promethazine suppository stability at room temperature

Generic name: Promethazine Suppositories [proe-METH-a-zeen] Drowsiness is the most prominent CNS effect of this drug. WebAdults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. 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. PRECAUTIONS- Information for Patients and Drug Interactions). 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. This method is capable of distinguishing Promethazine is also used to prevent and control nausea and vomiting that may occur after surgery, and with other medications to help relieve pain after surgery. Cardiovascular Increased or decreased blood pressure, tachycardia, bradycardia, faintness. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. 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. 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. It is used to ease pain . There may be drug take-back programs in your area. Note that any depressant effects of promethazine HCl are not reversed by naloxone. 2 0 obj It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. (See also Use the measuring spoon or cup that came with the medication or use a spoon made especially for measuring medication. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Household teaspoons may not be an accurate measuring device. Promethazine is in a class of medications called phenothiazines. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). A stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. Is NDC 0713-0526 included in the NDC Directory? This site complies with the HONcode standard for trustworthy health information: verify here. The initial dose should be given 30 to 60 minutes before anticipated travel, and may be repeated in 8 to 12 hours as needed. Indomethacin sustained-release suppositories containing sugar ester. PROMETHEGAN (Cosette Pharmaceuticals, Inc.): FDA Package In case of overdose, call the poison control helpline at 1-800-222-1222. Do not give this medicine (promethazine suppositories) to a child younger than 2 years of age. Medically reviewed by Drugs.com. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Thermal and photolytic degradation studies of promethazine Also tell the child's doctor if the child has not been drinking normally, has had excessive vomiting or diarrhea, or appears dehydrated. 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. H -Phenothiazine, 10-ethanamine, Stand up after about 15 minutes. Sedative doses may be given the night before surgery. http://goo.gl/c4Rm4p Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. Store them away from light, heat, and moisture. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. 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. To determine the activation energy necessary by constructing an Arrhenius plot. Promethazine comes as a tablet and syrup (liquid) to take by mouth and as a suppository to use rectally.When promethazine is used to treat allergies, it is usually taken one to four times daily, before meals and/or at bedtime. 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. Hematologic Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. 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. Do not share your drugs with others and do not take anyone else's drugs. Duplication for commercial use must be authorized by ASHP. this version. Glucose Tolerance Test Carcinogenicity Under the conditions of the National Toxicology Program (NTP) studies, there was no evidence of In vivo and in vitro release of indomethacin from water-soluble and fatty base suppositories. Promethazine HCl suppositories (promethazine hydrochloride suppositories) are contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. WebVaginal suppositories (e.g., Prostin E2): Before removing foil wrapper, allow vaginal suppository to warm to room temperature. It may be given to you for other reasons. All Rights Reserved. Caution should be exercised when administering parenteral formulations in pediatric patients 2 years of age and older; it is recommended that the lowest effective dose of oral formulations be used in and concomitant administration of other drugs with respiratory depressant effects be avoided in this patient population. WARNINGS Use in Pediatric Patients). PROMETHAZINE HYDROCHLORIDE The first-order rate constant increased with increasing pH. Signs of an allergic reaction, like rash; Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking. 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. Perennial and seasonal allergic rhinitis. WebIndomethacin suppositories are contraindicated in patients with a history of proctitis or recent rectal bleeding. Subsequent doses on succeeding days of travel should be given on rising and again before the evening meal. This possibility should be considered with Promethazine HCl Suppositories. PROMETHEGAN- promethazine hydrochloride suppository, 0713-0526-10, Off-label information indicates unopened bottle stable when maintained at continuous room In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required. Promethegan (promethazine hydrochloride) dose, indications, 20 N This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Medication Storage Flashcards | Quizlet If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. Please enable it to take advantage of the complete set of features! The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Dermatologic Dermatitis, photosensitivity, urticaria. