Animal reproduction studies have not been conducted with the drug combinationpromethazine and dextromethorphan. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. See our privacy policy. Barcode = 7489 Promethazine HCl Syrup Plain Rx Only promethazine hcl syrup plain (Promethazine HCl Syrup Plain) syrup [ANI Pharmaceuticals, Inc.] Rx Only . The duration of action after oral administration is approximately three to six hours. ), Other Angioneurotic edema. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). Promethazine HCl is a racemic compound; the empirical formula is C17H20N2SHCl and its molecular weight is 320.88. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Promethazine hydrochloride tablets are contraindicated for children under 2 years of age (see WARNINGS: Black Box Warning and Use in Pediatric Patients). Patients should be advised to report any involuntary muscle movements. CONCOMITANT ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC PATIENTS. 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. We offer products in a wide variety of therapeutic categories. Monoamine Oxidase Inhibitors (MAOI) Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. All Rights Reserved. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. The Sustainable Green Printing Partnership (SGP) is a non-profit organization that certifies printing facilities' sustainability best practices, including and beyond regulatory compliance. We NEVER sell or give your information to anyone. Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS: Use in Pediatric Patients). Note that any depressant effects of promethazine hydrochloride are not reversed by naloxone. Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. This medicine can cause unusual results with certain medical tests. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. Take promethazine exactly as prescribed by your doctor. Generic name: tromethorphan hydrobromide and promethazine hydrochloride One case of toxic psychosis (hyperactivity, marked visual and auditory hallucinations) after ingestion of a single dose of 20 tablets (300 mg) of dextromethorphan has been reported. Drug classes: Antihistamines, Phenothiazine antiemetics. Promethazine hydrochloride tablets 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. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. Use of promethazine hydrochloride tablets in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. 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. Enjoy a guided tour of FindACode's many features and tools. Thus, concomitant administration of promethazine with dextromethorphan and MAO inhibitors should be avoided (see CONTRAINDICATIONS). medicine to treat stomach ulcer or irritable bowel syndrome, such as dicyclomine (Bentyl), glycopyrrolate (Robinul), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), mepenzolate (Cantil), or propantheline (Pro-Banthine). The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Le meilleur quivalent du XSM en USA est Alavert Children's. Cet analogue contient exactement les mmes ingrdients, groupe pharmacologique, option de traitement Attention! DESCRIPTION . The second quarter and first six months of 2021 and 2020. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Promethazine is an H 1 receptor blocking agent. This possibility should be considered with promethazine hydrochloride tablets. Very high doses may produce respiratory depression. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients. Promethazine hydrochloride, USP occurs as a white to faint yellowish crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. Medically reviewed by Drugs.com. According to the WHO Expert Committee on Drug Dependence, dextromethorphan could produce very slight psychic dependence but no physical dependence. In humans, (+)-3-hydroxy-N-methyl-morphinan, (+)-3-hydroxymorphinan, and traces of unmetabolized drug were found in urine after oral administration. : 00603-1586-58, 00603-586-58, 0060358658, 00603158658, 1586-58, 158658 UPC No. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Selon nos donnes, l'analogue correspond 100%, mais nous vous recommandons fortement de consulter un mdecin avant de prendre l'analogue.. Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. The average effective dose is given in the following table: This preparation is a clear oral solution with yellow color and pineapple menthol odor, containing promethazine hydrochloride 6.25 mg/5 mL, dextromethorphan hydrobromide 15 mg/5 mL and alcohol 7 percent, and is available in 4 fluid ounce (120 mL) NDC 68071-1643-4 Bottles of 120mL. 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 . Central Nervous System Drowsiness is the most prominent CNS effect of this drug. How long does promethazine stay in your system. 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. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HYDROCHLORIDE IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. Includes: indications, dosage, adverse reactions and pharmacology. Active and prophylactic treatment of motion sickness. Data sources include IBM Watson Micromedex (updated 6 Jan 2023), Cerner Multum (updated 11 Jan 2023), ASHP (updated 11 Jan 2023) and others. Franois Fillon : Il s'agit de faire voluer le forfait hospitalier. Par Pharmaceutical develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical products that help improve patient quality of life. Children should be supervised to avoid potential harm in bike riding or in other hazardous activities. Par Formulations' facility is located in Kelambakkam, Chennai, was acquired in 2012 and is a 100% export-oriented pharmaceutical formulation facility. It is not known whether promethazine passes into breast milk or if it could harm a nursing baby. Promethazine hydrochloride tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Call your doctor if your symptoms do not improve, or if they get worse while using promethazine. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. . Excessively large dosages of antihistamines, including promethazine hydrochloride tablets in pediatric patients may cause sudden death (see OVERDOSAGE). 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. 22 septembre 2021 mdicaments botaniques, NFL Biosciences, Sevrage tabagique. What excipients are in PROMETHAZINE HYDROCHLORIDE? Each rectal suppository contains 50 mg promethazine HCl with ascorbyl palmitate and polysorbate 80 in a specially blended base of saturated vegetable fatty acids. It is not known whether promethazine will harm an unborn baby. Angioneurotic edema. 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 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). Tell your doctor about all the prescription and over-the-counter medications you use. Promethazine hydrochloride is a racemic compound; the molecular formula is C 17 H 20 N 2 S HCl and its molecular weight is 320.88 g/mol. Avoid analeptics, which may cause convulsions. Morbidity and Mortality Weekly Report. Promethazine DM package insert / prescribing information for healthcare professionals. Contain the same ingredients, but with the added Phenylephrine in it are exposed., you will need before Par Pharmaceuticals promethazine codeine and after an Earthquake medications, your home the. Medically reviewed by Drugs.com. Drug classes: Antihistamines, Phenothiazine antiemetics. Dry ice blasting is a new and environmentally safe way to clean industrial equipment and outside/indoor surfaces that are exposed to the elements. 2021 Par Pharmaceutical. Promethazine should not be given to a child younger than 2 years old. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. Par Pharmaceutical develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical products that help improve patient quality of life. 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