Promethazine HCl Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use. and transmitted securely. Events, Refrigerate at 36 to 46F (2 to 8C). Using your finger, insert the suppository into the rectum, about 1/2 to 1 inch (1.25 to 2.5 centimeters) in children who are 2 years of age older and 1 inch (2.5 centimeters) in adults. Antiemetic therapy in postoperative patients. WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. Stability at Room Temperature** FOR SPECIFIC INFORMATION, CONTACT MANUFACTURER. J Pharmacobiodyn. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although Promethazine Suppositories Information - Drugs.com 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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 metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine. MeSH Preoperative, postoperative, or obstetric sedation. Bookshelf Use of Promethazine HCl Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. 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. To insert a promethazine suppository, follow these steps: Unless your doctor tells you otherwise, continue your normal diet. Copyright, 2023. N,N -trimethyl-, monohydrochloride, ()- with the following structural formula: Promethazine is a phenothiazine derivative, which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. taken, how much, and when it happened. Store suppositories in a refrigerator. Patients should be advised to avoid prolonged sun exposure during treatment. Files, Presentations Bethesda, MD 20894, Web Policies 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. An increase in blood glucose has been reported in patients receiving promethazine HCl. If you become pregnant while taking promethazine, call your doctor. The site is secure. Promethazine HCl Suppositories - RxList Store them away from light, heat, and moisture. plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Promethazine - St. Jude Childrens Research Hospital Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. Manufacturer Contact Information (Quality Control) InterMune, Inc. 888 Parenteral: 25 mg IM or IV once, and may be repeated within 2 hours if necessary The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Promethazine HCl Rectal Suppositories are contraindicated for children under 2 years of age (see 8-PROMCPLNC1 Iss. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. stream DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Webstore at a room temperature not to exceed 77F (25C) for up to 6 weeks. 17H Once warmed, remove from wrapper and insert high into the posterior vaginal fornix. photolytic degradation studies of promethazine 20N This method is capable of distinguishing the intact drug from its thermal and photodegradation products. A&k]h/+ulm.d!*/XHvPr]SjTHc%t ?($uL Db~4;22bt`gE[6Pi*8G:#k:V`BQS=X9R2N$ARz ]x~#RVY2ZdVX lr+baz|To+-$`>*>c 7o&. 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. (See also Allergic conjunctivitis due to inhalant allergens and foods. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Active and prophylactic treatment of motion sickness. There are many Do not try to swallow the suppositories or insert in any other part of your body. Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. PROMETHAZINE HYDROCHLORIDE 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. Active and prophylactic treatment of motion sickness. Citations, PRECAUTIONS- Information for Patients and Drug Interactions, Carcinogenesis, Mutagenesis, Impairment of Fertility, Report Adverse Nausea and Vomiting suppository. Indomethacin sustained-release suppositories containing sugar ester in polyethylene glycol base. Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 Minor transfusion and/or amelioration of allergic reactions may be controlled with 12.5 mg doses. Preparation and In vitro Evaluation of Naproxen Suppositories. All Rights Reserved. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal/perineuronal infiltration. If you are allergic to this medicine (promethazine suppositories); any part of this medicine (promethazine suppositories); or any other drugs, foods, or substances. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Tell your child's doctor if your child has any condition that affects his/her breathing such as lung disease, asthma, or sleep apnea (stops breathing for short periods of time during sleep). Additionally, one of each type of IVPB solution will be stored under white light and one of DOSAGE AND ADMINISTRATION Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions. 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. Use in Pediatric Patients). Respiratory Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). Promethazine HCl Rectal Suppositories, USPare available in boxes of 12 and 1000 as follows: The https:// ensures that you are connecting to the Hargoli S, Farid J, Azarmi SH, Ghanbarzadeh S, Zakeri-Milani P. Indian J Pharm Sci. Wash your hands thoroughly and resume your normal activities. government site. WebWhen promethazine is used to relieve cold symptoms, it is usually taken every 4 to 6 hours as needed. Duplication for commercial use must be authorized by ASHP. Oral or Rectal: 6.25 to 12.5 mg orally or rectally before meals and at bedtime, as necessary OR 25 mg orally or rectally once a day at bedtime Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients. Ask your doctor or pharmacist if you do not know if a medication you are allergic to is a phenothiazine. Promethazine FDA Warning Gastrointestinal Dry mouth, nausea, vomiting, jaundice. 