Control) Pramlintide injection (Symlin) Promethazine suppositories (Promethegan) Proparacaine ophthalmic. Prophylaxis: Parenteral: To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or 30 days. Vasomotor rhinitis. Last updated on Jan 28, 2022. A linear relationship between peak height ratio (promethazine-promazine) and promethazine concentration is found up to a concentration of 600 micrograms/ml. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Bioequivalence and pharmacokinetic profile of promethazine hydrochloride suppositories in humans. Keep from freezing. Use of Promethazine HCl Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. (See Promethazine HCl is a racemic compound; the empirical formula is C http://www.fda.gov/Safety/MedWatch Dermographism. A stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. 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. View Labeling Archives, Oxygen may also be administered. 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. 17 H Nakajima T, Takashima Y, Furuya A, Ozawa Y, Kawashima Y. Chem Pharm Bull (Tokyo). room temperature 1984 Jun;7(6):392-9. doi: 10.1248/bpb1978.7.392. Perennial and seasonal allergic rhinitis. 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. Do not take more or less of it or take it more often than prescribed by your doctor. Oral solution: The oral solution should be measured with an accurate measuring device to decrease the risk of overdosage. Information is also available online at Promethazine HCl Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Promethazine HCl Suppositories should be used with caution in pediatric patients 2 years of age and older (see If your symptoms or health problems do not get better or if they become worse, call your doctor. Clinical Trials, A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. 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. 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. and transmitted securely. Preoperative, postoperative, or obstetric sedation. Subsequent doses on succeeding days of travel should be given on rising and again before the evening meal. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients. Glucose Tolerance Test Chem Pharm Bull (Tokyo). Nonteratogenic Effects Promethazine hydrochloride Oral / IV / Suppository 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. In the in vivo experiments, the plasma indomethacin levels after administration of suppositories stored at different temperatures were measured in conscious and anesthetized rats. There may be drug take-back programs in your area. Room-temperature storage of medications labeled for On longer trips, promethazine is usually taken in the morning and before the evening meal on each day of travel. Stability at Room Temperature** FOR SPECIFIC INFORMATION, CONTACT MANUFACTURER. Before your child takes this medicine (promethazine suppositories), tell the doctor if your child is taking any drugs that can cause breathing problems. Webstore at a room temperature not to exceed 77F (25C) for up to 6 weeks. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). How to classify reactions as zero, first, and second order reactions and their corresponding reactions rates. Promethazine Dosage Guide + Max Dose, Adjustments - Drugs.com ) for more information if you do not have access to a take-back program. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Promethazine is in a class of medications called phenothiazines. Avoid sun, sunlamps, and tanning beds. 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. Promethazine HCl Suppositories, USP are for rectal administration only. WebPromethazine is well absorbed from the gastrointestinal tract. Preoperative doses should be given with appropriate doses of an analgesic/hypnotic and an atropine-like agent. We comply with the HONcode standard for trustworthy health information. Duplication for commercial use must be authorized by ASHP. In case of overdose, call the poison control helpline at 1-800-222-1222. tablet. 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. 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 Remove the foil wrapper and insert the suppository high into the posterior vaginal fornix. 8-PROMCPLNC1 Iss. 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. J Pharmacobiodyn. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Use the measuring spoon or cup that came with the medication or use a spoon made especially for measuring medication. You could have more side effects. If you are 65 or older, use this medicine (promethazine suppositories) with care. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Note that any depressant effects of promethazine HCl are not reversed by naloxone. Antiemetic therapy in postoperative patients. Privacy Policy | Copyright 2023. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. 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. Phenergan Suppositories Dosage Vaginal Suppositories Allow suppository to reach room temperature just prior to administration. 3 0 obj If you take this medicine (promethazine suppositories) on a regular basis, take a missed dose as soon as you think about it. PDR For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused, Preoperative, postoperative, and obstetric (during labor) sedation, Oral and Rectal: 25 mg orally, or rectally once, then 12.5 to 25 mg every 4 to 6 hours as needed, Parenteral: 12.5 to 25 mg IM or IV every 4 hours as needed, Initial day: 25 mg orally or rectally 30 to 60 minutes before traveling, then 8 to 12 hours as needed, Succeeding days of travel: 25 mg orally or rectally upon rising, with the dose repeated before the evening meal. Tell your to you and the baby. (See also If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. 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). All Rights Reserved. Store them away from light, heat, and moisture. Files, Presentations The effect on later growth and development of the newborn is unknown. Box of 12 NDC 0713-0526-12 This method is capable of distinguishing the intact drug from its thermal and photodegradation products. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. Promethazine HCl Suppositories,USPare for rectal administration only. Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. It is used to ease pain . Talk with the doctor. 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. Dispense in well-closed container. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. 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. Copyright, 2023. AllergyThe average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. The site is secure. Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. Citations, PRECAUTIONS- Information for Patients and Drug Interactions, Carcinogenesis, Mutagenesis, Impairment of Fertility, Report Adverse tablet. Promethazine Suppositories | Cleveland Clinic Promethazine HCl 25mg. Signs of an allergic reaction, like rash; Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking. 0713-0536-10, 2 years and older: Treatment: Oral or Rectal: 1.1 mg/kg orally or rectally every 4 to 6 hours as needed. Be sure to mention any of the following: antidepressants ('mood elevators') such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); antihistamines; azathioprine (Imuran);barbiturates such as phenobarbital (Luminal); cancer chemotherapy; epinephrine (Epipen); ipratropium (Atrovent)medications for anxiety, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems; monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), and selegiline (Eldepryl, Emsam, Zelapar); narcotics and other pain medication; sedatives; sleeping pills;and tranquilizers. Promethazine may make your skin sensitive to sunlight. PROMETHAZINE HYDROCHLORIDE Webafter 24 hours of storage at room- temperature, when stored in a cool place (815 C), and when stored at room-temperature (1530 C). 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. MeSH Generic alternatives may be available. Many times this medicine (promethazine suppositories) is taken on an as needed basis. Federal government websites often end in .gov or .mil. Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. WebTo insert a promethazine suppository, follow these steps: If the suppository feels soft, hold it under cold, running water for 1 minute. 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. Use. Patients receiving parenteral formulations should report persistent/worsening pain or burning at the injection site. If you are taking any drugs that can stop your bone marrow from making some of the cells that your body needs. Promethazine HCl Suppositories should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Report Adverse Do not give this medicine (promethazine suppositories) to a child who is throwing up for an unknown reason. This medicine may cause very bad and sometimes deadly breathing problems. 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. Files, All Mapping 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. https://medlibrary.org/lib/rx/meds/promethegan-5/. Subcutaneous administration is contraindicated.