The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Promethazine hydrochloride tablets 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 hydrochloride. 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. Par Pharmaceutical develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical products that help improve patient quality of life. Promethazine is well absorbed from the gastrointestinal tract. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. Promethazine belongs to a group of medicines known as sedating antihistamines. ANTIEMETICS ARE NOT RECOMMENDED FOR TREATMENT OF UNCOMPLICATED VOMITING IN PEDIATRIC PATIENTS, AND THEIR USE SHOULD BE LIMITED TO PROLONGED VOMITING OF KNOWN ETIOLOGY. Very high doses may produce respiratory depression. Drinking alcohol can increase certain side effects of promethazine. 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). Equivalent du XSM en USA. The average effective dose of promethazine hydrochloride for the active therapy of nausea and vomiting in children or adults is 25 mg. It is not known whether promethazine or dextromethorphan is excreted in human milk. Headquarters Regions Greater Philadelphia Area, Great Lakes, Northeastern US. Codeine is an opioid (narcotic) cough suppressant. The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. 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. Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS: Use in Pediatric Patients). Descriptions. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Package insert / prescribing information THE EXTRAPYRAMIDAL SYMPTOMS WHICH CAN OCCUR SECONDARY TO PROMETHAZINE HYDROCHLORIDE ADMINISTRATION MAY BE CONFUSED WITH THE CNS SIGNS OF UNDIAGNOSED PRIMARY DISEASE, e.g., ENCEPHALOPATHY OR REYE'S SYNDROME. Neuroleptic malignant syndrome (potentially fatal) has also been reported (see WARNINGS, Neuroleptic Malignant Syndrome). Generic name: promethazine hydrochloride How does dry ice blasting work? The effect on later growth and development of the newborn is unknown. Drug classes: Antihistamines, Phenothiazine antiemetics. Avoid analeptics which may cause convulsions. A paradoxical reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Gastrointestinal Dry mouth, nausea, vomiting, jaundice. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP. Thus, concomitant administration of promethazine with dextromethorphan and MAO inhibitors should be avoided (see CONTRAINDICATIONS). 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. Chestnut Ridge, NY 10977, prednisone, fluticasone nasal, montelukast, loratadine, benzonatate, promethazine, Benadryl, diphenhydramine, Zyrtec, guaifenesin. Get timely coding industry updates, webinar notices, product discounts and special offers. Promethazine DM Cough Syrup, 6.25mg/15mg, 16oz Bottle $32.00 Item Code: 004890. It is labeled and distributed by Par Pharmaceutical. Promethazine with Codeine Oral Solution is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy . It is not known whether promethazine passes into breast milk or if it could harm a nursing baby. To make sure promethazine is safe for you, tell your doctor if you have: asthma, chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder; a weak immune system (bone marrow depression); enlarged prostate or problems with urination; low levels of calcium in your blood (hypocalcemia); or. Discover how to save hours each week. 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. Do not take this medicine in larger or smaller amounts or for longer than recommended. Be careful if you drive or do anything that requires you to be alert. Drowsiness is the most prominent CNS effect of this drug. Administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children. It is chemically designated as 3-methoxy-17-methyl-9, 13, 14-morphinan hydrobromide monohydrate. PAR and Hi-Tech are pharmaceutical manufacturers. Promethazine DM package insert / prescribing information for healthcare professionals. 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. 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. Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine hydrochloride in pediatric patients. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Promethazine is not for use in treating symptoms of asthma, pneumonia, or other lower respiratory tract infections. Codeine is an opioid medication that works in your brain to lessen your urge to cough. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. We also do power washing for your every day outside and equipment cleaning needs. Administration of promethazine hydrochloride has been associated with reported cholestatic jaundice. Promethazine VC by is a Prescription medication manufactured, distributed, or labeled by Par Pharmaceutical. Diazepam may be used to control convulsions. Promethazine Hydrochloride Promethazine Hydrochloride. Carefully follow your doctor's instructions when giving this medicine to a child of any age. 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 . Perennial and seasonal allergic rhinitis. If you do not have a dose-measuring device, ask your pharmacist for one. 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. 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. Acidosis and electrolyte losses should be corrected. 