17H Remove the wrapper. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use. Bookshelf Hallucinations (seeing or hearing things that are not there). Amelioration of allergic reactions to blood or plasma. Store promethazine tablets, oral solution, and solution for injection at room temperature between 68 - 77F and protect from light. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. Promethazine is also used to prevent and control nausea and vomiting that may occur after surgery, and with other medications to help relieve pain after surgery. This possibility should be considered with Promethazine HCl Suppositories. Promethazine may also be taken at bedtime the night before surgery to relieve anxiety and produce quiet sleep. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. If you are allergic to this medicine (promethazine suppositories); any part of this medicine (promethazine suppositories); or any other drugs, foods, or substances. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Comments: Oral or Rectal: 25 to 50 mg orally or rectally once The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Promethazine helps control symptoms, but will not treat the cause of the symptoms or speed recovery. You may also report side effects at https://www.fda.gov/medwatch. Call your doctor right away if you have slow, shallow, or trouble Would you like email updates of new search results? 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. If you have questions about side effects, call your doctor. WebPromethazine is an H1 receptor blocking agent. The administration of promethazine hydrochloride in 25-mg doses will control minor transfusion reactions of an allergic nature. 1984 Jun;7(6):392-9. doi: 10.1248/bpb1978.7.392. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Parenteral or rectal formulations may be used when patients cannot tolerate oral formulations. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. sharing sensitive information, make sure youre on a federal Parenteral: 12.5 mg IM or IV once, and may be repeated within 2 hours if necessary tablet. http://goo.gl/c4Rm4p 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. J Pharmacobiodyn. Parenteral: Treatment: 12.5 to 25 mg IM, IV, orally, or rectally every 4 hours as needed CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. Store promethazine rectal suppositories in a refrigerator between 36 - 46F. Unauthorized use of these marks is strictly prohibited. Promethazine HCl suppositories (promethazine hydrochloride 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. Promethazine HCl Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Keep all drugs out of the reach of children and pets. The site is secure. 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. Amylin Pharmaceuticals. Instead, the best way to dispose of your medication is through a medicine take-back program. Atropine-like signs and symptoms-dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms-may occur. This may lead to a higher chance of getting an. DOSAGE AND ADMINISTRATION if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking promethazine. 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). Stored in a warmer box to prevent crystallization When promethazine is used to relieve cold symptoms, it is usually taken every 4 to 6 hours as needed. Before WebTo insert a promethazine suppository, follow these steps: If the suppository feels soft, hold it under cold, running water for 1 minute. If you become pregnant while taking promethazine, call your doctor. 8-PROMCPLNC1 Iss. Tell your Presence in Breast Milk, Medline Plus, Store promethazine tablets and liquid at room temperature and away from excess heat and moisture (not in the bathroom). stream Subsequent doses on succeeding days of travel should be given on rising and again before the evening meal. WebPromethazine HCl 25mg. Patients should be advised to avoid prolonged sun exposure during treatment. WARNINGSCNS Depression and http://www.upandaway.org. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. Do not give this medicine (promethazine suppositories) to a child who is throwing up for an unknown reason. 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. Vasomotor rhinitis. How long does promethazine stay in your system? If suppository is soft, chill in a refrigerator or run cold water over it. Ask the doctor or pharmacist if you are not sure. 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. Accessibility Perennial and seasonal allergic rhinitis. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times. For preoperative medication children require doses of 0.5 mg per pound of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug. It is not known whether promethazine HCl is excreted in human milk. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. 30 days. 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. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Last updated on Apr 10, 2023. There are many drugs that Copyright, 2023. 1972 Dec;24:Suppl:133P-134. 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. It is soluble in water and freely soluble in alcohol. 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. Dispense in well-closed container. with your doctor, nurse, pharmacist, or other health care provider. Prophylactic doses may be used to prevent nausea and vomiting during surgery and the postoperative period. All Rights Reserved. WebStore the tablets and syrup at room temperature. WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. A linear relationship between peak height ratio (promethazine-promazine) and promethazine concentration is found up to a concentration of 600 micrograms/ml. In case of overdose, call the poison control helpline at 1-800-222-1222. Patients should be advised to report any involuntary muscle movements. Careers. Do not try to test for pregnancy at home. ) for more information if you do not have access to a take-back program. advice about side effects. 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. Deep IM injection is the preferred route of administration. WARNINGSBlack Box Warning and Talk with the doctor. 1 receptor blocking agent. IV formulations should be diluted to a concentration of 25 mg/mL or less. Nonteratogenic Effects Nonteratogenic Effects Promethazine HCl Bookshelf 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+-$`>*>c 7o&. It is also important information to carry with you in case of emergencies. Preoperative, postoperative, or obstetric sedation. For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated. Would you like email updates of new search results? Administration of 12.5 to 25 mg promethazine HCl by rectal suppository at bedtime will provide sedation in children. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. to you and the baby. Within the Prescription Medications section: Use Trial Bulletin to search for clinical trials involving this product: All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent. Promethazine HCl Suppositories may cause marked drowsiness or impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. In the in vitro release test using a dialysis cell method, much lower amounts of indomethacin were released from the suppositories stored at a high temperature than from those stored at a low temperature. HHS Vulnerability Disclosure, Help endobj hUV?Rr$F/~H>d'K[U[\6 n=>r,+wk2rP#hqB8&\,d `S6XGfRFLm1b%Ux/w4 *uU=pk6M;]-I%d.