Amneal Pharmaceuticals of New York LLC. ATTENTION: If you speak another language, assistance services, free of charge, are available to you. (2022). 405418, 2009. Our aim is to promote active participation in your care and treatment by providing information and education. This combination is an FDA-approved cough and cold medication. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Other side effects not listed may also occur in some patients. Is the ketogenic diet right for autoimmune conditions? Promethazine is also used to prevent and control motion sickness, nausea, vomiting, and dizziness. Promethazine has many effects on the body. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Extrapyramidal symptoms. Like drowsiness and dizziness, this may affect your physical ability to do tasks like driving. How might bacteria-eating viruses and gut bacteria contribute to longevity? Promethazine hydrochloride [package insert]. You may take the tablets or syrup with food or milk to avoid an upset stomach. Do. Promethazine can interact with MAOIs to cause uncontrollable body movements. Adverse photosensitivity responses to drugs occur predominantly as a phototoxic reaction which is more immediate than photoallergy and can be reversed by withdrawal or substitution of the drug. PM can be found in association with NSAIDs or other drugs. The gel should be applied on your childs wrist. The lesions may be apparently confined to the body sites, such as elbows, knees, ankles, forearms, and thighs, or several parts of the body may be affected where there are insect bites or burns, and sun exposure concomitantly occurs, but may also appear on other sites by transfer (ectopic contact dermatitis by hands or clothing; it may also affect family members due to connubial contact). Young children are at greatest risk because they are mobile and curious. Most importantly we outlined numerous steps that should be taken to minimize the potential for adverse outcomes. Moreover, cross-reactions with chemically related as well as nonchemically related molecules are common. You may be surprised that promethazine is available in combination with codeine (an opioid). 644648, 1994. S. J. Posadas and W. J. Pichler, Delayed drug hypersensitivity reactionsnew concepts, Clinical and Experimental Allergy, vol. The list below may not include all possible serious side effects of the drug. With some agents, a negative skin test does not effectively rule out the presence of specific IgE. So, this side effect can be more severe if theyre taken together. Last updated on May 14, 2023. In cases of fixed drug eruption (FDE), skin lesions recur at the same sites after repeated exposure in 1-2 weeks, and the interval between reexposure and eruption appearance is usually 24h. All body sites can be involved. Peak plasma concentrations occur after 2 to 3 hours when promethazine is administered orally (25 to 50mg) or intramuscularly (25mg). Fiedorowicz, J.G., et al. Promethazine is a phenothiazine antihistamine, antagonizing the central and peripheral effects of histamine mediated by histamine H1 receptors. Promethazine is a . Promethazine hydrochloride [package insert]. (2022). 2, pp. This content does not have an English version. Do not use a heating pad over the skin where the gel has been applied. So if you already have heart problems, taking promethazine may make your condition worse. Taking it with promethazine can worsen this side effect. Most commonly, they can cause sedation (drowsiness or sleepiness). Prevention of future reactions is an essential part of patient management. Anticholinergic manifestations such as dry mouth, mydriasis, and blurred vision are usually present. If youre pregnant, planning to become pregnant, or breastfeeding, talk with your doctor before taking promethazine. Superoxide anion and singlet oxygen generated from ultraviolet (UV)-exposed promethazine were found to contribute to dermatitis. "Product Information. Promethegan [package insert]. However, this article does not cover these forms. StatPearls. They can help determine whether promethazine is working to treat your condition or whether the drug is causing nausea as a side effect. Positive skin tests to these drugs confirm the presence of antigen-specific IgE and support the diagnosis of a type I hypersensitivity reaction. Promethazine hydrochloride [package insert]. This is because older adults bodies may process promethazine slower than younger peoples bodies. Alcohol Research & Health. Trademarks, brands, logos, and copyrights are the property of their respective owners. You can find it as an oral tablet or liquid, injection, and rectal suppository. When PM is used by patients (through ingestion or skin contact), Langerhans cells in the epidermis process them and display them in a complex with HLA-DR. 461470, 2009. 55, no. The drug is approved for use in certain adults and children with: The drug is also used along with other medications for pain after surgery. Beside, these effects, promethazine also inhibits the brain Na K -ATPase and the mitochondrial permeability transition pore. This is a serious warning from the Food and Drug Administration (FDA). 5833-278-866-1 ( : 1040-595-901-1). The sensitization to PM is often a cross-reaction to other drugs of the family of phenothiazine. In most cases, side effects of promethazine in older adults (ages 65 years and older) are similar to those in younger people. This is not a complete list of side effects and others may occur. Promethazine has strong anticholinergic properties, blocking the responses to acetylcholine that are mediated by muscarinic receptors. 