Promethazine HCl is a racemic compound; the empirical formula is C17H20N2SHCl and its molecular weight is Would you like email updates of new search results? 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. 2 years and older: Treatment: Oral or Rectal: 1.1 mg/kg orally or rectally every 4 to 6 hours as needed. A very bad and sometimes deadly health problem called. Post-marketing cases of respiratory depression, including fatalities, have been reported with use of this drug in pediatric patients less than 2 years of age. Promethazine HCl Suppositories administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. Get Label RSS Feed, The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. (current), promethazine HCl 12.5 MG Rectal Suppository, promethazine hydrochloride 12.5 MG Rectal Suppository, promethazine hydrochloride 12.5 MG Rectal Suppository [Promethegan], promethazine HCl 25 MG Rectal Suppository, promethazine hydrochloride 25 MG Rectal Suppository, promethazine hydrochloride 25 MG Rectal Suppository [Promethegan]. Subcutaneous administration is contraindicated. H-Phenothiazine, 10-ethanamine, You may report side effects to the FDA at 1-800-332-1088. Phenergan (Promethazine HCl) Suppositories are for rectal administration only. 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. 8600 Rockville Pike N,N -trimethyl-, monohydrochloride, ()- with the following structural formula: 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. pharmacist if you have questions about the best way to throw out drugs. 0713-0526-12, plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. The https:// ensures that you are connecting to the Preoperative, postoperative, or obstetric sedation. Do not give this medicine (promethazine suppositories) to a child who is throwing up for an unknown reason. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Promethazine may cause other side effects. 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. Minor transfusion and/or amelioration of allergic reactions may be controlled with 25 mg doses. South Plainfield, NJ 07080 See the FDA's Safe Disposal of Medicines website ( Promethazine may cause breathing to slow or stop, and may cause death in children. Diazepam may be used to control convulsions. 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. Use the measuring spoon or cup that came with the medication or use a spoon made especially for measuring medication. It is not known whether promethazine HCl is excreted in human milk. Patients should be advised to report any involuntary muscle movements. Take promethazine exactly as directed. Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder, which slowly oxidizes and turns blue on prolonged exposure to air. to make sure that it is safe for you to take this medicine (promethazine suppositories) with all of your drugs and health problems. talk to your doctor about the risks and benefits of taking promethazine if you are 65 years of age or older. 1 receptor blocking agent. 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. Doses should be adjusted to the age and severity of the patient. Rectally administered indomethacin should be used with caution in patients with hemorrhoids, anal, or rectal inflammation. 0713-0526-12 Promethegan Suppository Generic alternatives may be available. The in vitro and in vivo results show that the release of indomethacin from fatty-base suppositories stored at a high temperature is less than the release from those stored at a low temperature. WebTo insert a promethazine suppository, follow these steps: If the suppository feels soft, hold it under cold, running water for 1 minute. Amelioration of allergic reactions to blood or plasma. 1984 Jun;7(6):392-9. doi: 10.1248/bpb1978.7.392. This drug should be administered at a rate no greater than 25 mg/min. Promethazine Keep out of the reach of children. Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. Wash your hands thoroughly and resume your normal activities. Paradoxical Reactions 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. Do not take 2 doses at the same time or extra doses. Promethazine Suppositories Information - Drugs.com Avoid prolonged exposure to the sun. 20N Promethazine HCl Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function. 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 IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HCL BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED. Promethazine hydrochloride Oral / IV / Suppository J Pharmacobiodyn. Promethazine Ask your pharmacist any questions you have about refilling your prescription. Drug classes: Antihistamines, Phenothiazine antiemetics. Stimulation may be evident, especially in children and geriatric patients. Hargoli S, Farid J, Azarmi SH, Ghanbarzadeh S, Zakeri-Milani P. Indian J Pharm Sci. Tell all of your health care providers that you take this medicine (promethazine suppositories). and transmitted securely. If the suppository feels soft, hold it under cold, running water for 1 minute. Caution should be exercised when administering parenteral formulations in pediatric patients 2 years of age and older; it is recommended that the lowest effective dose of oral formulations be used in and concomitant administration of other drugs with respiratory depressant effects be avoided in this patient population. Carcinogenicity Under the conditions of the National Toxicology Program (NTP) studies, there was no evidence of If you have any questions about this medicine (promethazine suppositories), please talk Keep all drugs out of the reach of children and pets. Methods: During a 12-month period ending in June 2021, the prescribing information and published Room-temperature storage of medications labeled for ) for more information if you do not have access to a take-back program. This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. 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. Unauthorized use of these marks is strictly prohibited. However, many people have no side effects or only have minor side effects. Oral and rectal formulations may be used for nighttime, presurgical, or obstetrical sedation. 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. Pre- or postoperative use: 25 to 50 mg IM or IV once Nonteratogenic Effects Promethazine HCl Store promethazine tablets and liquid at room temperature and away from excess heat and moisture (not in the bathroom). 20 N This method is capable of distinguishing the intact drug from its thermal and photodegradation products. Clipboard, Search History, and several other advanced features are temporarily unavailable. This possibility should be considered with Promethazine HCl Suppositories. promethazine It is used to help motion sickness . what signs you had. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine HCl suppositories and observed closely. This medicine may cause very bad and sometimes deadly breathing problems. Promethazine is an H <> In the in vitro release test using a dialysis cell method, much lower amounts of indomethacin were released from the suppositories stored at a high temperature than from those stored at a low temperature. Put suppository into the rectum with gentle pressure, pointed end first. 