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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. To insert a promethazine suppository, follow these steps: Unless your doctor tells you otherwise, continue your normal diet. 2. HAZARDS IDENTIFICATION In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Development and validation of a HPLC method for the analysis of promethazine hydrochloride in hot-melt extruded dosage forms. prednisone, trazodone, hydroxyzine, ondansetron, montelukast, fluticasone nasal, lorazepam, loratadine, cetirizine, diazepam. Promethazine HCl Rectal Suppositories USP, are available as follows: Promethazine HCl Suppositories USP, 12.5 mg carton of 12 suppositories Promethazine HCl Suppositories USP, 25 mg carton of 12 suppositories Store refrigerated between 2-8C (36-46F). Dispense in well-closed container. Copy the URL below and paste it into your RSS Reader application. Manufacturer Contact. 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. 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. Information is also available online at Ask your doctor or pharmacist if you do not know if a medication you are allergic to is a phenothiazine. Subcutaneous administration is contraindicated. Promethazine: MedlinePlus Drug Information Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Promethazine HCl Suppositories, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. 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 It is used to help motion sickness . You will need to talk about the benefits and risks Unauthorized use of these marks is strictly prohibited. 8-PROMCPLNC1 Iss. suppository. Store refrigerated between 2-8C (36-46F). An increase in blood glucose has been reported in patients receiving promethazine HCl. 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 Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. Protect the medication from light. 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. Central Nervous System Phenergan, Promethegan, Antinaus 50, Phenadoz. Rectal suppositories Never take suppositories by mouth. Oral and rectal formulations may be used for nighttime, presurgical, or obstetrical sedation. Promethazine HCl Suppositories, USP are for rectal administration only. Pre- and Postoperative Use Par promethazine with codeine vs Hi-Tech promethazine with codeine? Promethazine HCl Suppositories administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. tell your doctor if you have or have ever had an enlarged prostate (a male reproductive gland); glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision); seizures; ulcers; blockage in the passage between the stomach and intestine; blockage in the bladder; asthma or other lung disease; sleep apnea; cancer;any condition that affects the production of blood cells in your bone marrow; or heart or liver disease. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Some drugs may have another patient information leaflet. 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. Clinical Trials, 17 H Diazepam may be used to control convulsions. Preoperative, postoperative, or obstetric sedation. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although 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. DOSAGE AND ADMINISTRATION Monoamine Oxidase Inhibitors (MAOI) WebPromethazine HCl 25mg. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times. Patient Medication Information. 0713-0536-10, Respiratory rate, especially in pediatric patients. Promethazine HCl is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. 1990 Jun;38(6):1680-3. doi: 10.1248/cpb.38.1680. PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP 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. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. The site is secure. Once treatment begins, the dose should be reduced to the smallest effective amount needed to control symptoms. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). You must check WebPROMETHAZINE (proe METH a zeen) prevents and treats the symptoms of an allergic reaction. xlI=ZMju! @ jzkZ$q{)w/_?FUV2Eg5nnf?eo w#T[)rUmp2ly!`w13?G]_LhFPpCsQH7ir_&C'57:/ To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or Stability at Room Temperature** FOR SPECIFIC INFORMATION, CONTACT MANUFACTURER. Patients should be advised to report any involuntary muscle movements. hUV?Rr$F/~H>d'K[U[\6 n=>r,+wk2rP#hqB8&\,d `S6XGfRFLm1b%Ux/w4 *uU=pk6M;]-I%d.@TdzJ]C//RbU=8q]W0,75ni. Check with your . sharing sensitive information, make sure youre on a federal talk to your doctor about the risks and benefits of taking promethazine if you are 65 years of age or older. See the FDA's Safe Disposal of Medicines website ( tablet. Lie down on your left side and raise your right knee to your chest. Tell your Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. PHARMACEUTICAL STABILITY OF PROMETHAZINE IN IV Accessibility Avoid sun, sunlamps, and tanning beds. Methods: During a 12-month period ending in June 2021, the prescribing information and published MeSH Treatment On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. % Stimulation may be evident, especially in children and geriatric patients. Indomethacin (Rectal Route) Proper Use - Mayo Clinic stream Follow all instructions closely. Promethazine Dosage Guide + Max Dose, Adjustments - Drugs.com Active and prophylactic treatment of motion sickness. Deep IM injection is the preferred route of administration. The average effective dose of promethazine HCl