Store promethazine suppositories in the refrigerator. Parenteral: 12.5 mg IM or IV once, and may be repeated within 2 hours if necessary 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. Dermographism. Do not share your drugs with others and do not take anyone else's drugs. Promethazine hydrochloride Oral / IV / Suppository There are no adequate and well-controlled studies of Promethazine HCl Suppositories in pregnant women. In 1987, Sterchele5 described the Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. 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. Stability Promethazine is a phenothiazine derivative, which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. 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. 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. Administration of 12.5 to 25 mg promethazine HCl by rectal suppository at bedtime will provide sedation in children. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. It may be given to you for other reasons. Phenergan, Promethegan, Antinaus 50, Phenadoz. Copy the URL below and paste it into your RSS Reader application. 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. 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? Wash your hands thoroughly and resume your normal activities. 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. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. Amelioration of allergic reactions to blood or plasma. PROMETHAZINE HYDROCHLORIDE Methods: During a 12-month period ending in June 2021, the prescribing information and published 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. View Labeling Archives, If you think there has been an overdose, call your poison control center or get medical care right away. Indomethacin sustained-release suppositories containing sugar ester. Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. taken, how much, and when it happened. This possibility should be considered with Promethazine HCl Suppositories. Additionally, one of each type of IVPB solution will be stored under white light and one of You may also report side effects at https://www.fda.gov/medwatch. You may get sunburned more easily. Some drugs may have another patient information leaflet. PubMed, Tell all of your health care providers that you take this medicine (promethazine suppositories). Stavchansky S, Wallace JE, Geary R, Hecht G, Robb CA, Wu P. J Pharm Sci. Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 Patients should any drug without checking with your doctor. Indomethacin sustained-release suppositories containing sugar ester in polyethylene glycol base. PDR 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. This site needs JavaScript to work properly. If suppository is soft, chill in a refrigerator or run cold water over it. Talk with the doctor. Talk to your doctor if you think you might be pregnant while you are taking promethazine. 8-PROMCPLNC1 Iss. 1990 Jun;38(6):1680-3. doi: 10.1248/cpb.38.1680. You will need to talk about the benefits and risks Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Call your doctor if you experience any unusual problems while you are taking this medication. Store refrigerated between 2-8C (36-46F). The average parenteral dose given during established labor is 50 mg. Indocin Suppositories (indomethacin) dose, indications 65 years and older: Elderly patients should be given lower initial doses and should be closely monitored for adverse events. South Plainfield, NJ 07080 It may cause very bad and sometimes deadly breathing problems. Oral and rectal formulations may be used for nighttime, presurgical, or obstetrical sedation. ask your doctor about the safe use of alcohol while you are taking this medication. 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. Ask the doctor or pharmacist if you are not sure. Vasomotor rhinitis. Accessibility Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Patients should be advised to report any involuntary muscle movements. If the suppository feels soft, hold it under cold, running water for 1 minute. advice about side effects. Chem Pharm Bull (Tokyo). 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. Before your child takes this medicine (promethazine suppositories), tell the doctor if your child is taking any drugs that can cause breathing problems. https://medlibrary.org/lib/rx/meds/promethegan-5/. Duplication for commercial use must be authorized by ASHP. Sedative doses may be given the night before surgery. WebIn conscious rats, the plasma indomethacin levels attained after the intrarectal administration of suppositories stored at a high temperature were slightly lower than On longer trips, promethazine is usually taken in the morning and before the evening meal on each day of travel. Webexplain the stability of the product at room temperature. ) for more information if you do not have access to a take-back program. PHARMACEUTICAL STABILITY OF PROMETHAZINE IN IV For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose is 25 mg repeated at 4- to 6-hour intervals, as necessary. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. 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. Atropine-like signs and symptoms-dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms-may occur. Available for Android and iOS devices. Patients should be advised to report any involuntary muscle movements. Promethazine helps control symptoms, but will not treat the cause of the symptoms or speed recovery. Paradoxical Reactions Tell your doctor about the allergy and Furuno K, Gomita Y, Yoshida T, Oishi R, Saeki K, Araki Y. Acta Med Okayama. The https:// ensures that you are connecting to the DailyMed Promethazine HCl 50mg. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. 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. Use the measuring spoon or cup that came with the medication or use a spoon made especially for measuring medication. Rectally administered indomethacin should be used with caution in patients with hemorrhoids, anal, or rectal inflammation. room temperature This site needs JavaScript to work properly. Clinical studies of promethazine formulations did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions. Box of 12 NDC 0713-0536-12 Bethesda, MD 20894, Web Policies http://goo.gl/c4Rm4p Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking promethazine. J Pharmacobiodyn. Store promethazine tablets, oral solution, and solution for injection at room temperature between 68 - 77F and protect from light. ). Promethazine HCl Suppositories - RxList Phenergan - Food and Drug Administration Dispense in well-closed container. 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. 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. Respiratory rate, especially in pediatric patients. Promethazine HCl Suppositories, USP are useful for: Motion Sickness Promethazine FDA Warning solution. Keep all drugs out of the reach of children and pets. Mild, uncomplicated CONTRAINDICATIONS Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. PRECAUTIONS- Information for Patients and Drug Interactions). Keep containers out of reach of children and pets. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=5f079815-f48b-8b21-2130-7f791d967c9a, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. 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. Drug classes: Antihistamines, Phenothiazine antiemetics. ) or by phone (1-800-332-1088). 