promethazine suppository stability at room temperature

Use this medicine (promethazine suppositories) as ordered by your doctor. WebWhen promethazine is used to relieve cold symptoms, it is usually taken every 4 to 6 hours as needed. DOSAGE AND ADMINISTRATION Box of 12 NDC 0713-0526-12 20 N The initial dose should be given 30 to 60 minutes before anticipated travel, and may be repeated in 8 to 12 hours as needed. All Rights Reserved. Careers. Minor transfusion and/or amelioration of allergic reactions may be controlled with 25 mg doses. Drug classes: Antihistamines, Phenothiazine antiemetics. Do not take more or less of it or take it more often than prescribed by your doctor. It may be given to you for other reasons. 1992 Aug;46(4):223-31. doi: 10.18926/AMO/32623. Treatment 2 0 obj WebIndomethacin suppositories are contraindicated in patients with a history of proctitis or recent rectal bleeding. Preparation and In vitro Evaluation of Naproxen Suppositories. This drug should be administered at a rate no greater than 25 mg/min. Ask your pharmacist any questions you have about refilling your prescription. Deep IM injection is the preferred route of administration. to make sure that it is safe for you to take this medicine (promethazine suppositories) with all of your drugs and health problems. Maximum dose: 25 Note that any depressant effects of promethazine HCl are not reversed by naloxone. endobj 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. Do not drive a car or operate machinery until you know how this medication affects you. The in vitro and in vivo results show that the release of indomethacin from fatty-base suppositories stored at a high temperature is less than the release from those stored at a low temperature. AHFS Using your finger, insert the suppository into the rectum, about 1/2 to 1 inch (1.25 to 2.5 centimeters) in children who are 2 years of age older and 1 inch (2.5 centimeters) in adults. Promethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Accessibility It is also important information to carry with you in case of emergencies. WebAdults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. Promethazine HCl is a racemic compound; the empirical formula is C 17 H 20 N 2 SHCl and its molecular weight is 320.88. If you take this medicine (promethazine suppositories) on a regular basis, take a missed dose as soon as you think about it. Mild, uncomplicated CONTRAINDICATIONS Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. Do not give this medicine (promethazine suppositories) to a child who is throwing up for an unknown reason. Patients should be advised to report any involuntary muscle movements. If you experience any of the following symptoms, call your doctor immediately: If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Vasomotor rhinitis. 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. Tell all of your health care providers that you take this medicine (promethazine suppositories). Other Angioneurotic edema. Atropine-like signs and symptoms-dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms-may occur. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. WARNINGSRespiratory Depression). Pre- or postoperative use: 25 to 50 mg IM or IV once Study on absorption of indomethacin from sustained-release suppositories containing hydrogenated soybean lecithin in rabbits. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND 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). Last updated on Apr 10, 2023. 1984 Jun;7(6):392-9. doi: 10.1248/bpb1978.7.392. Accessibility If suppository is soft, chill in a refrigerator or run cold water over it. Updated Promethazine HCl in 12.5- to 25-mg doses for children and 50-mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use. Parenteral formulations of this drug may cause severe chemical irritation and tissue damage regardless of the route. Oxidative degradation of pharmaceutically important phenothiazines III: Kinetics and mechanism of promethazine oxidation. The average adult dose is 25 mg taken twice daily. https://medlibrary.org/lib/rx/meds/promethegan-5/. The photolytic degradation of promethazine hydrochloride does not follow simple first-order kinetics. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. Allergic conjunctivitis due to inhalant allergens and foods. Promethazine HCl is a racemic compound; the empirical formula is C Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates. is this? The first-order rate constant increased with increasing pH. Rectally administered indomethacin should be used with caution in patients with hemorrhoids, anal, or rectal inflammation. Parenteral: 25 mg IM or IV once, and may be repeated within 2 hours if necessary WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. Promethazine can interfere with the results of home pregnancy tests. 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%. J Pharm Pharmacol. You could have more side effects. Talk to your doctor if you think you might be pregnant while you are taking promethazine. Promethazine is an H Promethazine HCl Suppositories, USPare useful for: Use in Pediatric Patients). WebIn conscious rats, the plasma indomethacin levels attained after the intrarectal administration of suppositories stored at a high temperature were slightly lower than Promethazine HCl Suppositories may lower seizure threshold. 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. Promethazine HCl Rectal Suppositories, USPare available in boxes of 12 and 1000 as follows: The site is secure. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. Promethazine HCl Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Combination products containing promethazine and codeine should not be given to children younger than 16 years old. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. pharmacist if you have questions about the best way to throw out drugs. A wide range of weight-based doses have resulted in respiratory depression in these patients. Unable to load your collection due to an error, Unable to load your delegates due to an error. 2SHCl and its molecular weight is 320.88. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Promethazine HCl Suppositories, USP are for rectal administration only. Administration of 12.5 to 25 mg promethazine HCl by rectal suppository at bedtime will provide sedation in children. Oral or Rectal: 6.25 to 12.5 mg orally or rectally before meals and at bedtime, as necessary OR 25 mg orally or rectally once a day at bedtime Preoperative medication: 1.1 mg/kg IM, IV, orally, or rectally once. , 4500 East-West Highway, Suite 900, Bethesda, Maryland. suppository. Report Adverse Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 03/2020 VC7409, Boxed Warnings, 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. Promethazine helps control symptoms, but will not treat the cause of the symptoms or speed recovery. WebThe NDC Packaged Code 0713-0526-12 is assigned to a package of 12 suppository in 1 box of Promethegan, a human prescription drug labeled by Cosette Pharmaceuticals, Inc.. Pediatric patients should be supervised to avoid potential harm in bike riding or other hazardous activities. The information is not a substitute for medical care. 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. Long-term animal studies have not been performed to assess the carcinogenic potential of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with this drug. 1 receptor blocking agent. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although Your doctor may need to change the doses of your medications or monitor you carefully for side effects. The .gov means its official. Epinephrine Because of the potential for promethazine HCl to reverse epinephrines vasopressor effect, epinephrine should NOT be used to treat hypotension associated with Promethazine HCl Suppositories overdose. Events, This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Before Stability at Room Temperature** FOR SPECIFIC INFORMATION, CONTACT MANUFACTURER. Clipboard, Search History, and several other advanced features are temporarily unavailable. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. IV: Treatment should be injected into a large vein, avoiding sites in the hand/wrist if possible. 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. 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. (See Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. There may be drug take-back programs in your area. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused, Preoperative, postoperative, and obstetric (during labor) sedation, Oral and Rectal: 25 mg orally, or rectally once, then 12.5 to 25 mg every 4 to 6 hours as needed, Parenteral: 12.5 to 25 mg IM or IV every 4 hours as needed, Initial day: 25 mg orally or rectally 30 to 60 minutes before traveling, then 8 to 12 hours as needed, Succeeding days of travel: 25 mg orally or rectally upon rising, with the dose repeated before the evening meal. Once warmed, remove from wrapper and insert high into the posterior vaginal fornix. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 17H However, many people have no side effects or only have minor side effects. official website and that any information you provide is encrypted 1990 Jun;38(6):1680-3. doi: 10.1248/cpb.38.1680. Amelioration of allergic reactions to blood or plasma. Promethazine is in a class of medications called phenothiazines. Clipboard, Search History, and several other advanced features are temporarily unavailable. 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. 30 days. You may also report side effects at https://www.fda.gov/medwatch. Promethazine may cause breathing to slow or stop, and may cause death in children. 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. Do not share your drugs with others and do not take anyone else's drugs. Par promethazine with codeine vs Hi-Tech promethazine with codeine? Avoid prolonged exposure to the sun. Absorption and bioavailability of calcium and magnesium salts of indomethacin from rectal suppositories. 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&. (See also Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction. (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]. WARNING: Take promethazine exactly as directed. Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. Ask your doctor or pharmacist if you are not sure. Tell your 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. 301-657-3000. Hargoli S, Farid J, Azarmi SH, Ghanbarzadeh S, Zakeri-Milani P. Indian J Pharm Sci. Convulsions may rarely occur. 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. Brand name: Phenergan Remove the wrapper. Pediatric patients should be supervised to avoid potential harm in bike riding or other hazardous activities. 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. Promethazine is a phenothiazine derivative, which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. Promethazine HCl Suppositories are for rectal administration only. IV formulations should be diluted to a concentration of 25 mg/mL or less. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Stand up after about 15 minutes. We comply with the HONcode standard for trustworthy health information. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Do not start, stop, or change the dose of 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. Some drugs may have another patient information leaflet. Do not try to swallow the suppositories or insert in any other part of your body. After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. what signs you had. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 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. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. H -Phenothiazine, 10-ethanamine, Promethazine HCl is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking promethazine. Promethazine was nonmutagenic in the :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 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. Control) Pramlintide injection (Symlin) Promethazine suppositories (Promethegan) Proparacaine ophthalmic. The average parenteral dose given during established labor is 50 mg. 65 years and older: Elderly patients should be given lower initial doses and should be closely monitored for adverse events. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. Federal government websites often end in .gov or .mil. When promethazine is used to relieve cold symptoms, it is usually taken every 4 to 6 hours as needed. WARNINGSCNS Depression and 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. ) for more information if you do not have access to a take-back program. Hallucinations have also been reported. 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. 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. Nausea and Vomiting June 14, 2022. Promethazine HCl 50mg. Bethesda, MD 20894, Web Policies Limited experience with dialysis indicates that it is not helpful. Dermographism. 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. Webexplain the stability of the product at room temperature. 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. 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. 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. 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. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. Avoid driving and doing other tasks or actions that call for you to be. PROMETHAZINE HCL SUPPOSITORIES SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. In 1987, Sterchele5 described the Uses of Promethazine Suppositories: It is used to ease allergy signs. Remove the wrapper. Keep this medication in the carton or container it came in, tightly closed, and out of reach of children. 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. Hold it in place for a few moments. Keep all drugs out of the reach of children and pets. WebPromethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. If your child is throwing up for an unknown reason. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Store promethazine rectal suppositories in a refrigerator between 36 - 46F. Unable to load your collection due to an error, Unable to load your delegates due to an error. Do not handle too much. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. Stay informed and get access to the latest news, 4500 East-West Highway, Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. WebPROMETHAZINE (proe METH a zeen) prevents and treats the symptoms of an allergic reaction. Disclaimer. In anesthetized rats, the plasma indomethacin levels were markedly lower than those in conscious rats, and the influence of the storage temperature on the plasma indomethacin levels was clearly observed. xlI=ZMju! @ jzkZ$q{)w/_?FUV2Eg5nnf?eo w#T[)rUmp2ly!`w13?G]_LhFPpCsQH7ir_&C'57:/ MeSH Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine HCl suppositories and observed closely. Active and prophylactic treatment of motion sickness. official website and that any information you provide is encrypted WARNINGS Use in Pediatric Patients). 2 years and older: Treatment: Oral or Rectal: 1.1 mg/kg orally or rectally every 4 to 6 hours as needed. Take the missed dose as soon as you remember it. There are no adequate and well-controlled studies of Promethazine HCl Suppositories in pregnant women. Perennial and seasonal allergic rhinitis. (see Generic name: Promethazine Suppositories [proe-METH-a-zeen] to you and the baby. Would you like email updates of new search results? Amelioration of allergic reactions to blood or plasma. 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. Please enable it to take advantage of the complete set of features! Preoperative, postoperative, or obstetric sedation. PRECAUTIONS- Information for Patients and Drug Interactions, Cosette Pharmaceuticals, Inc. product information by RSS, Additional medications in the Prescription Medications section by. It is used to help motion sickness . Off-label information indicates unopened bottle stable when maintained at continuous room WARNINGS Use in Pediatric Patients). 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. It is used to ease pain . All oral versions (tablets, syrup) of promethazine should be stored in the original, labeled container at room temperature. In case of overdose, call the poison control helpline at 1-800-222-1222. 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. Promethazine HCl Suppositories, USP are for rectal administration only. WebPromethazine HCl 25mg. Do not try to test for pregnancy at home. Manufacturer Contact. Be sure to mention any of the following: antidepressants ('mood elevators') such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); antihistamines; azathioprine (Imuran);barbiturates such as phenobarbital (Luminal); cancer chemotherapy; epinephrine (Epipen); ipratropium (Atrovent)medications for anxiety, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems; monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), and selegiline (Eldepryl, Emsam, Zelapar); narcotics and other pain medication; sedatives; sleeping pills;and tranquilizers.
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