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. 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. Rx Item-Prometh Dm Ws 6.25-15MG 473 ML Sol by Par Pharma USA . Excessively large dosages of antihistamines, including promethazine hydrochloride, in pediatric patients may cause sudden death (see OVERDOSAGE). All Rights Reserved. Long-term animal studies have not been performed to assess the carcinogenic potential of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with this drug. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether. This causes watery eyes, runny or blocked nose, sneezing, skin rashes, itching etc. Promethazine hydrochloride tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Promethegan Description. Dosage form: oral solution 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. Dosage must be individualized. Available for Android and iOS devices. 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. Oral Pharmaceuticals / Promethazine DM Cough Syrup, 6.25mg/15mg, 16oz Bottle. 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). PAR Pharmaceuticals. How long does promethazine stay in your system? The duration of action after oral administration is approximately three to six hours. : 00603-1586-58, 00603-586-58, 0060358658, 00603158658, 1586-58, 158658 UPC No. Find many great new & used options and get the best deals for Avomin 25mg Tablets - 2 x 28 - RM24 at the best online prices at eBay! We will gladly match any competitors' current advertised price. It is about equal to codeine in depressing the cough reflex. Hematologic Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. Promethazine is in a group of drugs called phenothiazines (FEEN-oh-THYE-a-zeens). 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). 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. Available for Android and iOS devices. PARPHARM.COM 2021 Par Pharmaceutical. 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. Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates. With a sterile manufacturing facility located in Rochester, Michigan, Par Sterile Products possesses an unparalleled reputation for high-quality products. (See WARNINGS Promethazine; Respiratory Depression. Hallucinations have also been reported. Drug classes: Antihistamines, Phenothiazine antiemetics. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. 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. 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. ANTIEMETICS ARE NOT RECOMMENDED FOR TREATMENT OF UNCOMPLICATED VOMITING IN PEDIATRIC PATIENTS, AND THEIR USE SHOULD BE LIMITED TO PROLONGED VOMITING OF KNOWN ETIOLOGY. Promethazine was nonmutagenic in the Salmonella test system of Ames. Take the missed dose as soon as you remember. Dermatologic Dermatitis, photosensitivity, urticaria. Attention should be given to the re-establishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. No charge. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. Call your doctor if your symptoms do not improve, or if they get worse while using promethazine. 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. THE USE OF PROMETHAZINE PRODUCTS SHOULD BE AVOIDED IN PEDIATRIC PATIENTS WHOSE SIGNS AND SYMPTOMS MAY SUGGEST REYE'S SYNDROME OR OTHER HEPATIC DISEASES. Our impressive portfolio of prescription products is comprised of liquid, solids and semi-solids, among other dosage forms. All Rights Reserved. Select the Trade Name to see similar products. Children should be supervised to avoid potential harm in bike riding or in other hazardous activities. Ambulatory patients should be told to avoid engaging in such activities until it is known that they do not become drowsy or dizzy from promethazine and dextromethorphan therapy. The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Promethazine HCl is a racemic compound; the empirical formula is C17H20N2SHCl and its molecular weight is 320.88. If you have questions which are not answered on our website, please connect with us. In therapeutic dosage dextromethorphan does not inhibit ciliary activity. PAR promethazine with codeine is a purple syrup and Hi-Tech promethazine with codeine is a red syrup. 24/7 Online support. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Dextromethorphan is rapidly absorbed from the gastrointestinal tract and exerts its effect in 15 to 30 minutes. Do not start a new medication without telling your doctor. View Full Comparison #981867; 2,281; Grifols Therapeutics Inc (TDVAX) #13533013101; Td Vaccine 7 Years of Age and Older Tetanus and Diphtheria Toxoids Adsorbed Injection Single Dose Vial 0.5 mL #911398; 1,648; For more information, call 1-800-845-8210. . Promethazine Description. Drug class: Upper respiratory combinations. Free samples for all orders. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Carefully follow your doctor's instructions when giving this medicine to a child of any age. Promethazine hydrochloride, USP occurs as a white to faint yellowish crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. Severe hypotension usually responds to the administration of norepinephrine or phenylephrine. 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.

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