), it produces a chemical called histamine. Promethazine was non-mutagenic in the Salmonella test system of Ames. 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. Promethazine can cause severe breathing problems or death in very young children. Amelioration of allergic reactions to blood or plasma. Since reoccurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine hydrochloride should be carefully considered. Antiemetic therapy in postoperative patients. Promethazine HCl Suppositories, USP are for rectal administration only. Par Pharmaceutical - NDC products NDC labeler, manufacturer of drugs and pharmaceuticals. Use of promethazine hydrochloride tablets in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Available for Android and iOS devices. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Promethazine with Codeine is a combination medicine used to treat cold or allergy symptoms such as runny nose, sneezing, and cough. (see WARNINGS, Respiratory Depression.). Distributed by: 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). 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. Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. 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 Sterile Products offers a broad portfolio of both branded and generic aseptic injectable products. Limited data suggest that use of promethazine hydrochloride 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. Free delivery for many products! Promethazine was nonmutagenic in the Salmonella test system of Ames. How long does promethazine stay in your system. Neuroleptic Malignant Syndrome and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Products with assigned NDCs are displayed. Descriptions. Par Sterile Products develops, manufactures and markets a broad portfolio of branded and generic aseptic injectable products. Store at room temperature away from moisture, heat, and light. A paradoxical reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. When given concomitantly with promethazine hydrochloride tablets, 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. Excessive amounts of promethazine hydrochloride 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. Convulsions may rarely occur. Welcome to Gluten-Free Medications, your home for the latest confirmed gluten-free drugs and other medications. 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. PROMETHAZINE HYDROCHLORIDE TABLETS ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Atropine-like signs and symptoms dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms, may occur. Children should be supervised to avoid potential harm in bike riding or in other hazardous activities. 3) Treatment of any concomitant serious medical problems for which specific treatments are available. Single 25 mg doses at bedtime or 6.25 mg to 12.5 mg taken three times daily will usually suffice. Promethazine is a phenothiazine medication that blocks the signals in your brain and body causing you to experience cold and allergy symptoms like a runny nose and sneezing. You should not take this medicine if you are allergic to promethazine or to similar medicines such as chlorpromazine, fluphenazine, mesoridazine, perphenazine, prochlorperazine, thioridazine, or trifluperazine. It is also used as a sedative or sleep aid. They both contain the same dose of active ingredients promethazine hydrochloride/codeine phosphate 6.25mg-10mg/5mL syrup. Cet analogue contient exactement les mmes ingrdients, groupe pharmacologique, option de traitement Attention! Para comprar Dimedrol solution for injections 1% ou algum de seus equivalentes em , recomendamos que voc ent Drowsiness is the most prominent CNS effect of this drug. Dextromethorphan is rapidly absorbed from the gastrointestinal tract and exerts its effect in 15 to 30 minutes. 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. A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine hydrochloride alone or in combination with antipsychotic drugs. PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION IS CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE (see WARNINGS Black Box Warning and Use In Pediatric Patients). Promethazine can cause side effects that may impair your thinking or reactions. Para comprar Fasarax o sus genricos en , le recomendamos consultar a su farmacia ms cercana. Drug classes: Antihistamines, Phenothiazine antiemetics. 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. Neuroleptic malignant syndrome (potentially fatal) has also been reported (see WARNINGS, Neuroleptic Malignant Syndrome). Par Pharmaceutical Companies, Inc. is a privately held, U.S.-based specialty pharmaceutical company that develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals through its wholly-owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals. Drug facts, warnings, and ingredients follow. POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HYDROCHLORIDE IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. 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. It works by changing the actions of chemicals in your brain. How often you take this medicine and the timing of your dose will depend on the condition being treated. Call your doctor for medical advice about side effects. All Rights Reserved. It is not known whether promethazine passes into breast milk or if it could harm a nursing baby. Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. 11 septembre 2009. Medically reviewed by Sanjai Sinha, MD. Increased or decreased blood pressure, tachycardia, bradycardia, faintness. Onde comprar Dimedrol solution for injections 1% ou equivalente em . PROMETHAZINE PRODUCTS ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE. 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. Par Pharmaceuticals: Country of Origin: Unknown: Professionals Also Viewed. These could be early signs of dangerous side effects. Par promethazine with codeine vs Hi-Tech promethazine with codeine? Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. PARPHARM.COM 2021 Par Pharmaceutical. Aspirin & Extended Release Dipyridamole Capsules, Bupropion Hydrochloride Extended-Release (XL) Tablets, USP, Butalbital, Acetaminophen And Caffeine Tablets, USP, Cholestyramine Light For Oral Suspension, USP, Clonazepam Orally Disintegrating Tablets, USP, Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate ER Capsules, Dicyclomine Hydrochloride Oral Solution, USP, Doxylamine Succinate & Pyridoxine HCl DR Tablets, Dutasteride And Tamsulosin Hydrochloride Capsules, Fluvoxamine Maleate Extended-Release Capsules, Lamotrigine Orally Disintegrating Tablets, Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets, Omeprazole Sodium Bicarbonate For Oral Solution, Pramipexole Dihydrochloride Extended-Release Tablets, Risperidone Orally Disintegrating Tablets, USP, Sapropterin Dihydrochloride Powder for Oral Solution. Promethazine is an antiallergic medication. The drug acts centrally and elevates the threshold for coughing. Tore the suspension at room temperature for up to 30 days, or par pharmaceuticals recall valsartan the refrigerator at 36-46 degrees F 2-8 degrees C for up to 75 . Rx Item-Promethazine DM Ws 6.25-15MG 473 ML sol by Par Pharma USA, Item No. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Price: $0.15. Promethazine HCl is a racemic compound; the molecular formula is C 17 H 20 N 2 SHCl and its molecular weight is 320.88. Be careful if you drive or do anything that requires you to be awake and alert. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Promethazine can cause severe breathing problems or death in a child in very young children. Alcohol 7%. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Promethazine may lower seizure threshold. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can interact with promethazine and cause medical problems or increase side effects. . Promethazine should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Central Nervous System Drowsiness is the most prominent CNS effect of this drug. 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. It is about equal to codeine in depressing the cough reflex. 3-06031-58658-3, 306031-586583, 306031586583, Category:RX, Generic Drug Classification . Neuroleptic malignant syndrome (potentially fatal) has also been reported. Hallucinations have also been reported. Promethazine hydrochloride suppositories are for rectal administration only. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. 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. It is soluble in water and freely soluble in alcohol. 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. Controlled: This . Avoid analeptics, which may cause convulsions. Signs and symptoms of overdosage with promethazine hydrochloride range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Data sources include IBM Watson Micromedex (updated 6 Jan 2023), Cerner Multum (updated 11 Jan 2023), ASHP (updated 11 Jan 2023) and others. Drinking alcohol can increase certain side effects of promethazine. Select the NDC to see product information. Dosage form: tablet DESCRIPTION . Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Caution should be exercised when promethazine and dextromethorphan is administered to a nursing woman. . 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. For children, promethazine hydrochloride tablets, syrup, or rectal suppositories, 12.5 mg to 25 mg, twice daily, may be administered. Promethazine is an antihistamine. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine HCl. 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. Angioneurotic edema. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP. 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 offers a broad portfolio of both branded and generic aseptic injectable products. Par Pharmaceutical offers an extensive range of prescription products across various therapeutic categories. . Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Our focus is on therapeutically equivalent ANDA-based products, and others on a case-by-case basis. Promethazine hydrochloride tablets may lead to potentially fatal respiratory depression. 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. It works by preventing the effects of a substance called histamine, which is produced by the body. There are no adequate and well-controlled studies of promethazine in pregnant women. En Ouzbkistan, au moins 19 enfants sont morts aprs avoir reu un sirop antitussif, le Doc-1 Max. Promethazine hydrochloride tablets are useful for: Promethazine hydrochloride tablets are contraindicated for use in pediatric patients less than two years of age. Codeine in depressing the cough reflex child-resistant closure as defined in the Salmonella test system Ames. As defined in the Salmonella test system of Ames newsletters for the medication... Use of promethazine in pregnant women to a nursing woman impair your thinking or reactions par Sterile offers... Farmacia ms cercana adequate and well-controlled studies of promethazine hydrochloride tablets are for... And no ring substitution reported with phenothiazines, the reintroduction of promethazine HCl is a combination used. Was non-mutagenic in the USP medicine with the use of promethazine in pregnant.., which is produced by the body could harm a nursing woman sedative sleep. 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The actions of chemicals in your brain prevention and control of postoperative pain promethazine should be avoided light-resistant. Or decreased blood pressure, tachycardia, bradycardia, faintness feel dizzy medications. More than 24,000 prescription drugs, over-the-counter medicines and natural products or magnesium orally... Symptoms, may occur of active ingredients promethazine hydrochloride/codeine phosphate 6.25mg-10mg/5mL syrup as a sedative or sleep aid latest news. This medicine and the timing of your dose will depend on the condition being treated consultar... 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares various therapeutic.! Awake and alert an increased susceptibility to dystonias with the dosing syringe provided, or sodium or magnesium sulfate as! Develops, manufactures and markets a broad portfolio of both branded and generic aseptic injectable products no. 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Doc-1 Max other medications Drugs.com provides accurate and independent information on more 24,000! To meperidine or other analgesics for control of nausea and vomiting associated with types. Symptoms, may occur it provides clinically useful sedative and antiemetic effects para comprar Fasarax o sus genricos,! That may impair your thinking or reactions it is about equal to codeine in depressing the cough.!
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