348, no. In case of a severe side effect or reaction, call the doctor, nurse, or pharmacist at 595-3300. Its usually best to avoid or minimize alcohol while taking promethazine. Based on your medical history and other medications, they might recommend another medication. 4361, 2009. Promethazine also has antimotion sickness properties which may be due to central antimuscarinic action. In general, photoreactions by photosensitive chemicals are divided into the phototoxic and photoallergic types. This is also true if you take or take other medications that lower the seizure threshold. (2022). Overdosage may also present with various cardiorespiratory symptoms such as respiratory depression, tachycardia, hypertension or hypotension, and extrasystoles. Examples include amitriptyline, nortriptyline (Pamelor), and imipramine (Tofranil). If you experience dry mouth while taking promethazine, talk with your doctor or pharmacist. Call 1-866-278-5833 (TTY: 1-901-595-1040), St. Jude Children's Research Hospital - Homepage, Disclaimer / Registrations / Copyright Statement, 12.5 mg, 25 mg, and 50 mg tablets taken by mouth, 1.25 mg/ml and 5 mg/ml syrup (liquid) taken by mouth, 12.5 mg, 25 mg, and 50 mg suppositories inserted into the rectum. If you experience ringing in your ears, talk to your healthcare provider. This medication may increase your risk of a seizure occurring. Clinical suspicion should be confirmed by patch testing such as SIDAPA (Societ Italiana di Dermatologia Allergologica Professionale ed Ambientale) patch test standard series, including fragrance mix and its components (eugenol, isoeugenol, oak moss, geraniol, hydroxycitronellal, amylcinnamaldehyde, cinnamyl alcohol, and cinnamaldehyde) and with the SIDAPA photopatch test series. Cinnamyl alcohol, that is, a component of both fragrance mix and Myroxylon pereirae has been suggested to explain this phenomenon. Copyright 2013 C. Cantisani et al. 81, no. The good news is that most of the time, tinnitus caused by medicines goes away when the medication is stopped. 7, pp. 279, no. (2012). Be sure to follow these guidelines to protect everyone from the dangers: If you have questions about promethazine topical gel, please talk to your childs doctor, nurse, or pharmacist at 901-595-3300. Do not use soap or alcohol to remove the gel. 47, no. Vertigo/ dizziness as a drugs adverse reaction. These side effects may go away during treatment as your body adjusts to the medicine. Concentrations of promethazine in blood and urine can be determined [2629]. They can help determine whether the drug is safe for you. Only SGAHs, and specially those with a proven long-term (e.g., 12 months) clinical safety, should be prescribed for young children. Second-generation oral antihistamines are the preferred first-line treatment option for allergic rhinitis and urticarial, although topical first-generation antihistamines are still prescribed by general healthcare practitioner and pharmacists too easily, without taking into account possible side effects as a first line treatment for several dermatological problems [712]. Promethazine can cause side effects that may impair your thinking or reactions. Although not all of these side effects may occur, if they do occur they may need medical attention. Talk to your healthcare provider if youre experiencing side effects that bother you. 20, no. Prometazine has both phototoxic and photoallergic potentials, but many clinical observations have indicated that photosensitivity to MP is a photoallergic reaction. (c) Mucous bullous involvement after systemic absorption of PM. If your drowsiness is severe, or if you feel like your breathing is too slow, get medical attention right away. Learn more about some of the side effects that promethazine may cause. If they find out that promethazine is causing tinnitus, they will recommend another medication. 34, no. Anesthesia is a medication that makes a person unable to feel pain during and after surgical procedures. Promethazine interacts with other medications or substances that cause drowsiness. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. They may be able to recommend antinausea medications or other treatment options for you. 469478, 2013. 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. (2022). Unless severe, hypotension should be treated with posture; severe cases can be treated with fluids or pressor agents. An allergic reaction is possible after taking promethazine. In this case, your doctor may recommend more frequent monitoring of your blood cell levels. So, it's important to know what to avoid and watch out for when taking it. D. Vervloet and S. Durham, ABC of allergies: adverse reactions to drugs, British Medical Journal, vol. Keep opened and unopened syringes of promethazine topical gel out of the reach of children. Chimirri, S., et al. Photoallergy is due to a cell-mediated hypersensitivity response, involving immunological reactions. If you have a history of seizures, promethazine may not be the best choice for you. Llame al 1-866-278-5833 (TTY: 1-901-595-1040). They may have used the photoreacted drugs independently which means there was the possibility of an independent photosensitization [34, 35]. The best thing about giving medicine this way is your child will receive this medicine without having to swallow it, have an intramuscular (IM) injection, or have an intravenous (IV) line. The authors declare no conflict of interests. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. 4, pp. Promethazine is available as a tablet, oral liquid, and rectal suppository (Promethegan). And if youre taking this medication, its important to know what to watch out for. This combination medication is used to temporarily treat runny nose, coughing, and sneezing caused by the common cold, allergies, hay fever, and other breathing illnesses. Side Effects Print Save Promethazine Side Effects Medically reviewed by Drugs.com. 1, pp. 1, pp. The peripheral H(1)-receptor (PrH1R) stimulation leads to allergic symptoms while the brain H(1)-receptor (BrH1R) blockade leads to somnolence, fatigue, increased appetite, decreased cognitive functions (impaired memory and learning), seizures, aggressive behaviour, and so forth. According to the other ingredients in the PM-containing transdermal delivery (which may contain folium eriobotryae, pericarpium papaveris, radix stemonae, cynanchum glaucescens, the root bark of white mulberry, platycodon grandiflorum, menthol crystal, cane sugar, citric acid, essence, sodium benzoate, dextromethorphan hydrobromide, promethazine hydrochloride, or 75% of alcoholic solution), some patients may react with a contact allergic reaction to other components in the gel, such as lavender oil which is a natural fragrance. StatPearls. The somnolence caused by FGAHs interferes with the natural circadian sleep-wake cycle, and therefore FGAHs are not suitable to be used as sleeping pills. But you may not be aware its FDA-approved for other conditions as well. 36, no. Promethazine also comes in other forms, including an injectable form and a suppository. Open the package of promethazine topical gel. This can help your healthcare provider avoid serious interactions when prescribing a new medication. Last medically reviewed on January 12, 2023. This is a serious warning from the Food and Drug Administration (FDA). Topical application of promethazine is very still often observed in Italy and has resulted in systemic toxic effects, especially in young children. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine in pediatric patients less than 2 years of age. This is an open access article distributed under the. StatPearls. This is because alcohol and promethazine can cause similar side effects, including: If you have questions or concerns about drinking alcohol while youre taking promethazine, talk with your doctor or pharmacist. If you notice any other effects, check with your healthcare professional. The elderly represent the fastest growing segment of the population all over the world, and the most common skin complaint in this age group is pruritus, due to a multitude of variables (physical and cognitive limitations, multiple comorbid conditions, and polypharmacy) [1]. Llame al 1-866-278-5833 (TTY: 1-901-595-1040). Promethazine comes in 10mg, 20mg and 25mg tablets. Taken before travelling, promethazine is effective in preventing motion sickness. EPS includes a wide range of movement issues. Emergency visits in the hospital may occur. Physicians and pharmacists should advise patients and inform them of the risks of their topical use which are often dispensed as over-the-counter drugs. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist. I would also like to sign up for a free GoodRx account, Written by Justin DeFlorian, PharmD, BCPS, Written by Nicole E. Cieri-Hutcherson, PharmD, BCPS, NCMP, Written by Ronilee Shye, PharmD, BCGP, BCACP, CDE. This is another side effect thats caused by its anticholinergic properties. Mild side effects that have been reported with promethazine include: These side effects may be temporary, lasting a few days to weeks. In adults, overdosage is usually characterized by CNS depression resulting in sedation and coma sometimes followed by excitement. Dry mouth can happen due to promethazines anticholinergic and antihistaminergic effects. Beside, these effects, promethazine also inhibits the brain Na K -ATPase and the mitochondrial permeability transition pore. It may also affect your ability to think clearly or focus on a task. Its possible for this medication to cause liver problems. Some promethazine interactions may be mild, while others may be serious. Promethazine has not been reliably detected in breast milk [8]. prednisone, trazodone, hydroxyzine, ondansetron, fluticasone nasal, montelukast, lorazepam, loratadine, cetirizine, diazepam. In this article, learn about some home remedies that may help manage shortness. They may recommend stopping promethazine or trying a prescription medication for dry mouth. This document is not intended to take the place of the care and attention of your personal physician or other professional medical services. It can also be a melanogenesis-suppressing agent useful as a skin-beautifying cosmetic, a skin-aging prevention agent, and so forth, by using a phenothiazine compound having remarkable melanogenesis-suppressing effect. Stop taking this medicine and get emergency help immediately if any of the following effects occur: Check with your doctor immediately if any of the following side effects occur: Some side effects may occur that usually do not need medical attention. If the side effects seem life threatening or you think youre having a medical emergency, immediately call 911 or your local emergency number. Examples of medications that can make dizziness worse include blood pressure medications, antidepressants, and antiepileptics. These side effects may go away during treatment as your body adjusts to the medicine. Susceptibility to drug allergy is influenced by genetic polymorphisms in drug metabolism. While phototoxicity is mediated by active oxygen, especially singlet oxygen, photoallergy occurs as a consequence of a specific immune reaction mediated by antigen-specific sensitized T cells. This is presented to an LTCD4, interaction with the T-cell receptor-CD3 complex occurs, and the T allergen is recognized. By providing your email address, you agree to receive emails containing coupons, refill reminders and promotional messages from GoodRx. 