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. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. Report Adverse Nonteratogenic Effects Promethazine HCl The product's dosage form is suppository and is administered via rectal form. Call your doctor right away if you have slow, shallow, or trouble 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. Use of Promethazine HCl Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Phenergan (Promethazine HCl) Suppositories are for rectal administration only. Development and validation of a HPLC method for the analysis of promethazine hydrochloride in hot-melt extruded dosage forms. Limited experience with dialysis indicates that it is not helpful. Amelioration of allergic reactions to blood or plasma. Stand up after about 15 minutes. Treatment of overdosage is essentially symptomatic and supportive. Comments: 2 years and older: 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. talk to your doctor about the risks and benefits of taking promethazine if you are 65 years of age or older. Do not handle too much. When promethazine is used to relieve cold symptoms, it is usually taken every 4 to 6 hours as needed. endobj Chem Pharm Bull (Tokyo). Use in Pediatric Patients). Avoid analeptics, which may cause convulsions. prednisone, trazodone, hydroxyzine, ondansetron, montelukast, fluticasone nasal, lorazepam, loratadine, cetirizine, diazepam. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. Do not let anyone else take your medication. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> 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. How long does promethazine stay in your system? Kinetic studies were performed to determine the photolytic and thermal degradation rates of promethazine hydrochloride as a function of pH. Ask your doctor or pharmacist if you are not sure. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Convulsions may rarely occur. Parenteral or rectal formulations may be used when patients cannot tolerate oral formulations. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Patients should The stability of aqueous solutions of promethazine hydrochloride as a function of pH. 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 Use this medicine (promethazine suppositories) as ordered by your doctor. Promethazine HCl Suppositories are useful for: Perennial and seasonal allergic rhinitis. sharing sensitive information, make sure youre on a federal 1 receptor blocking agent. 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. Avoid sun, sunlamps, and tanning beds. Pregnancy Tests 2013 Mar;75(2):143-8. If you think there has been an overdose, call your poison control center or get medical care right away. All Rights Reserved. if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking promethazine. Preoperative medication: 1.1 mg/kg IM, IV, orally, or rectally once. 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. Hallucinations (seeing or hearing things that are not there). 2 years and older: Treatment: Oral or Rectal: 1.1 mg/kg orally or rectally every 4 to 6 hours as needed. Control) Pramlintide injection (Symlin) Promethazine suppositories (Promethegan) Proparacaine ophthalmic. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Antiemetic therapy in postoperative patients. Active and prophylactic treatment of motion sickness. (A left-handed person should lie on the right side and raise the left knee.). 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. Chem Pharm Bull (Tokyo). Throw away unused or expired drugs. Other Angioneurotic edema. with your doctor, nurse, pharmacist, or other health care provider. 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. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use of Promethazine HCl Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Box of 12 NDC 0713-0536-12 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. Promethazine HCl Suppositories, USP are useful for: Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Cardiovascular Increased or decreased blood pressure, tachycardia, bradycardia, faintness. See the FDA's Safe Disposal of Medicines website ( 8-PROMCPLNC1 Iss. Keep this medication in the carton or container it came in, tightly closed, and out of reach of 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 You may report side effects to the FDA at 1-800-332-1088. 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. If you become pregnant while taking promethazine, call your doctor. All oral versions (tablets, syrup) of promethazine should be stored in the original, labeled container at room temperature. Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. For children, Promethazine HCl Rectal Suppositories, 12.5 to 25 mg, twice daily, may be administered. IV formulations should be diluted to a concentration of 25 mg/mL or less. H -Phenothiazine, 10-ethanamine, 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. This site needs JavaScript to work properly. 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. 1978 Aug;67(8):1133-8. doi: 10.1002/jps.2600670828. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Neuroleptic malignant syndrome (potentially fatal) has also been reported (See Bethesda, MD 20894, Web Policies Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although Ask your doctor or pharmacist if you do not know if a medication you are allergic to is a phenothiazine. WARNINGSRespiratory Depression). Presence in Breast Milk, Medline Plus, Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 8600 Rockville Pike suppository. Allergic conjunctivitis due to inhalant allergens and foods. 