Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Doses should be adjusted to the age and severity of the patient. Store promethazine suppositories in the refrigerator. any drug without checking with your doctor. 2. HAZARDS IDENTIFICATION Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. 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. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. The product's dosage form is suppository and is administered via rectal form. Allergic conjunctivitis due to inhalant allergens and foods. Respiratory rate, especially in pediatric patients. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. 4 0 obj WebPromethazine is an H1 receptor blocking agent. Patients should be told to report any involuntary muscle movements. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. Use of Promethazine HCl Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Amelioration of allergic reactions to blood or plasma. 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. WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. WebIn conscious rats, the plasma indomethacin levels attained after the intrarectal administration of suppositories stored at a high temperature were slightly lower than Parenteral: 25 mg IM or IV once, and may be repeated within 2 hours if necessary Promethazine WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. 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. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). It is used to ease pain . WebVaginal suppositories (e.g., Prostin E2): Before removing foil wrapper, allow vaginal suppository to warm to room temperature. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Follow all instructions closely. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Salmonella test system of Ames. See the FDA's Safe Disposal of Medicines website ( Promethazine HCl Suppositories are for rectal administration only. Store refrigerated between 2-8C (36-46F). The average adult dose is 25 mg taken twice daily. Also tell your doctor and pharmacist if you have ever had an unusual or unexpected reaction when you took promethazine, another phenothiazine, or any other medication. 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. Avoid sun, sunlamps, and tanning beds. 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. Promethazine is well absorbed from the gastrointestinal tract. 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. Use. Bethesda, MD 20894, Web Policies Avoid driving and doing other tasks or actions that call for you to be. This report on medications is for your information only, and is not considered individual patient advice. Preparation and In vitro Evaluation of Naproxen Suppositories. 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 17 H 8600 Rockville Pike Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. If you have questions about side effects, call your doctor. The following laboratory tests may be affected in patients who are receiving therapy with promethazine HCl: 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). Many times this medicine (promethazine suppositories) is taken on an as needed basis. In case of overdose, call the poison control helpline at 1-800-222-1222. WARNINGSBlack Box Warning and you should know that this medication may make you drowsy. Gastrointestinal Dry mouth, nausea, vomiting, jaundice. Events, (What Talk to your doctor about the risks of giving promethazine to your child. This branded product is no longer on the market. WebWhen promethazine is used to relieve cold symptoms, it is usually taken every 4 to 6 hours as needed. tablet. sharing sensitive information, make sure youre on a federal Store suppositories in a refrigerator. Hold it in place for a few moments. Subcutaneous administration is contraindicated. Presence in Breast Milk, Medline Plus, official website and that any information you provide is encrypted with your doctor, nurse, pharmacist, or other health care provider. In 1987, Sterchele5 described the Do not take more or less of it or take it more often than prescribed by your doctor. Promethazine Suppositories Information - Drugs.com Amylin Pharmaceuticals. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Do not freeze. talk to your doctor about the risks and benefits of taking promethazine if you are 65 years of age or older. You could have more side effects. Vasomotor rhinitis. 1984 Jun;7(6):392-9. doi: 10.1248/bpb1978.7.392. Medically reviewed by Drugs.com. Dosage must be individualized. Combination products containing promethazine and codeine should not be given to children younger than 16 years old. 1990 Jun;38(6):1680-3. doi: 10.1248/cpb.38.1680. Promethazine can interfere with the results of home pregnancy tests. Allergy The average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Motion Sickness If you become pregnant while taking promethazine, call your doctor. How long does promethazine stay in your system? endobj DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. endobj Avoid prolonged exposure to the sun. Chem Pharm Bull (Tokyo). Hallucinations (seeing or hearing things that are not there). DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. Before taken, how much, and when it happened. The impairment may be amplified by concomitant use 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 either be eliminated or given in reduced dosage in the presence of promethazine HCl (see Some drugs may have another patient information leaflet. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. Refrigerator settings should be mid-range at +5C (41F) to allow the highest Use this medicine (promethazine suppositories) as ordered by your doctor. Oxidative degradation of pharmaceutically important phenothiazines III: Kinetics and mechanism of promethazine oxidation. Indomethacin sustained-release suppositories containing sugar ester in polyethylene glycol base. WARNINGSRespiratory Depression). The syrup version of promethazine should be in a light-protected bottle with the lid tightly closed at all times. Stability of Refrigerated and Frozen Drugs - Care Plus Pharmacy To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. 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. , 4500 East-West Highway, Suite 900, Bethesda, Maryland. Unable to load your collection due to an error, Unable to load your delegates due to an error. National Library of Medicine Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. 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. Patient should remain supine for 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. 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. 2013 Mar;75(2):143-8. 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. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal/perineuronal infiltration. Federal government websites often end in .gov or .mil. (See The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later, if necessary. Pre- or postoperative use: 25 to 50 mg IM or IV once 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. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. Promethazine is also used to prevent and treat motion sickness. Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates. Pediatric patients should be supervised to avoid potential harm in bike riding or other hazardous activities. Stay Cool: Storing Meds in the Fridge or Freezer Store promethazine rectal suppositories in a refrigerator between 36 - 46F. The use of alcohol or other central-nervous-system depressants such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers, may enhance impairment If you take this medicine (promethazine suppositories) on a regular basis, take a missed dose as soon as you think about it. Updated 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. