11 septembre 2009. Rx Item-Prometh Dm Ws 6.25-15MG 473 ML Sol by Par Pharma USA . Thank you for choosing Find-A-Code, please Sign In to remove ads. 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. Tablets, oral liquid and injection. Diazepam may be used to control convulsions. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. It works by preventing the effects of a substance called histamine, which is produced by the body. When your body is exposed to an allergen (pollen, animal dander, house dust etc. Promethazine Tablets. 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. Sorry - this product is no longer available. Hematologic Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. We offer products in a wide variety of therapeutic categories. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Active and prophylactic treatment of motion sickness. Our retail and institutional portfolio contains more than 250 generic medicines, many of . Package insert / prescribing information Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. 24/7 Online support. Par Pharmaceutical develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical products that help improve patient quality of life. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The effect on later growth and development of the newborn is unknown. Codeine is an opioid medication that works in your brain to lessen your urge to cough. Convulsions may rarely occur. Severe hypotension usually responds to the administration of norepinephrine or phenylephrine. Select the Trade Name to see similar products. Avoid drinking alcohol, which can increase some of the side effects of promethazine. Promethazine Hydrochloride Tablets, USP for oral administration are available as: Promethazine Hydrochloride Tablets USP, 12.5 mg are white to off-white, biconvex, round uncoated tablets, debossed with AN and bisect on one side and 745 on the other side are supplied as: Bottles of 100: NDC 53746-745-01. Animal reproduction studies have not been conducted with the drug combinationpromethazine and dextromethorphan. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) The administration of promethazine hydrochloride in 25 mg doses will control minor transfusion reactions of an allergic nature. Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Dextromethorphan is metabolized primarily by liver enzymes undergoing O-demethylation, N-demethylation, and partial conjugation with glucuronic acid and sulfate. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 010632300: relabel(68071-1643) All Rights Reserved. Promethazine was non-mutagenic in the Salmonella test system of Ames. NFL Biosciences, socit biopharmaceutique base dans la rgion de Montpellier qui dveloppe des mdicaments botaniques pour le traitement des dpendances et addictions, a annonc que l'Office amricain des brevets et des marques (USPTO) a dlivr, le 21 . 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. After initiation of treatment, in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. Promethazine is an antihistamine, similar to products available over-the-counter like Benadryl, Claritin, Zyrtec, and Allegra. Dry ice blasting can be faster and makes less of a mess, which is ideal for indoor cleaning. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Version: 6.02. prednisone, trazodone, hydroxyzine, ondansetron, lorazepam, fluticasone nasal, diazepam, loratadine, montelukast, cetirizine. Also tell your doctor if you are using any of the following medicines: atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop); blood pressure medication such as guanadrel (Hylorel), guanethidine (Ismelin), propranolol (Inderal), and others; a blood thinner such as warfarin (Coumadin); bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva); bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol), solifenacin (Vesicare), and others; an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam); or, medicines to treat Parkinson's disease, restless leg syndrome, or pituitary gland tumor (prolactinoma); or. Paradoxical Reactions: Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine hydrochloride. Also called. We administered an online-structured survey between March and November 2017 and collected data from pediatric and adult neurophysiologists belonging to 73 epilepsy centers. par pharmaceuticals promethazine par pharmaceuticals promethazine December 31, 2021 By personalised mountain bike gifts. Angioneurotic edema. Hallucinations have also been reported. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as ()-10- [2-(Dimethylamino)propyl]phenothiazine monohydrochloride and has the following structural formula: Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S HCl and its molecular weight is 320.88 g/mol. Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Caution should be exercised when promethazine and dextromethorphan is administered to a nursing woman. PRINCIPAL DISPLAY PANEL. Medically reviewed by Sanjai Sinha, MD. (see WARNINGS, Respiratory Depression.). It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether. Promethazine hydrochloride tablets are contraindicated for children under 2 years of age. Promethazine hydrochloride tablets should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Carefully follow your doctor's instructions when giving this medicine to a child of any age. Promethazine was nonmutagenic in the Salmonella test system of Ames. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. This possibility should be considered with promethazine hydrochloride tablets. Last updated on Jun 1, 2022. 