2 SHCl and its molecular weight is 320.88. This site complies with the HONcode standard for trustworthy health information: verify here. 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. Available for Android and iOS devices. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients. This drug should be administered at a rate no greater than 25 mg/min. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. 1987 Jun;76(6):441-5. doi: 10.1002/jps.2600760606. Promethazine HCl is a racemic compound; the empirical formula is C FDA Safety Recalls, 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. Manufacturer Contact. Call your doctor for medical 20 N Low white blood cell counts have happened with this medicine (promethazine suppositories). 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. Minor transfusion and/or amelioration of allergic reactions may be controlled with 12.5 mg doses. 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. Unauthorized use of these marks is strictly prohibited. suppository. <> It may be given to you for other reasons. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. We comply with the HONcode standard for trustworthy health information. The administration of promethazine hydrochloride in 25-mg doses will control minor transfusion reactions of an allergic nature. WebPromethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Gastrointestinal Dry mouth, nausea, vomiting, jaundice. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. 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. WebTo insert a promethazine suppository, follow these steps: If the suppository feels soft, hold it under cold, running water for 1 minute. PRECAUTIONS- Information for Patients and Drug Interactions). You must check Dispense in well-closed container. Nonteratogenic Effects.). Keep all drugs in a safe place. WebStore the tablets and syrup at room temperature. A stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. Bethesda MD 20814 An official website of the United States government. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine, 10-ethanamine, Ask your pharmacist any questions you have about refilling your prescription. WARNINGS Use in Pediatric Patients). Generic name: Promethazine Suppositories [proe-METH-a-zeen] Dosage must be individualized. Store promethazine tablets, oral solution, and solution for injection at room temperature between 68 - 77F and protect from light. Indomethacin sustained-release suppositories containing sugar ester in polyethylene glycol base. Avoid driving and doing other tasks or actions that call for you to be. 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. 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. It is used to treat sleep problems. You may also report side effects at https://www.fda.gov/medwatch. Nonteratogenic Effects Drowsiness is the most prominent CNS effect of this drug. Copy the URL below and paste it into your RSS Reader application. this version. WebIndomethacin suppositories are contraindicated in patients with a history of proctitis or recent rectal bleeding. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 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. Before Promethazine HCl 12.5mg. Promethazine can cause side effects. This drug should not be used to treat nausea and vomiting of unknown etiology. Promethazine HCl Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Some drugs may have another patient information leaflet. Take promethazine exactly as directed. WebPromethazine HCL Suppository, Rectal - Uses, Side Effects, and More Common Brand(S): Phenergan, Promethegan Generic Name(S): promethazine View Free Coupon pharmacist if you have questions about the best way to throw out drugs. Shakiness, trouble moving around, or stiffness. Check with your pharmacist. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. 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%. The injection solution should be inspected for particulate matter and discoloration before administration. Stay informed and get access to the latest news, 4500 East-West Highway, Promethazine is an H WebVaginal suppositories (e.g., Prostin E2): Before removing foil wrapper, allow vaginal suppository to warm to room temperature. 1990 Apr;38(4):1027-31. doi: 10.1248/cpb.38.1027. Patients should be advised to avoid prolonged sun exposure during treatment. endobj PROMETHEGAN- promethazine hydrochloride suppository, 0713-0526-10, 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. Do not start, stop, or change the dose of Take promethazine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Promethazine suppositories are for rectal use only. Do not try to swallow the suppositories or insert in any other part of your body. Nakajima T, Takashima Y, Furuya A, Ozawa Y, Kawashima Y. Chem Pharm Bull (Tokyo). 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. Remove the wrapper. WebPromethazine HCl Suppositories are for rectal administration only. <> Use. Store promethazine suppositories in the refrigerator. 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. WebPromethazine Hydrochloride Sensitization Not applicable.

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