Promethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Store promethazine tablets and liquid at room temperature and away from excess heat and moisture (not in the bathroom). Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. IV: Treatment should be injected into a large vein, avoiding sites in the hand/wrist if possible. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. 03/2020 VC7409, Boxed Warnings, Medication Storage Flashcards | Quizlet 1987 Jun;76(6):441-5. doi: 10.1002/jps.2600760606. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. 2 years and older: Patients should be advised to report any involuntary muscle movements. and transmitted securely. WebPromethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Keep from freezing. . Generic name: Promethazine Suppositories [proe-METH-a-zeen] Atropine-like signs and symptoms-dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms-may occur. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not freeze the oral liquid. WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Promethazine hydrochloride Oral / IV / Suppository Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. It is not known whether promethazine HCl is excreted in human milk. In the in vivo experiments, the plasma indomethacin levels after administration of suppositories stored at different temperatures were measured in conscious and anesthetized rats. Promethazine HCl Suppositories - RxList DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Stored in a warmer box to prevent crystallization Promethazine HCl 50mg. 2. HAZARDS IDENTIFICATION 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Store promethazine tablets, oral solution, and solution for injection at room temperature between 68 - 77F and protect from light. Promethazine: MedlinePlus Drug Information 20N J Pharm Sci. Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. 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&. Do not try to swallow the suppositories or insert in any other part of your body. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. solution. 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. Minor transfusion and/or amelioration of allergic reactions may be controlled with 25 mg doses. Study on absorption of indomethacin from sustained-release suppositories containing hydrogenated soybean lecithin in rabbits. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 4 0 obj Stavchansky S, Wallace JE, Geary R, Hecht G, Robb CA, Wu P. J Pharm Sci. Patient should remain supine for Promethazine HCl may be used alone or as an adjunct to narcotic analgesics during labor and delivery. Some drugs may have another patient information leaflet. Diazepam may be used to control convulsions. 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. Information (Quality. Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. Box of 12 NDC 0713-0526-12 Tell all of your health care providers that you take this medicine (promethazine suppositories). Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. 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. PROMETHEGAN (Cosette Pharmaceuticals, Inc.): FDA Package It is used to ease pain . Rectally administered indomethacin should be used with caution in patients with hemorrhoids, anal, or rectal inflammation. to make sure that it is safe for you to take this medicine (promethazine suppositories) with all of your drugs and health problems. Preoperative, postoperative, or obstetric sedation. (see Ask your doctor or pharmacist if you do not know if a medication you are allergic to is a phenothiazine. A linear relationship between peak height ratio (promethazine-promazine) and promethazine concentration is found up to a concentration of 600 micrograms/ml. In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required. 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. 20 N 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. 8-PROMCPLNC1 Iss. J Pharmacobiodyn. In case of overdose, call the poison control helpline at 1-800-222-1222. 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. Patients should Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 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 tablet. Store them away from light, heat, and moisture. Do not share your drugs with others and do not take anyone else's drugs. Stability Call your doctor right away if you have slow, shallow, or trouble Promethazine There are many Promethazine - St. Jude Childrens Research Hospital Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Chem Pharm Bull (Tokyo). Allergy The average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. FDA Safety Recalls, 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%. Tell your doctor if any of these symptoms are severe or do not go away: Some side effects can be serious. When promethazine is used to relieve cold symptoms, it is usually taken every 4 to 6 hours as needed. You could have more side effects. Information is also available online at There are no adequate and well-controlled studies of Promethazine HCl Suppositories in pregnant women. 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. Prophylactic doses may be used to prevent nausea and vomiting during surgery and the postoperative period. Preoperative doses should be given with appropriate doses of an analgesic/hypnotic and an atropine-like agent. After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. Drowsiness is the most prominent CNS effect of this drug. 