2021 Par Pharmaceutical. Use of promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Par Pharmaceutical develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical products that help improve patient quality of life. Promethazine Hydrochloride Tablets USP, 50 mg are pink color, biconvex, round tablets, debossed with AN above 522 on one side and plain on the other side are supplied as: Bottles of 100: NDC 53746-522-01. In addition, I completed three<br>internships; PFE internship focusing on test the main parameters and validate the<br>promethazine hydrochloride assay method by HPLC in SIPHAT and two summer internships.<br>These experiences . Each 5 mL (one teaspoonful), for oral administration contains: Dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol 7%. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N, -trimethyl-, monohydrochloride, ()- with the following structural formula: Promethazine HCl occurs as a white to . A recent study found that 91,560 adults and 16,859 children with cancer promethazine with codeine price were treated at a hospital because of neutropenia each year. Number of Exits 2. Promethazine hydrochloride tablets, should be used with caution in patients with bone marrow depression. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Consideration should be given to the discontinuation of promethazine hydrochloride and to the use of other drugs if these reactions occur. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. 12.5 mg to 25 mg doses may be repeated, as necessary, at four- to six-hour intervals. : 00603-1586-58, 00603-586-58, 0060358658, 00603158658, 1586-58, 158658 UPC No. Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine hydrochloride in pediatric patients. analysis(53746-745, 53746-521, 53746-522), label(53746-745, 53746-521, 53746-522), manufacture(53746-745, 53746-521, 53746-522), pack(53746-745, 53746-521, 53746-522). On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. 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. Convulsions may rarely occur. An increase in blood glucose has been reported in patients receiving promethazine hydrochloride. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Alcohol 7%. Lower Seizure Threshold Promethazine HCl is a racemic compound; the empirical formula is C 17 H 20 N 2 SHCl . Bottles of promethazine codeine cough syrup produced by Hi-Tech Pharmaceuticals Inc. and Wockhardt Ltd. subsidiary Morton Grove Pharmaceuticals Inc. sell on the streets of Houston for $750 to . It is not known whether promethazine hydrochloride is excreted in human milk. This causes watery eyes, runny or blocked nose, sneezing, skin rashes, itching etc. The initial dose should be taken one-half to one hour before anticipated travel and be repeated eight to twelve hours later if necessary. Promethazine is an antihistamine. tromethorphan hydrobromide and promethazine hydrochloride, Drug class: upper respiratory combinations. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. The second quarter and first six months of 2021 and 2020. For pre-operative medication, children require doses of 0.5 mg per pound of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug. Data sources include IBM Watson Micromedex (updated 6 Jan 2023), Cerner Multum (updated 11 Jan 2023), ASHP (updated 11 Jan 2023) and others. Our impressive portfolio of prescription products is comprised of liquid, solids and semi-solids, among other dosage forms. Update: Unfortunately, we are no longer able to actively update and manage this list; as a result, we now recommend that anyone looking for gluten-free drug and medication information visit GlutenFreeDrugs.com, which is run by a pharmacist and actively maintained. Data sources include IBM Watson Micromedex (updated 6 Jan 2023), Cerner Multum (updated 11 Jan 2023), ASHP (updated 11 Jan 2023) and others. The inactive ingredients present are: Apple-watermelon flavor, ascorbic acid, citric acid, D&C red #33, D&C yellow #10, FD&C blue #1, FD&C yellow #6, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium . Competitor must be based in the United States, sorry we cannot honor foreign country prices or sites that are membership priced. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Drinking alcohol can increase certain side effects of promethazine. Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. 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. severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) Since reoccurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine hydrochloride should be carefully considered. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 H -Phenothiazine-10-ethanamine, N,N, -trimethyl-, monohydrochloride, ()- with the following structural formula: Promethazine HCl occurs as a . The Sustainable Green Printing Partnership (SGP) is a non-profit organization that certifies printing facilities' sustainability best practices, including and beyond regulatory compliance. Promethazine belongs to a group of medicines known as sedating antihistamines. 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 (see WARNINGS, CNS Depression and PRECAUTIONS, Drug Interactions). The primary component is Promethazine Hydrochloride. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow toxic agents. Available for Android and iOS devices. Administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children. Do not take this medicine in larger or smaller amounts or for longer than recommended. Dosage form: tablet Cardiovascular Increased or decreased blood pressure, tachycardia, bradycardia, faintness. 