promethazine suppository stability at room temperaturepromethazine suppository stability at room temperature

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. Oral or Rectal: 1.1 mg/kg orally or rectally every 4 to 6 hours as needed, 2 years and older: Hold it in place for a few moments. June 14, 2022. WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. In case of overdose, call the poison control helpline at 1-800-222-1222. Subcutaneous administration is contraindicated. Perennial and seasonal allergic rhinitis. This may lead to a higher chance of getting an. 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. (See PROMETHAZINE WARNINGS Use in Pediatric Patients). Sedative doses may be given the night before surgery. (see Generic name: Promethazine Suppositories [proe-METH-a-zeen] 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. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Promethazine is also used to prevent and treat motion sickness. Influence of storage temperature on indomethacin release from Bethesda, MD 20894, Web Policies How to classify reactions as zero, first, and second order reactions and their corresponding reactions rates. FOIA Talk with the doctor. If you are 65 or older, use this medicine (promethazine suppositories) with care. endobj Where do I get this medication? Store promethazine rectal suppositories in a refrigerator between 36 - 46F. Files, Presentations Manufacturer Contact. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use. Alcohol can make the side effects of promethazine worse. The .gov means its official. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 There may be drug take-back programs in your area. Dermographism. Careers. Keep from freezing. Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates. and transmitted securely. and transmitted securely. This site needs JavaScript to work properly. 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. Events, (What 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. Updated Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 to 25 mg in children and 25- to 50-mg doses in adults. Promethazine HCl Suppositories, USP are useful for: Store them away from light, heat, and moisture. The product's dosage form is suppository and is administered via rectal form. Oral or Rectal: 6.25 to 12.5 mg orally or rectally before meals and at bedtime, if necessary, OR 25 mg orally or rectally once a day at bedtime Maximum dose: 25 Promethazine is an H An official website of the United States government. 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. Methods: During a 12-month period ending in June 2021, the prescribing information and published Dermatologic Dermatitis, photosensitivity, urticaria. 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. Par promethazine with codeine vs Hi-Tech promethazine with codeine? Promethazine FDA Warning Vasomotor rhinitis. Keep containers out of reach of children and pets. All Rights Reserved. PROMETHEGAN- promethazine hydrochloride suppositoryCosette Pharmaceuticals, Inc. Each rectal suppository contains 12.5 mg or 25 mg promethazine HCl with ascorbyl palmitate, colloidal silicon dioxide, white wax, hard fat, and glyceryl monostearate. Pre- or postoperative use: 25 to 50 mg IM or IV once An increase in blood glucose has been reported in patients receiving promethazine HCl. Patients should be advised to report any involuntary muscle movements. Promethazine Suppositories Information - Drugs.com Nausea and Vomiting Federal government websites often end in .gov or .mil. 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. Control) Pramlintide injection (Symlin) Promethazine suppositories (Promethegan) Proparacaine ophthalmic. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal/perineuronal infiltration. Refrigerator settings should be mid-range at +5C (41F) to allow the highest Disclaimer. Read all information given to you. The average adult dose is 25 mg taken twice daily. Promethazine HCl 50mg. Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions. 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 Promethazine HCl Suppositories, USP are for rectal administration only. Do not freeze. Administered IV as an adjunct to anesthesia or analgesia with reduced amounts of meperidine of other narcotic analgesics in special surgical situations (e.g., repeated bronchoscopy, ophthalmic surgery, poor-risk patients), Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. 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 FDA Safety Recalls, How long does promethazine stay in your system? Active and prophylactic treatment of motion sickness, Oral and Rectal: 25 mg orally every 4 to 6 hours as needed. This site complies with the HONcode standard for trustworthy health information: verify here. Promethazine HCl is a racemic compound; the empirical formula is C National Library of Medicine H -Phenothiazine, 10-ethanamine, HHS Vulnerability Disclosure, Help Accessibility Generic alternatives may be available. Paradoxical Reactions Accessibility https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=5f079815-f48b-8b21-2130-7f791d967c9a, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery, Antiemetic therapy in postoperative patients. Promethazine may cause breathing to slow or stop, and may cause death in children. Dosage must be individualized. to make sure that it is safe for you to take this medicine (promethazine suppositories) with all of your drugs and health problems. Minor transfusion and/or amelioration of allergic reactions may be controlled with 25 mg doses. WebTo insert a promethazine suppository, follow these steps: If the suppository feels soft, hold it under cold, running water for 1 minute. 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. Promethazine can interfere with the results of home pregnancy tests. These results suggest that in conscious rats many factors such as a locomotor hyperactivity and enhancement of gastrointestinal motility caused by the rectal administration mask the real character of suppositories. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. RxNorm, & Articles, All Stored in a warmer box to prevent crystallization Promethazine hydrochloride Oral / IV / Suppository 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 Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Active and prophylactic treatment of motion sickness. Promethazine may cause other side effects. If you are allergic to this medicine (promethazine suppositories); any part of this medicine (promethazine suppositories); or any other drugs, foods, or substances. Duplication for commercial use must be authorized by ASHP. Clipboard, Search History, and several other advanced features are temporarily unavailable. The American Society of Health-System Pharmacists <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Promethazine suppositories are for rectal use only. Phenergan Suppositories Dosage This includes your doctors, nurses, pharmacists, and dentists. Adverse reactions include burning, pain, thrombophlebitis, tissue necrosis, and gangrene. Last updated on Jan 28, 2022. Copyright, 2023. Rectal suppositories Never take suppositories by mouth. 17H PROMETHAZINE HCL SUPPOSITORIES SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see 1 0 obj this version. WARNINGSCNS Depression and Take promethazine exactly as directed. Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 WebPromethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Allergic conjunctivitis due to inhalant allergens and foods. J Pharm Pharmacol. To insert a promethazine suppository, follow these steps: Unless your doctor tells you otherwise, continue your normal diet. Atropine-like signs and symptoms-dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms-may occur. Pre- and Postoperative Use - Promethazine HCl in 12.5 to 25 mg doses for children and 50 mg 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. Promethazine may also be taken at bedtime the night before surgery to relieve anxiety and produce quiet sleep. Older adults should not usually take promethazine because it is not as safe as other medications that can be used to treat the same conditions. Promethazine HCl Suppositories are for rectal administration only. Avoid sun, sunlamps, and tanning beds. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Prophylactic doses may be used to prevent nausea and vomiting during surgery and the postoperative period. Available for Android and iOS devices. suppository. 1984 Jun;7(6):392-9. doi: 10.1248/bpb1978.7.392. This possibility should be considered with Promethazine HCl Suppositories. Do not drive a car or operate machinery until you know how this medication affects you. Store promethazine tablets, oral solution, and solution for injection at room temperature between 68 - 77F and protect from light. Tell your doctor about the allergy and Central Nervous System IV formulations should be diluted to a concentration of 25 mg/mL or less. All oral versions (tablets, syrup) of promethazine should be stored in the original, labeled container at room temperature. WebStore the tablets and syrup at room temperature. PRECAUTIONSDrug Interactions). You must check Promethegan (promethazine hydrochloride) dose, indications, Promethazine HCl Suppositories, USPare useful for: Promethazine is well absorbed from the gastrointestinal tract. Promethazine WebIn conscious rats, the plasma indomethacin levels attained after the intrarectal administration of suppositories stored at a high temperature were slightly lower than 8600 Rockville Pike Bioequivalence and pharmacokinetic profile of promethazine hydrochloride suppositories in humans. Note that any depressant effects of promethazine HCl are not reversed by naloxone. 2 SHCl and its molecular weight is 320.88. Do not let anyone else take your medication. Usual Pediatric Dose for Nausea/Vomiting. Copy the URL below and paste it into your RSS Reader application. Parenteral formulations: Store ampoules in the carton until ready to use. 20N Promethazine HCl is a racemic compound; the empirical formula is C17H20N2SHCl and its molecular weight is Active and prophylactic treatment of motion sickness. Amelioration of allergic reactions to blood or plasma. Sedation Do not take 2 doses at the same time or extra doses. 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. PHARMACEUTICAL STABILITY OF PROMETHAZINE IN IV Promethazine may make your skin sensitive to sunlight. plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. 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. Store refrigerated between 2-8C (36-46F). Avoid prolonged exposure to the sun. 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 ( 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. 4 0 obj Promethazine should not routinely be used to treat vomiting in children; it should only be used in specific cases when a doctor decides that it is needed. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. J Pharm Sci. Clinical Trials, Before your child takes this medicine (promethazine suppositories), tell the doctor if your child is taking any drugs that can cause breathing problems. 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. Do not take more or less of it or take it more often than prescribed by your doctor. Promethazine is also used to prevent and control nausea and vomiting that may occur after surgery, and with other medications to help relieve pain after surgery. Drowsiness is the most prominent CNS effect of this drug. official website and that any information you provide is encrypted Hargoli S, Farid J, Azarmi SH, Ghanbarzadeh S, Zakeri-Milani P. Indian J Pharm Sci. The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. AllergyThe average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Bookshelf <> WebThe NDC Packaged Code 0713-0526-12 is assigned to a package of 12 suppository in 1 box of Promethegan, a human prescription drug labeled by Cosette Pharmaceuticals, Inc.. Promethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. PROMETHAZINE HYDROCHLORIDE Treatment 03/2020 VC7409, Boxed Warnings, It may cause very bad and sometimes deadly breathing problems. Comments: 2 years and older: This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. taken, how much, and when it happened. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HCL BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Doses should be adjusted to the age and severity of the patient. Call your doctor or get medical 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. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex).