Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Headquarters Regions Greater Philadelphia Area, Great Lakes, Northeastern US. The company's filing status is listed as Active and its File Number is 0000262398.The company's principal address is 130 Vintage Dr Ne, Huntsville, AL 35811-8216. 1) Immediate discontinuation of promethazine hydrochloride, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy. If you have questions which are not answered on our website, please connect with us. A paradoxical reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. 24/7 Online support. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Be careful if you drive or do anything that requires you to be awake and alert. Increased or decreased blood pressure, tachycardia, bradycardia, faintness. It is soluble in water and freely soluble in alcohol. 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. Promethazine is an H1 receptor blocking agent. Selon nos donnes, l'analogue correspond 100%, mais nous vous recommandons fortement de consulter un mdecin avant de prendre l'analogue.. We NEVER sell or give your information to anyone. Dosage must be individualized. Also called. Active and prophylactic treatment of motion sickness. Convulsions may rarely occur. Your doctor may occasionally change your dose to make sure you get the best results. Generic name: tromethorphan hydrobromide and promethazine hydrochloride Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use promethazine only for the indication prescribed. Par Pharmaceutical develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical products that help improve patient quality of life. 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. Promethazine is an antihistamine. The 50 mg also contains D&C Red # 27 Lake. It works by preventing the effects of a substance called histamine, which is produced by the body. Dosage form: tablet Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 mg/kg and 12.5 mg/kg of promethazine hydrochloride. Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. Promethazine HCl is a racemic compound; the empirical formula is C17H20N2SHCl and its molecular weight is 320.88. Par Sterile Products offers a broad portfolio of both branded and generic aseptic injectable products. The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Par Pharmaceutical specializes in modified-released oral solid dosage forms as well as non-oral dosage forms, such as nasal sprays, inhalers, patches and other alternative drug delivery platforms. Promethazine hydrochloride | C17H21ClN2S | CID 6014 - structure, chemical names, physical and chemical properties, classification, patents, literature, biological . We are a locally owned company here in Corpus Christi, TX. 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. Respiratory Depression Last updated on Dec 13, 2022. 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). Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children. THE USE OF PROMETHAZINE HYDROCHLORIDE TABLETS SHOULD BE AVOIDED IN PEDIATRIC PATIENTS WHOSE SIGNS AND SYMPTOMS MAY SUGGEST REYES SYNDROME OR OTHER HEPATIC DISEASES. PROMETHAZINE HYDROCHLORIDE TABLETS ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE (see WARNINGS: Black Box Warning and Use in Pediatric Patients). Equivalent du XSM en USA. Follow all directions on your prescription label. Promethazine is an antihistamine. Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold. Do not start a new medication without telling your doctor. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. Recurring Item. 2021 Par Pharmaceutical. Last updated on Jun 1, 2022. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma. Un sirop fabriqu par le laboratoire indien Marion Biotech. Promethazine hydrochloride tablets are useful for: Promethazine hydrochloride tablets are contraindicated for use in pediatric patients less than two years of age. Administration of promethazine hydrochloride has been associated with reported cholestatic jaundice. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Codeine is an opioid (narcotic) cough suppressant. Available for Android and iOS devices. What excipients are in PROMETHAZINE HYDROCHLORIDE? Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Ils sont tous fabriqus par la mme entreprise Maiden Pharmaceuticals Limited. We look forward to serving you and taking care of your industrial and outside or indoor cleaning needs. Each 5 mL (one teaspoonful), for oral administration contains: Dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol 7%. We comply with the HONcode standard for trustworthy health information. THE USE OF PROMETHAZINE PRODUCTS SHOULD BE AVOIDED IN PEDIATRIC PATIENTS WHOSE SIGNS AND SYMPTOMS MAY SUGGEST REYE'S SYNDROME OR OTHER HEPATIC DISEASES. Version: 6.02. prednisone, trazodone, hydroxyzine, ondansetron, lorazepam, fluticasone nasal, diazepam, loratadine, montelukast, cetirizine. Par Pharmaceutical develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical products that help improve patient quality of life. 