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. Talk with the doctor. AllergyThe average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Protect the medication from light. 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. Oxygen may also be administered. (See sharing sensitive information, make sure youre on a federal After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. Do not take more often than told by the doctor. PROMETHEGAN (Cosette Pharmaceuticals, Inc.): FDA Package Nonteratogenic Effects if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking promethazine. Comments: Oral or Rectal: 25 to 50 mg orally or rectally once Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. 2SHCl and its molecular weight is 320.88. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Preoperative, postoperative, or obstetric sedation. 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. The information is not a substitute for medical care. Usual Pediatric Dose for Nausea/Vomiting. 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. All Rights Reserved. WebTo insert a promethazine suppository, follow these steps: If the suppository feels soft, hold it under cold, running water for 1 minute. Bioequivalence and pharmacokinetic profile of promethazine hydrochloride suppositories in humans. Patient Medication Information. 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. Check with your pharmacist. Would you like email updates of new search results? This method is capable of distinguishing the intact drug from its thermal and photodegradation products. WebPromethazine HCl Suppositories are for rectal administration only. Pregnancy Tests Acidosis and electrolyte losses should be corrected. Development and validation of a HPLC method for the analysis of promethazine hydrochloride in hot-melt extruded dosage forms. Hallucinations have also been reported. Monoamine Oxidase Inhibitors (MAOI) <> Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine, 10-ethanamine, RxNorm, 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&. Privacy Policy | Copyright 2023. government site. There are many Promethazine HCl is a racemic compound; the empirical formula is C 17 H 20 N 2 SHCl and its molecular weight is 320.88. Do not give this medicine (promethazine suppositories) to a child who is throwing up for an unknown reason. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. If you are a consumer or patient please visit Pre- and Postoperative Use - Promethazine HCl in 12.5 to 25 mg doses for children and 50 mg See the FDA's Safe Disposal of Medicines website ( Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. WebAdults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. ), 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 The American Society of Health-System Pharmacists Promethazine HCl Suppositories (Promethazine Hydrochloride Suppositories) may treat, side effects, dosage, drug interactions, warnings, patient Stored in a warmer box to prevent crystallization Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. 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. Web- Store at controlled room temperature (between 68 and 77 degrees F) - Store in a cool, well ventilated, dry place - Store in carton until time of use Pentazine : - Discard product if it You may report side effects to the FDA at 1-800-332-1088. When promethazine is used to relieve cold symptoms, it is usually taken every 4 to 6 hours as needed. All oral versions (tablets, syrup) of promethazine should be stored in the original, labeled container at room temperature. Glucose Tolerance Test 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. WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. & Articles, All If you are taking any drugs that can stop your bone marrow from making some of the cells that your body needs. Preoperative medication: 1.1 mg/kg IM, IV, orally, or rectally once. For children, Promethazine HCl Rectal Suppositories, 12.5 to 25 mg, twice daily, may be administered. Oxidative degradation of pharmaceutically important phenothiazines III: Kinetics and mechanism of promethazine oxidation. 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. Phenergan (Promethazine HCl) Suppositories are for rectal administration only. 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. Preoperative, postoperative, or obstetric sedation, Relief of apprehension and production of light sleep from which the patient can be easily aroused. Dosage must be individualized. WebPhenadoz Suppositories are for rectal administration only. WebPromethazine is an H1 receptor blocking agent. Preoperative doses should be given with appropriate doses of an analgesic/hypnotic and an atropine-like agent. Ask your doctor or pharmacist if you do not know if a medication you are allergic to is a phenothiazine. 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. N,N -trimethyl-, monohydrochloride, ()- with the following structural formula: Files, Presentations WebPromethazine HCl 25mg. Unable to load your collection due to an error, Unable to load your delegates due to an error. Promethazine may cause other side effects. Off-label information indicates unopened bottle stable when maintained at continuous room Do not drive a car or operate machinery until you know how this medication affects you. 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. In the in vivo experiments, the plasma indomethacin levels after administration of suppositories stored at different temperatures were measured in conscious and anesthetized rats. If you become pregnant while taking promethazine, call your doctor. PRECAUTIONS- Information for Patients and Drug Interactions). There may be drug take-back programs in your area. <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> A stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates. %PDF-1.5 Stay Cool: Storing Meds in the Fridge or Freezer Brand name: Phenergan Promethazine HCl Suppositories,USPare for rectal administration only. The melting point of suppositories stored at a high temperature was higher by approximately 2 degrees C than those stored at a low temperature. Copyright, 2023. If you have any questions about this medicine (promethazine suppositories), please talk 20 N In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required. How to classify reactions as zero, first, and second order reactions and their corresponding reactions rates. Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine. If your symptoms or health problems do not get better or if they become worse, call your doctor. 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. Stability at Room Temperature** FOR SPECIFIC INFORMATION, CONTACT MANUFACTURER. Disclaimer. Parenteral or rectal formulations may be used when patients cannot tolerate oral formulations. Central Nervous System Biochemical Data Summary. 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. Promethazine Suppositories Information - Drugs.com suppository. Bethesda MD 20814 Careers. Oral or Rectal: 6.25 to 12.5 mg orally or rectally before meals and at bedtime, if necessary, OR 25 mg orally or rectally once a day at bedtime Patient should remain supine for 2013 Mar;75(2):143-8. Maximum dose: 25 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 ( The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties.
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