WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. Dermographism. Instead, the best way to dispose of your medication is through a medicine take-back program. Promethazine HCl Suppositories may cause marked drowsiness or impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. A stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. View Labeling Archives, The site is secure. is this? The administration of promethazine hydrochloride in 25-mg doses will control minor transfusion reactions of an allergic nature. Files, Presentations WARNINGSNeuroleptic Malignant Syndrome). The effect on later growth and development of the newborn is unknown. 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. to make sure that it is safe for you to take this medicine (promethazine suppositories) with all of your drugs and health problems. 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. Phenergan Suppositories Dosage Paradoxical Reactions National Library of Medicine Promethazine Dosage Guide + Max Dose, Adjustments - Drugs.com 0713-0526-12, Patient should remain supine for This includes your doctors, nurses, pharmacists, and dentists. Medically reviewed by Drugs.com. FDA Safety Recalls, Parenteral formulations of this drug may cause severe chemical irritation and tissue damage regardless of the route. H -Phenothiazine, 10-ethanamine, Once treatment begins, the dose should be reduced to the smallest effective amount needed to control symptoms. Refrigerate at 36 to 46F (2 to 8C). Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Promethazine HCl is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. FROZEN Drugs A very bad and sometimes deadly health problem called. Phenergan, Promethegan, Antinaus 50, Phenadoz. Note that any depressant effects of promethazine HCl are not reversed by naloxone. All Rights Reserved. Carcinogenicity Under the conditions of the National Toxicology Program (NTP) studies, there was no evidence of In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required. promethazine 8600 Rockville Pike Stand up after about 15 minutes. IV formulations should be diluted to a concentration of 25 mg/mL or less. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Par promethazine with codeine vs Hi-Tech promethazine with codeine? PHARMACEUTICAL STABILITY OF PROMETHAZINE IN IV 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. This report on medications is for your information only, and is not considered individual patient advice. Active and prophylactic treatment of motion sickness, Oral and Rectal: 25 mg orally every 4 to 6 hours as needed. When promethazine is used to treat motion sickness, it is taken 30 to 60 It may be given to you for other reasons. Study on absorption of indomethacin from sustained-release suppositories containing hydrogenated soybean lecithin in rabbits. Webafter 24 hours of storage at room- temperature, when stored in a cool place (815 C), and when stored at room-temperature (1530 C). 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. Drug classes: Antihistamines, Phenothiazine antiemetics. Preoperative, postoperative, or obstetric sedation. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 Check with your (See ), More about getting RSS News & Updates from DailyMed, 12 in 1 BOX; Type 0: Not a Combination Product, 1000 in 1 BOX; Type 0: Not a Combination Product, Cosette Pharmaceuticals NC Laboratories, LLC, analysis(0713-0526, 0713-0536) , label(0713-0526, 0713-0536) , manufacture(0713-0526, 0713-0536) , pack(0713-0526, 0713-0536), 6 drugs that can do this. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. An increase in blood glucose has been reported in patients receiving promethazine HCl. 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. Wash your hands thoroughly and resume your normal activities. Before Manufacturer Contact Information (Quality Control) InterMune, Inc. 888 WebPromethazine HCl Suppositories are for rectal administration only. Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. Amelioration of allergic reactions to blood or plasma. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Promethazine HCl Suppositories may cause marked drowsiness or impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking promethazine. Information (Quality. Phenergan (Promethazine HCl) Suppositories are for rectal administration only. photolytic degradation studies of promethazine Dermatologic Dermatitis, photosensitivity, urticaria. 25 mg, white, bullet-shaped suppository wrapped in silver foil. Remove the wrapper. 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 concomitant use of alcohol or other central nervous system depressants, including narcotic analgesics, sedatives, hypnotics, and tranquilizers, may have an additive effect and should be avoided or their dosage reduced. Do not try to test for pregnancy at home. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Unauthorized use of these marks is strictly prohibited. Bookshelf The injection solution should be inspected for particulate matter and discoloration before administration. Patients should be told to report any involuntary muscle movements. Allergy The average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Pediatric patients should be supervised to avoid potential harm in bike riding or other hazardous activities. To determine the activation energy necessary by constructing an Arrhenius plot. 2 years and older: Treatment: Oral or Rectal: 1.1 mg/kg orally or rectally every 4 to 6 hours as needed. Ask your doctor or pharmacist if you do not know if a medication you are allergic to is a phenothiazine. WebPhenadoz Suppositories are for rectal administration only. The release of indomethacin from fatty-base suppositories, which had been stored at a low (4 degrees C) and a high (25-30 degrees C) temperature for about one month, was examined in vitro and in vivo. Promethazine HCl Suppositories should be used with caution in pediatric patients 2 years of age and older (see Do not The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. The syrup version of promethazine should be in a light-protected bottle with the lid tightly closed at all times. 