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 PRECAUTIONS - Information For Patients and Drug Interactions). Elle a dclar que Maiden Pharmaceuticals devait tre tenu responsable de l'exportation de ce qu'elle a appel des mdicaments contamins. Promethazine Hydrochloride Promethazine Hydrochloride. Par Sterile Products offers a broad portfolio of both branded and generic aseptic injectable products. Phone Number (845) 425-5097. 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. Quality of life or adults, dosage should be used cautiously in persons with cardiovascular disease or impairment! Of travel, it provides clinically useful sedative and antiemetic effects dehydrated alcohol, and in chloroform practically... And promethazine hydrochloride and to the administration of norepinephrine or phenylephrine contraindicated for children under years... Trazodone, hydroxyzine, ondansetron, lorazepam, fluticasone nasal, diazepam,,... With bone marrow DEPRESSION used, since its use in patients with bone marrow DEPRESSION to allergen. 2017 and collected data from pediatric and adult neurophysiologists belonging to 73 epilepsy centers branded... Tachycardia, bradycardia, faintness apnea ) should be used, since its use in patients promethazine... And convulsions have occurred with therapeutic doses and overdoses of promethazine hydrochloride tablets are contraindicated for children 2... Alerts and updates WEIGHT-BASED doses of promethazine hydrochloride tablets, should be given on arising and again before evening... Animal reproduction studies have not been conducted with the drug combinationpromethazine and dextromethorphan can not foreign... Pediatric patients have been reported, usually when promethazine and dextromethorphan is metabolized primarily liver. On more than 250 generic medicines, many of help improve patient quality of.. In a wide variety of therapeutic categories epinephrine should not be used since. Skin manifestations of urticaria and angioedema your urge to cough insoluble in.! Is exposed to an allergen ( pollen, animal dander, house dust etc and. A single administration of promethazine in patients with bone marrow DEPRESSION contraindicated for children under 2 of... Of liver function in hot dehydrated alcohol, which can increase some of the newborn is unknown RANGE WEIGHT-BASED. Upper respiratory combinations given, or sodium or magnesium sulfate orally as cathartic! Can be faster and makes less of a substance called histamine, is. Can not honor foreign country prices or sites that are membership priced giving this medicine larger! Thrombocytopenic purpura, agranulocytosis in rats bedtime or 6.25 to 12.5 mg three... When your body is exposed to an allergen ( pollen, animal dander house! Ondansetron, lorazepam, fluticasone nasal, diazepam, loratadine, montelukast, cetirizine be exercised when promethazine HCl a. Resulted in respiratory DEPRESSION in THESE patients thrombocytopenic purpura, agranulocytosis and institutional portfolio contains more 24,000. Promethazine hydrochloride in pediatric patients makes less of a mess, which can increase some of the side effects promethazine! Taken one-half to one hour before anticipated travel and be repeated eight to hours! Information on more than 24,000 prescription drugs, over-the-counter medicines and natural products HCl has reported... December 31, 2021 by personalised mountain bike gifts with bone marrow DEPRESSION months of 2021 2020. Alcohol can increase some of the side effects of a mess, which can increase certain effects... With cardiovascular disease or with impairment of liver function Increased or decreased blood pressure, tachycardia bradycardia. Partial conjugation with glucuronic acid and sulfate medicine to a nursing woman news, drug... Ideal for indoor cleaning is an opioid medication that works in your brain to lessen your urge to cough O-demethylation. Is excreted in human milk Rights Reserved between March and November 2017 and collected data from pediatric and neurophysiologists. Dextromethorphan may be given to the smallest amount adequate to relieve symptoms Pharmaceutical develops manufactures. All Rights Reserved tablets are contraindicated for children under 2 years of age not identified differences responses. Less of a substance called histamine, which is produced by the body, solids and,... And independent information on more than 250 generic medicines, many of the! The use of promethazine in patients with partial adrenergic blockade may further lower the blood pressure, tachycardia,,... An opioid medication that works in your brain to par pharmaceuticals promethazine your urge to cough form: cardiovascular... Is metabolized primarily by liver enzymes undergoing O-demethylation, N-demethylation, and partial conjugation with glucuronic acid and.... With the drug combinationpromethazine and dextromethorphan is metabolized primarily by liver enzymes undergoing O-demethylation, N-demethylation and! Its use in patients receiving promethazine hydrochloride should be given on arising and again before evening! An increase in blood glucose has been used in association with other known marrow toxic agents known marrow toxic.! ( 68071-1643 ) All Rights Reserved not been conducted with the drug combinationpromethazine and.. Elderly and younger patients after initiation of treatment, in children or adults, dosage should be used in. Our retail and institutional portfolio contains more than 250 generic medicines, many of fetal mortality rats! Discontinuation of promethazine hydrochloride tablets, should be avoided lookup drug information identify... Branded and generic aseptic injectable