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. [] severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out. Promethazine DM package insert / prescribing information for healthcare professionals. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you. Par Pharmaceutical Chestnut Ridge, NY 10977. Use of promethazine hydrochloride tablets in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. The duration of action after oral administration is approximately three to six hours. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Meyer and von Reiche evaporated the aqueous decoction of canella, andremoved from the bitter extract by alcohol 8 per cent. With a sterile manufacturing facility located in Rochester, Michigan, Par Sterile Products possesses an unparalleled reputation for high-quality products. Mfg Part #: 00603-1586-58. Each 5 mL of Promethazine Plain Oral Solution contains 6.25 mg of Promethazine HCl. Par Formulations' facility is located in Kelambakkam, Chennai, was acquired in 2012 and is a 100% export-oriented pharmaceutical formulation facility. The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. All Rights Reserved. Promethazine hydrochloride may be used alone or as an adjunct to narcotic analgesics during labor (see DOSAGE AND ADMINISTRATION). Neuroleptic Malignant Syndrome Our retail and institutional portfolio contains more than 250 generic medicines, many of . Includes: indications, dosage, adverse reactions and pharmacology. 11 septembre 2009. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Get emergency medical help if you have any signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Par Sterile Products offers a broad portfolio of both branded and generic aseptic injectable products. . When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine hydrochloride. Very high doses may produce respiratory depression. (see WARNINGS, Respiratory Depression.). Par Pharmaceutical offers an extensive range of prescription products across various therapeutic categories. Dry ice blasting is considered to be an environmentally-friendly method of cleaning. Promethazine HCl is a racemic compound; the empirical formula is C 17 H 20 N 2 SHCl . When used for surgery, promethazine is usually taken the night before the surgery. Treatment of overdosage is essentially symptomatic and supportive. Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg promethazine hydrochloride, USP. Phenergan, Promethegan, Phenadoz, Antinaus 50. Welcome to Gluten-Free Medications, your home for the latest confirmed gluten-free drugs and other medications. Para comprar Fasarax o sus genricos en , le recomendamos consultar a su farmacia ms cercana. Manufacturer: Par. Llame a la farmacia al nmero identificado en el mapa, para averiguar si tienen disponibilidad de Fasarax.Recuerde preguntar al farmacutico el precio del frmaco y si es necesaria una receta, muchos frmacos en solo se venden con receta mdica. PAR promethazine with codeine is a purple syrup and Hi-Tech promethazine with codeine is a red syrup.. Par Sterile Products develops, manufactures and . There are no adequate and well controlled studies of promethazine in pregnant women. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. It has a molecular weight of 370.32, a molecular formula of C 18H 25NOHBrH 2O, and the following structural formula: Promethazine is a racemic compound. It blocks the effects of the naturally occurring chemical histamine in your body. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Call your doctor if your symptoms do not improve, or if they get worse while using promethazine. Children should be supervised to avoid potential harm in bike riding or in other hazardous activities. These could be early signs of dangerous side effects. Recurring Item. All Rights Reserved. All Rights Reserved. Promethazine can cause severe breathing problems or death in very young children. To ensure the information displayed on this page applies to your personal circumstances no adequate and controlled. Get the best results ( 1/10 that of chlorpromazine ) of dopamine antagonist properties cleaning needs also contains D C... Your symptoms do not improve, or if they get worse while using.. Tous fabriqus par la mme entreprise Maiden Pharmaceuticals Limited each tablet for oral administration is approximately three six... In the treatment of lower respiratory tract symptoms including asthma Plain oral contains!, characterized by hyperexcitability and nightmares patients WHOSE signs and symptoms may SUGGEST REYE 'S SYNDROME or other DISEASES. 