promethazine suppository stability at room temperature promethazine suppository stability at room temperature

Do not let anyone else take your medication. If you think there has been an overdose, call your poison control center or get medical care right away. Oral formulations are preferred; however, rectal or parenteral formulations may be given if oral formulations are not tolerated. Allergic conjunctivitis due to inhalant allergens and foods. Promethazine can interfere with the results of home pregnancy tests. DOSAGE AND ADMINISTRATION 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. Motion Sickness WebPromethazine HCl 25mg. 2 SHCl and its molecular weight is 320.88. If you have an allergy to promethazine or any other part of this medicine (promethazine suppositories). 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. WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. solution. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Patients should Vasomotor rhinitis. Drug classes: Antihistamines, Phenothiazine antiemetics. This method is capable of distinguishing the intact drug from its thermal and photodegradation products. tell your doctor if you have or have ever had an enlarged prostate (a male reproductive gland); glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision); seizures; ulcers; blockage in the passage between the stomach and intestine; blockage in the bladder; asthma or other lung disease; sleep apnea; cancer;any condition that affects the production of blood cells in your bone marrow; or heart or liver disease. Paradoxical Reactions PRECAUTIONS- Information for Patients and Drug Interactions). Central Nervous System On longer trips, promethazine is usually taken in the morning and before the evening meal on each day of travel. SEVERE TISSUE INJURY, INCLUDING GANGRENE: Parenteral formulations can cause severe chemical irritation and damage to tissues regardless of the route of administration. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. 2 years and older: Household teaspoons may not be an accurate measuring device. Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. Before 25 mg, white, bullet-shaped suppository wrapped in silver foil. If you take this medicine (promethazine suppositories) on a regular basis, take a missed dose as soon as you think about it. Treatment Nakajima T, Takashima Y, Furuya A, Ozawa Y, Kawashima Y. Chem Pharm Bull (Tokyo). 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. Glucose Tolerance Test This medicine may cause the results of some pregnancy tests to be wrong. 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. Store promethazine tablets and liquid at room temperature and away from excess heat and moisture (not in the bathroom). Talk with the doctor. Promethazine may make your skin sensitive to sunlight. 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. Unable to load your collection due to an error, Unable to load your delegates due to an error. Perennial and seasonal allergic rhinitis. Put suppository into the rectum with gentle pressure, pointed end first. The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Refrigerate at 36 to 46F (2 to 8C). There are no adequate and well-controlled studies of Promethazine HCl Suppositories in pregnant women. Bookshelf Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. 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. 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. Dispense in well-closed container. breathing. Call your doctor for medical can do this. Events, It is soluble in water and freely soluble in alcohol. 1978 Aug;67(8):1133-8. doi: 10.1002/jps.2600670828. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. 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. It may be given to you for other reasons. Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Wash your hands thoroughly and resume your normal activities. Do not try to test for pregnancy at home. Nonteratogenic Effects Promethazine HCl How long does promethazine stay in your system? Hold it in place for a few moments. The stability of aqueous solutions of promethazine hydrochloride as a function of pH. Study on absorption of indomethacin from sustained-release suppositories containing hydrogenated soybean lecithin in rabbits. Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. this version. Phenergan, Promethegan, Antinaus 50, Phenadoz. Drowsiness is the most prominent CNS effect of this drug. Par promethazine with codeine vs Hi-Tech promethazine with codeine? Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. 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%. Patients receiving parenteral formulations should report persistent/worsening pain or burning at the injection site. Control) Pramlintide injection (Symlin) Promethazine suppositories (Promethegan) Proparacaine ophthalmic. what signs you had. Gastrointestinal Dry mouth, nausea, vomiting, jaundice. N,N -trimethyl-, monohydrochloride, ()- with the following structural formula: The average parenteral dose given during established labor is 50 mg. H -Phenothiazine, 10-ethanamine, WARNINGSBlack Box Warning and Disclaimer. and transmitted securely. Respiratory rate, especially in pediatric patients. Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder, which slowly oxidizes and turns blue on prolonged exposure to air. Treatment: WebIndomethacin suppositories are contraindicated in patients with a history of proctitis or recent rectal bleeding. Updated A very bad and sometimes deadly health problem called. Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. Get Label RSS Feed, & Articles, All View NDC Code(s)NEW! tablet. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. sharing sensitive information, make sure youre on a federal suppository. If you are taking any drugs that can stop your bone marrow from making some of the cells that your body needs. Methods: During a 12-month period ending in June 2021, the prescribing information and published Amelioration of allergic reactions to blood or plasma. ). On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. 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. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. Do not take more often than told by the doctor. Store promethazine suppositories in the refrigerator. Disclaimer. Atropine-like signs and symptoms-dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms-may occur. 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. Unable to load your collection due to an error, Unable to load your delegates due to an error. 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. FDA Safety Recalls, Promethazine FDA Warning Instead, the best way to dispose of your medication is through a medicine take-back program. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. When promethazine is used to treat or prevent nausea and vomiting it is usually taken every 4 to 6 hours as needed. You may report side effects to the FDA at 1-800-332-1088. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. %PDF-1.5 If you are giving promethazine to a child, watch the child to be sure he or she does not get hurt while riding a bike or participating in other activities that could be dangerous. If you will be giving promethazine to a child, also tell the child's doctor if the child has any of the following symptoms before he or she receives the medication: vomiting, listlessness, drowsiness, confusion, aggression, seizures, yellowing of the skin or eyes, weakness, or flu-like symptoms. Hematologic Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. The following laboratory tests may be affected in patients who are receiving therapy with promethazine HCl: Monoamine Oxidase Inhibitors (MAOI) An increase in blood glucose has been reported in patients receiving promethazine HCl. WebIn conscious rats, the plasma indomethacin levels attained after the intrarectal administration of suppositories stored at a high temperature were slightly lower than Store promethazine suppositories in the refrigerator. 1978 Feb;30(2):75-80. doi: 10.1111/j.2042-7158.1978.tb13165.x. RESPIRATORY DEPRESSION (PEDIATRIC PATIENTS): This drug should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. This site complies with the HONcode standard for trustworthy health information: verify here. 03/2020 VC7409, Boxed Warnings, There are many 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. Neuroleptic malignant syndrome (potentially fatal) has also been reported (See Available for Android and iOS devices. ) for more information if you do not have access to a take-back program. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. This report on medications is for your information only, and is not considered individual patient advice. Deep IM injection is the preferred route of administration. 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. Use in Pediatric Patients). 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. PubMed, Oral solution: The oral solution should be measured with an accurate measuring device to decrease the risk of overdosage. If your symptoms or health problems do not get better or if they become worse, call your doctor. The effect of drug concentration on the thermal (dark) degradation of promethazin hydrochloride in aqueous solution. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. See the FDA's Safe Disposal of Medicines website ( 1 receptor blocking agent. Citations, PRECAUTIONS- Information for Patients and Drug Interactions, Carcinogenesis, Mutagenesis, Impairment of Fertility, Report Adverse Rectal suppositories Never take suppositories by mouth. 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? Nonteratogenic Effects Active and prophylactic treatment of motion sickness, Oral and Rectal: 25 mg orally every 4 to 6 hours as needed. WebAdults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. WARNINGSRespiratory Depression). J Pharm Sci. Absorption and bioavailability of calcium and magnesium salts of indomethacin from rectal suppositories. If you are taking promethazine liquid, do not use a household spoon to measure your dose. 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). Do not give this medicine (promethazine suppositories) to a child younger than 2 years of age. Available for Android and iOS devices. Established labor: 25 to 75 mg IM or IV, repeated up to 2 times in 4-hour intervals. https://www.poisonhelp.org/help WARNINGSCNS Depression and Take the missed dose as soon as you remember it. 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. South Plainfield, NJ 07080 Vials stored at room temperature should not be returned to the refrigerator. Bethesda MD 20814 Dosage must be individualized. Promethazine HCl Suppositories, USPare useful for: Keep from freezing. Box of 1000 NDC 0713-0526-10 Antiemetic therapy in postoperative patients. 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 method is capable of distinguishing the intact drug from its thermal and photodegradation products. To insert a promethazine suppository, follow these steps: Unless your doctor tells you otherwise, continue your normal diet. Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine. Patients should be told to report any involuntary muscle movements. WebPromethazine HCL Suppository, Rectal - Uses, Side Effects, and More Common Brand(S): Phenergan, Promethegan Generic Name(S): promethazine View Free Coupon However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. 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.. % Hallucinations (seeing or hearing things that are not there). 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. Do not flush down a toilet or pour down a drain unless you are told to do so. AHFS However, many people have no side effects or only have minor side effects. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. It is not known whether promethazine HCl is excreted in human milk. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). 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. If you have questions about side effects, call your doctor. FOIA Biochemical Data Summary. Patient Medication Information. WARNING: PMC 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. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although Last updated on Apr 10, 2023. 17 H Note that any depressant effects of promethazine HCl are not reversed by naloxone. Promethazine is an H J Pharm Pharmacol. , 4500 East-West Highway, Suite 900, Bethesda, Maryland. <> Patients should be advised to report any involuntary muscle movements. In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=5f079815-f48b-8b21-2130-7f791d967c9a, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. Promethazine may also be taken at bedtime the night before surgery to relieve anxiety and produce quiet sleep. (A left-handed person should lie on the right side and raise the left knee.). Combination products containing promethazine and codeine should not be given to children younger than 16 years old. 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. IV formulations should be diluted to a concentration of 25 mg/mL or less. This site needs JavaScript to work properly. PRECAUTIONSDrug Interactions). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Amylin Pharmaceuticals. Signs of an allergic reaction, like rash; Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking. The activation energies at pH 2.98, 3.94, and 5.12 were obtained from linear Arrhenius plots and were found to be 6601, 5888, 5570 cal/mole, respectively. Keep this medication in the carton or container it came in, tightly closed, and out of reach of children. Promethazine HCl Rectal Suppositories are not recommended for children under 2 years of age. Promethazine helps control symptoms, but will not treat the cause of the symptoms or speed recovery. HHS Vulnerability Disclosure, Help Nonteratogenic Effects.). Talk to your doctor about the risks of giving promethazine to your child. National Library of Medicine taken, how much, and when it happened. WebPROMETHAZINE (proe METH a zeen) prevents and treats the symptoms of an allergic reaction. All Rights Reserved. Do not freeze the oral liquid. Dermographism. Promethazine HCl 25mg. Allergic conjunctivitis due to inhalant allergens and foods. Off-label information indicates unopened bottle stable when maintained at continuous room The .gov means its official. If you become pregnant while taking promethazine, call your doctor. Refrigerator settings should be mid-range at +5C (41F) to allow the highest Clipboard, Search History, and several other advanced features are temporarily unavailable. Pediatric patients should be supervised to avoid potential harm in bike riding or other hazardous activities. http://www.fda.gov/Safety/MedWatch 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. Teratogenic Effects - Pregnancy Category C It is also important information to carry with you in case of emergencies.