4 0 obj The following laboratory tests may be affected in patients who are receiving therapy with promethazine HCl: Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. 25 mg, white, bullet-shaped suppository wrapped in silver foil. 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. Promethazine: MedlinePlus Drug Information 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. 1 0 obj All Rights Reserved. R)EU4u:/uug83YR/^dL P?062v*6>As5>) ,]'bHK80Ume4xWTJy$yI p7[I?ruO[P8kW,]6-tg4IE&()LV l=-V4{d]|O On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. you should know that this medication may make you drowsy. Would you like email updates of new search results? 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. Check with your Stability WebPromethazine HCl Suppositories are for rectal administration only. Promethazine is well absorbed from the gastrointestinal tract. WebAdults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. WARNING: Minor transfusion and/or amelioration of allergic reactions may be controlled with 12.5 mg doses. DOSAGE AND ADMINISTRATION Indomethacin sustained-release suppositories containing sugar ester in polyethylene glycol base. Do not handle too much. 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 Treatment: 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. View NDC Code(s)NEW! WebTo insert a promethazine suppository, follow these steps: If the suppository feels soft, hold it under cold, running water for 1 minute. The photolytic degradation of promethazine hydrochloride does not follow simple first-order kinetics. WARNINGSRespiratory Depression). Would you like email updates of new search results? 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. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Indomethacin (Rectal Route) Proper Use - Mayo Clinic Stored in a warmer box to prevent crystallization Additionally, one of each type of IVPB solution will be stored under white light and one of DailyMed Promethazine HCl Suppositories, USP are for rectal administration only. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. We comply with the HONcode standard for trustworthy health information. 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. Preoperative doses should be given with appropriate doses of an analgesic/hypnotic and an atropine-like agent. Oral or Rectal: 1.1 mg/kg orally or rectally every 4 to 6 hours as needed, 2 years and older: 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. 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. Do not give this medicine (promethazine suppositories) to a child younger than 2 years of age. Household teaspoons may not be an accurate measuring device. Acidosis and electrolyte losses should be corrected. 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. 0713-0526-12 Promethegan Suppository breathing. We comply with the HONcode standard for trustworthy health information. Promethazine is a phenothiazine derivative, which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. For children, Promethazine HCl Rectal Suppositories, 12.5 to 25 mg, twice daily, may be administered. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use. PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP Teratogenic Effects - Pregnancy Category C This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. Limited data suggest that use of promethazine HCl during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. Vasomotor rhinitis. This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Tell all of your health care providers that you take this medicine (promethazine suppositories). Dosage must be individualized. Promethazine can cause side effects. Parenteral formulations of this drug may cause severe chemical irritation and tissue damage regardless of the route. Influence of storage temperature on indomethacin release from Do not try to test for pregnancy at home. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Avoid sun, sunlamps, and tanning beds. Keep all drugs in a safe place. 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. 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 Pediatric patients should be supervised to avoid potential harm in bike riding or other hazardous activities. This site complies with the HONcode standard for trustworthy health information: verify here. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Last updated on Apr 10, 2023. Chem Pharm Bull (Tokyo). Unable to load your collection due to an error, Unable to load your delegates due to an error. Clinical studies of promethazine formulations did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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. 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. Duplication for commercial use must be authorized by ASHP. Promethazine HCl Suppositories, USP are for rectal administration only. doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: All drugs may cause side effects. PROMETHEGAN (Cosette Pharmaceuticals, Inc.): FDA Package 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. Dinoprostone Events, (What RxNorm, Maximum dose: 25 Absorption and bioavailability of calcium and magnesium salts of indomethacin from rectal suppositories. The injection solution should be inspected for particulate matter and discoloration before administration. 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. Promethazine HCl 12.5mg. Active and prophylactic treatment of motion sickness, Oral and Rectal: 25 mg orally every 4 to 6 hours as needed. Brand name: Phenergan Box of 12 NDC 0713-0536-12 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. Hold it in place for a few moments. Information (Quality. The melting point of suppositories stored at a high temperature was higher by approximately 2 degrees C than those stored at a low temperature. 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. PRECAUTIONSDrug Interactions). 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 Take the missed dose as soon as you remember it. Promethazine On longer trips, promethazine is usually taken in the morning and before the evening meal on each day of travel. Unable to load your collection due to an error, Unable to load your delegates due to an error. Furuno K, Gomita Y, Yoshida T, Oishi R, Saeki K, Araki Y. Acta Med Okayama. 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. 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). Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Promethazine may cause other side effects. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine. Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. tablet. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or 1 receptor blocking agent. 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. For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated. Events, Patients should be advised to avoid prolonged sun exposure during treatment. 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. Promethazine HCl Suppositories, USPare useful for: tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine, 10-ethanamine, Store promethazine suppositories in the refrigerator. PDR tablet. IV formulations should be diluted to a concentration of 25 mg/mL or less. FDA Safety Recalls, In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required. Tell your Promethazine Dosage Guide + Max Dose, Adjustments - Drugs.com It is also important information to carry with you in case of emergencies. Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. Stability of Refrigerated and Frozen Drugs - Care Plus Pharmacy Read all information given to you. The information is not a substitute for medical care. WARNINGSNeuroleptic Malignant Syndrome). Thermal and photolytic degradation studies of promethazine Drowsiness is the most prominent CNS effect of this drug. MeSH sharing sensitive information, make sure youre on a federal 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. It works by blocking the action of a certain natural substance in the body. This may lead to a higher chance of getting an. 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). PROMETHAZINE HYDROCHLORIDE Do not take more or less of it or take it more often than prescribed by your doctor.
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