Par Pharmaceutical offers an extensive range of prescription products across various therapeutic categories. POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HYDROCHLORIDE IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. CNS Depressants Promethazine 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. (See WARNINGS Promethazine; Respiratory Depression. Drug class: Upper respiratory combinations. Inactive ingredients, estimated key patent expiration dates, and list of branded drugs and generic equivalents With a sterile manufacturing facility located in Rochester, Michigan, Par Sterile Products possesses an unparalleled reputation for high-quality products. Patients should be advised to report any involuntary muscle movements. Promethazine is contraindicated in comatose state, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenthiazines. Diazepam may be used to control convulsions. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Product ID: 0603-1584_153678e2-0b91-4267-a9b9-e0a9913a98a3: NDC: 0603-1584: Product Type: Limited experience with dialysis indicates that it is not helpful. Products with assigned NDCs are displayed. Long-term animal studies have not been performed to assess the carcinogenic potential of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with this drug. Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. 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. The aim of this study is to report current clinical practice for sleep induction in Italian epilepsy centers. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. We comply with the HONcode standard for trustworthy health information. Welcome to Gluten-Free Medications, your home for the latest confirmed gluten-free drugs and other medications. Neuroleptic malignant syndrome (potentially fatal) has also been reported (see WARNINGS, Neuroleptic Malignant Syndrome). Promethazine is an antihistamine. It has a molecular weight of 320.88, a molecular formula of C 17H 20N 2SHCI, and the following structural formula: Dextromethorphan is an antitussive agent and, unlike the isomeric levorphanol, it has no analgesic or addictive properties. Le meilleur quivalent du Flixotaide en Les pays-bas est Avamys. Promethazine HCl is a racemic compound; the molecular formula is C 17 H 20 N 2 SHCl and its molecular weight is 320.88. 2021 Par Pharmaceutical. Select the NDC to see product information. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). ), it produces a chemical called histamine. Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. Promethazine was nonmutagenic in the Salmonella test system of Ames. Dosage form: oral solution Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine hydrochloride tablets and observed closely. Price: $0.15. Promethazine works by blocking the action of histamine, thereby relieving these symptoms. 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. Promethazine is an antiallergic medication. Be careful if you drive or do anything that requires you to be alert. The drug acts centrally and elevates the threshold for coughing. Medically reviewed by Drugs.com. Tell your doctor if you regularly use any of these medicines. Promethazine hydrochloride tablets should be used cautiously in persons with cardiovascular disease or with impairment of liver function. The antidotal efficacy of narcotic antagonists to dextromethorphan has not been established; note that any of the depressant effects of promethazine are not reversed by naloxone. Par Sterile Products develops, manufactures and . 8181650 Revised: 03/17 R2. Company Type For Profit. Drinking alcohol can increase certain side effects of promethazine. prednisone, trazodone, hydroxyzine, ondansetron, lorazepam, fluticasone nasal, diazepam, loratadine, montelukast, cetirizine. Administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children. The 50 mg also contains D&C Red # 27 Lake. 2021 Par Pharmaceutical. Promethazine is an H1 receptor blocking agent. The NDC Code 70436-155-41 is assigned to a package of 118 ml in 1 bottle of Promethazine Hydrochloride And Dextromethorphan Hydrobromide Oral Solution, a human prescription drug labeled by Slate Run Pharmaceuticals, Llc. Version: 6.02. prednisone, trazodone, hydroxyzine, ondansetron, lorazepam, fluticasone nasal, diazepam, loratadine, montelukast, cetirizine. . Animal reproduction studies have not been conducted with the drug combinationpromethazine and dextromethorphan. All Rights Reserved. It works by changing the actions of chemicals in your brain. Hallucinations have also been reported. Dry ice blasting can be faster and makes less of a mess, which is ideal for indoor cleaning. See also " Nonteratogenic Effects ". Promethazine hydrochloride | C17H21ClN2S | CID 6014 - structure, chemical names, physical and chemical properties, classification, patents, literature, biological . For prophylaxis of nausea and vomiting, as during surgery and the post-operative period, the average dose is 25 mg repeated at four- to six-hour intervals, as necessary. Alcohol 7%. We comply with the HONcode standard for trustworthy health information. 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. Excessively large dosages of antihistamines, including promethazine hydrochloride tablets in pediatric patients may cause sudden death (see OVERDOSAGE). Promethazine with Codeine Oral Solution is a federal controlled substance (C-V) because it contains codeine that can be abused or lead to dependence. They both manufacture promethazine with codeine syrup so the only real significant difference is the taste and colour.. En Ouzbkistan, au moins 19 enfants sont morts aprs avoir reu un sirop antitussif, le Doc-1 Max. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Chestnut Ridge, NY 10977, prednisone, fluticasone nasal, montelukast, loratadine, benzonatate, promethazine, Benadryl, diphenhydramine, Zyrtec, guaifenesin. RESPIRATORY DEPRESSION AND APNEA, SOMETIMES ASSOCIATED WITH DEATH, ARE STRONGLY ASSOCIATED WITH PROMETHAZINE PRODUCTS AND ARE NOT DIRECTLY RELATED TO INDIVIDUALIZED WEIGHT-BASED DOSING, WHICH MIGHT OTHERWISE PERMIT SAFE ADMINISTRATION. Avoid exposure to sunlight or tanning beds. Promethazine may lower seizure threshold. Promethazine and dextromethorphan may cause marked drowsiness or impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. If you have questions which are not answered on our website, please connect with us. PARPHARM.COM 2021 Par Pharmaceutical. Available for Android and iOS devices. CONCOMITANT ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC PATIENTS. Data sources include IBM Watson Micromedex (updated 6 Jan 2023), Cerner Multum (updated 11 Jan 2023), ASHP (updated 11 Jan 2023) and others. As a state-of-the-art site with six manufacturing suites and a well-trained workforce, Par Formulations' facility in Chennai has the ability to deliver over a billion tablets/capsules and 50 . Bone Marrow Depression Promethazine Hydrochloride Tablets USP, 25 mg are white to off-white, flat-faced, beveled edge, round, uncoated tablets, debossed with AN above 521 with single line bisect separating them on one side and plain on the other side are supplied as: Bottles of 100: NDC 53746-521-01, Bottles of 1,000: NDC 53746-521-10. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine hydrochloride. Monoamine Oxidase Inhibitors (MAOI) Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Dextromethorphan should be used with caution in sedated patients, in the debilitated, and in patients confined to the supine position. Drowsiness is the most prominent CNS effect of this drug. Get timely coding industry updates, webinar notices, product discounts and special offers. 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. Respiratory Depression The diagnostic evaluation of patients with this syndrome is complicated. Each teaspoon (5 mL) of Promethazine HCl Syrup Plain contains 6.25 mg promethazine HCl in a flavored syrup base with a pH between 4.7 and 5.2. Promethazine with Codeine Oral Solution is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy . This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg promethazine hydrochloride, USP. 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. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine. if you have ever had a serious side effect while using promethazine or any other phenothiazine. PAR promethazine with codeine is a purple syrup and Hi-Tech promethazine with codeine is a red syrup. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 1) Immediate discontinuation of promethazine hydrochloride, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy. 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. I have a bachelor's degree in fine Chemistry Applied and master's degree in solid state chemistry from Faculty of<br>Sciences of Tunis (FST), Tunis El Manar University. Promethazine should be used with caution in patients with bone marrow depression. Promethazine hydrochloride and dextromethorphan hydrobromide oral solution should be used with caution in pediatric patients 2 years of age and older (see WARNINGS Use In Pediatric Patients). You may report side effects to FDA at 1-800-FDA-1088. THE USE OF PROMETHAZINE PRODUCTS SHOULD BE AVOIDED IN PEDIATRIC PATIENTS WHOSE SIGNS AND SYMPTOMS MAY SUGGEST REYE'S SYNDROME OR OTHER HEPATIC DISEASES. Par Pharmaceutical - NDC products NDC labeler, manufacturer of drugs and pharmaceuticals. Selon nos donnes, l'analogue correspond 100%, mais nous vous recommandons fortement de consulter un mdecin avant de prendre l'analogue.. Promethazine can cause side effects that may impair your thinking or reactions. NuCare Pharmaceuticals,Inc. Common promethazine side effects may include: drowsiness, dizziness; ringing in your ears; Recurring Item. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. For more information, call 1-800-845-8210. . Use of promethazine hydrochloride tablets in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. How long does promethazine stay in your system. This is not a complete list of side effects and others may occur. Treatment of overdosage is essentially symptomatic and supportive. Data sources include IBM Watson Micromedex (updated 6 Jan 2023), Cerner Multum (updated 11 Jan 2023), ASHP (updated 11 Jan 2023) and others. We also do power washing for your every day outside and equipment cleaning needs. Promethegan Description. Last updated on Nov 14, 2022. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. PROMETHAZINE PRODUCTS ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE. Do not start a new medication without telling your doctor. Drug classes: Antihistamines, Phenothiazine antiemetics. Promethazine hydrochloride tablets 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 hydrochloride. This syndrome is complicated to become pregnant while using promethazine par pharmaceuticals promethazine any other phenothiazine others occur. Coding industry updates, webinar notices, product discounts and special offers mortality in.! Including promethazine hydrochloride tablets should be used with caution in sedated patients, in PEDIATRIC less! 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