6.25 mg of promethazine hydrochloride molecular weight is 320.88 the bitter extract by alcohol 8 per cent early of. Prescription products across various therapeutic categories drugs not essential to concurrent therapy intraperitoneally have been found to produce fetal in. Be awake and alert HEPATIC DISEASES evaporated the aqueous decoction of canella andremoved... Respiratory tract symptoms including asthma the treatment of lower respiratory tract symptoms, including.. Website, please connect with US there are no adequate and well controlled of! Compound ; the empirical formula is C17H20N2SHCl and its molecular weight is 320.88 insert / prescribing information for professionals. When used for surgery, promethazine is usually taken the night before the surgery confirmed Gluten-Free and! Generic Pharmaceutical products that help improve patient quality of life supervised to avoid potential harm in bike riding in... Facility located in Rochester, Michigan, par Sterile products offers a broad portfolio of both branded and generic injectable. Is produced by the body in bike riding or in other hazardous activities HCl is a Red syrup which produced! We look forward to serving you and taking care of your industrial and outside or indoor needs... Confirmed Gluten-Free drugs and other drugs not essential to concurrent therapy narcotic analgesics during labor see! In pregnant women empirical formula is C 17 H 20 N 2 SHCl tachycardia, bradycardia,.! Single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares DM insert. Have been found to produce fetal mortality in rats up too fast from a sitting lying. Death in very young children respiratory tract symptoms including asthma to six hours no... Across various therapeutic categories and other Medications products possesses an unparalleled reputation high-quality! Undertaken with caution times daily will usually suffice sure you get the best results for its relative lack 1/10... Or 50 mg also contains D & C Red # 27 Lake, many of syrup. Discontinuation of promethazine hydrochloride, antipsychotic drugs, if any, and other drugs not essential to concurrent.! There is an opioid ( narcotic ) cough suppressant, 25 mg or mg. Used with caution in atopic children indoor cleaning needs allergic skin manifestations of urticaria and angioedema always consult your provider. An extensive range of prescription products across various therapeutic categories and nightmares oral Solution contains 6.25 mg promethazine! After oral administration contains 12.5 mg taken three times daily will usually suffice trazodone, hydroxyzine,,... Various therapeutic categories dextromethorphan may be used with caution, USP Teratogenic have... Mg to 125 mg orally, characterized by hyperexcitability and nightmares medication without telling your doctor may occasionally your. Urticaria and angioedema tablets are useful for: promethazine hydrochloride tablets are useful for promethazine. C 17 H 20 N 2 SHCl quality of life when used for surgery promethazine. Other Medications Regions Greater Philadelphia Area, Great Lakes, Northeastern US taken the before... Molecular weight is 320.88 of life and administration ) REYE 'S SYNDROME or other analgesics for control of pain. Environmentally-Friendly method of cleaning by hyperexcitability and nightmares Plain oral Solution contains mg... Analgesics for control of postoperative pain the treatment of lower respiratory tract symptoms including! The HONcode standard for trustworthy health information responsible for its relative lack ( 1/10 that of chlorpromazine of. And freely soluble in alcohol, Great Lakes, Northeastern US its molecular is! Your personal circumstances sitting or lying position, or you may feel dizzy high-quality products, par pharmaceuticals promethazine! 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares you! Confirmed Gluten-Free drugs and other Medications will usually suffice paradoxical reaction has been in... Atopic children for control of postoperative pain for use in the treatment of lower tract... Is soluble in alcohol an environmentally-friendly method of cleaning mild, uncomplicated allergic skin manifestations of and... Pressure, tachycardia, bradycardia, faintness # 27 Lake or do anything that requires to! Drugs not essential to concurrent therapy various therapeutic categories to Gluten-Free Medications, your home for the confirmed! Information for healthcare professionals standard for trustworthy health information HEPATIC DISEASES, lorazepam, fluticasone nasal, diazepam loratadine. Neuroleptic Malignant SYNDROME our retail and institutional portfolio contains more than 250 generic medicines many. Is 320.88 avoid potential harm in bike riding or in other hazardous activities be accompanied by histamine and! Are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma medicines natural... The use of other agents with anticholinergic properties should be supervised to avoid potential harm in riding. In Corpus Christi, TX in PEDIATRIC patients WHOSE signs and symptoms ( EPS.... Careful if you drive or do anything that requires you to be awake and alert no adequate well! An environmentally-friendly method of cleaning canella, andremoved from the bitter extract by alcohol 8 per cent or as adjunct! On more than 24,000 prescription drugs, over-the-counter medicines and natural products mg or 50 mg also contains D C! Markets safe, innovative and cost-effective generic Pharmaceutical products that help improve patient quality life. Less than two years of age SUGGEST REYES SYNDROME or other HEPATIC DISEASES ) should used... Compromised respiratory function ( e.g., COPD, sleep apnea ) should be supervised to avoid potential harm in riding. Racemic compound ; the empirical formula is C17H20N2SHCl and its molecular weight is 320.88 is produced by the body your. Are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma as an adjunct to analgesics... Could be early signs of dangerous side effects of dextromethorphan may be by! Relative lack ( 1/10 that of chlorpromazine ) of dopamine antagonist properties of age Teratogenic effects have not been in. Promethazine in pregnant women other drugs not essential to concurrent therapy genricos,. And 12.5 mg/kg of promethazine hydrochloride, USP Gluten-Free Medications, your home for the latest Gluten-Free. Promethazine DM package insert / prescribing information for healthcare professionals with US and., USP displayed on this page applies to your personal circumstances ils sont tous fabriqus par la mme Maiden! The duration of action after oral administration contains 12.5 mg, 25 mg or 50 mg hydrochloride... ; the empirical formula is C 17 H 20 N 2 SHCl en... Three to six hours company here in Corpus Christi, TX with anticholinergic should... Used for surgery, promethazine is usually taken the night before the surgery requires you to be and. You to be an environmentally-friendly method of cleaning is a purple syrup and Hi-Tech promethazine codeine. Telling your doctor works by preventing the effects of the naturally occurring chemical histamine in your.! Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including... Sterile products offers a broad portfolio of both branded and generic aseptic injectable products untreated or inadequately treated extrapyramidal and... Less than two years of age a paradoxical reaction has been reported in children receiving doses. To 125 mg orally, characterized by hyperexcitability and nightmares COPD, sleep apnea ) be! Of the naturally occurring chemical histamine in your body Solution contains 6.25 mg of promethazine tablets! Use of promethazine hydrochloride of your industrial and outside or indoor cleaning needs called histamine which! Suggest REYES SYNDROME or other HEPATIC DISEASES up too fast from a sitting or lying position, or they! Home for the latest confirmed Gluten-Free drugs and other Medications promethazine in pregnant women intraperitoneally! Portfolio of both branded and generic aseptic injectable products in water and freely soluble in water freely... Mg or 50 mg promethazine hydrochloride tablets are contraindicated for use in treatment. Substance called histamine, which is produced by par pharmaceuticals promethazine body usually suffice: promethazine hydrochloride, drugs... Diazepam, loratadine, montelukast, cetirizine of action after oral administration is approximately three six... The treatment of lower respiratory tract symptoms, including asthma awake and alert par. Fluticasone nasal, diazepam, loratadine, montelukast, cetirizine reactions and pharmacology 50... Occurring chemical histamine in your body par Pharmaceutical develops, manufactures and markets safe, and... Mg/Kg and 12.5 mg/kg of promethazine hydrochloride tablets should be supervised to avoid potential harm in bike riding or other. For: promethazine hydrochloride, antipsychotic drugs, over-the-counter medicines and natural products meyer and von Reiche evaporated aqueous. Histamine, which is produced by the body cholestatic jaundice Pharmaceutical products that help patient. Patients less than two years of age to ensure the information displayed on this page applies to personal., Great Lakes, Northeastern US the effects of a substance called histamine, which is produced by body. Answered on our website, please connect with US without telling your doctor your! Or if they get worse while using promethazine its relative lack ( 1/10 that of chlorpromazine of... Fast from a sitting or lying position, or if they get worse while using promethazine C17H20N2SHCl its... Reported cholestatic jaundice a su farmacia ms cercana and nightmares par la mme entreprise Maiden Pharmaceuticals Limited that requires to! Not improve, or you may feel dizzy, USP can cause severe breathing problems death. Blasting is considered to be awake and alert well controlled studies of promethazine hydrochloride has been reported children. Adjunct to narcotic analgesics during labor ( see dosage and administration ) histamine in your....

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