There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. 010632300: relabel(68071-1643) Drug facts, warnings, and ingredients follow. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine hydrochloride tablets and observed closely. (See WARNINGS Promethazine; Neuroleptic Malignant Syndrome.). Promethazine may lower seizure threshold. We NEVER sell or give your information to anyone. It works by preventing the effects of a substance called histamine, which is produced by the body. Do not take this medicine in larger or smaller amounts or for longer than recommended. PROMETHAZINE HYDROCHLORIDE TABLETS ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE. Dextromethorphan may produce central excitement and mental confusion. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether. PROMETHAZINE HYDROCHLORIDE SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. Includes: indications, dosage, adverse reactions and pharmacology. (see WARNINGS, Respiratory Depression.). All Rights Reserved. Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Neuroleptic Malignant Syndrome Acidosis and electrolyte losses should be corrected. Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Promethazine / codeine is a combination of two medications: promethazine and codeine. Dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) (see PRECAUTIONS, Drug Interactions). Also called. They both manufacture promethazine with codeine syrup so the only real significant difference is the taste and colour.. When your body is exposed to an allergen (pollen, animal dander, house dust etc. Get up slowly and steady yourself to prevent a fall. Promethazine hydrochloride tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Hematologic Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. Get timely coding industry updates, webinar notices, product discounts and special offers. CONCOMITANT ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC PATIENTS. 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. Since reoccurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine hydrochloride should be carefully considered. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Active and prophylactic treatment of motion sickness. Administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children. Only in cases of extreme overdosage or individual sensitivity do vital signs including respiration, pulse, blood pressure, temperature, and EKG need to be monitored. Promethazine and dextromethorphan should be given to a pregnant woman only if clearly needed. 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. Promethazine with Codeine may also be used for purposes not listed in this medication guide. Common promethazine side effects may include: drowsiness, dizziness; ringing in your ears; 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. The duration of action after oral administration is approximately three to six hours. If a child is using this medicine, tell your doctor if the child has any changes in weight. Stop using promethazine and call your doctor at once if you have: severe drowsiness, weak or shallow breathing; a light-headed feeling, like you might pass out; confusion, agitation, hallucinations, nightmares; jaundice (yellowing of the skin or eyes); uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); easy bruising or bleeding (nosebleeds, bleeding gums); sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, trouble swallowing; or. It is not known whether promethazine or dextromethorphan is excreted in human milk. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 3-06031-58658-3, 306031-586583, 306031586583, Category:RX, Generic Drug Classification . Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. Par Sterile Products offers a broad portfolio of both branded and generic aseptic injectable products. 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. PAR Pharmaceuticals. It is used to prevent (or treat) feelings of sickness (nausea). Rx Item-Promethazine DM Ws 6.25-15MG 473 ML sol by Par Pharma USA, Item No. Our focus is on therapeutically equivalent ANDA-based products, and others on a case-by-case basis. Package insert / prescribing information Drowsiness is the most prominent CNS effect of this drug. There are no adequate and well controlled studies of promethazine in pregnant women. Promethazine is in a group of drugs called phenothiazines (FEEN-oh-THYE-a-zeens). Promethazine was nonmutagenic in the Salmonella test system of Ames. The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. 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. How long does promethazine stay in your system. Promethazine Plain Syrup. Antiemetic therapy in postoperative patients. . CNS Depression PRINCIPAL DISPLAY PANEL. Par Pharmaceutical develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical and branded injectable products that help improve patient quality of life. Par, among the top leaders in the U.S. generics industry, possesses an expanding portfolio that includes sterile injectables, alternative dosage forms and . Promethazine hydrochloride tablets should be used cautiously in persons with cardiovascular disease or with impairment of liver function. The product's dosage form is solution and is administered via oral form. Administration of 12.5 mg to 25 mg promethazine hydrochloride by the oral route or by rectal suppository at bedtime will provide sedation in children. These could be early signs of dangerous side effects. The 50 mg also contains D&C Red # 27 Lake. We will gladly match any competitors' current advertised price. Company Type For Profit. if you have ever had a serious side effect while using promethazine or any other phenothiazine. 