Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 (A left-handed person should lie on the right side and raise the left knee.). This method is capable of distinguishing the intact drug from its thermal and photodegradation products. 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. Allergy The average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Bookshelf Do not try to swallow the suppositories or insert in any other part of your body. Box of 12 NDC 0713-0536-12 WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. 301-657-3000. Parenteral: 25 mg IM or IV once, and may be repeated within 2 hours if necessary The https:// ensures that you are connecting to the If you have an allergy to promethazine or any other part of this medicine (promethazine suppositories). if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking promethazine. 2SHCl and its molecular weight is 320.88. <> government site. It works by blocking the action of a certain natural substance in the body. 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. 1984 Jun;7(6):392-9. doi: 10.1248/bpb1978.7.392. 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. advice about side effects. official website and that any information you provide is encrypted Dermographism. Citations, PRECAUTIONS- Information for Patients and Drug Interactions, Carcinogenesis, Mutagenesis, Impairment of Fertility, Report Adverse This site needs JavaScript to work properly. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. When promethazine is used to treat motion sickness, it is taken 30 to 60 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). xlI=ZMju! @ jzkZ$q{)w/_?FUV2Eg5nnf?eo w#T[)rUmp2ly!`w13?G]_LhFPpCsQH7ir_&C'57:/ Alcohol can make the side effects of promethazine worse. HHS Vulnerability Disclosure, Help Preoperative medication: 1.1 mg/kg IM, IV, orally, or rectally once. In 1987, Sterchele5 described the If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. When promethazine is used to relieve cold symptoms, it is usually taken every 4 to 6 hours as needed. The initial dose should be given 30 to 60 minutes before anticipated travel, and may be repeated in 8 to 12 hours as needed. 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). To determine the activation energy necessary by constructing an Arrhenius plot. The injection solution should be inspected for particulate matter and discoloration before administration. Minor transfusion and/or amelioration of allergic reactions may be controlled with 12.5 mg doses. Store refrigerated between 2-8C (36-46F). Use the measuring spoon or cup that came with the medication or use a spoon made especially for measuring medication. ). Dermatologic Dermatitis, photosensitivity, urticaria. Last updated on Jan 28, 2022. The photolytic degradation of promethazine hydrochloride does not follow simple first-order kinetics. Disclaimer. Copyright, 2023. AHFS Amelioration of allergic reactions to blood or plasma. Phenergan Suppositories Dosage Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Unauthorized use of these marks is strictly prohibited. Promethazine: MedlinePlus Drug Information 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. For children, Promethazine HCl Rectal Suppositories, 12.5 to 25 mg, twice daily, may be administered. The first-order rate constant increased with increasing pH. 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. Labels, All Index The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. WebWhen promethazine is used to relieve cold symptoms, it is usually taken every 4 to 6 hours as needed. PRECAUTIONS- Information for Patients and Drug Interactions, Cosette Pharmaceuticals, Inc. product information by RSS, Additional medications in the Prescription Medications section by. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Promethazine HCl is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. 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. Promethazine was nonmutagenic in the Pediatric patients should be supervised to avoid potential harm in bike riding or other hazardous activities. AllergyThe average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. RxNorm, Study on absorption of indomethacin from sustained-release suppositories containing hydrogenated soybean lecithin in rabbits. Phenergan, Promethegan, Antinaus 50, Phenadoz. Dinoprostone South Plainfield, NJ 07080 Promethazine hydrochloride Oral / IV / Suppository 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. This branded product is no longer on the market. If you have any of these health problems: If you have any of these health problems: Low blood cell count or poor bone marrow function. WebRefrigerated medications should be stored at temperatures between 2oC and 8oC (35oF to 46oF). Manufacturer Contact. Privacy Policy | Copyright 2023. Preoperative, postoperative, or obstetric sedation. WebAdults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or Webstore at a room temperature not to exceed 77F (25C) for up to 6 weeks. Hematologic Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. Active and prophylactic treatment of motion sickness, Oral and Rectal: 25 mg orally every 4 to 6 hours as needed. Rectal suppositories Never take suppositories by mouth. 1990 Jun;38(6):1680-3. doi: 10.1248/cpb.38.1680. stream Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. 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. Adverse reactions include burning, pain, thrombophlebitis, tissue necrosis, and gangrene. 03/2020 VC7409, Boxed Warnings, and transmitted securely. WARNINGSRespiratory Depression). 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. Oral formulations are preferred; however, rectal or parenteral formulations may be given if oral formulations are not tolerated. Federal government websites often end in .gov or .mil. 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. Use of Promethazine HCl Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Vasomotor rhinitis. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Usual Pediatric Dose for Nausea/Vomiting. Webexplain the stability of the product at room temperature. Do not take 2 doses at the same time or extra doses. Promethazine can cause side effects. Chem Pharm Bull (Tokyo). Promethazine is well absorbed from the gastrointestinal tract. 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. <> When promethazine is used to treat or prevent nausea and vomiting it is usually taken every 4 to 6 hours as needed. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. Oral solution: The oral solution should be measured with an accurate measuring device to decrease the risk of overdosage. drugs that can do this. Promethazine may also be taken at bedtime the night before surgery to relieve anxiety and produce quiet sleep. 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. Box of 12 NDC 0713-0526-12 The American Society of Health-System Pharmacists Do not freeze. Talk with the doctor. ), 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 8600 Rockville Pike (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]. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Patients should be advised to report any involuntary muscle movements. Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. can do this. 