800-349-8919 Store promethazine tablets, oral solution, and solution for injection at room temperature between 68 - 77F and protect from light. prednisone, trazodone, hydroxyzine, ondansetron, montelukast, fluticasone nasal, lorazepam, loratadine, cetirizine, diazepam. Parenteral or rectal formulations may be used when patients cannot tolerate oral formulations. Store promethazine tablets and liquid at room temperature and away from excess heat and moisture (not in the bathroom). Development and validation of a HPLC method for the analysis of promethazine hydrochloride in hot-melt extruded dosage forms. The melting point of suppositories stored at a high temperature was higher by approximately 2 degrees C than those stored at a low temperature. It is also important information to carry with you in case of emergencies. 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. Tell your Bioequivalence and pharmacokinetic profile of promethazine hydrochloride suppositories in humans. Ask the doctor or pharmacist if you are not sure. can do this. RxNorm, 1990 Jun;38(6):1680-3. doi: 10.1248/cpb.38.1680. 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. Promethazine can cause side effects. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. PROMETHAZINE HCL SUPPOSITORIES ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE (see WARNINGS-Black Box Warning and Use in Pediatric Patients). 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. Neuroleptic malignant syndrome (potentially fatal) has also been reported (See Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. 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. Promethazine is also used to prevent and treat motion sickness. Store promethazine rectal suppositories in a refrigerator between 36 - 46F. Tell your doctor if any of these symptoms are severe or do not go away: Some side effects can be serious. Labels, All Index Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Respiratory rate, especially in pediatric patients. The .gov means its official. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. This method is capable of distinguishing the intact drug from its thermal and photodegradation products. There are many drugs that Allergic conjunctivitis due to inhalant allergens and foods. WARNINGSBlack Box Warning and Before (See also FROZEN Drugs FOIA Many times this medicine (promethazine suppositories) is taken on an as needed basis. 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. Use of Promethazine HCl Suppositories in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. If you are taking promethazine liquid, do not use a household spoon to measure your dose. Promethazine HCl Suppositories (Promethazine Hydrochloride Suppositories) may treat, side effects, dosage, drug interactions, warnings, patient We comply with the HONcode standard for trustworthy health information. If you experience any of the following symptoms, call your doctor immediately: If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Deep IM injection is the preferred route of administration. Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. Patient should remain supine for 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%. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. 8-PROMCPLNC1 Iss. 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. Dermographism. suppository. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. The injection solution should be inspected for particulate matter and discoloration before administration. 1989 Nov;37(11):3145-7. doi: 10.1248/cpb.37.3145. Alcohol can make the side effects of promethazine worse. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. you should know that this medication may make you drowsy. DOSAGE AND ADMINISTRATION Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. Webtype of IVPB solution will be stored at room temperature (21C), 4C, and 37C in the dark. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Webafter 24 hours of storage at room- temperature, when stored in a cool place (815 C), and when stored at room-temperature (1530 C). Salmonella test system of Ames. Treatment: Patients should be told to report any involuntary muscle movements. PDR Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates. Remove the wrapper. MeSH This report on medications is for your information only, and is not considered individual patient advice. PubMed, WebRefrigerated medications should be stored at temperatures between 2oC and 8oC (35oF to 46oF). Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Promethazine HCl Rectal Suppositories are contraindicated for children under 2 years of age (see A stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 Promethazine HCl Rectal Suppositories, USP are available in boxes of 12 and 1000 as follows: 12.5 mg, white, bullet-shaped suppository wrapped in silver foil. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although Do not let anyone else take your medication. Allergic conjunctivitis due to inhalant allergens and foods. Influence of storage temperature on indomethacin release from Talk with the doctor. Lie down on your left side and raise your right knee to your chest. Do not try to test for pregnancy at home. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. The .gov means its official. Keep from freezing. IV formulations should be diluted to a concentration of 25 mg/mL or less. WebVaginal suppositories (e.g., Prostin E2): Before removing foil wrapper, allow vaginal suppository to warm to room temperature. PROMETHAZINE HYDROCHLORIDE Hematologic Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. The first-order rate constant increased with increasing pH. WebPromethazine HCl 25mg. (See breathing. (see <> tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Clipboard, Search History, and several other advanced features are temporarily unavailable. 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. Antiemetic therapy in postoperative patients. Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine. When promethazine is used to relieve cold symptoms, it is usually taken every 4 to 6 hours as needed. WARNINGSCNS Depression and Promethazine Suppositories Description Each rectal suppository contains 12.5 mg or 25 mg promethazine HCl with ascorbyl palmitate, cocoa butter, colloidal silicon dioxide, and white wax. Promethazine Hydrochloride Suppositories are for rectal administration only. You must check tablet. If you are a consumer or patient please visit Citations, PRECAUTIONS- Information for Patients and Drug Interactions, Carcinogenesis, Mutagenesis, Impairment of Fertility, Report Adverse On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. 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 Patients should 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. Do not start, stop, or change the dose of Promethazine HCl 50mg. Promethazine HCl 50mg. Information (Quality. Talk to your doctor about the risks of giving promethazine to your child. 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. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Stability Promethazine HCl 12.5mg. J Pharm Pharmacol. PMC Copy the URL below and paste it into your RSS Reader application. Sedation Subsequent doses on succeeding days of travel should be given on rising and again before the evening meal. Do not try to swallow the suppositories or insert in any other part of your body. Promethazine FDA Warning Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients. Promethazine HCl Suppositories, USP are useful for: 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. 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.
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