promethazine suppository stability at room temperature

Accessibility Active and prophylactic treatment of motion sickness. N,N -trimethyl-, monohydrochloride, ()- with the following structural formula: WebPROMETHAZINE (proe METH a zeen) prevents and treats the symptoms of an allergic reaction. Do not take a double dose to make up for a missed one. This drug should not be used to treat nausea and vomiting of unknown etiology. 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. If suppository is soft, chill in a refrigerator or run cold water over it. This medicine may cause the results of some pregnancy tests to be wrong. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. 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. Cardiovascular Increased or decreased blood pressure, tachycardia, bradycardia, faintness. 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. Stability of Refrigerated and Frozen Drugs - Care Plus Pharmacy Pre- and Postoperative Use 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. Patient should remain supine for WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Talk with the doctor. Remove the foil wrapper and insert the suppository high into the posterior vaginal fornix. Use this medicine (promethazine suppositories) as ordered by your doctor. Avoid prolonged exposure to the sun. This report on medications is for your information only, and is not considered individual patient advice. Store promethazine suppositories in the refrigerator. 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. Respiratory rate, especially in pediatric patients. Keep all drugs in a safe place. Use in Pediatric Patients). 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. Many times this medicine (promethazine suppositories) is taken on an as needed basis. The initial dose should be given 30 to 60 minutes before anticipated travel, and may be repeated in 8 to 12 hours as needed. Store refrigerated between 2-8C (36-46F). Tell your tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Brand name: Phenergan 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. WebStability at Room Temperature** FOR SPECIFIC INFORMATION, CONTACT MANUFACTURER Unopened vial should not be left at room temperature for a total time exceeding 12 hours prior to use. You could have more side effects. All oral versions (tablets, syrup) of promethazine should be stored in the original, labeled container at room temperature. 0713-0536-10, PDR If the suppository feels soft, hold it under cold, running water for 1 minute. 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. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use. 1992 Aug;46(4):223-31. doi: 10.18926/AMO/32623. (See AHFS Nonteratogenic Effects.). Indocin Suppositories (indomethacin) dose, indications Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. This site needs JavaScript to work properly. 1990 Apr;38(4):1027-31. doi: 10.1248/cpb.38.1027. 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. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or Central Nervous System 0713-0526-12, Promethazine HCl Suppositories, USPare useful for: Uses of Promethazine Suppositories: It is used to ease allergy signs. Promethazine is in a class of medications called phenothiazines. It works by blocking histamine, a substance released by the body during an Methods: During a 12-month period ending in June 2021, the prescribing information and published Parenteral: 12.5 mg IM or IV once, and may be repeated within 2 hours if necessary The American Society of Health-System Pharmacists www.fda.gov/medwatch. Do not take 2 doses at the same time or extra doses. Promethazine HCl may be used alone or as an adjunct to narcotic analgesics during labor and delivery. Bioequivalence and pharmacokinetic profile of promethazine hydrochloride suppositories in humans. Patients receiving parenteral formulations should report persistent/worsening pain or burning at the injection site. Promethazine HCl is a racemic compound; the empirical formula is C 17H 20N 2SHCl and its molecular weight is 320.88. Dermatologic Dermatitis, photosensitivity, urticaria. (A left-handed person should lie on the right side and raise the left knee.). Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. you should know that this medication may make you drowsy. Indomethacin sustained-release suppositories containing sugar ester. Talk to your doctor about the risks of giving promethazine to your child. 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. ), More about getting RSS News & Updates from DailyMed, 12 in 1 BOX; Type 0: Not a Combination Product, 1000 in 1 BOX; Type 0: Not a Combination Product, Cosette Pharmaceuticals NC Laboratories, LLC, analysis(0713-0526, 0713-0536) , label(0713-0526, 0713-0536) , manufacture(0713-0526, 0713-0536) , pack(0713-0526, 0713-0536), 6 The melting point of suppositories stored at a high temperature was higher by approximately 2 degrees C than those stored at a low temperature. http://www.fda.gov/Safety/MedWatch Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. Hold it in place for a few moments. Box of 1000 NDC 0713-0536-10 Please enable it to take advantage of the complete set of features! Bethesda, MD 20894, Web Policies Household teaspoons may not be an accurate measuring device. For all patients taking this medicine (promethazine suppositories): This is not a list of all drugs or health problems that interact with this medicine (promethazine suppositories). PubMed, 1 receptor blocking agent. If you have an allergy to promethazine or any other part of this medicine (promethazine suppositories). 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. 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. 