@TdzJ]C//RbU=8q]W0,75ni. Careers. 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. How to classify reactions as zero, first, and second order reactions and their corresponding reactions rates. Unauthorized use of these marks is strictly prohibited. Nausea and Vomiting 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. 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. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Respiratory Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). Limited experience with dialysis indicates that it is not helpful. 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). 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. Keep all drugs in a safe place. pharmacist if you have questions about the best way to throw out drugs. 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. Follow all instructions closely. Promethazine HCl 25mg. 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. Promethazine is an H 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 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. 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. 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. Keep containers out of reach of children and pets. FOIA Alcohol can make the side effects of promethazine worse. PubMed, is this? Unable to load your collection due to an error, Unable to load your delegates due to an error. A wide range of weight-based doses have resulted in respiratory depression in these patients. R)EU4u:/uug83YR/^dL P?062v*6>As5>) ,]'bHK80Ume4xWTJy$yI p7[I?ruO[P8kW,]6-tg4IE&()LV l=-V4{d]|O This site complies with the HONcode standard for trustworthy health information: verify here. Talk with the doctor. Diazepam may be used to control convulsions. The stability of aqueous solutions of promethazine hydrochloride as a function of pH. Talk to your doctor about the risks of giving promethazine to your child. Store suppositories in a refrigerator. 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. Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. The photolytic degradation of promethazine hydrochloride does not follow simple first-order kinetics. WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. 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. N,N -trimethyl-, monohydrochloride, ()- with the following structural formula: Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. taken, how much, and when it happened. PMC Do not flush down a toilet or pour down a drain unless you are told to do so. Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see Household teaspoons may not be an accurate measuring device. J Pharm Sci. Promethazine HCl Suppositories (Promethazine Hydrochloride Suppositories) may treat, side effects, dosage, drug interactions, warnings, patient . Glucose Tolerance Test There are many WARNINGSRespiratory Depression). <> to make sure that it is safe for you to take this medicine (promethazine suppositories) with all of your drugs and health problems. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. WebPromethazine Hydrochloride Sensitization Not applicable. Privacy Policy | Copyright 2023. The average adult dose is 25 mg taken twice daily. tablet. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine, 10-ethanamine, 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. (A left-handed person should lie on the right side and raise the left knee.). 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 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. 03/2020 VC7409, Boxed Warnings, Some drugs may have another patient information leaflet. Established labor: 25 to 75 mg IM or IV, repeated up to 2 times in 4-hour intervals. Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates. This method is capable of distinguishing 0713-0526-12, 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. Read all information given to you. Patients should be advised to report any involuntary muscle movements. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions. 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. If you have an allergy to promethazine or any other part of this medicine (promethazine suppositories). EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. Dosage must be individualized. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Accessibility Bethesda MD 20814 800-349-8919 WARNINGSNeuroleptic Malignant Syndrome). Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Vaginal Suppositories Allow suppository to reach room temperature just prior to administration. Gastrointestinal Dry mouth, nausea, vomiting, jaundice. www.fda.gov/medwatch. Allergy The average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. 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. This branded product is no longer on the market. Pregnancy Tests 65 years and older: Elderly patients should be given lower initial doses and should be closely monitored for adverse events. Webstore at a room temperature not to exceed 77F (25C) for up to 6 weeks. Parenteral formulations: Store ampoules in the carton until ready to use. Minor transfusion and/or amelioration of allergic reactions may be controlled with 25 mg doses. Webexplain the stability of the product at room temperature. and transmitted securely. Duplication for commercial use must be authorized by ASHP. Bioequivalence and pharmacokinetic profile of promethazine hydrochloride suppositories in humans. PRECAUTIONSDrug Interactions). Uses of Promethazine Suppositories: It is used to ease allergy signs. Additionally, one of each type of IVPB solution will be stored under white light and one of Talk to your doctor if you think you might be pregnant while you are taking promethazine. WARNINGS Use in Pediatric Patients). All Rights Reserved. WARNINGSCNS Depression and % Promethazine HCl Suppositories should be used with caution in pediatric patients 2 years of age and older (see 2SHCl and its molecular weight is 320.88. 2013 Mar;75(2):143-8. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Patient should remain supine for Phenergan, Promethegan, Antinaus 50, Phenadoz. Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. Promethazine can cause side effects. The first-order rate constant increased with increasing pH. Maximum dose: 25 Federal government websites often end in .gov or .mil. Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. (see Parenteral: 25 mg IM or IV once, and may be repeated within 2 hours if necessary This drug should be administered at a rate no greater than 25 mg/min. Box of 12 NDC 0713-0526-12 Promethazine HCl 12.5mg. government site. Patients should Do not take 2 doses at the same time or extra doses. There are no adequate and well-controlled studies of Promethazine HCl Suppositories in pregnant women. This includes your doctors, nurses, pharmacists, and dentists. PRECAUTIONS- Information for Patients and Drug Interactions).

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