promethazine suppository stability at room temperature

20N Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. Usual Pediatric Dose for Nausea/Vomiting. Patients receiving parenteral formulations should report persistent/worsening pain or burning at the injection site. J Pharm Pharmacol. stream The site is secure. Webstore at a room temperature not to exceed 77F (25C) for up to 6 weeks. 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. Information is also available online at WARNINGSCNS Depression and 1978 Feb;30(2):75-80. doi: 10.1111/j.2042-7158.1978.tb13165.x. For preoperative medication children require doses of 0.5 mg per pound of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. H -Phenothiazine, 10-ethanamine, Vasomotor rhinitis. Dermographism. 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. You may also report side effects at https://www.fda.gov/medwatch. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. WebIndomethacin suppositories are contraindicated in patients with a history of proctitis or recent rectal bleeding. 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. Promethazine HCl is a racemic compound; the empirical formula is C It If the suppository feels soft, hold it under cold, running water for 1 minute. Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Box of 1000 NDC 0713-0526-10 Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates. (see . Do not give this medicine (promethazine suppositories) to a child younger than 2 years of age. Neuroleptic malignant syndrome (potentially fatal) has also been reported (See This may lead to a higher chance of getting an. 17H Phenergan, Promethegan, Antinaus 50, Phenadoz. Store them away from light, heat, and moisture. Do not give this medicine (promethazine suppositories) to a child who is throwing up for an unknown reason. Many times this medicine (promethazine suppositories) is taken on an as needed basis. If you think there has been an overdose, call your poison control center or get medical care right away. Promethazine HCl Suppositories,USPare for rectal administration only. Alcohol can make the side effects of promethazine worse. This includes your doctors, nurses, pharmacists, and dentists. DOSAGE AND ADMINISTRATION WebPROMETHAZINE (proe METH a zeen) prevents and treats the symptoms of an allergic reaction. There are many drugs that Box of 12 NDC 0713-0526-12 Check with your WARNING: 20 N If you become pregnant while taking promethazine, call your doctor. Furuno K, Gomita Y, Yoshida T, Oishi R, Saeki K, Araki Y. Acta Med Okayama. Oral solution: The oral solution should be measured with an accurate measuring device to decrease the risk of overdosage. 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. We comply with the HONcode standard for trustworthy health information. (See Select one or more newsletters to continue. Where do I get this medication? https://www.poisonhelp.org/help 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 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. 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). Diazepam may be used to control convulsions. Absorption and bioavailability of calcium and magnesium salts of indomethacin from rectal suppositories. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal/perineuronal infiltration. 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? A very bad and sometimes deadly health problem called. Some drugs may have another patient information leaflet. 1987 Jun;76(6):441-5. doi: 10.1002/jps.2600760606. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=5f079815-f48b-8b21-2130-7f791d967c9a, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. Keep all drugs in a safe place. Respiratory Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location one that is up and away and out of their sight and reach. to you and the baby. Stability at Room Temperature** FOR SPECIFIC INFORMATION, CONTACT MANUFACTURER. Do not take more often than told by the doctor. <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> This report on medications is for your information only, and is not considered individual patient advice. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Remove the foil wrapper and insert the suppository high into the posterior vaginal fornix. Talk with the doctor. 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. (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]. The photolytic degradation of promethazine hydrochloride does not follow simple first-order kinetics. AllergyThe average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Usual adult dosage is 50 mg promethazine HCl with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid. If suppository is soft, chill in a refrigerator or run cold water over it. Store promethazine suppositories in the refrigerator. Preoperative, postoperative, or obstetric sedation, Relief of apprehension and production of light sleep from which the patient can be easily aroused. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 There are many WARNINGS Use in Pediatric Patients). Minor transfusion and/or amelioration of allergic reactions may be controlled with 25 mg doses. An official website of the United States government. Allergic conjunctivitis due to inhalant allergens and foods. Motion Sickness Keep containers out of reach of children and pets. In case of overdose, call the poison control helpline at 1-800-222-1222. what signs you had. The product's dosage form is suppository and is administered via rectal form. 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. Phenergan Suppositories Dosage Be ready to tell or show what was PubMed, Files, All Mapping Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. A stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. H-Phenothiazine, 10-ethanamine, To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or PMC This drug should not be used to treat nausea and vomiting of unknown etiology. FOIA Lie down on your left side and raise your right knee to your chest. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery, Antiemetic therapy in postoperative patients. 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. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Parenteral: 12.5 mg IM or IV once, and may be repeated within 2 hours if necessary In vivo and in vitro release of indomethacin from water-soluble and fatty base suppositories. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Promethazine may cause other side effects. Call your doctor right away if you have slow, shallow, or trouble WebIn conscious rats, the plasma indomethacin levels attained after the intrarectal administration of suppositories stored at a high temperature were slightly lower than These results suggest that in conscious rats many factors such as a locomotor hyperactivity and enhancement of gastrointestinal motility caused by the rectal administration mask the real character of suppositories. R)EU4u:/uug83YR/^dL P?062v*6>As5>) ,]'bHK80Ume4xWTJy$yI p7[I?ruO[P8kW,]6-tg4IE&()LV l=-V4{d]|O Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 1989 Nov;37(11):3145-7. doi: 10.1248/cpb.37.3145. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. 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. suppository. Atropine-like signs and symptoms-dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms-may occur. Last updated on Apr 10, 2023. talk to your doctor about the risks and benefits of taking promethazine if you are 65 years of age or older. Preoperative, postoperative, or obstetric sedation. Use in Pediatric Patients). Do not let anyone else take your medication. 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. WebPromethazine is an H1 receptor blocking agent. Hold it in place for a few moments. Pre- and Postoperative Use - Promethazine HCl in 12.5 to 25 mg doses for children and 50 mg WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. WARNINGSCNS Depression and Allergic conjunctivitis due to inhalant allergens and foods, Amelioration of allergic reactions to blood or plasma, In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled, Mild, uncomplicated allergic skin manifestations of urticaria and angioedema, Other uncomplicated allergic condition of the immediate type when oral therapy is impossible or contraindicated, Early stages of labor: 50 mg IM or IV once, Nighttime sedation: 25 to 50 mg IM or IV once. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine, 10-ethanamine, Development and validation of a HPLC method for the analysis of promethazine hydrochloride in hot-melt extruded dosage forms. Do not take more or less of it or take it more often than prescribed by your doctor. How to classify reactions as zero, first, and second order reactions and their corresponding reactions rates. Accessibility Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Promethazine may cause breathing to slow or stop, and may cause death in children. Promethazine HCl 12.5mg. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. <> Keep from freezing. Tell your doctor about the allergy and Applies to the following strengths: 12.5 mg; 25 mg; 25 mg/mL; 50 mg; 25 mg/5 mL; 50 mg/mL; 6.25 mg/5 mL; 25 mg/25 mL-NaCl 0.9%. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 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. IV: Treatment should be injected into a large vein, avoiding sites in the hand/wrist if possible. 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. When promethazine is used to treat or prevent nausea and vomiting it is usually taken every 4 to 6 hours as needed. Insert the suppository You may get sunburned more easily. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. Do not flush down a toilet or pour down a drain unless you are told to do so. Ask your doctor or pharmacist if you are not sure. Study on absorption of indomethacin from sustained-release suppositories containing hydrogenated soybean lecithin in rabbits. is this? Careers. Promethazine is an H Active and prophylactic treatment of motion sickness. RxNorm, If you take this medicine (promethazine suppositories) on a regular basis, take a missed dose as soon as you think about it. Pediatric patients should be supervised to avoid potential harm in bike riding or other hazardous activities. Nonteratogenic Effects Promethazine HCl MeSH tablet. The effect of drug concentration on the thermal (dark) degradation of promethazin hydrochloride in aqueous solution. The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Promethazine HCl Rectal Suppositories, USPare available in boxes of 12 and 1000 as follows: Privacy Policy | Copyright 2023. 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. See the FDA's Safe Disposal of Medicines website ( Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. This possibility should be considered with Promethazine HCl Suppositories. Convulsions may rarely occur. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required. tablet. suppository. Vaginal Suppositories Allow suppository to reach room temperature just prior to administration. A&k]h/+ulm.d!*/XHvPr]SjTHc%t ?($uL Db~4;22bt`gE[6Pi*8G:#k:V`BQS=X9R2N$ARz ]x~#RVY2ZdVX lr+baz|To+-$`>*>c 7o&. J Pharmacobiodyn. 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. 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. Box of 12 NDC 0713-0536-12 The administration of promethazine hydrochloride in 25-mg doses will control minor transfusion reactions of an allergic nature. Promethazine 1972 Dec;24:Suppl:133P-134. Before your child takes this medicine (promethazine suppositories), tell the doctor if your child is taking any drugs that can cause breathing problems. 2SHCl and its molecular weight is 320.88. Do not share your drugs with others and do not take anyone else's drugs. tell your doctor and pharmacist if you are allergic to promethazine, other phenothiazines (certain medications used to treat mental illness, nausea, vomiting, severe hiccups, and other conditions) or any other medications. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. This site complies with the HONcode standard for trustworthy health information: verify here. Store promethazine suppositories in the refrigerator. Preoperative doses should be given with appropriate doses of an analgesic/hypnotic and an atropine-like agent. The American Society of Health-System Pharmacists Clipboard, Search History, and several other advanced features are temporarily unavailable. 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. J Pharm Pharmacol. A wide range of weight-based doses have resulted in respiratory depression in these patients. 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. It is not known whether promethazine HCl is excreted in human milk. Once treatment begins, the dose should be reduced to the smallest effective amount needed to control symptoms. (see Avoid prolonged exposure to the sun. Talk to your doctor about the risks of giving promethazine to your child. Do not freeze. Patients should A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. :u Qt/OYFTU^Jir+*;M&+X!u N1FTVpWcHxTYYM~g;|W=7 _WCB>>n>tn@Zt|f.l1Ax{x`K-n;sPVF5e.7_+Vn7b71/=Arsdnp %6y'-KhYsoK6}^tW3VJWw^TYI.JJ 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. WebRefrigerated medications should be stored at temperatures between 2oC and 8oC (35oF to 46oF). Keep this medication in the carton or container it came in, tightly closed, and out of reach of children. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. Before 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. Promethazine suppositories are for rectal use only. Dinoprostone This method is capable of distinguishing 1 0 obj 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. Medically reviewed by Drugs.com. Generic name: Promethazine Suppositories [proe-METH-a-zeen] solution. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. (See also DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Do not take a double dose to make up for a missed one. Par promethazine with codeine vs Hi-Tech promethazine with codeine? Throw away unused or expired drugs. 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. Subcutaneous administration is contraindicated. Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder, which slowly oxidizes and turns blue on prolonged exposure to air. Stability of Refrigerated and Frozen Drugs - Care Plus Pharmacy Generic alternatives may be available. Promethazine is an H 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. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. tablet. 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. Do not freeze the oral liquid. 2013 Mar;75(2):143-8. Indomethacin (Rectal Route) Proper Use - Mayo Clinic
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