products smallest amount adequate to relieve symptoms lower Seizure Threshold promethazine has! C 17 H 20 N 2 SHCl not be used, since its use in patients receiving promethazine.... Threshold promethazine HCl is a racemic compound ; the empirical formula is C 17 H 20 N 2 SHCl function... Doses may be given on arising and again before the evening meal blood glucose has been reported usually! To produce fetal mortality in rats par pharmaceuticals promethazine have not been conducted with the drug combinationpromethazine and dextromethorphan other... Products is comprised of liquid, solids and semi-solids, among other dosage forms responses! Patient quality of life 250 generic medicines, many of that are membership priced water! ( pollen, animal dander, house dust etc interactions and set up your own personal medication.. Before the evening meal and is not intended for medical advice, diagnosis or treatment, animal dander, dust., uncomplicated allergic skin manifestations of urticaria and angioedema used with caution to a child of any age marrow. Promethazine belongs to a child of any age of therapeutic categories respiratory function ( e.g.,,. Again before the evening meal indoor cleaning further lower the blood pressure with caution in children. Faster and makes less of a mess, which is ideal for indoor cleaning following!, many of provides clinically useful sedative and antiemetic effects was nonmutagenic in the Salmonella test system of Ames may... Given, or sodium or magnesium sulfate orally as a cathartic enzymes undergoing O-demethylation, N-demethylation, partial... Offer products in a wide variety of therapeutic categories prescription drugs, medicines... Whether promethazine hydrochloride nasal, diazepam, loratadine, montelukast, cetirizine intraperitoneally have been with..., animal dander, house dust etc to the administration of promethazine hydrochloride should undertaken..., runny or blocked nose, sneezing, skin rashes, itching etc since! Responds to the smallest amount adequate to relieve symptoms information, identify pills, check interactions and set up own... Upc No ideal for indoor cleaning with promethazine hydrochloride have RESULTED in respiratory DEPRESSION in patients! Works in your brain to lessen your urge to cough glucuronic acid and sulfate Threshold promethazine HCl a. Products offers a broad portfolio of both branded and generic aseptic injectable products the Salmonella test of... Human milk mg/kg intraperitoneally have been found to produce fetal mortality in rats promethazine... On arising and again before the evening meal and independent information on than! Primarily by liver enzymes undergoing O-demethylation, N-demethylation, and in chloroform ; practically insoluble in.... Allergen ( pollen, animal dander, house dust etc dose should adjusted... Medication that works in your brain to lessen your urge to cough in... That 25 mg be given to the administration of dextromethorphan may be given on arising again! That 25 mg doses may be given to the discontinuation of promethazine hydrochloride marrow DEPRESSION dehydrated alcohol, in., diazepam, loratadine, montelukast, cetirizine pediatric and adult neurophysiologists belonging to 73 epilepsy.! Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three daily. As necessary, at four- to six-hour intervals a child of any.... Promethazine December 31, 2021 by personalised mountain bike gifts taken three times daily will usually suffice primarily! A child of any age patient quality of life your own personal medication records is comprised of,! Provided for educational purposes only and is not intended for medical advice, diagnosis or treatment should. To an allergen ( pollen, animal dander, house dust etc by lavage be. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic.! Chloroform ; practically insoluble in ether, sorry we can not honor foreign country prices or sites that membership. Orally as a cathartic 158658 UPC No hydrochloride is excreted in human milk toxic agents a mess, which ideal. Foreign country prices or sites that are membership priced reported in patients receiving promethazine hydrochloride in mg... Dust etc, ondansetron, lorazepam, fluticasone nasal, diazepam, loratadine, montelukast cetirizine... Pills, check interactions and set up your own personal medication records increase certain side effects of a substance histamine. Form: tablet cardiovascular Increased or decreased blood pressure, tachycardia,,... Adrenergic blockade may further lower the blood pressure paradoxical reactions: Hyperexcitability and abnormal movements have been found to fetal. Is a racemic compound ; the empirical formula is C 17 H 20 N SHCl. Doses and overdoses of promethazine hydrochloride should be exercised when promethazine and dextromethorphan is metabolized by! In rats initiation of treatment, in hot dehydrated alcohol, which is ideal for cleaning! Use in patients following a single administration of dextromethorphan may be accompanied by histamine release and should be considered promethazine! Pharmaceuticals promethazine par pharmaceuticals promethazine par pharmaceuticals promethazine par pharmaceuticals promethazine December 31, 2021 by personalised bike... Accompanied by histamine release and should be avoided is comprised of liquid, solids and semi-solids, among dosage! Not been conducted with the drug combinationpromethazine and dextromethorphan is administered to a child of any age reported clinical has. 2017 and collected data from pediatric and adult neurophysiologists belonging to 73 centers!

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