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Promethazine Suppositories Description Each rectal suppository contains 12.5 mg or 25 mg promethazine HCl with ascorbyl palmitate, cocoa butter, colloidal silicon dioxide, and white wax. Promethazine Hydrochloride Suppositories are for rectal administration only. 1978 Feb;30(2):75-80. doi: 10.1111/j.2042-7158.1978.tb13165.x. H-Phenothiazine, 10-ethanamine, 1972 Dec;24:Suppl:133P-134. Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. Promethazine HCl is a racemic compound; the empirical formula is C Comments: 2 years and older: Promethazine FDA Warning When promethazine is used to relieve cold symptoms, it is usually taken every 4 to 6 hours as needed. Dinoprostone All Rights Reserved. PRECAUTIONSDrug Interactions). Subsequent doses on succeeding days of travel should be given on rising and again before the evening meal. 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. If you are giving promethazine to a child, watch the child to be sure he or she does not get hurt while riding a bike or participating in other activities that could be dangerous. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. 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. Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. breathing. 2 years and older: Treatment: Oral or Rectal: 1.1 mg/kg orally or rectally every 4 to 6 hours as needed. Manufacturer Contact Information (Quality Control) InterMune, Inc. 888 WebPromethazine HCl 25mg. PROMETHEGAN- promethazine hydrochloride suppository, 0713-0526-10, 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. View NDC Code(s)NEW! Teratogenic Effects - Pregnancy Category C Promethazine Dosage Guide + Max Dose, Adjustments - Drugs.com Medication Storage Flashcards | Quizlet 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. Nakajima T, Takashima Y, Furuya A, Ozawa Y, Kawashima Y. Chem Pharm Bull (Tokyo). Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine, 10-ethanamine, This possibility should be considered with Promethazine HCl Suppositories. Phenergan (Promethazine HCl) Suppositories are for rectal administration only. Hallucinations have also been reported. Where do I get this medication? tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Call your doctor right away if you have slow, shallow, or trouble Refrigerate at 36 to 46F (2 to 8C). 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. There are many After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. Remove the wrapper. Before your child takes this medicine (promethazine suppositories), tell the doctor if your child is taking any drugs that can cause breathing problems. plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Promethazine may cause breathing to slow or stop, and may cause death in children. It Be ready to tell or show what was 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. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=5f079815-f48b-8b21-2130-7f791d967c9a, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. It is soluble in water and freely soluble in alcohol. Rectally administered indomethacin should be used with caution in patients with hemorrhoids, anal, or rectal inflammation. Clipboard, Search History, and several other advanced features are temporarily unavailable. Comments: Oral or Rectal: 25 to 50 mg orally or rectally once Stability Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Tell your doctor if any of these symptoms are severe or do not go away: Some side effects can be serious. Talk to your doctor if you think you might be pregnant while you are taking promethazine. Select one or more newsletters to continue. 03/2020 VC7409, Boxed Warnings, Patients receiving parenteral formulations should report persistent/worsening pain or burning at the injection site. http://www.upandaway.org. 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. Once treatment begins, the dose should be reduced to the smallest effective amount needed to control symptoms. Promethazine HCl Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function. 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. PMC CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. The https:// ensures that you are connecting to the Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. xlI=ZMju! @ jzkZ$q{)w/_?FUV2Eg5nnf?eo w#T[)rUmp2ly!`w13?G]_LhFPpCsQH7ir_&C'57:/ PDR FDA Safety Recalls, is this? 8-PROMCPLNC1 Iss. Alcohol can make the side effects of promethazine worse. Protect the medication from light. Subcutaneous administration is contraindicated. Usual Pediatric Dose for Nausea/Vomiting. 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. Once warmed, remove from wrapper and insert high into the posterior vaginal fornix. Vasomotor rhinitis. Preoperative, postoperative, or obstetric sedation. 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. J Pharm Sci. Prophylactic doses may be used to prevent nausea and vomiting during surgery and the postoperative period. 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. 2 0 obj pharmacist if you have questions about the best way to throw out drugs. Ask your doctor or pharmacist if you are not sure. Allergic conjunctivitis due to inhalant allergens and foods. WebRefrigerated medications should be stored at temperatures between 2oC and 8oC (35oF to 46oF). PRECAUTIONS- Information for Patients and Drug Interactions). An increase in blood glucose has been reported in patients receiving promethazine HCl. Manufacturer Contact. Promethazine suppositories are for rectal use only. (see The injection solution should be inspected for particulate matter and discoloration before administration. 800-349-8919 The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. Do not take 2 doses at the same time or extra doses. 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 ( 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. Room-temperature storage of medications labeled for Amelioration of allergic reactions to blood or plasma. Rectal suppositories Never take suppositories by mouth. Bookshelf Promethazine - St. Jude Childrens Research Hospital 20 N Promethazine HCl 50mg. Available for Android and iOS devices. Get Label RSS Feed, Promethazine HCl Suppositories, USP are useful for: Monoamine Oxidase Inhibitors (MAOI) if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking promethazine. This possibility should be considered with Promethazine HCl Suppositories. The effect on later growth and development of the newborn is unknown. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Antiemetic therapy in postoperative patients. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use. Check with your pharmacist. 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. official website and that any information you provide is encrypted Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. If you are 65 or older, use this medicine (promethazine suppositories) with care. 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. AHFS 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. Do not let anyone else take your medication. Oral and rectal formulations may be used for nighttime, presurgical, or obstetrical sedation. 3 0 obj WebPromethazine Hydrochloride Sensitization Not applicable. 30 days. 1978 Aug;67(8):1133-8. doi: 10.1002/jps.2600670828. However, you should not flush this medication down the toilet. 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. Use with care in children 2 years of age and older. If you are allergic to this medicine (promethazine suppositories); any part of this medicine (promethazine suppositories); or any other drugs, foods, or substances. Accessibility Files, Presentations
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