Parenteral or rectal formulations may be used when patients cannot tolerate oral formulations. Store promethazine suppositories in the refrigerator. Administration of 12.5 to 25 mg promethazine HCl by rectal suppository at bedtime will provide sedation in children. can do this. Additionally, one of each type of IVPB solution will be stored under white light and one of Information (Quality. Parenteral: 25 mg IM or IV once, and may be repeated within 2 hours if necessary 1989 Nov;37(11):3145-7. doi: 10.1248/cpb.37.3145. This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Use with care in children 2 years of age and older. Clipboard, Search History, and several other advanced features are temporarily unavailable. A stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. 1978 Aug;67(8):1133-8. doi: 10.1002/jps.2600670828. Absorption and bioavailability of calcium and magnesium salts of indomethacin from rectal suppositories. N,N -trimethyl-, monohydrochloride, ()- with the following structural formula: Usual Pediatric Dose for Nausea/Vomiting. Parenteral formulations of this drug may cause severe chemical irritation and tissue damage regardless of the route. The stability of aqueous solutions of promethazine hydrochloride as a function of pH. 8600 Rockville Pike Vasomotor rhinitis. Amelioration of allergic reactions to blood or plasma. FOIA Tell your doctor or pharmacist about all the medications your child is taking, especially barbiturates such as phenobarbital (Luminal), medications for anxiety, narcotic medications for pain, sedatives, sleeping pills, and tranquilizers. 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. 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. WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. Adverse reactions include burning, pain, thrombophlebitis, tissue necrosis, and gangrene. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. 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. Bethesda, MD 20894, Web Policies 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. %PDF-1.5 Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking promethazine. Promethazine was nonmutagenic in the ). PMC IV: Treatment should be injected into a large vein, avoiding sites in the hand/wrist if possible. stream This may lead to a higher chance of getting an. Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. <> Generic name: Promethazine Suppositories [proe-METH-a-zeen] (A left-handed person should lie on the right side and raise the left knee.). If you are a consumer or patient please visit Patient should remain supine for Manufacturer Contact. The .gov means its official. 2SHCl and its molecular weight is 320.88. Shakiness, trouble moving around, or stiffness. Convulsions may rarely occur. Do not take 2 doses at the same time or extra doses. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or <> Tell your doctor if any of these symptoms are severe or do not go away: Some side effects can be serious. Check with your DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. WARNINGSNeuroleptic Malignant Syndrome). Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions. Accessibility The use of alcohol or other central-nervous-system depressants such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers, may enhance impairment The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. 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. In the in vivo experiments, the plasma indomethacin levels after administration of suppositories stored at different temperatures were measured in conscious and anesthetized rats. Medically reviewed by Drugs.com. This drug should be administered at a rate no greater than 25 mg/min. If you have an allergy to promethazine or any other part of this medicine (promethazine suppositories). & Articles, All Last updated on Apr 10, 2023. 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 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. Promethazine HCl Suppositories may lower seizure threshold. PROMETHEGAN- promethazine hydrochloride suppository, 0713-0526-10, Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Prophylaxis: Parenteral: This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. In the event that vasopressors are considered for the management of severe hypotension that does not respond to intravenous fluids and repositioning, the administration of norepinephrine or phenylephrine should be considered. Federal government websites often end in .gov or .mil. Protect the medication from light. Doses should be adjusted to the age and severity of the patient. Do not CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. Also tell the child's doctor if the child has not been drinking normally, has had excessive vomiting or diarrhea, or appears dehydrated. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 2 years and older: Treatment: Oral or Rectal: 1.1 mg/kg orally or rectally every 4 to 6 hours as needed. National Library of Medicine 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. 30 days. Avoid prolonged exposure to the sun. It may be given to you for other reasons. Promethazine may cause breathing to slow or stop, and may cause death in children. 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. Do not give this medicine (promethazine suppositories) to a child younger than 2 years of age. 0713-0536-10, An official website of the United States government. 3 0 obj Keep from freezing. The average parenteral dose given during established labor is 50 mg. When promethazine is used to treat motion sickness, it is taken 30 to 60 We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. Allergy The average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. South Plainfield, NJ 07080 Teratogenic Effects - Pregnancy Category C You may also report side effects at https://www.fda.gov/medwatch. 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. Hold it in place for a few moments. Acidosis and electrolyte losses should be corrected. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. WARNINGSCNS Depression and Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. In anesthetized rats, the plasma indomethacin levels were markedly lower than those in conscious rats, and the influence of the storage temperature on the plasma indomethacin levels was clearly observed. (See also Subcutaneous administration is contraindicated. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Before Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery, Antiemetic therapy in postoperative patients. solution. Please enable it to take advantage of the complete set of features! Allergic conjunctivitis due to inhalant allergens and foods. 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. Usual adult dosage is 50 mg promethazine HCl with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid. FDA Safety Recalls, Bethesda, MD 20894, Web Policies 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. Hallucinations have also been reported. 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. It is also important information to carry with you in case of emergencies. The following laboratory tests may be affected in patients who are receiving therapy with promethazine HCl: 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. Respiratory rate, especially in pediatric patients. You may get sunburned more easily. The .gov means its official. WebTo insert a promethazine suppository, follow these steps: If the suppository feels soft, hold it under cold, running water for 1 minute. endobj Treatment: Promethazine is well absorbed from the gastrointestinal tract. Stability at Room Temperature** FOR SPECIFIC INFORMATION, CONTACT MANUFACTURER. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. 1984 Jun;7(6):392-9. doi: 10.1248/bpb1978.7.392. 1987 Jun;76(6):441-5. doi: 10.1002/jps.2600760606. Avoid driving and doing other tasks or actions that call for you to be. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The effect of drug concentration on the thermal (dark) degradation of promethazin hydrochloride in aqueous solution. Promethazine HCl is a racemic compound; the empirical formula is C to make sure that it is safe for you to take this medicine (promethazine suppositories) with all of your drugs and health problems. hUV?Rr$F/~H>d'K[U[\6 n=>r,+wk2rP#hqB8&\,d `S6XGfRFLm1b%Ux/w4 *uU=pk6M;]-I%d.@TdzJ]C//RbU=8q]W0,75ni. Promethazine HCl 50mg. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. (see Medically reviewed by Drugs.com. To insert a promethazine suppository, follow these steps: Unless your doctor tells you otherwise, continue your normal diet. Promethazine HCl may be used alone or as an adjunct to narcotic analgesics during labor and delivery. Keep this medication in the carton or container it came in, tightly closed, and out of reach of children. Allergic conjunctivitis due to inhalant allergens and foods. 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. View NDC Code(s)NEW! Labels, All Index 25 mg, white, bullet-shaped suppository wrapped in silver foil. Promethazine helps control symptoms, but will not treat the cause of the symptoms or speed recovery. Box of 12 NDC 0713-0526-12 Active and prophylactic treatment of motion sickness. <> Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal/perineuronal infiltration. Avoid prolonged exposure to the sun. Clinical Trials, Methods: During a 12-month period ending in June 2021, the prescribing information and published 25 mg, white, bullet-shaped suppository wrapped in silver foil. (see WebPromethazine HCl 25mg. http://www.upandaway.org. Motion Sickness what signs you had. The administration of promethazine hydrochloride in 25-mg doses will control minor transfusion reactions of an allergic nature. The information is not a substitute for medical care. Remove the wrapper. :u Qt/OYFTU^Jir+*;M&+X!u N1FTVpWcHxTYYM~g;|W=7 _WCB>>n>tn@Zt|f.l1Ax{x`K-n;sPVF5e.7_+Vn7b71/=Arsdnp %6y'-KhYsoK6}^tW3VJWw^TYI.JJ Combination products containing promethazine and codeine should not be given to children younger than 16 years old. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. PRECAUTIONSDrug Interactions). (See Indomethacin sustained-release suppositories containing sugar ester. 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. Keep all drugs in a safe place. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. Call your doctor for medical This medicine may cause the results of some pregnancy tests to be wrong. Phenergan, Promethegan, Antinaus 50, Phenadoz. 1972 Dec;24:Suppl:133P-134. Amelioration of allergic reactions to blood or plasma. Promethazine HCl Suppositories administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. Distributedby: Cosette Pharmaceuticals, Inc. 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. Updated Tell your doctor about the allergy and official website and that any information you provide is encrypted 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. Promethazine is also used to prevent and treat motion sickness. Disclaimer. 1990 Jun;38(6):1680-3. doi: 10.1248/cpb.38.1680. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Unable to load your collection due to an error, Unable to load your delegates due to an error. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients. 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. Please enable it to take advantage of the complete set of features! Dermatologic Dermatitis, photosensitivity, urticaria. It is used to help motion sickness . WebPhenadoz Suppositories are for rectal administration only. WebPromethazine HCl Suppositories are for rectal administration only. Promethazine may also be taken at bedtime the night before surgery to relieve anxiety and produce quiet sleep. 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. 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. PMC to you and the baby. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. prednisone, trazodone, hydroxyzine, ondansetron, montelukast, fluticasone nasal, lorazepam, loratadine, cetirizine, diazepam. 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. 8600 Rockville Pike WebVaginal suppositories (e.g., Prostin E2): Before removing foil wrapper, allow vaginal suppository to warm to room temperature. 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. Promethazine HCl Suppositories may lower seizure threshold. this version. 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. If your child is throwing up for an unknown reason. The melting point of suppositories stored at a high temperature was higher by approximately 2 degrees C than those stored at a low temperature. Wash your hands thoroughly and resume your normal activities. Patients should be told to report any involuntary muscle movements. advice about side effects. 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 Suppositories are useful for: Perennial and seasonal allergic rhinitis. Stavchansky S, Wallace JE, Geary R, Hecht G, Robb CA, Wu P. J Pharm Sci. Bookshelf Use of Promethazine HCl Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. . 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. Generic alternatives may be available. Call your doctor or get medical Promethazine HCl 12.5mg. You must check if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking promethazine. It works by blocking the action of a certain natural substance in the body. In vivo and in vitro release of indomethacin from water-soluble and fatty base suppositories. Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. In case of overdose, call the poison control helpline at 1-800-222-1222. 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. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location one that is up and away and out of their sight and reach. Box of 12 NDC 0713-0536-12 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. 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. government site. WARNINGS Use in Pediatric Patients). 2 SHCl and its molecular weight is 320.88. The release of indomethacin from fatty-base suppositories, which had been stored at a low (4 degrees C) and a high (25-30 degrees C) temperature for about one month, was examined in vitro and in vivo. Careers. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. 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. 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. HHS Vulnerability Disclosure, Help Select one or more newsletters to continue. H -Phenothiazine, 10-ethanamine, Avoid sun, sunlamps, and tanning beds. This drug should not be used to treat nausea and vomiting of unknown etiology. Ask your doctor or pharmacist if you are not sure. If the suppository feels soft, hold it under cold, running water for 1 minute. help if any of these side effects or any other side effects bother you or do not go away: These are not all of the side effects that may occur. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Keep out of the reach of children. 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. Talk with the doctor. Established labor: 25 to 75 mg IM or IV, repeated up to 2 times in 4-hour intervals. If you are taking any drugs that can stop your bone marrow from making some of the cells that your body needs.
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