1 0 obj Clinical Trials, If the suppository feels soft, hold it under cold, running water for 1 minute. Tell your Indocin Suppositories (indomethacin) dose, indications 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 50mg. Promethazine suppositories are for rectal use only. Cardiovascular Increased or decreased blood pressure, tachycardia, bradycardia, faintness. Privacy Policy | Copyright 2023. Indomethacin sustained-release suppositories containing sugar ester in polyethylene glycol base. Remove the foil wrapper and insert the suppository high into the posterior vaginal fornix. Hallucinations (seeing or hearing things that are not there). Promethazine 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. Clipboard, Search History, and several other advanced features are temporarily unavailable. WARNING: Bethesda, MD 20894, Web Policies An official website of the United States government. Administered IV as an adjunct to anesthesia or analgesia with reduced amounts of meperidine of other narcotic analgesics in special surgical situations (e.g., repeated bronchoscopy, ophthalmic surgery, poor-risk patients), Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Comments: 2 years and older: Promethazine HCl Suppositories (Promethazine Hydrochloride Suppositories) may treat, side effects, dosage, drug interactions, warnings, patient WARNINGSBlack Box Warning and The following laboratory tests may be affected in patients who are receiving therapy with promethazine HCl: Promethazine HCl Rectal Suppositories are not recommended for children under 2 years of age. plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. 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. PubMed, Would you like email updates of new search results? This medicine may cause the results of some pregnancy tests to be wrong. Vasomotor rhinitis. Ask your pharmacist any questions you have about refilling your prescription. Thermal and photolytic degradation studies of promethazine 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. 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. https://medlibrary.org/lib/rx/meds/promethegan-5/. Acidosis and electrolyte losses should be corrected. Generic name: Promethazine Suppositories [proe-METH-a-zeen] Salmonella test system of Ames. Mild, uncomplicated CONTRAINDICATIONS Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. Shakiness, trouble moving around, or stiffness. 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. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. talk to your doctor about the risks and benefits of taking promethazine if you are 65 years of age or older. 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.. Do not handle too much. WARNINGSCNS Depression and If you have an allergy to promethazine or any other part of this medicine (promethazine suppositories). If you are 65 or older, use this medicine (promethazine suppositories) with care. Before Federal government websites often end in .gov or .mil. WebWhen promethazine is used to relieve cold symptoms, it is usually taken every 4 to 6 hours as needed. If you take this medicine (promethazine suppositories) on a regular basis, take a missed dose as soon as you think about it. Subsequent doses on succeeding days of travel should be given on rising and again before the evening meal. Other Angioneurotic edema. Promethegan (promethazine hydrochloride) dose, indications, tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Avoid driving and doing other tasks or actions that call for you to be. Vasomotor rhinitis. Promethazine HCl is a racemic compound; the empirical formula is C (See also CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. Do not freeze the oral liquid. Perennial and seasonal allergic rhinitis. 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. 2 years and older: and transmitted securely. 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 treat sleep problems. 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. All oral versions (tablets, syrup) of promethazine should be stored in the original, labeled container at room temperature. Report Adverse Promethazine helps control symptoms, but will not treat the cause of the symptoms or speed recovery. The https:// ensures that you are connecting to the H-Phenothiazine, 10-ethanamine, 1 receptor blocking agent. Monoamine Oxidase Inhibitors (MAOI) Some drugs may have another patient information leaflet. Webtype of IVPB solution will be stored at room temperature (21C), 4C, and 37C in the dark. Store suppositories in a refrigerator. you should know that this medication may make you drowsy. Distributedby: Cosette Pharmaceuticals, Inc. 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. You may also report side effects at https://www.fda.gov/medwatch. Use with care in children 2 years of age and older. June 14, 2022. 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. Promethazine may cause breathing to slow or stop, and may cause death in children. Follow all instructions closely. 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. 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. If you think there has been an overdose, call your poison control center or get medical care right away. 8-PROMCPLNC1 Iss. 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. Pregnancy Tests Put suppository into the rectum with gentle pressure, pointed end first. There are no adequate and well-controlled studies of Promethazine HCl Suppositories in pregnant women. This possibility should be considered with Promethazine HCl Suppositories. Patient Medication Information. Keep from freezing. Avoid prolonged exposure to the sun. It Available for Android and iOS devices. The site is secure. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. ask your doctor about the safe use of alcohol while you are taking this medication. 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. Dispense in well-closed container. View NDC Code(s)NEW! sharing sensitive information, make sure youre on a federal Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients. 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. Allergic conjunctivitis due to inhalant allergens and foods. Bioequivalence and pharmacokinetic profile of promethazine hydrochloride suppositories in humans. Promethazine HCl Suppositories may lower seizure threshold. Careers. Promethazine HCl Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Dosage must be individualized. J Pharm Sci. sharing sensitive information, make sure youre on a federal PROMETHEGAN (Cosette Pharmaceuticals, Inc.): FDA Package WebPromethazine HCl 25mg. Adverse reactions include burning, pain, thrombophlebitis, tissue necrosis, and gangrene. 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. <> Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 WARNINGSRespiratory Depression). 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. AllergyThe average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. 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. prednisone, trazodone, hydroxyzine, ondansetron, montelukast, fluticasone nasal, lorazepam, loratadine, cetirizine, diazepam. 4 0 obj Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. There are many drugs that The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. Events, (What Copy the URL below and paste it into your RSS Reader application. This method is capable of distinguishing Promethazine is in a class of medications called phenothiazines. Promethazine was nonmutagenic in the Limited data suggest that use of promethazine HCl during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE 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.
