Also tell your doctor and pharmacist if you have ever had an unusual or unexpected reaction when you took promethazine, another phenothiazine, or any other medication. Copy the URL below and paste it into your RSS Reader application. to make sure that it is safe for you to take this medicine (promethazine suppositories) with all of your drugs and health problems. PMC Webafter 24 hours of storage at room- temperature, when stored in a cool place (815 C), and when stored at room-temperature (1530 C). , 4500 East-West Highway, Suite 900, Bethesda, Maryland. Active and prophylactic treatment of motion sickness. This medicine may cause very bad and sometimes deadly breathing problems. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. 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. https://medlibrary.org/lib/rx/meds/promethegan-5/. There are no adequate and well-controlled studies of Promethazine HCl Suppositories in pregnant women. WebRefrigerated medications should be stored at temperatures between 2oC and 8oC (35oF to 46oF). <>
Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. sharing sensitive information, make sure youre on a federal Gastrointestinal Dry mouth, nausea, vomiting, jaundice. Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. 8600 Rockville Pike Established labor: 25 to 75 mg IM or IV, repeated up to 2 times in 4-hour intervals. 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. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. Store promethazine suppositories in the refrigerator. Promethazine Suppositories Description Each rectal suppository contains 12.5 mg or 25 mg promethazine HCl with ascorbyl palmitate, cocoa butter, colloidal silicon dioxide, and white wax. Promethazine Hydrochloride Suppositories are for rectal administration only. 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. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. WebPromethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
room temperature Promethazine HCl Suppositories,USPare for rectal administration only. Phenergan (Promethazine HCl) Suppositories are for rectal administration only. solution. It may cause very bad and sometimes deadly breathing problems. Hold it in place for a few moments. Tell all of your health care providers that you take this medicine (promethazine suppositories). This includes your doctors, nurses, pharmacists, and dentists. http://www.upandaway.org. R)EU4u:/uug83YR/^dL P?062v*6>As5>) ,]'bHK80Ume4xWTJy$yI
p7[I?ruO[P8kW,]6-tg4IE&()LV l=-V4{d]|O Ask your doctor or pharmacist if you do not know if a medication you are allergic to is a phenothiazine. Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. Medically reviewed by Drugs.com. Promethazine HCl 25mg. WARNINGS Use in Pediatric Patients). Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Promethazine may cause breathing to slow or stop, and may cause death in children. 1978 Aug;67(8):1133-8. doi: 10.1002/jps.2600670828. This report on medications is for your information only, and is not considered individual patient advice. National Library of Medicine A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. 2 0 obj
Promethazine is also used to prevent and treat motion sickness. Generic name: Promethazine Suppositories [proe-METH-a-zeen] continuous twisting movements of the hands and feet, wide pupils (black circles in the middle of the eyes), difficulty falling asleep or staying asleep, hallucinations (seeing things or hearing voices that do not exist), overwhelming or unmanageable fear or emotion, uncontrollable shaking of a part of the body, sore throat, fever, chills, and other signs of infection, inability to respond to people around you, swelling of the face, eyes, lips, tongue, throat, arms, hands, feet, ankles, or lower legs. Lie down on your left side and raise your right knee to your chest. Stored in a warmer box to prevent crystallization Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. When promethazine is used to relieve cold symptoms, it is usually taken every 4 to 6 hours as needed. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Copyright, 2023. When promethazine is used to treat or prevent nausea and vomiting it is usually taken every 4 to 6 hours as needed. If you think there has been an overdose, call your poison control center or get medical care right away. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>>
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. 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. If you are 65 or older, use this medicine (promethazine suppositories) with care. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Hallucinations have also been reported. pharmacist if you have questions about the best way to throw out drugs. J Pharm Pharmacol. <>
Stability HHS Vulnerability Disclosure, Help Generic alternatives may be available. official website and that any information you provide is encrypted 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). PMC Patients receiving parenteral formulations should report persistent/worsening pain or burning at the injection site. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. 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 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. A linear relationship between peak height ratio (promethazine-promazine) and promethazine concentration is found up to a concentration of 600 micrograms/ml.
0713-0526-12 Promethegan Suppository 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). WebPROMETHAZINE (proe METH a zeen) prevents and treats the symptoms of an allergic reaction. 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. <>
Hargoli S, Farid J, Azarmi SH, Ghanbarzadeh S, Zakeri-Milani P. Indian J Pharm Sci. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 H-Phenothiazine, 10-ethanamine, Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients. Before The product's dosage form is suppository and is administered via rectal form. You may report side effects to the FDA at 1-800-332-1088. http://www.fda.gov/Safety/MedWatch
Privacy Policy | Copyright 2023. 25 mg, white, bullet-shaped suppository wrapped in silver foil. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Rectal suppositories Never take suppositories by mouth. Webexplain the stability of the product at room temperature. June 14, 2022. 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. Bioequivalence and pharmacokinetic profile of promethazine hydrochloride suppositories in humans. Atropine-like signs and symptoms-dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms-may occur. If you experience any of the following symptoms, call your doctor immediately: If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (
Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates.
DailyMed 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 Last updated on Apr 10, 2023. 3 0 obj
Oral or Rectal: 1.1 mg/kg orally or rectally every 4 to 6 hours as needed, 2 years and older: This material is provided for educational purposes only and is not intended for medical advice, diagnosis or 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. Refrigerator settings should be mid-range at +5C (41F) to allow the highest Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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.
Promethazine Suppositories | Cleveland Clinic 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. 30 days. J Pharm Sci. Promethazine HCl is a racemic compound; the empirical formula is C 17 H 20 N 2 SHCl and its molecular weight is 320.88. Hallucinations (seeing or hearing things that are not there). It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. 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
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