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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. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). R)EU4u:/uug83YR/^dL P?062v*6>As5>) ,]'bHK80Ume4xWTJy$yI p7[I?ruO[P8kW,]6-tg4IE&()LV l=-V4{d]|O This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. PRECAUTIONS- Information for Patients and Drug Interactions). Monoamine Oxidase Inhibitors (MAOI) Patients should Vasomotor rhinitis. Promethazine HCl Suppositories (Promethazine Hydrochloride Suppositories) may treat, side effects, dosage, drug interactions, warnings, patient Promethazine HCl Suppositories, USPare useful for: If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Pre- or postoperative use: 25 to 50 mg IM or IV once Avoid analeptics, which may cause convulsions. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. Sedation Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. Promethazine HCl is a racemic compound; the empirical formula is C This report on medications is for your information only, and is not considered individual patient advice. Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. If you are a consumer or patient please visit Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 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. 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. Box of 1000 NDC 0713-0536-10 Hold it in place for a few moments. Thermal and photolytic degradation studies of promethazine 1984 Jun;7(6):392-9. doi: 10.1248/bpb1978.7.392. Stay informed and get access to the latest news, 4500 East-West Highway, Ask the doctor or pharmacist if you are not sure. Promethazine HCl Rectal Suppositories USP, are available as follows: Promethazine HCl Suppositories USP, 12.5 mg carton of 12 suppositories Promethazine HCl Suppositories USP, 25 mg carton of 12 suppositories Store refrigerated between 2-8C (36-46F). Dispense in well-closed container. Comments: 2 years and older: If you are taking any drugs that can stop your bone marrow from making some of the cells that your body needs. It is not known whether promethazine HCl is excreted in human milk. Patient should remain supine for Refrigerator settings should be mid-range at +5C (41F) to allow the highest If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Development and validation of a HPLC method for the analysis of promethazine hydrochloride in hot-melt extruded dosage forms. View Labeling Archives, plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. 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. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Deep IM injection is the preferred route of administration. 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. endobj Atropine-like signs and symptoms-dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms-may occur. Promethazine Dosage Guide + Max Dose, Adjustments - Drugs.com However, you should not flush this medication down the toilet. It is used to treat sleep problems. This medicine may cause the results of some pregnancy tests to be wrong. Rectally administered indomethacin should be used with caution in patients with hemorrhoids, anal, or rectal inflammation. The following laboratory tests may be affected in patients who are receiving therapy with promethazine HCl: tablet. 1978 Feb;30(2):75-80. doi: 10.1111/j.2042-7158.1978.tb13165.x. 25 mg, white, bullet-shaped suppository wrapped in silver foil. How long does promethazine stay in your system? 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. Promethazine HCl Suppositories, USP are for rectal administration only. 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. Bookshelf Active and prophylactic treatment of motion sickness. 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. H-Phenothiazine, 10-ethanamine, Hallucinations (seeing or hearing things that are not there). Use in Pediatric Patients). It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. 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). IV: Treatment should be injected into a large vein, avoiding sites in the hand/wrist if possible. Each rectal suppository contains 12.5 mg or 25 mg promethazine HCl with ascorbyl palmitate, colloidal silicon dioxide, white wax, hard fat, and glyceryl monostearate. Oral formulations are preferred; however, rectal or parenteral formulations may be given if oral formulations are not tolerated. 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. Caution should be exercised when administering parenteral formulations in pediatric patients 2 years of age and older; it is recommended that the lowest effective dose of oral formulations be used in and concomitant administration of other drugs with respiratory depressant effects be avoided in this patient population. Sedative doses may be given the night before surgery. 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. WebPhenadoz Suppositories are for rectal administration only. Patient Medication Information. Box of 12 NDC 0713-0536-12 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. PHARMACEUTICAL STABILITY OF PROMETHAZINE IN IV Report Adverse This site complies with the HONcode standard for trustworthy health information: verify here. Gastrointestinal Dry mouth, nausea, vomiting, jaundice. Do not freeze. sharing sensitive information, make sure youre on a federal Avoid prolonged exposure to the sun. 800-349-8919 Respiratory Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). Generic alternatives may be available. Avoid driving and doing other tasks or actions that call for you to be. 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. <> MeSH Promethazine is in a class of medications called phenothiazines. Vaginal Suppositories Allow suppository to reach room temperature just prior to administration. (See WebPromethazine Suppositories Insulin Formulations Latanoprost Ophthalmic Drops Etonogestrel/Ethinyl Estradiol Vaginal Rings Name common medications stored at room temperature Antibiotic powders for reconstitution How is mannitol stored? Box of 12 NDC 0713-0526-12 Dinoprostone Stand up after about 15 minutes. 25 mg, white, bullet-shaped suppository wrapped in silver foil. WARNING: this version. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. If you have any questions about this medicine (promethazine suppositories), please talk suppository. For children, Promethazine HCl Rectal Suppositories, 12.5 to 25 mg, twice daily, may be administered. The site is secure. you should know that this medication may make you drowsy. Before your child takes this medicine (promethazine suppositories), tell the doctor if your child is taking any drugs that can cause breathing problems. Carcinogenicity Under the conditions of the National Toxicology Program (NTP) studies, there was no evidence of and transmitted securely. However, many people have no side effects or only have minor side effects. Promethazine FDA Warning RESPIRATORY DEPRESSION (PEDIATRIC PATIENTS): This drug should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Call your doctor for medical PRECAUTIONS- Information for Patients and Drug Interactions). <> PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP All Rights Reserved. Phenergan, Promethegan, Antinaus 50, Phenadoz. Promethazine is used with other medications to treat anaphylaxis (sudden, severe allergic reactions) and the symptoms of the common cold such as sneezing, cough, and runny nose. It is used to ease pain . Promethazine PROMETHEGAN (Cosette Pharmaceuticals, Inc.): FDA Package Other Angioneurotic edema. Parenteral: Treatment: 12.5 to 25 mg IM, IV, orally, or rectally every 4 hours as needed 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. 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%. 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. Promethazine HCl Suppositories may lower seizure threshold. This branded product is no longer on the market. Antiemetic therapy in postoperative patients. Promethazine HCl is a racemic compound; the empirical formula is C 17 H 20 N 2 SHCl and its molecular weight is 320.88. 8600 Rockville Pike Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. 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. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. We comply with the HONcode standard for trustworthy health information. An official website of the United States government. what signs you had. Unable to load your collection due to an error, Unable to load your delegates due to an error. Oral and rectal formulations may be used for nighttime, presurgical, or obstetrical sedation. 17H Careers. On longer trips, promethazine is usually taken in the morning and before the evening meal on each day of travel. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. Minor transfusion and/or amelioration of allergic reactions may be controlled with 12.5 mg doses. Indomethacin sustained-release suppositories containing sugar ester. Amylin Pharmaceuticals. This method is capable of distinguishing Promethazine HCl Suppositories administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. Promethazine may also be taken at bedtime the night before surgery to relieve anxiety and produce quiet sleep. ). https://medlibrary.org/lib/rx/meds/promethegan-5/. Call your child's doctor immediately and get emergency medical treatment if your child has difficulty breathing, wheezes, slows or pauses in breathing, or stops breathing. with your doctor, nurse, pharmacist, or other health care provider. 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. There are many endobj 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 having any laboratory test, tell your doctor and the laboratory personnel that you are taking promethazine. You may report side effects to the FDA at 1-800-332-1088. PDR Brand name: Phenergan Pregnancy Tests PROMETHAZINE HYDROCHLORIDE Check with your pharmacist. Promethazine comes as a tablet and syrup (liquid) to take by mouth and as a suppository to use rectally.When promethazine is used to treat allergies, it is usually taken one to four times daily, before meals and/or at bedtime. WARNINGSCNS Depression and Remove the foil wrapper and insert the suppository high into the posterior vaginal fornix. 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. & Articles, All National Library of Medicine Bethesda, MD 20894, Web Policies To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or Stability at Room Temperature** FOR SPECIFIC INFORMATION, CONTACT MANUFACTURER. Preoperative medication: 1.1 mg/kg IM, IV, orally, or rectally once. All oral versions (tablets, syrup) of promethazine should be stored in the original, labeled container at room temperature. Preoperative, postoperative, or obstetric sedation, Relief of apprehension and production of light sleep from which the patient can be easily aroused. Keep all drugs out of the reach of children and pets. WARNINGSBlack Box Warning and Usual Pediatric Dose for Nausea/Vomiting. AHFS Active and prophylactic treatment of motion sickness. The product's dosage form is suppository and is administered via rectal form. An official website of the United States government. HHS Vulnerability Disclosure, Help can do this. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 30 days. Select one or more newsletters to continue. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Paradoxical Reactions solution. Patients should be advised to report any involuntary muscle movements. If you have questions about side effects, call your doctor. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. There may be drug take-back programs in your area. PMC Nausea and Vomiting Use of Promethazine HCl Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Promethazine Rectal: Uses, Side Effects Indomethacin (Rectal Route) Proper Use - Mayo Clinic Vasomotor rhinitis. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Promethazine HCl Suppositories should be used with caution in pediatric patients 2 years of age and older (see Dermatologic Dermatitis, photosensitivity, urticaria. This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Where do I get this medication? The American Society of Health-System Pharmacists Limited experience with dialysis indicates that it is not helpful. 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. PubMed, suppository. ) or by phone (1-800-332-1088). You must check It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Store promethazine tablets and liquid at room temperature and away from excess heat and moisture (not in the bathroom). Please enable it to take advantage of the complete set of features! It is used to help motion sickness . Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. 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 301-657-3000. Take the missed dose as soon as you remember it. The administration of promethazine hydrochloride in 25-mg doses will control minor transfusion reactions of an allergic nature. Diazepam may be used to control convulsions. Do not share your drugs with others and do not take anyone else's drugs. Promethazine HCl Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Promethazine can cause side effects. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients. Preoperative doses should be given with appropriate doses of an analgesic/hypnotic and an atropine-like agent. IV formulations should be diluted to a concentration of 25 mg/mL or less. to make sure that it is safe for you to take this medicine (promethazine suppositories) with all of your drugs and health problems. The photolytic degradation of promethazine hydrochloride does not follow simple first-order kinetics. 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. FROZEN Drugs Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations.