Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. 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 drug is not only used in the treatment of allergic reactions, such as hay fever, but it can also be used as a sedative, to prevent motion sickness, and to combat nausea and vomiting (including morning sickness). Nausea and Vomiting Promethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. A dosage of 0.25 to 1 mg/kg/dose IM/IV (Max: 25 mg/dose) is recommended for other indications. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. PROMETHAZINE HCl SUPPOSITORIES ARE CONTRAINDICATED FOR THE USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE. Promethazine Hydrochloride Suppositories are for rectal administration only. We comply with the HONcode standard for trustworthy health information. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later, if necessary. Sedation - This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. The suppository is for rectal use only. Administration of 12.5 to 25 mg promethazine HCl by rectal suppository at bedtime will provide sedation in children. Medically reviewed by Drugs.com. For motion sickness, the first dose of promethazine should be used 30 to 60 minutes before beginning travel. This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Select one or more newsletters to continue. Promethazine is a prescription drug. 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. Phenergan (Promethazine HCl) Suppositories are for rectal administration only. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Available for Android and iOS devices. The dose of promethazine depends on the condition being treated. Central Nervous System - Drowsiness is the most prominent CNS effect of this drug. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered. 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. Each rectal suppository contains 12.5 mg or 25 mg promethazine HCl with ascorbyl palmitate, cocoa butter, colloidal silicon dioxide, and white wax. Neuroleptic malignant syndrome (potentially fatal) has also been reported. The suppository is for rectal use only.For motion sickness, the first dose of promethazine should be used 30 to 60 minutes before beginning travel. Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. Syrup: 6.25 milligrams per 5 milliliters (6.25 mg/5 mL… RESPIRATORY DEPRESSION AND APNEA, SOMETIMES ASSOCIATED WITH DEATH, ARE STRONGLY ASSOCIATED WITH PROMETHAZINE PRODUCTS AND ARE NOT DIRECTLY RELATED TO INDIVIDUALIZED WEIGHT-BASED DOSING, WHICH MIGHT OTHERWISE PERMIT SAFE ADMINISTRATION. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. List promethazine HCL suppository, rectal side effects by likelihood and severity ; Who should not take promethazine HCL suppository, rectal? Excessively large dosages of antihistamines, including Promethazine HCl Suppositories, in pediatric patients may cause sudden death (see OVERDOSAGE). Promethazine HCl Suppositories are useful for: Perennial and seasonal allergic rhinitis. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. Promethazine HCl Suppositories may lower seizure threshold. Pharmacology, adverse reactions, warnings and side effects. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. You should not drink alcohol while taking promethazine. Try to empty your bowel and bladder just before using the promethazine suppository. Gastrointestinal - Dry mouth, nausea, vomiting, jaundice. Motion Sickness - The average adult dose is 25 mg taken twice daily. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. Administration of 12.5 to 25 mg Promethazine HCl by rectal suppository at bedtime will provide sedation in children. Dosage Form: rectal suppository. Promethazine HCl Suppositories administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. Promethazine HCl is a racemic compound; the empirical formula is C17H20N2S•HCl and its molecular weight is 320.88. Paradoxical Reactions - Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCl. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. Promethazine Hydrochloride Suppositories USP, 12.5 mg. prednisone, trazodone, hydroxyzine, lorazepam, ondansetron, fluticasone nasal, loratadine, montelukast, cetirizine, diazepam. Other - Angioneurotic edema. Promethazine HCl Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Prior to removing the wrapper, if a suppository feels soft, the patient should first hold The suppository form is used when medications cannot be taken by mouth.Promethazine is an antihistamine and works by blocking a certain natural substance that your body makes during an … The diagnostic evaluation of patients with this syndrome is complicated. 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. Rectal suppositories are typically prescribed when oral formulations cannot be used.7 Promethazine injections usually work within five minutes and last four times longer than either tablets, syrups, or suppositories.3 Promethazine is offered in the following formulations: 1. Allergy The average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Promethazine is a phenothiazine derivative, which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. 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. eve the symptoms of allergic reactions such as allergic rhinitis Diazepam may be used to control convulsions. CONCOMITANT ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC PATIENTS. 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. How long does promethazine stay in your system. PROMETHEGAN (promethazine hydrochloride suppository) comes in different strengths and amounts. Data sources include IBM Watson Micromedex (updated 3 May 2021), Cerner Multum™ (updated 4 May 2021), ASHP (updated 3 May 2021) and others. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Allergy - The average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. 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. (See WARNINGS - Respiratory Depression). There are no adequate and well-controlled studies of Promethazine HCl Suppositories in pregnant women. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient ANTIEMETICS ARE NOT RECOMMENDED FOR TREATMENT OF UNCOMPLICATED VOMITING IN PEDIATRIC PATIENTS, AND THEIR USE SHOULD BE LIMITED TO PROLONGED VOMITING OF KNOWN ETIOLOGY. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. For children, Promethazine HCl Rectal Suppositories, 12.5 to 25 mg, twice daily, may be administered. Remain lying down for a few minutes after using this medication, and avoid having a bowel movement for an hour or longer so the drug will be absorbed. Phenergan (Promethazine HCl) Rectal Suppositories are not recommended for children under 2 years of age. Phenergan (promethazine) is an antihistamine used to prevent and treat nausea and vomiting related to surgery or motion sickness. Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates. In the event that vasopressors are considered for the management of severe hypotension which does not respond to intravenous fluids and repositioning, the administration of norepinephrine or phenylephrine should be considered. Remove the outer wrapper from the suppository before inserting it. A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. 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). The administration of promethazine hydrochloride in 25-mg doses will control minor transfusion reactions of an allergic nature. and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Convulsions may rarely occur. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. 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. Preoperative, postoperative, or obstetric sedation. 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. 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. 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 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. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCl SUPPOSITORIES TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. The effect on later growth and development of the newborn is unknown (see also Nonteratogenic Effects). 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. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. For children, Phenergan (Promethazine HCl) Rectal Suppositories, 12.5 to 25 mg, twice daily, may be administered. Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. Promethazine, an antihistamine initially developed in France in the 1940s, was approved for the U.S. in 1951. Promethazine HCl Suppositories should be used with caution in pediatric patients 2 years of age and older (see WARNINGS - Use in Pediatric Patients). Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. 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