloride, ()- with the following structural formula: Promethazine is a phenothiazine derivative, which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. Additionally, one of each type of IVPB solution will be stored under white light and one of 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. stream Phenergan, Promethegan, Antinaus 50, Phenadoz. Hallucinations have also been reported. Avoid sun, sunlamps, and tanning beds. 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. The American Society of Health-System Pharmacists The first-order rate constant increased with increasing pH. Would you like email updates of new search results? 8600 Rockville Pike Alcohol can make the side effects of promethazine worse. Preoperative doses should be given with appropriate doses of an analgesic/hypnotic and an atropine-like agent. 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. Promethazine - St. Jude Childrens Research Hospital Medically reviewed by Drugs.com. In 1987, Sterchele5 described the Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. AllergyThe average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. It may cause very bad and sometimes deadly breathing problems. Perennial and seasonal allergic rhinitis. suppository. Study on absorption of indomethacin from sustained-release suppositories containing hydrogenated soybean lecithin in rabbits. 0713-0536-12, Teratogenic Effects - Pregnancy Category C. PROMETHAZINE HCL SUPPOSITORIES ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE (see WARNINGS-Black Box Warning and Use in Pediatric Patients). View Labeling Archives, Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking promethazine. 2 years and older: This possibility should be considered with Promethazine HCl Suppositories. 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.
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