for the active therapy of nausea and vomiting in children or adults is 25 mg. 12.5- to 25-mg doses may be repeated, as necessary, at 4- to 6-hour intervals. Tell your doctor about the allergy and Promethazine Suppositories | Cleveland Clinic We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. Hallucinations (seeing or hearing things that are not there). https://www.poisonhelp.org/help Throw away unused or expired drugs. Promethazine Careers. Antiemetic therapy in postoperative patients. All oral versions (tablets, syrup) of promethazine should be stored in the original, labeled container at room temperature. SEVERE TISSUE INJURY, INCLUDING GANGRENE: Parenteral formulations can cause severe chemical irritation and damage to tissues regardless of the route of administration. How long does promethazine stay in your system? 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. Last updated on Apr 10, 2023. Vasomotor rhinitis. Usual Pediatric Dose for Nausea/Vomiting. 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. 1990 Apr;38(4):1027-31. doi: 10.1248/cpb.38.1027. Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine. Store promethazine tablets and liquid at room temperature and away from excess heat and moisture (not in the bathroom). Amelioration of allergic reactions to blood or plasma. If you take this medicine (promethazine suppositories) on a regular basis, take a missed dose as soon as you think about it. Promethazine HCl Rectal Suppositories are not recommended for children under 2 years of age. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=5f079815-f48b-8b21-2130-7f791d967c9a, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. Atropine-like signs and symptoms-dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms-may occur. <> In 1987, Sterchele5 described the Ask the doctor or pharmacist if you are not sure. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. Pregnancy Tests FDA Safety Recalls, Paradoxical Reactions Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Would you like email updates of new search results? Neuroleptic malignant syndrome (potentially fatal) has also been reported (See However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Promethazine Suppositories Information - Drugs.com 2 years and older: Treatment: Oral or Rectal: 1.1 mg/kg orally or rectally every 4 to 6 hours as needed. https://medlibrary.org/lib/rx/meds/promethegan-5/. Bookshelf The effect of drug concentration on the thermal (dark) degradation of promethazin hydrochloride in aqueous solution. Hold it in place for a few moments. %PDF-1.5 Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Subcutaneous administration is contraindicated. FOIA WARNINGSBlack Box Warning and It works by blocking the action of a certain natural substance in the body. Bethesda, MD 20894, Web Policies How to classify reactions as zero, first, and second order reactions and their corresponding reactions rates. Allergic conjunctivitis due to inhalant allergens and foods. 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. If you have an allergy to promethazine or any other part of this medicine (promethazine suppositories). DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Use in Pediatric Patients). 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. Absorption and bioavailability of calcium and magnesium salts of indomethacin from rectal suppositories. The product's dosage form is suppository and is administered via rectal form. and transmitted securely. 2 years and older: Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients. If you are taking promethazine liquid, do not use a household spoon to measure your dose. It works by blocking histamine, a substance released by the body during an government site. An official website of the United States government. Remove the foil wrapper and insert the suppository high into the posterior vaginal fornix. Promethazine HCl is a racemic compound; the empirical formula is C 17 H 20 N 2 SHCl and its molecular weight is 320.88. Promethazine HCl 50mg. Phenergan Suppositories Dosage Promethazine may cause other side effects. FOIA (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]. It is also important information to carry with you in case of emergencies. Available for Android and iOS devices. Promethazine can cause side effects. Treatment of overdosage is essentially symptomatic and supportive. Promethazine Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Promethazine was nonmutagenic in the 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. It is used to treat sleep problems. Ask your doctor or pharmacist if you are not sure. WebTo insert a promethazine suppository, follow these steps: If the suppository feels soft, hold it under cold, running water for 1 minute. Drug classes: Antihistamines, Phenothiazine antiemetics. If you are a consumer or patient please visit In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Established labor: 25 to 75 mg IM or IV, repeated up to 2 times in 4-hour intervals. endobj The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. (see Nausea and Vomiting PRECAUTIONS- Information for Patients and Drug Interactions, Cosette Pharmaceuticals, Inc. product information by RSS, Additional medications in the Prescription Medications section by. Updated pharmacist if you have questions about the best way to throw out drugs. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic.

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