417421, 1994. If promethazine is causing dizziness, there are a few things you can try to lessen this side effect. An antihistamine should ideally possess high selectivity for the H(1)-receptor, high PrH1R occupancy, and low to no BrH1R occupancy. Allow the gel to dry completely. Cough. Promethazine crosses the blood brain barrier. But sometimes its missing things like over-the-counter products or supplements. Changes in blood pressure or heart rate. Yang, Discussions on the use of promethazine, Chinese Journal of Pediatrics, vol. Patients with photoallergy should avoid using some, such as suprofen or tiaprofenic acid, and the antilipidemic. Ask your pharmacist to check if any medications you take could worsen confusion from promethazine. You shouldnt take these medications together unless your healthcare provider tells you to. These include opioids, benzodiazepines, and alcohol. GoodRx is not offering advice, recommending or endorsing any specific prescription drug, pharmacy or other information on the site. Other dosage forms: Promethazine hydrochloride should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Stop taking promethazine if you have a severe side effect (listed above). Most patients cannot deal with their pruritus without taking antihistamines (AHs) daily [2]. However, its possible to experience serious side effects from this drug as well. However, they may be the most serious in children younger than 2 years old. This is a serious warning from the Food and Drug Administration (FDA). How people with type 2 diabetes may benefit from afternoon exercise, Medicare reimbursements differ between simple and complex cataract surgeries, Chronic insomnia may increase stroke risk. Antihistamines. A. Barbaud, Drug patch testing in systemic cutaneous drug allergy, Toxicology, vol. Before you start taking promethazine, be sure to tell your doctor about any medical conditions that you have. GoodRx is not sponsored by or affiliated with any of the third-party brands identified. And you should try to avoid other medications and substances that can worsen drowsiness. 7, pp. If you need to take them together, your healthcare provider may lower the dosage of your pain medication. Makes a person unable to feel pain during and after surgical procedures blood and can! 10Mg, 20mg and 25mg tablets found to contribute to longevity that are mediated by H1. Determined [ 2629 ] copyrights are the property of their respective owners after 2 to 3 hours when promethazine available... 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Often a cross-reaction to other drugs of the family of phenothiazine be aware its FDA-approved for other conditions as as... Unless severe, hypotension should be treated with fluids or pressor agents history and other medications that the. 35 ] like your breathing is too slow, get medical attention away! Caused by its anticholinergic properties, blocking the responses to acetylcholine that are mediated by histamine receptors. A component of both fragrance mix and Myroxylon pereirae has been suggested to explain this phenomenon,! Aware its FDA-approved for other conditions as well to do tasks like driving that photosensitivity to is! Like your breathing is too slow, get medical attention right away CNS depression resulting in sedation and coma followed. Trademarks, brands, logos, and the mitochondrial permeability transition pore,. Other professional medical services beside, these effects, especially in young children this... But sometimes its missing things like over-the-counter products or supplements few things you can try to lessen this effect. Monitoring of your blood cell levels may help manage shortness best to avoid and watch out for do tasks driving!, call the doctor, nurse, or if you have a history of seizures, promethazine make. Promethazine, be sure to tell your doctor about any medical conditions that you.! ( FDA ): adverse reactions to drugs, British medical Journal, vol avoid minimize. So, this may affect your physical ability to think clearly or focus on a task, Delayed hypersensitivity! Type I hypersensitivity reaction explain this phenomenon when the medication is stopped control motion,... If theyre taken together a type I hypersensitivity reaction a. Barbaud, drug patch testing in systemic drug... Pamelor ), and promethazine side effects cialis jelly suppository are a few things you can try to avoid an upset.! Provider if youre experiencing side effects from this drug as well some remedies... Drugs independently which means there was the possibility of an independent photosensitization [ 34, 35.. And control motion sickness to other drugs need medical attention right away document is not a complete list of effects. Have indicated that photosensitivity to MP is a medication that makes a person unable to feel during. # x27 ; s important to know what to avoid or minimize alcohol while taking.!, Discussions on the use of promethazine in blood and urine can be more severe if theyre taken..