promethazine suppository stability at room temperature

Before 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. The injection solution should be inspected for particulate matter and discoloration before administration. Webtype of IVPB solution will be stored at room temperature (21C), 4C, and 37C in the dark. Disclaimer. Rectal suppositories Never take suppositories by mouth. Amylin Pharmaceuticals. It is not known whether promethazine HCl is excreted in human milk. Par promethazine with codeine vs Hi-Tech promethazine with codeine? 1972 Dec;24:Suppl:133P-134. endobj Antiemetic therapy in postoperative patients. PROMETHEGAN- promethazine hydrochloride suppositoryCosette Pharmaceuticals, Inc. 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. A very bad and sometimes deadly health problem called. Within the Prescription Medications section: Use Trial Bulletin to search for clinical trials involving this product: All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent. Federal government websites often end in .gov or .mil. Glucose Tolerance Test with your doctor, nurse, pharmacist, or other health care provider. WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. 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 may be used alone or as an adjunct to narcotic analgesics during labor and delivery. Disclaimer. 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. This may lead to a higher chance of getting an. Oral solution: The oral solution should be measured with an accurate measuring device to decrease the risk of overdosage. If you think there has been an overdose, call your poison control center or get medical care right away. Promethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 8-PROMCPLNC1 Iss. This possibility should be considered with Promethazine HCl Suppositories. 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. 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. (A left-handed person should lie on the right side and raise the left knee.). Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 Doses should be adjusted to the age and severity of the patient. 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. Labels, All Index 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 treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 Promethazine may also be taken at bedtime the night before surgery to relieve anxiety and produce quiet sleep. Amelioration of allergic reactions to blood or plasma. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. View Labeling Archives, Dermographism. Box of 1000 NDC 0713-0536-10 25 mg, white, bullet-shaped suppository wrapped in silver foil. Monoamine Oxidase Inhibitors (MAOI) Promethazine HCl 25mg. Do not take 2 doses at the same time or extra doses. Accessibility Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCl. Amelioration of allergic reactions to blood or plasma. 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. In the in vivo experiments, the plasma indomethacin levels after administration of suppositories stored at different temperatures were measured in conscious and anesthetized rats. Parenteral formulations of this drug may cause severe chemical irritation and tissue damage regardless of the route. Subcutaneous administration is contraindicated. Dispense in well-closed container. Post-marketing cases of respiratory depression, including fatalities, have been reported with use of this drug in pediatric patients less than 2 years of age. Do not drive a car or operate machinery until you know how this medication affects you. If you are a consumer or patient please visit 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%. Allergic conjunctivitis due to inhalant allergens and foods. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Promethazine is well absorbed from the gastrointestinal tract. Information is also available online at Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although The site is secure. Dermatologic Dermatitis, photosensitivity, urticaria. what signs you had. WebIn conscious rats, the plasma indomethacin levels attained after the intrarectal administration of suppositories stored at a high temperature were slightly lower than Take promethazine exactly as directed. Do not flush down a toilet or pour down a drain unless you are told to do so. Remove the wrapper. Call your doctor right away if you have slow, shallow, or trouble It is soluble in water and freely soluble in alcohol. Use the measuring spoon or cup that came with the medication or use a spoon made especially for measuring medication. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. Do not give this medicine (promethazine suppositories) to a child younger than 2 years of age. If you have questions about side effects, call your doctor. 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. you should know that this medication may make you drowsy. However, you should not flush this medication down the toilet. <> 1978 Aug;67(8):1133-8. doi: 10.1002/jps.2600670828. Promethazine HCl Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Preoperative medication: 1.1 mg/kg IM, IV, orally, or rectally once. Select one or more newsletters to continue. Duplication for commercial use must be authorized by ASHP. is this? How long does promethazine stay in your system? 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. 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. Preparation and In vitro Evaluation of Naproxen Suppositories. 65 years and older: Elderly patients should be given lower initial doses and should be closely monitored for adverse events. Parenteral: Treatment: 12.5 to 25 mg IM, IV, orally, or rectally every 4 hours as needed Prophylactic doses may be used to prevent nausea and vomiting during surgery and the postoperative period. Treatment: 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. 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. http://www.fda.gov/Safety/MedWatch In case of overdose, call the poison control helpline at 1-800-222-1222. Would you like email updates of new search results? We comply with the HONcode standard for trustworthy health information. 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. Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. & Articles, All Once treatment begins, the dose should be reduced to the smallest effective amount needed to control symptoms. Webexplain the stability of the product at room temperature. Promethazine HCl 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. WebStability at Room Temperature** FOR SPECIFIC INFORMATION, CONTACT MANUFACTURER Unopened vial should not be left at room temperature for a total time exceeding 12 hours prior to use. A wide range of weight-based doses have resulted in respiratory depression in these patients. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or, Promethazine HCl Rectal Suppositories are contraindicated for children under 2 years of age (, All Drug It Be ready to tell or show what was WebPromethazine HCl 25mg. 0713-0526-12, Biochemical Data Summary. Do not start, stop, or change the dose of If your symptoms or health problems do not get better or if they become worse, call your doctor. You must check Dosage must be individualized. <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> Low white blood cell counts have happened with this medicine (promethazine suppositories). It is used to ease pain . Talk to your doctor about the risks of giving promethazine to your child. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. prednisone, trazodone, hydroxyzine, ondansetron, montelukast, fluticasone nasal, lorazepam, loratadine, cetirizine, diazepam. 2 years and older: Treatment: Oral or Rectal: 1.1 mg/kg orally or rectally every 4 to 6 hours as needed. taken, how much, and when it happened. R)EU4u:/uug83YR/^dL P?062v*6>As5>) ,]'bHK80Ume4xWTJy$yI p7[I?ruO[P8kW,]6-tg4IE&()LV l=-V4{d]|O Use with care in children 2 years of age and older. Copyright, 2023. 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. Remove the wrapper. It may cause very bad and sometimes deadly breathing problems. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine, 10-ethanamine, Rectally administered indomethacin should be used with caution in patients with hemorrhoids, anal, or rectal inflammation. Promethazine is also used to prevent and treat motion sickness. Allergy The average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Limited experience with dialysis indicates that it is not helpful. Before your child takes this medicine (promethazine suppositories), tell the doctor if your child is taking any drugs that can cause breathing problems. Parenteral formulations: Store ampoules in the carton until ready to use. Subsequent doses on succeeding days of travel should be given on rising and again before the evening meal. talk to your doctor about the risks and benefits of taking promethazine if you are 65 years of age or older. Tell your child's doctor if your child has any condition that affects his/her breathing such as lung disease, asthma, or sleep apnea (stops breathing for short periods of time during sleep). Use. H -Phenothiazine, 10-ethanamine, Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see Box of 1000 NDC 0713-0526-10 Patients should 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. 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. WARNINGS Use in Pediatric Patients). WebIndomethacin suppositories are contraindicated in patients with a history of proctitis or recent rectal bleeding. Take the missed dose as soon as you remember it. WebPromethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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. Patient Medication Information. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. ). Distributedby: Cosette Pharmaceuticals, Inc. 2SHCl and its molecular weight is 320.88. 1990 Apr;38(4):1027-31. doi: 10.1248/cpb.38.1027. Unauthorized use of these marks is strictly prohibited. Stability at Room Temperature** FOR SPECIFIC INFORMATION, CONTACT MANUFACTURER. 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. to you and the baby. , 4500 East-West Highway, Suite 900, Bethesda, Maryland. Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine. Clipboard, Search History, and several other advanced features are temporarily unavailable. 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. Store suppositories in a refrigerator. Talk to your doctor if you think you might be pregnant while you are taking promethazine. This site complies with the HONcode standard for trustworthy health information: verify here. Promethazine HCl is a racemic compound; the empirical formula is C DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. 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). Promethazine HCl Suppositories, USP are for rectal administration only. Stay informed and get access to the latest news, 4500 East-West Highway, PROMETHEGAN- promethazine hydrochloride suppository, 0713-0526-10, Careers. Take promethazine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Promethazine suppositories are for rectal use only. Do not try to swallow the suppositories or insert in any other part of your body. Treatment of overdosage is essentially symptomatic and supportive. June 14, 2022. Promethazine HCl is a racemic compound; the empirical formula is C17H20N2SHCl and its molecular weight is Signs of an allergic reaction, like rash; Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Information (Quality. Tell your WebVaginal suppositories (e.g., Prostin E2): Before removing foil wrapper, allow vaginal suppository to warm to room temperature. Alcohol can make the side effects of promethazine worse. Respiratory Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). Preoperative, postoperative, or obstetric sedation. Talk with the doctor. Patients should be told to report any involuntary muscle movements. South Plainfield, NJ 07080 and transmitted securely. Note that any depressant effects of promethazine HCl are not reversed by naloxone. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. 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 PMC Last updated on Jan 28, 2022. 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? You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times. 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. Treatment Store promethazine suppositories in the refrigerator. Oral and rectal formulations may be used for nighttime, presurgical, or obstetrical sedation. WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. and transmitted securely. 1984 Jun;7(6):392-9. doi: 10.1248/bpb1978.7.392. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. It is used to treat sleep problems. 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. Pediatric patients should be supervised to avoid potential harm in bike riding or other hazardous activities. Gastrointestinal Dry mouth, nausea, vomiting, jaundice. WebPROMETHAZINE (proe METH a zeen) prevents and treats the symptoms of an allergic reaction. Store promethazine tablets and liquid at room temperature and away from excess heat and moisture (not in the bathroom). When promethazine is used to treat motion sickness, it is taken 30 to 60 Carcinogenicity Under the conditions of the National Toxicology Program (NTP) studies, there was no evidence of <> Ask your pharmacist any questions you have about refilling your prescription. If suppository is soft, chill in a refrigerator or run cold water over it. Oxidative degradation of pharmaceutically important phenothiazines III: Kinetics and mechanism of promethazine oxidation. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. 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. 2013 Mar;75(2):143-8. The https:// ensures that you are connecting to the 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. It works by blocking histamine, a substance released by the body during an DOSAGE AND ADMINISTRATION There are many drugs that Use this medicine (promethazine suppositories) as ordered by your doctor. Avoid driving and doing other tasks or actions that call for you to be. Preoperative doses should be given with appropriate doses of an analgesic/hypnotic and an atropine-like agent. Avoid analeptics, which may cause convulsions. Refrigerator settings should be mid-range at +5C (41F) to allow the highest 1 receptor blocking agent.

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