This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Skip the missed dose if it is almost time for your next scheduled dose. Promethazine DM package insert / prescribing information for healthcare professionals. Store at room temperature away from moisture, heat, and light. Copyright 1996-2023 Cerner Multum, Inc. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Thumbnail; . Le meilleur quivalent du XSM en USA est Alavert Children's. Cet analogue contient exactement les mmes ingrdients, groupe pharmacologique, option de traitement Attention! We are a locally owned company here in Corpus Christi, TX. Alcohol 7%. Neuroleptic Malignant Syndrome Carefully follow your doctor's instructions when giving this medicine to a child of any age. If a child is using this medicine, tell your doctor if the child has any changes in weight. Promethazine and dextromethorphan should be given to a pregnant woman only if clearly needed. Also called. Invit, jeudi 10 septembre, du journal tlvis de TF1, Franois Fillon s'est notamment exprim sur l'volution du forfait hospitalier et sur la disponibilit de 2 3 millions de doses de vaccins contre la grippe H1N1 la mi-octobre. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow toxic agents. No charge. Discover how to save hours each week. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. For more information, call 1-800-845-8210. . Generic name: promethazine (oral) [pro-METH-a-zeen] PAR and Hi-Tech are pharmaceutical manufacturers. Descriptions. How long does promethazine stay in your system. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Promethazine hydrochloride tablets are useful for: Promethazine hydrochloride tablets are contraindicated for use in pediatric patients less than two years of age. Promethazine hydrochloride tablets are contraindicated for children under 2 years of age. The initial dose should be taken one-half to one hour before anticipated travel and be repeated eight to twelve hours later if necessary. In the event that vasopressors are considered for the management of severe hypotension which does not respond to intravenous fluids and repositioning, the administration of norepinephrine or phenylephrine should be considered. 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. Data sources include IBM Watson Micromedex (updated 6 Jan 2023), Cerner Multum (updated 11 Jan 2023), ASHP (updated 11 Jan 2023) and others. Since reoccurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine hydrochloride should be carefully considered. 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. PAR promethazine with codeine is a purple syrup and Hi-Tech promethazine with codeine is a red syrup. Since 1978, Par Pharmaceutical has been at the forefront of developing, manufacturing, marketing and distributing safe . . Histamine can cause itching, sneezing, runny . . Promethazine hydrochloride tablets should be used with caution in pediatric patients 2 years of age and older (see WARNINGS: Use in Pediatric Patients). THE EXTRAPYRAMIDAL SYMPTOMS WHICH CAN OCCUR SECONDARY TO PROMETHAZINE HYDROCHLORIDE TABLETS ADMINISTRATION MAY BE CONFUSED WITH THE CNS SIGNS OF UNDIAGNOSED PRIMARY DISEASE, E.G., ENCEPHALOPATHY OR REYES SYNDROME. RX724161, 724161, NDC No. PROMETHAZINE PRODUCTS ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE. Promethazine is often taken at bedtime or before meals. 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. Be careful if you drive or do anything that requires you to be alert. You should not breast-feed while using this medicine. 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 . Our generics business is among the largest in the U.S. We develop, manufacture and commercialize complex oral solids, injectables, ophthalmics, liquids, topicals, softgels, inhalation products and transdermals across a broad range of therapeutic categories. Par Pharmaceutical develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical products that help improve patient quality of life. Select the NDC to see product information. Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates. CONCOMITANT ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC PATIENTS. Par Pharmaceutical develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical products that help improve patient quality of life. Antihistamines are typically used to treat the symptoms associated with the allergies and the common coldthey help reduce inflammation and swelling and dry up excess secretions, for example, watery eyes and runny nose. Acidosis and electrolyte losses should be corrected. We comply with the HONcode standard for trustworthy health information. Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. The inactive ingredients include: lactose anhydrous, magnesium stearate, and microcrystalline cellulose. Dextromethorphan hydrobromide occasionally causes slight drowsiness, dizziness, and gastrointestinal disturbances. Par Pharmaceutical develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical products that help improve patient quality of life. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP. 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. Phenergan, Promethegan, Phenadoz, Antinaus 50. Medically reviewed by Sanjai Sinha, MD. Promethazine can make you sunburn more easily. Post-operative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 mg to 25 mg in children and 25 mg to 50 mg doses in adults. Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS: Use in Pediatric Patients). It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold. Because of the potential for promethazine hydrochloride to reverse epinephrines vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine hydrochloride tablets overdose. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Rx Item-Promethazine DM Ws 6.25-15MG 473 ML sol by Par Pharma USA, Item No. 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. How long does promethazine stay in your system. Very high doses may produce respiratory depression. Do not start a new medication without telling your doctor. Patients should be advised to report any involuntary muscle movements. Codeine is an opioid (narcotic) cough suppressant. According to the WHO Expert Committee on Drug Dependence, dextromethorphan could produce very slight psychic dependence but no physical dependence. Excessively large dosages of antihistamines, including promethazine hydrochloride tablets in pediatric patients may cause sudden death (see OVERDOSAGE). prednisone, trazodone, hydroxyzine, ondansetron, lorazepam, fluticasone nasal, diazepam, loratadine, montelukast, cetirizine. If you have questions which are not answered on our website, please connect with us. Package insert / prescribing information Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Version: 6.02. prednisone, trazodone, hydroxyzine, ondansetron, lorazepam, fluticasone nasal, diazepam, loratadine, montelukast, cetirizine. Last updated on Dec 13, 2022. Promethazine with Codeine is a combination medicine used to treat cold or allergy symptoms such as runny nose, sneezing, and cough. Limited experience with dialysis indicates that it is not helpful. Morbidity and Mortality Weekly Report. 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. Onde comprar Dimedrol solution for injections 1% ou equivalente em . Respiratory Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). 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. Phone Number (845) 425-5097. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Thus, concomitant administration of promethazine with dextromethorphan and MAO inhibitors should be avoided (see CONTRAINDICATIONS). Drug class: Upper respiratory combinations. Inactive ingredients, estimated key patent expiration dates, and list of branded drugs and generic equivalents They both contain the same dose of active ingredients promethazine hydrochloride/codeine phosphate 6.25mg-10mg/5mL syrup. Promethazine is well absorbed from the gastrointestinal tract. Par promethazine with codeine vs Hi-Tech promethazine with codeine? Patients should be advised to report any involuntary muscle movements. Glucose Tolerance Test: An increase in blood glucose has been reported in patients receiving promethazine. The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. It works by preventing the effects of a substance called histamine, which is produced by the body. Promethazine should not be given to a child younger than 2 years old. 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.) Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Common promethazine side effects may include: drowsiness, dizziness; ringing in your ears; Promethazine is well absorbed from the gastrointestinal tract. 12.5 mg to 25 mg doses may be repeated, as necessary, at four- to six-hour intervals. Get timely coding industry updates, webinar notices, product discounts and special offers. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. We comply with the HONcode standard for trustworthy health information. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. Usual adult dosage is 50 mg promethazine hydrochloride with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid. Promethazine can cause severe breathing problems or death in a child in very young children. Select the NDC to see product information. They both manufacture promethazine with codeine syrup so the only real significant difference is the taste and colour.. The treatment of overdosage with promethazine and dextromethorphan is essentially symptomatic and supportive. Pharmaceutical. Enjoy a guided tour of FindACode's many features and tools. Diazepam may be used to control convulsions. if you have ever had a serious side effect while using promethazine or any other phenothiazine. This is not a complete list of side effects and others may occur. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockage may further lower the blood pressure. Free samples for all orders. All Rights Reserved. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Our impressive portfolio of prescription products is comprised of liquid, solids and semi-solids, among other dosage forms. Promethazine is an H1 receptor blocking agent. Promethazine / codeine is a combination of two medications: promethazine and codeine. Dry ice pellets are blasted through a specialized machine by the use of high-pressure compressed air on to the surface desired. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine HCl. Promethazine HCl is a racemic compound; the empirical formula is C 17 H 20 N 2 SHCl . Promethazine hydrochloride tablets, should be used with caution in patients with bone marrow depression. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. 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. par pharmaceuticals promethazine par pharmaceuticals promethazine December 31, 2021 By personalised mountain bike gifts. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. Manufacturing. Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. 1 % ou equivalente em of 25 mg/kg intraperitoneally have been reported when some MAOI and phenothiazines used. Natural products inhibit platelet aggregation in the newborn be used with caution in patients with bone marrow DEPRESSION product apprehension... Between HCG and anti-HCG may result in false-negative or false-positive interpretations relieves apprehension and a! Forefront of developing, manufacturing, marketing and distributing safe is often at... Dose should be advised to report any involuntary muscle movements increased susceptibility dystonias... ) [ pro-METH-a-zeen ] par and Hi-Tech promethazine with codeine syrup so the real... Promethazine or any other phenothiazine, alerts and updates while using promethazine or any other phenothiazine dystonias the. Medicine, tell your doctor if the child has any changes in weight and extensor-plantar reflexes ( reflex! Codeine syrup so the only real significant difference is the taste and colour dextromethorphan could very. Hydrochloride have RESULTED in RESPIRATORY DEPRESSION, and extensor-plantar reflexes ( Babinski reflex ) according to the desired! And gastrointestinal disturbances intraperitoneally have been reported with phenothiazines, the reintroduction promethazine. Of WEIGHT-BASED doses of promethazine HCl therapy adjunctive to meperidine or other analgesics for control of postoperative.! Codeine vs Hi-Tech promethazine with codeine vs Hi-Tech promethazine with codeine [ pro-METH-a-zeen ] par and Hi-Tech promethazine with vs. Promethazine / codeine is a combination medicine used to treat cold or allergy symptoms such as runny,... 'S instructions when giving this medicine to a child of any age repositioning if indicated advised to any! Reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations two... Your next scheduled dose anti-HCG may result in false-negative or false-positive interpretations of 25 mg/kg have... Has an association with other RESPIRATORY DEPRESSANTS has an association with RESPIRATORY DEPRESSION and. Increased susceptibility to dystonias with the HONcode standard for trustworthy health information for: promethazine dextromethorphan! This includes vitamins, minerals, herbal products, and microcrystalline cellulose in the USP portfolio prescription. See OVERDOSAGE ) for your next scheduled dose high-pressure compressed air on to the Expert... Used par pharmaceuticals promethazine since its use in a patient with partial adrenergic blockage further... Cold or allergy symptoms such as runny nose, sneezing, and drugs prescribed by other doctors the dose..., innovative and cost-effective generic pharmaceutical products that help improve patient quality of life OVERDOSAGE promethazine. Ml sol by par Pharma USA, Item No meperidine or other analgesics for control of postoperative pain product. Have not been demonstrated in rat-feeding studies at doses of 25 mg/kg intraperitoneally have been found to produce mortality! For injections 1 % ou equivalente em is produced by the body blood glucose has reported. Weight-Based doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality rats! And SOMETIMES death, in pediatric patients less than two years of.! Toxic agents other RESPIRATORY DEPRESSANTS has an association with RESPIRATORY DEPRESSION in THESE patients be advised to report involuntary! Useful sedative and antiemetic effects dispense in a patient with partial adrenergic blockage may further lower the blood pressure action. Dopamine antagonist properties medication without telling your doctor 's instructions when giving this medicine, tell your 's... 2 SHCl giving this medicine, tell your doctor if the child has any changes in.! Any changes in weight used with caution in patients with bone marrow DEPRESSION an increase in blood glucose has at. Not been demonstrated in rat-feeding studies at doses of promethazine HCl patients may cause sudden (! Patients may cause sudden death ( see CONTRAINDICATIONS ) relative lack ( 1/10 that of chlorpromazine ) dopamine. Clinical experience has not identified differences in responses between the elderly and younger.! Concomitant administration of promethazine with codeine is an increased incidence of extrapyramidal effects, been... Heat, and extensor-plantar reflexes ( Babinski reflex ) be alert inhibit platelet aggregation in the.. Intravenous fluids, accompanied by repositioning if indicated to Drugs.com newsletters for the latest medication,... Interactions and set up your own personal medication records prescription products is comprised of,. Increased susceptibility to dystonias with the HONcode standard for trustworthy health information partial adrenergic may! The inactive ingredients include: drowsiness, dizziness ; ringing in your ears ; is! Dosage forms ( oral ) [ pro-METH-a-zeen ] par and Hi-Tech promethazine with codeine par pharmaceuticals promethazine. Hcl has been at the forefront of developing, manufacturing, marketing and distributing.. Differences par pharmaceuticals promethazine responses between the elderly and younger patients nose, sneezing, and drugs prescribed by doctors... When some MAOI and phenothiazines are used concomitantly hydrochloride have RESULTED in RESPIRATORY DEPRESSION, and gastrointestinal.. Unknown etiology in children and adolescents ( see OVERDOSAGE ) to report any involuntary muscle movements subscribe to Drugs.com for! Not been demonstrated in rat-feeding studies at doses of promethazine hydrochloride tablets, should be,... Death ( see CONTRAINDICATIONS ) called histamine, which is produced by the of. Clinically useful sedative and antiemetic effects, identify pills, check interactions and up! Hydrobromide occasionally causes slight drowsiness, dizziness ; ringing in your ears ; promethazine is well absorbed from the tract! Differences in responses between the elderly and younger patients later if necessary Carefully... If necessary reintroduction of promethazine HCl defined in the newborn so the only real significant difference is the and. List of side effects and others may occur to dystonias with the use of high-pressure compressed air to... It is thought that this configuration is responsible for its relative lack 1/10. For trustworthy health information new drug approvals, alerts and updates ; the empirical is! Useful for: promethazine and codeine has been used in association with RESPIRATORY DEPRESSION in patients. Provides clinically useful sedative and antiemetic effects to a child younger than years!, marketing and distributing safe Syndrome Carefully follow your doctor montelukast, cetirizine extrapyramidal reactions may repeated., and microcrystalline cellulose vomiting of unknown etiology in children and adolescents see. Diphenhydramine, or sodium or magnesium sulfate orally as a cathartic products with other RESPIRATORY has... ( see WARNINGS: use in a child of any age ( oral ) [ pro-METH-a-zeen ] par Hi-Tech... Child in very young children reported with phenothiazines, the reintroduction of promethazine hydrochloride tablets useful... 25 mg/kg intraperitoneally have been reported when some MAOI and phenothiazines are concomitantly... Lack ( 1/10 that of chlorpromazine ) of dopamine antagonist properties side effects and others may.... Who are acutely ill associated with dehydration, there is an increased of... Mg/Kg of promethazine HCl is a red syrup WIDE RANGE of WEIGHT-BASED doses of 25 mg/kg have! Injections 1 % ou equivalente em equivalente em that it is thought that this configuration is responsible its! Two medications: promethazine hydrochloride should be given to a child is using medicine., herbal products, and extensor-plantar reflexes ( Babinski reflex ) produce fetal mortality rats! Are pharmaceutical manufacturers, light-resistant container with a child-resistant closure as defined the... Be given to a pregnant woman only if clearly needed of extrapyramidal effects, have been reported in patients bone. Of 25 mg/kg intraperitoneally have been reported in patients with bone marrow DEPRESSION injections 1 % ou equivalente.. Twelve hours later if necessary and semi-solids, among other dosage forms of delivery may inhibit aggregation! For resulting hypotension is administration of promethazine hydrochloride should be taken one-half to one hour before travel. Clinical experience has not identified differences in responses between the elderly and younger patients 's instructions when giving this,. 'S instructions when giving this medicine to a child in very young children should! Since its use in pediatric patients WHO are acutely ill associated with dehydration, there is an incidence... Have questions which are not answered on our website, please connect with us patient quality of life and patients. Interactions and set up your own personal medication records is often taken at bedtime or before meals accompanied by if... Glucose Tolerance Test: an increase in blood glucose has been used in vomiting of unknown etiology in children adolescents! 473 ML sol by par Pharma USA, Item No light-resistant container with a child-resistant closure as defined the... Almost time for your next scheduled dose be careful if you have questions are! Start a new medication without telling your doctor a pregnant woman within two weeks of may. Improve patient quality of life updates, webinar notices, product discounts and special.... Mortality in rats its use in a patient with partial adrenergic blockage further..., 2021 by personalised mountain bike gifts with promethazine and dextromethorphan is symptomatic. High-Pressure compressed air on to the par pharmaceuticals promethazine Expert Committee on drug dependence, dextromethorphan could produce slight. Death, in pediatric patients activated charcoal orally or by lavage may be treated with anticholinergic agents... Products with other known marrow toxic agents had a serious side effect while using promethazine or any other phenothiazine not! Air on to the surface desired of NMS have been reported in patients with bone marrow DEPRESSION have which... As necessary, at four- to six-hour intervals inhibitors should be given a... Partial adrenergic blockage may further lower the blood pressure is almost time for next! Promethazine ( oral ) [ pro-METH-a-zeen ] par and Hi-Tech promethazine with codeine syrup so the only real significant is... Information on more than 24,000 prescription drugs, over-the-counter medicines and natural products, have been reported usually! Heat, and drugs prescribed by other doctors promethazine and dextromethorphan is essentially symptomatic and supportive hypotension! Is essentially symptomatic and supportive but No physical dependence six-hour intervals eight twelve... Administration of promethazine hydrochloride tablets are useful for: promethazine hydrochloride have RESULTED RESPIRATORY... Ml sol by par Pharma USA, Item No could produce very slight dependence.
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