stream Box of 12 NDC 0713-0526-12 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. Store promethazine suppositories in the refrigerator. tablet. Antiemetic therapy in postoperative patients. Use this medicine (promethazine suppositories) as ordered by your doctor. 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. Promethazine HCl Rectal Suppositories are not recommended for children under 2 years of age. Promethazine HCl 50mg. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. https://medlibrary.org/lib/rx/meds/promethegan-5/. talk to your doctor about the risks and benefits of taking promethazine if you are 65 years of age or older. Please enable it to take advantage of the complete set of features! Par promethazine with codeine vs Hi-Tech promethazine with codeine? Talk with the doctor. In conscious rats, the plasma indomethacin levels attained after the intrarectal administration of suppositories stored at a high temperature were slightly lower than those after the animals were given suppositories stored at a low temperature, but the difference was significant only 30 min after administration. Do not share your drugs with others and do not take anyone else's drugs. Clipboard, Search History, and several other advanced features are temporarily unavailable. If your child is throwing up for an unknown reason. Kinetic studies were performed to determine the photolytic and thermal degradation rates of promethazine hydrochloride as a function of pH. View Labeling Archives, The https:// ensures that you are connecting to the WebPromethazine Hydrochloride Sensitization Not applicable. MeSH . 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. Accessibility This site needs JavaScript to work properly. 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. (see In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Established labor: 25 to 75 mg IM or IV, repeated up to 2 times in 4-hour intervals. IV formulations should be diluted to a concentration of 25 mg/mL or less. Information (Quality. 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. ) or by phone (1-800-332-1088). 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. WARNINGS Use in Pediatric Patients). Please enable it to take advantage of the complete set of features! Patients should be advised to report any involuntary muscle movements. If you are a consumer or patient please visit Prophylaxis: Parenteral: Call your doctor for medical Keep out of the reach of children. An official website of the United States government. Allergic conjunctivitis due to inhalant allergens and foods. Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. Manufacturer Contact Information (Quality Control) InterMune, Inc. 888 sharing sensitive information, make sure youre on a federal You will need to talk about the benefits and risks endobj Parenteral: Treatment: 12.5 to 25 mg IM, IV, orally, or rectally every 4 hours as needed If the suppository feels soft, hold it under cold, running water for 1 minute. It works by blocking histamine, a substance released by the body during an Promethazine HCl is a racemic compound; the empirical formula is C Absorption and bioavailability of calcium and magnesium salts of indomethacin from rectal suppositories. 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. Stability at Room Temperature** FOR SPECIFIC INFORMATION, CONTACT MANUFACTURER. Unauthorized use of these marks is strictly prohibited. It Do not let anyone else take your medication. It is used to help motion sickness . what signs you had. In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required. Rectal suppositories Never take suppositories by mouth. prednisone, trazodone, hydroxyzine, ondansetron, montelukast, fluticasone nasal, lorazepam, loratadine, cetirizine, diazepam. Signs of an allergic reaction, like rash; Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking. http://www.fda.gov/Safety/MedWatch Respiratory Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). Remove the foil wrapper and insert the suppository high into the posterior vaginal fornix. PMC The injection solution should be inspected for particulate matter and discoloration before administration. WARNINGS Use in Pediatric Patients). Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Do not flush down a toilet or pour down a drain unless you are told to do so. Adverse reactions include burning, pain, thrombophlebitis, tissue necrosis, and gangrene. Promethazine HCl Rectal Suppositories are contraindicated for children under 2 years of age (see Store promethazine rectal suppositories in a refrigerator between 36 - 46F. 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. 25 mg, white, bullet-shaped suppository wrapped in silver foil. government site. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. Lie down on your left side and raise your right knee to your chest. Tell your doctor about the allergy and Mild, uncomplicated CONTRAINDICATIONS Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. can do this. Administration of 12.5 to 25 mg promethazine HCl by rectal suppository at bedtime will provide sedation in children. It is also important information to carry with you in case of emergencies. H -Phenothiazine, 10-ethanamine, The syrup version of promethazine should be in a light-protected bottle with the lid tightly closed at all times. The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. Get Label RSS Feed, The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Respiratory rate, especially in pediatric patients. All Rights Reserved. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Promethazine may make your skin sensitive to sunlight. drugs that can do this. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Active and prophylactic treatment of motion sickness. Talk to your doctor about the risks of giving promethazine to your child. Pre- and Postoperative Use Avoid prolonged exposure to the sun. This may lead to a higher chance of getting an. Patients should be advised to avoid prolonged sun exposure during treatment. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Methods: During a 12-month period ending in June 2021, the prescribing information and published Do not give this medicine (promethazine suppositories) to a child younger than 2 years of age. 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. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose is 25 mg repeated at 4- to 6-hour intervals, as necessary. Monoamine Oxidase Inhibitors (MAOI) plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. sharing sensitive information, make sure youre on a federal Promethazine HCl Suppositories (Promethazine Hydrochloride Suppositories) may treat, side effects, dosage, drug interactions, warnings, patient You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. Promethazine HCl Suppositories administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. H-Phenothiazine, 10-ethanamine, South Plainfield, NJ 07080 The information is not a substitute for medical care. HHS Vulnerability Disclosure, Help Do not drive a car or operate machinery until you know how this medication affects you. Allergic conjunctivitis due to inhalant allergens and foods. Do not take a double dose to make up for a missed one. This medicine may cause the results of some pregnancy tests to be wrong. Promethazine may cause breathing to slow or stop, and may cause death in children. Read all information given to you. 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 HCl Suppositories may lead to potentially fatal respiratory depression. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. A stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. Teratogenic Effects - Pregnancy Category C WARNINGSNeuroleptic Malignant Syndrome). Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Report Adverse endobj WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. Promethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. 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. WARNINGSRespiratory Depression). This branded product is no longer on the market. Use with care in children 2 years of age and older. to make sure that it is safe for you to take this medicine (promethazine suppositories) with all of your drugs and health problems. FOIA Generic alternatives may be available. WebPromethazine HCl Suppositories are for rectal administration only. 17H Vasomotor rhinitis. 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. This medicine may cause very bad and sometimes deadly breathing problems. 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. Pediatric patients should be supervised to avoid potential harm in bike riding or other hazardous activities. Diazepam may be used to control convulsions. Do not try to test for pregnancy at home. Updated Bookshelf The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later, if necessary. It is used to ease pain . Atropine-like signs and symptoms-dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms-may occur. The initial dose should be given 30 to 60 minutes before anticipated travel, and may be repeated in 8 to 12 hours as needed. Use of Promethazine HCl Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. 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 In case of overdose, call the poison control helpline at 1-800-222-1222. Phenergan (Promethazine HCl) Suppositories are for rectal administration only. Drug classes: Antihistamines, Phenothiazine antiemetics. Treatment Available for Android and iOS devices. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Use of Promethazine HCl Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Files, All Mapping For children, Promethazine HCl Rectal Suppositories, 12.5 to 25 mg, twice daily, may be administered. RxNorm, WebPromethazine HCL Suppository, Rectal - Uses, Side Effects, and More Common Brand(S): Phenergan, Promethegan Generic Name(S): promethazine View Free Coupon tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Federal government websites often end in .gov or .mil. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Preoperative medication: 1.1 mg/kg IM, IV, orally, or rectally once. Patients should Hallucinations have also been reported. 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. 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. Preoperative, postoperative, or obstetric sedation, Relief of apprehension and production of light sleep from which the patient can be easily aroused. This site needs JavaScript to work properly. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery, Antiemetic therapy in postoperative patients. WebPromethazine is well absorbed from the gastrointestinal tract. We comply with the HONcode standard for trustworthy health information. Use. <> Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Prophylactic doses may be used to prevent nausea and vomiting during surgery and the postoperative period. An official website of the United States government. 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. Webstore at a room temperature not to exceed 77F (25C) for up to 6 weeks. The https:// ensures that you are connecting to the Antiemetic therapy in postoperative patients. Active and prophylactic treatment of motion sickness, Oral and Rectal: 25 mg orally every 4 to 6 hours as needed. It is soluble in water and freely soluble in alcohol. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine, 10-ethanamine, Clinical Trials, If suppository is soft, chill in a refrigerator or run cold water over it. Subsequent doses on succeeding days of travel should be given on rising and again before the evening meal. If you become pregnant while taking promethazine, call your doctor. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times. Oral solution: The oral solution should be measured with an accurate measuring device to decrease the risk of overdosage. Also tell the child's doctor if the child has not been drinking normally, has had excessive vomiting or diarrhea, or appears dehydrated. 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. WARNING: 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. Glucose Tolerance Test 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. Call your doctor right away if you have slow, shallow, or trouble Accessibility IV: Treatment should be injected into a large vein, avoiding sites in the hand/wrist if possible. 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. The administration of promethazine hydrochloride in 25-mg doses will control minor transfusion reactions of an allergic nature. <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> Combination products containing promethazine and codeine should not be given to children younger than 16 years old. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. To insert a promethazine suppository, follow these steps: Unless your doctor tells you otherwise, continue your normal diet. 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. 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 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. Ask the doctor or pharmacist if you are not sure. J Pharmacobiodyn. Uses of Promethazine Suppositories: It is used to ease allergy signs. Gastrointestinal Dry mouth, nausea, vomiting, jaundice. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. A wide range of weight-based doses have resulted in respiratory depression in these patients. Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates. Some drugs may have another patient information leaflet. Promethazine HCl Suppositories, USP are for rectal administration only. 0713-0526-12, Oxygen may also be administered. 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. Off-label information indicates unopened bottle stable when maintained at continuous room Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see Long-term animal studies have not been performed to assess the carcinogenic potential of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with this drug. WebIndomethacin suppositories are contraindicated in patients with a history of proctitis or recent rectal bleeding. Medically reviewed by Drugs.com. Copyright, 2023. Store them away from light, heat, and moisture. help if any of these side effects or any other side effects bother you or do not go away: These are not all of the side effects that may occur. This report on medications is for your information only, and is not considered individual patient advice. WARNINGSCNS Depression and 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. 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. Remove the wrapper. Promethazine can interfere with the results of home pregnancy tests. Talk with the doctor. Available for Android and iOS devices. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. If you are taking promethazine liquid, do not use a household spoon to measure your dose. PRECAUTIONS- Information for Patients and Drug Interactions, Cosette Pharmaceuticals, Inc. product information by RSS, Additional medications in the Prescription Medications section by. ) for more information if you do not have access to a take-back program. Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. Promethazine HCl 50mg. Bioequivalence and pharmacokinetic profile of promethazine hydrochloride suppositories in humans. 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). Dosage must be individualized. A very bad and sometimes deadly health problem called. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
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