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. Follow all instructions closely. View NDC Code(s)NEW! It may cause very bad and sometimes deadly breathing problems. Preoperative, postoperative, or obstetric sedation. There may be drug take-back programs in your area. Promethazine HCl Rectal Suppositories are contraindicated for children under 2 years of age (see Deep IM injection is the preferred route of administration. Avoid prolonged exposure to the sun. Protect the medication from light. suppository. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. 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 addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. 8600 Rockville Pike Box of 12 NDC 0713-0536-12 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). WebAdults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. Hold it in place for a few moments. Bioequivalence and pharmacokinetic profile of promethazine hydrochloride suppositories in humans. Promethazine Dosage Guide + Max Dose, Adjustments - Drugs.com Dosage must be individualized. 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. Parenteral formulations: Store ampoules in the carton until ready to use. 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. endobj The effect of drug concentration on the thermal (dark) degradation of promethazin hydrochloride in aqueous solution. 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. with your doctor, nurse, pharmacist, or other health care provider. <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> 17 H 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. If suppository is soft, chill in a refrigerator or run cold water over it. Promethazine HCl Suppositories administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. This possibility should be considered with Promethazine HCl Suppositories. Talk with the doctor. 1984 Jun;7(6):392-9. doi: 10.1248/bpb1978.7.392. Clinical Trials, Last updated on Jan 28, 2022. Amelioration of allergic reactions to blood or plasma. Parenteral or rectal formulations may be used when patients cannot tolerate oral formulations. Call your doctor or get medical Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Indocin Suppositories (indomethacin) dose, indications However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. 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. Store promethazine rectal suppositories in a refrigerator between 36 - 46F. 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 301-657-3000. Clipboard, Search History, and several other advanced features are temporarily unavailable. If you have any questions about this medicine (promethazine suppositories), please talk is this? Active and prophylactic treatment of motion sickness. Oral or Rectal: 1.1 mg/kg orally or rectally every 4 to 6 hours as needed, 2 years and older: Subcutaneous administration is contraindicated. endobj % PROMETHAZINE HYDROCHLORIDE WebPromethazine is well absorbed from the gastrointestinal tract. Administration of 12.5 to 25 mg promethazine HCl by rectal suppository at bedtime will provide sedation in children. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. 1978 Aug;67(8):1133-8. doi: 10.1002/jps.2600670828. http://www.upandaway.org. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. SEVERE TISSUE INJURY, INCLUDING GANGRENE: Parenteral formulations can cause severe chemical irritation and damage to tissues regardless of the route of administration. Talk to your doctor about the risks of giving promethazine to your child. Preoperative medication: 1.1 mg/kg IM, IV, orally, or rectally once. 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. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. Oxidative degradation of pharmaceutically important phenothiazines III: Kinetics and mechanism of promethazine oxidation. Do not try to test for pregnancy at home. Would you like email updates of new search results? Phenergan (Promethazine HCl) Suppositories are for rectal administration only. Promethazine HCl Rectal Suppositories, USPare available in boxes of 12 and 1000 as follows: Use of Promethazine HCl Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Sedation government site. The first-order rate constant increased with increasing pH. Promethegan (promethazine hydrochloride) dose, indications, You may report side effects to the FDA at 1-800-332-1088. Dispense in well-closed container. Monoamine Oxidase Inhibitors (MAOI) Post-marketing cases of respiratory depression, including fatalities, have been reported with use of this drug in pediatric patients less than 2 years of age. 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, Antiemetic therapy in postoperative patients. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal/perineuronal infiltration. View Labeling Archives, N,N -trimethyl-, monohydrochloride, ()- with the following structural formula: Webafter 24 hours of storage at room- temperature, when stored in a cool place (815 C), and when stored at room-temperature (1530 C). Citations, PRECAUTIONS- Information for Patients and Drug Interactions, Carcinogenesis, Mutagenesis, Impairment of Fertility, Report Adverse & Articles, All 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. Par promethazine with codeine vs Hi-Tech promethazine with codeine? https://www.poisonhelp.org/help FOIA Biochemical Data Summary. WebPromethazine is an H1 receptor blocking agent. 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. tablet. If you think there has been an overdose, call your poison control center or get medical care right away. Low white blood cell counts have happened with this medicine (promethazine suppositories). ask your doctor about the safe use of alcohol while you are taking this medication. drugs that can do this. The melting point of suppositories stored at a high temperature was higher by approximately 2 degrees C than those stored at a low temperature. MeSH Ask your pharmacist any questions you have about refilling your prescription. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or 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. government site. A wide range of weight-based doses have resulted in respiratory depression in these patients. 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. PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP Use with care in children 2 years of age and older. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Read all information given to you. Report Adverse This drug should not be used to treat nausea and vomiting of unknown etiology. The American Society of Health-System Pharmacists Off-label information indicates unopened bottle stable when maintained at continuous room Stay informed and get access to the latest news, 4500 East-West Highway, You may get sunburned more easily. Store suppositories in a refrigerator. 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. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 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. Ask your doctor or pharmacist if you are not sure. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. Minor transfusion and/or amelioration of allergic reactions may be controlled with 12.5 mg doses. The initial dose should be given 30 to 60 minutes before anticipated travel, and may be repeated in 8 to 12 hours as needed. Thermal and photolytic degradation studies of promethazine Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Do not give this medicine (promethazine suppositories) to a child younger than 2 years of age. PRECAUTIONSDrug Interactions). Treatment Promethazine HCl Suppositories may lower seizure threshold. 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 The https:// ensures that you are connecting to the WebPhenadoz Suppositories are for rectal administration only. sharing sensitive information, make sure youre on a federal 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 are a consumer or patient please visit Room-temperature storage of medications labeled for Patients receiving parenteral formulations should report persistent/worsening pain or burning at the injection site. HHS Vulnerability Disclosure, Help 25 mg, white, bullet-shaped suppository wrapped in silver foil. Stand up after about 15 minutes. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. 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. Promethazine HCl is a racemic compound; the empirical formula is C17H20N2SHCl and its molecular weight is Talk with the doctor. Promethazine HCl Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function. 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. Par promethazine with codeine vs Hi-Tech promethazine with codeine? Alcohol can make the side effects of promethazine worse. MeSH 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. Promethazine HCl Suppositories,USPare for rectal administration only. Pre- and Postoperative Use Vials stored at room temperature should not be returned to the refrigerator. Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. It works by blocking the action of a certain natural substance in the body. Do not drive a car or operate machinery until you know how this medication affects you. 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. This drug should be administered at a rate no greater than 25 mg/min. 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. to you and the baby. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. official website and that any information you provide is encrypted Glucose Tolerance Test Maximum dose: 25 The site is secure. Use this medicine (promethazine suppositories) as ordered by your doctor. Other Angioneurotic edema. Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. It is used to treat sleep problems. Neuroleptic malignant syndrome (potentially fatal) has also been reported (See When promethazine is used to treat motion sickness, it is taken 30 to 60 2 SHCl and its molecular weight is 320.88. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Pre- or postoperative use: 25 to 50 mg IM or IV once Additionally, one of each type of IVPB solution will be stored under white light and one of Avoid prolonged exposure to the sun. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Chem Pharm Bull (Tokyo). Subsequent doses on succeeding days of travel should be given on rising and again before the evening meal. Distributedby: Cosette Pharmaceuticals, Inc. 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). WARNINGSBlack Box Warning and Remove the wrapper. The syrup version of promethazine should be in a light-protected bottle with the lid tightly closed at all times. Use. Call your doctor if you experience any unusual problems while you are taking this medication. Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Files, Presentations http://www.fda.gov/Safety/MedWatch The site is secure. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. 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. An official website of the United States government. Once treatment begins, the dose should be reduced to the smallest effective amount needed to control symptoms. WARNING: If you take this medicine (promethazine suppositories) on a regular basis, take a missed dose as soon as you think about it. https://medlibrary.org/lib/rx/meds/promethegan-5/. Promethazine Rectal: Uses, Side Effects