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 . Other reported clinical experience has not identified differences in responses between the elderly and younger patients. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. Phenergan, Promethegan, Phenadoz, Antinaus 50. Promethazine should not be given to a child younger than 2 years old. Neuroleptic malignant syndrome (potentially fatal) has also been reported (see WARNINGS, Neuroleptic Malignant Syndrome). Thus, concomitant administration of promethazine with dextromethorphan and MAO inhibitors should be avoided (see CONTRAINDICATIONS). 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 hydrochloride (see PRECAUTIONS, Information for Patients and Drug Interactions). Since 1978, Par Pharmaceutical has been at the forefront of developing, manufacturing, marketing and distributing safe . 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. PROMETHAZINE HYDROCHLORIDE SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. 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. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HYDROCHLORIDE BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED. Promethazine is an antihistamine, similar to products available over-the-counter like Benadryl, Claritin, Zyrtec, and Allegra. Side effects such as confusion and severe drowsiness may be more likely in older adults. We comply with the HONcode standard for trustworthy health information. 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. Number of Exits 2. Patients should be advised to report any involuntary muscle movements. All Rights Reserved. Increased or decreased blood pressure, tachycardia, bradycardia, faintness. Treatment of overdosage is essentially symptomatic and supportive. [] 3) Treatment of any concomitant serious medical problems for which specific treatments are available. tromethorphan hydrobromide and promethazine hydrochloride, Drug class: upper respiratory combinations. Promethazine hydrochloride in 12.5 mg to 25 mg doses for children and 50 mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep. 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). Limited experience with dialysis indicates that it is not helpful. Par Pharmaceutical develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical products that help improve patient quality of life. Promethazine is an antiallergic medication. Data sources include IBM Watson Micromedex (updated 6 Jan 2023), Cerner Multum (updated 11 Jan 2023), ASHP (updated 11 Jan 2023) and others. Do not start a new medication without telling your doctor. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Brand name: Phenergan Inactive Ingredients: Ascorbic acid, citric acid, D&C yellow #10, FD&C yellow #6, menthol, methylparaben, orange pineapple flavor, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose. Promethazine HCl is a racemic compound; the empirical formula is C 17 H 20 N 2 SHCl . 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 . The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated. severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out. Overdose symptoms may include overactive reflexes, loss of coordination, severe drowsiness or weakness, fainting, dilated pupils, weak or shallow breathing, or seizure (convulsions). ATOM 21 1 N1y N 24.1512 -19.0928 2 C8y C 25.3914 -19.7915 3 C8y C 22.9575 -19.7915 4 C1b C 24.1512 -17.6779 POST-MARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HYDROCHLORIDE IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP. 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, 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. Promethazine hydrochloride tablets, should be used with caution in patients with bone marrow depression. Cet analogue contient exactement les mmes ingrdients, groupe pharmacologique Attention! This causes watery eyes, runny or blocked nose, sneezing, skin rashes, itching etc. 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. Controlled: This . Acidosis and electrolyte losses should be corrected. Learn how to get the most out of your subscription. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Welcome to Gluten-Free Medications, your home for the latest confirmed gluten-free drugs and other medications. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Each teaspoon (5 mL) of Promethazine HCl Syrup Plain contains 6.25 mg promethazine HCl in a flavored syrup base with a pH between 4.7 and 5.2. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockage may further lower the blood pressure. Limited data suggest that use of promethazine HCl 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. Par promethazine with codeine vs Hi-Tech promethazine with codeine? Clinical studies of promethazine hydrochloride formulations did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Warnings, Neuroleptic Malignant Syndrome ) not take this medicine, tell your doctor about all your prescription and medications. Are CONTRAINDICATED for USE in a group of drugs called phenothiazines ( FEEN-oh-THYE-a-zeens.! Focus is on therapeutically equivalent ANDA-based products, and ingredients follow longer than recommended given to pregnant... 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