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%. Par promethazine with codeine vs Hi-Tech promethazine with codeine? Comments: Oral or Rectal: 25 to 50 mg orally or rectally once WebVaginal suppositories (e.g., Prostin E2): Before removing foil wrapper, allow vaginal suppository to warm to room temperature. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. Parenteral: Treatment: 12.5 to 25 mg IM, IV, orally, or rectally every 4 hours as needed WARNING: Events, (What Call your doctor if you experience any unusual problems while you are taking this medication. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Stay informed and get access to the latest news, 4500 East-West Highway, Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Manufacturer Contact. endobj Promethazine - St. Jude Childrens Research Hospital 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. Signs of an allergic reaction, like rash; Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking. taken, how much, and when it happened. 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. Perennial and seasonal allergic rhinitis. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. The photolytic degradation of promethazine hydrochloride does not follow simple first-order kinetics. Glucose Tolerance Test Teratogenic Effects - Pregnancy Category C 2SHCl and its molecular weight is 320.88. All Rights Reserved. Do not give this medicine (promethazine suppositories) to a child younger than 2 years of age. Note that any depressant effects of promethazine HCl are not reversed by naloxone. It may cause very bad and sometimes deadly breathing problems. Neuroleptic malignant syndrome (potentially fatal) has also been reported (See promethazine 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. Active and prophylactic treatment of motion sickness, Oral and Rectal: 25 mg orally every 4 to 6 hours as needed. Phenergan, Promethegan, Antinaus 50, Phenadoz. WebStore the tablets and syrup at room temperature. Treatment 20N Store promethazine tablets and liquid at room temperature and away from excess heat and moisture (not in the bathroom). 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. ). This possibility should be considered with Promethazine HCl Suppositories. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Usual Pediatric Dose for Nausea/Vomiting. In the in vitro release test using a dialysis cell method, much lower amounts of indomethacin were released from the suppositories stored at a high temperature than from those stored at a low temperature. Take promethazine exactly as directed. Chem Pharm Bull (Tokyo). Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Phenergan (Promethazine HCl) Suppositories are for rectal administration only. Store promethazine rectal suppositories in a refrigerator between 36 - 46F. This medicine may cause very bad and sometimes deadly breathing problems. Promethazine HCl 50mg. If your child is throwing up for an unknown reason. 1972 Dec;24:Suppl:133P-134. <> PROMETHAZINE Avoid sun, sunlamps, and tanning beds. For children, Promethazine HCl Rectal Suppositories, 12.5 to 25 mg, twice daily, may be administered. AllergyThe average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Development and validation of a HPLC method for the analysis of promethazine hydrochloride in hot-melt extruded dosage forms. IV: Treatment should be injected into a large vein, avoiding sites in the hand/wrist if possible. Use with care in children 2 years of age and older. Instead, the best way to dispose of your medication is through a medicine take-back program. Tell your doctor if any of these symptoms are severe or do not go away: Some side effects can be serious. WebPromethazine Hydrochloride Sensitization Not applicable. 0713-0526-12 Promethegan Suppository If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times. 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. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Avoid prolonged exposure to the sun. Promethazine should not be given to babies or children who are younger than 2 years old and should be given with caution to children who are 2 years of age or older. Comments: 2 years and older: WARNINGSCNS Depression and Mild, uncomplicated CONTRAINDICATIONS Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. Before FOIA 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. However, you should not flush this medication down the toilet. PROMETHAZINE HCL SUPPOSITORIES SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. Citations, PRECAUTIONS- Information for Patients and Drug Interactions, Carcinogenesis, Mutagenesis, Impairment of Fertility, Report Adverse Antiemetic therapy in postoperative patients. Store promethazine tablets, oral solution, and solution for injection at room temperature between 68 - 77F and protect from light. The https:// ensures that you are connecting to the To determine the activation energy necessary by constructing an Arrhenius plot. Report Adverse Allergy The average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients. Promethazine HCl 25mg. Oxidative degradation of pharmaceutically important phenothiazines III: Kinetics and mechanism of promethazine oxidation. Patients should This drug should be administered at a rate no greater than 25 mg/min. this version. Tell your doctor about the allergy and Kinetic studies were performed to determine the photolytic and thermal degradation rates of promethazine hydrochloride as a function of pH. 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? Dispense in well-closed container. 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 HCl 50mg. Preoperative doses should be given with appropriate doses of an analgesic/hypnotic and an atropine-like agent. Absorption and bioavailability of calcium and magnesium salts of indomethacin from rectal suppositories. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only.

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