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. Promethazine FDA Warning Respiratory rate, especially in pediatric patients. If you have questions about side effects, call your doctor. Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. Promethazine should not routinely be used to treat vomiting in children; it should only be used in specific cases when a doctor decides that it is needed. FOIA 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. Promethazine Is NDC 0713-0526 included in the NDC Directory? tablet. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. pharmacist if you have questions about the best way to throw out drugs. If you are a consumer or patient please visit 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. Stability sharing sensitive information, make sure youre on a federal If you are taking promethazine liquid, do not use a household spoon to measure your dose. Comments: 2 years and older: Stand up after about 15 minutes. Brand name: Phenergan Vasomotor rhinitis. Promethazine HCl Suppositories - RxList Stability of Refrigerated and Frozen Drugs - Care Plus Pharmacy PHARMACEUTICAL STABILITY OF PROMETHAZINE IN IV Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking promethazine. 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. You may also report side effects at https://www.fda.gov/medwatch. Take the missed dose as soon as you remember it. 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. Unable to load your collection due to an error, Unable to load your delegates due to an error. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Promethazine is used to relieve the symptoms of allergic reactions such as allergic rhinitis (runny nose and watery eyes caused by allergy to pollen, mold or dust), allergic conjunctivitis (red, watery eyes caused by allergies), allergic skin reactions, and allergic reactions to blood or plasma products. sharing sensitive information, make sure youre on a federal Promethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. You may report side effects to the FDA at 1-800-332-1088. 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. Comments: Oral or Rectal: 25 to 50 mg orally or rectally once Careers. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required. Promethazine HCl Rectal Suppositories are not recommended for children under 2 years of age. Insert the suppository Mild, uncomplicated CONTRAINDICATIONS Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. WebVaginal suppositories (e.g., Prostin E2): Before removing foil wrapper, allow vaginal suppository to warm to room temperature. Antiemetic therapy in postoperative patients. Room-temperature storage of medications labeled for A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. prednisone, trazodone, hydroxyzine, ondansetron, montelukast, fluticasone nasal, lorazepam, loratadine, cetirizine, diazepam. Patients should Promethazine is an H 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. (See also tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. WebTo insert a promethazine suppository, follow these steps: If the suppository feels soft, hold it under cold, running water for 1 minute. 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. Nakajima T, Takashima Y, Furuya A, Ozawa Y, Kawashima Y. Chem Pharm Bull (Tokyo). Allergic conjunctivitis due to inhalant allergens and foods. Protect the medication from light. Keep all drugs out of the reach of children and pets. tell your doctor if you have or have ever had an enlarged prostate (a male reproductive gland); glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision); seizures; ulcers; blockage in the passage between the stomach and intestine; blockage in the bladder; asthma or other lung disease; sleep apnea; cancer;any condition that affects the production of blood cells in your bone marrow; or heart or liver disease. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. Oxygen may also be administered. Parenteral formulations of this drug may cause severe chemical irritation and tissue damage regardless of the route. Preoperative doses should be given with appropriate doses of an analgesic/hypnotic and an atropine-like agent. Please enable it to take advantage of the complete set of features! Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 to 25 mg in children and 25- to 50-mg doses in adults. Development and validation of a HPLC method for the analysis of promethazine hydrochloride in hot-melt extruded dosage forms. If suppository is soft, chill in a refrigerator or run cold water over it. Medically reviewed by Drugs.com. Dosage must be individualized. There are no adequate and well-controlled studies of Promethazine HCl Suppositories in pregnant women. However, you should not flush this medication down the toilet. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Select one or more newsletters to continue. tablet. tablet. Tell your doctor if any of these symptoms are severe or do not go away: Some side effects can be serious. This may lead to a higher chance of getting an. The syrup version of promethazine should be in a light-protected bottle with the lid tightly closed at all times. 8600 Rockville Pike Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. A wide range of weight-based doses have resulted in respiratory depression in these patients. Do not flush down a toilet or pour down a drain unless you are told to do so. However, many people have no side effects or only have minor side effects. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. Nausea and Vomiting 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. 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. Low white blood cell counts have happened with this medicine (promethazine suppositories). Promethazine HCl Suppositories,USPare for rectal administration only. 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. Treatment: CNS Depressants Promethazine HCl Suppositories may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. Before Salmonella test system of Ames. 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%. Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine. If you have high blood sugar (diabetes), you will need to watch your blood sugar closely. Promethazine HCl Suppositories may lower seizure threshold. Check with your 2 years and older: <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> There may be drug take-back programs in your area. Patient should remain supine for Amelioration of allergic reactions to blood or plasma. PDR Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. 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. 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. Clinical Trials, Generic alternatives may be available. CNS Depressants Promethazine HCl Suppositories may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. Phenergan (Promethazine HCl) Suppositories are for rectal administration only. Convulsions may rarely occur. Avoid prolonged exposure to the sun. WARNINGSNeuroleptic Malignant Syndrome). 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 HCl, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine, 10-ethanamine, Ask your doctor or pharmacist if you are not sure. WebIndomethacin suppositories are contraindicated in patients with a history of proctitis or recent rectal bleeding. 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.
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