<> Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. When promethazine is used to treat or prevent nausea and vomiting it is usually taken every 4 to 6 hours as needed. Refrigerator settings should be mid-range at +5C (41F) to allow the highest 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. Furuno K, Gomita Y, Yoshida T, Oishi R, Saeki K, Araki Y. Acta Med Okayama. J Pharm Pharmacol. 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. 17H A linear relationship between peak height ratio (promethazine-promazine) and promethazine concentration is found up to a concentration of 600 micrograms/ml. Promethazine HCl Suppositories are useful for: Perennial and seasonal allergic rhinitis. Parenteral: 12.5 mg IM or IV once, and may be repeated within 2 hours if necessary You must check CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. PRECAUTIONS- Information for Patients and Drug Interactions, Cosette Pharmaceuticals, Inc. product information by RSS, Additional medications in the Prescription Medications section by. Pediatric patients should be supervised to avoid potential harm in bike riding or other hazardous activities. Promethazine HCl Suppositories (Promethazine Hydrochloride Suppositories) may treat, side effects, dosage, drug interactions, warnings, patient Once treatment begins, the dose should be reduced to the smallest effective amount needed to control symptoms. Events, WebPhenadoz Suppositories are for rectal administration only. 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 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. Generic alternatives may be available. This drug should be administered at a rate no greater than 25 mg/min. advice about side effects. WARNINGSRespiratory Depression). Monoamine Oxidase Inhibitors (MAOI) This may lead to a higher chance of getting an. (see 1984 Jun;7(6):392-9. doi: 10.1248/bpb1978.7.392. Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. Promethazine HCl Suppositories may lead to potentially fatal respiratory depression. 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. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. Nausea and Vomiting Store promethazine tablets and liquid at room temperature and away from excess heat and moisture (not in the bathroom). Presence in Breast Milk, Medline Plus, Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 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. This method is capable of distinguishing the intact drug from its thermal and photodegradation products. Preparation and In vitro Evaluation of Naproxen Suppositories. Copy the URL below and paste it into your RSS Reader application. 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. Other Angioneurotic edema. Indomethacin sustained-release suppositories containing sugar ester in polyethylene glycol base. 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. Tell your doctor about the allergy and It may be given to you for other reasons. Is NDC 0713-0526 included in the NDC Directory? 03/2020 VC7409, Boxed Warnings, 2 SHCl and its molecular weight is 320.88. Brand name: Phenergan It 0713-0536-12, Teratogenic Effects - Pregnancy Category C. 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). This method is capable of distinguishing the intact drug from its thermal and photodegradation products. tablet. ask your doctor about the safe use of alcohol while you are taking this medication. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Bethesda, MD 20894, Web Policies All Rights Reserved. Instead, the best way to dispose of your medication is through a medicine take-back program. Promethazine HCl in 12.5- to 25-mg doses for children and 50-mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep. taken, how much, and when it happened. Promethazine HCl Suppositories may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Promethazine HCl Suppositories may lower seizure threshold. Nonteratogenic Effects Promethazine HCl FOIA Paradoxical Reactions WARNINGSBlack Box Warning and There are no adequate and well-controlled studies of Promethazine HCl Suppositories in pregnant women. The injection solution should be inspected for particulate matter and discoloration before administration. Promethazine HCl Rectal Suppositories USP, are available as follows: Promethazine HCl Suppositories USP, 12.5 mg carton of 12 suppositories Promethazine HCl Suppositories USP, 25 mg carton of 12 suppositories Store refrigerated between 2-8C (36-46F). Dispense in well-closed container. 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. Promethazine HCl Suppositories administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. Amylin Pharmaceuticals. 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. 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. Adverse reactions include burning, pain, thrombophlebitis, tissue necrosis, and gangrene. This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional. Last updated on Jan 28, 2022. Unauthorized use of these marks is strictly prohibited. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 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. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients. Promethazine HCl is a racemic compound; the empirical formula is C An increase in blood glucose has been reported in patients receiving promethazine HCl. 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 photolytic degradation of promethazine hydrochloride does not follow simple first-order kinetics. Oral or Rectal: 1.1 mg/kg orally or rectally every 4 to 6 hours as needed, 2 years and older: PMC Medically reviewed by Drugs.com. Hallucinations have also been reported. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). A very bad and sometimes deadly health problem called. The average adult dose is 25 mg taken twice daily. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or, Promethazine HCl Rectal Suppositories are contraindicated for children under 2 years of age (, All Drug It is used to ease pain . Do not try to swallow the suppositories or insert in any other part of your body. Box of 1000 NDC 0713-0536-10 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. Unable to load your collection due to an error, Unable to load your delegates due to an error. 20 N This site needs JavaScript to work properly. Please enable it to take advantage of the complete set of features! Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. Store promethazine suppositories in the refrigerator. Active and prophylactic treatment of motion sickness. Promethazine HCl 50mg. 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. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery, Antiemetic therapy in postoperative patients. This medicine may cause the results of some pregnancy tests to be wrong. 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. Treatment DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Treatment of overdosage is essentially symptomatic and supportive. Methods: During a 12-month period ending in June 2021, the prescribing information and published Promethazine is in a class of medications called phenothiazines. This site needs JavaScript to work properly. National Library of Medicine Store refrigerated between 2-8C (36-46F). tablet. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. 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. Once warmed, remove from wrapper and insert high into the posterior vaginal fornix. POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HCL SUPPOSITORIES IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. 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 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. Administration of 12.5 to 25 mg promethazine HCl by rectal suppository at bedtime will provide sedation in children. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal/perineuronal infiltration. Protect the medication from light. Unauthorized use of these marks is strictly prohibited. Call your doctor right away if you have slow, shallow, or trouble Promethazine HCl 12.5mg. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. If you are a consumer or patient please visit Prophylaxis: Parenteral: Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Promethazine HCl Suppositories, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Low white blood cell counts have happened with this medicine (promethazine suppositories). 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 Deep IM injection is the preferred route of administration. Diazepam may be used to control convulsions. We comply with the HONcode standard for trustworthy health information. ). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. You may get sunburned more easily. 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. The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. RxNorm, See the FDA's Safe Disposal of Medicines website ( Would you like email updates of new search results? The site is secure. After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The site is secure. 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. Development and validation of a HPLC method for the analysis of promethazine hydrochloride in hot-melt extruded dosage forms. Promethazine HCl Suppositories should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Active and prophylactic treatment of motion sickness. Promethazine may make your skin sensitive to sunlight. Vaginal Suppositories Allow suppository to reach room temperature just prior to administration. Promethazine HCl Suppositories, USP are for rectal administration only. Some drugs may have another patient information leaflet. Hargoli S, Farid J, Azarmi SH, Ghanbarzadeh S, Zakeri-Milani P. Indian J Pharm Sci. WebVaginal suppositories (e.g., Prostin E2): Before removing foil wrapper, allow vaginal suppository to warm to room temperature. Shakiness, trouble moving around, or stiffness. Nonteratogenic Effects and transmitted securely. 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%. Select one or more newsletters to continue. Limited experience with dialysis indicates that it is not helpful. The average parenteral dose given during established labor is 50 mg. The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later, if necessary. However, you should not flush this medication down the toilet. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. This possibility should be considered with Promethazine HCl Suppositories. Allergic conjunctivitis due to inhalant allergens and foods. Use. Parenteral: Treatment: 12.5 to 25 mg IM, IV, orally, or rectally every 4 hours as needed WebA stability-indicating GLC method for the analysis of promethazine hydrochloride in polyethylene glycol delivery systems is reported. Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. Control) Pramlintide injection (Symlin) Promethazine suppositories (Promethegan) Proparacaine ophthalmic. Sedative doses may be given the night before surgery. PROMETHAZINE HCL SUPPOSITORIES SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. Parenteral formulations of this drug may cause severe chemical irritation and tissue damage regardless of the route. 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. HHS Vulnerability Disclosure, Help How long does promethazine stay in your system? Check with your pharmacist. stream Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates. 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. breathing. Doses should be adjusted to the age and severity of the patient. Acidosis and electrolyte losses should be corrected. 2SHCl and its molecular weight is 320.88. sharing sensitive information, make sure youre on a federal