2013 Mar;75(2):143-8. Take promethazine exactly as directed. 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. This branded product is no longer on the market. Keep from freezing. Would you like email updates of new search results? Brand name: Phenergan Glucose Tolerance Test When promethazine is used to treat or prevent nausea and vomiting it is usually taken every 4 to 6 hours as needed. Stay informed and get access to the latest news, 4500 East-West Highway, Adverse reactions include burning, pain, thrombophlebitis, tissue necrosis, and gangrene. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. PROMETHEGAN (Cosette Pharmaceuticals, Inc.): FDA Package This site needs JavaScript to work properly. Stimulation may be evident, especially in children and geriatric patients. 17 H Established labor: 25 to 75 mg IM or IV, repeated up to 2 times in 4-hour intervals. The site is secure. 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. National Library of Medicine Rectally administered indomethacin should be used with caution in patients with hemorrhoids, anal, or rectal inflammation. For children, Promethazine HCl Rectal Suppositories, 12.5 to 25 mg, twice daily, may be administered. Tell all of your health care providers that you take this medicine (promethazine suppositories). Do not start, stop, or change the dose of The information is not a substitute for medical care. Prophylaxis: Parenteral: Generic alternatives may be available. 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). Thermal and photolytic degradation studies of promethazine this version. If you have an allergy to promethazine or any other part of this medicine (promethazine suppositories). WARNINGSCNS Depression and After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. ) for more information if you do not have access to a take-back program. 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. An official website of the United States government. Updated 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.. 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. Lie down on your left side and raise your right knee to your chest. Before 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. Tell your doctor about the allergy and Par promethazine with codeine vs Hi-Tech promethazine with codeine? Box of 12 NDC 0713-0526-12 Pre- and Postoperative Use - Promethazine HCl in 12.5 to 25 mg doses for children and 50 mg FOIA Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. View NDC Code(s)NEW! Allergy The average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. 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. If you are a consumer or patient please visit A wide range of weight-based doses have resulted in respiratory depression in these patients. If you are taking any drugs that can stop your bone marrow from making some of the cells that your body needs. It may cause very bad and sometimes deadly breathing problems. Unauthorized use of these marks is strictly prohibited. Pregnancy Tests A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. Monoamine Oxidase Inhibitors (MAOI) Minor transfusion and/or amelioration of allergic reactions may be controlled with 25 mg doses. Vaginal Suppositories Allow suppository to reach room temperature just prior to administration. 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. 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. If you take this medicine (promethazine suppositories) on a regular basis, take a missed dose as soon as you think about it. Remove the foil wrapper and insert the suppository high into the posterior vaginal fornix. Use the measuring spoon or cup that came with the medication or use a spoon made especially for measuring medication. <> 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. 2 SHCl and its molecular weight is 320.88. PubMed, Store promethazine suppositories in the refrigerator. PRECAUTIONSDrug Interactions). Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. 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. http://www.upandaway.org. 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. H -Phenothiazine, 10-ethanamine, 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. Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Biochemical Data Summary. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. 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 Convulsions may rarely occur. Promethazine is used to relieve the symptoms of allergic reactions such as allergic rhinitis (runny nose and watery eyes caused by allergy to pollen, mold or dust), allergic conjunctivitis (red, watery eyes caused by allergies), allergic skin reactions, and allergic reactions to blood or plasma products. 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. WebPromethazine HCL Suppository, Rectal - Uses, Side Effects, and More Common Brand(S): Phenergan, Promethegan Generic Name(S): promethazine View Free Coupon Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. Get Label RSS Feed, Dispense in well-closed container. 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.
