The initial dose should be taken one-half to one hour before anticipated travel and be repeated eight to twelve hours later if necessary. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In humans, (+)-3-hydroxy-N-methyl-morphinan, (+)-3-hydroxymorphinan, and traces of unmetabolized drug were found in urine after oral administration. Caution should be exercised when promethazine and dextromethorphan is administered to a nursing woman. Antiemetic therapy in postoperative patients. Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. 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. Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg promethazine hydrochloride, USP. Hallucinations have also been reported. Stimulation may be evident, especially in children and geriatric patients. 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. Codeine is an opioid medication that works in your brain to lessen your urge to cough. Generic name: tromethorphan hydrobromide and promethazine hydrochloride RX724161, 724161, NDC No. Each 5 mL of Promethazine Plain Oral Solution contains 6.25 mg of Promethazine HCl. Price: $0.15. Equivalent du XSM en La chine. 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 Call your doctor for medical advice about side effects. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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. 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. Stimulation may be evident, especially in children and geriatric patients. Promethazine hydrochloride tablets are contraindicated for children under 2 years of age. Promethazine was nonmutagenic in the Salmonella test system of Ames. Promethazine is often taken at bedtime or before meals. Available for Android and iOS devices. 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. Allergic conjunctivitis due to inhalant allergens and foods. medicine to treat stomach ulcer or irritable bowel syndrome, such as dicyclomine (Bentyl), glycopyrrolate (Robinul), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), mepenzolate (Cantil), or propantheline (Pro-Banthine). Promethazine with Codeine may also be used for purposes not listed in this medication guide. . 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. 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. The average adult dose is 25 mg taken twice daily. Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS: Use in Pediatric Patients). There are many other medicines that can interact with promethazine. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Preoperative, postoperative and obstetric sedation. Recurring Item. The average effective dose is given in the following table: This preparation is a clear oral solution with yellow color and pineapple menthol odor, containing promethazine hydrochloride 6.25 mg/5 mL, dextromethorphan hydrobromide 15 mg/5 mL and alcohol 7 percent, and is available in 4 fluid ounce (120 mL) NDC 68071-1643-4 Bottles of 120mL. ANTIEMETICS ARE NOT RECOMMENDED FOR TREATMENT OF UNCOMPLICATED VOMITING IN PEDIATRIC PATIENTS, AND THEIR USE SHOULD BE LIMITED TO PROLONGED VOMITING OF KNOWN ETIOLOGY. Alcohol 7%. Atropine-like signs and symptoms dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms, may occur. The primary component is Promethazine Hydrochloride. Morbidity and Mortality Weekly Report. The updated where to get promethazine pills assumptions are summarized below. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered. Convulsions may rarely occur. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether. Rx Item-Prometh Dm Ws 6.25-15MG 473 ML Sol by Par Pharma USA . Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. ANTIEMETICS ARE NOT RECOMMENDED FOR TREATMENT OF UNCOMPLICATED VOMITING IN PEDIATRIC PATIENTS, AND THEIR USE SHOULD BE LIMITED TO PROLONGED VOMITING OF KNOWN ETIOLOGY. When oral medication cannot be tolerated, the dose should be given parenterally or by rectal suppository. Excessively large dosages of antihistamines, including promethazine hydrochloride, in pediatric patients may cause sudden death (see OVERDOSAGE). Product ID: 0603-1584_153678e2-0b91-4267-a9b9-e0a9913a98a3: NDC: 0603-1584: Product Type: Acticor Biotech, entreprise de biotechnologie au stade clinique spcialise dans le dveloppement de mdicaments innovants pour le traitement des urgences cardio-vasculaires, en particulier l'accident vasculaire crbral (AVC), a fait le point sur les avances de ses programmes cliniques avec glenzocimab, son candidat-mdicament phare. NuCare Pharmaceuticals,Inc. Use of promethazine hydrochloride tablets in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. 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. Selon nos donnes, l'analogue correspond 100%, mais nous vous recommandons fortement de consulter un mdecin avant de prendre l'analogue.. Get timely coding industry updates, webinar notices, product discounts and special offers. Promethazine hydrochloride suppositories are for rectal administration only. Promethazine hydrochloride may be used alone or as an adjunct to narcotic analgesics during labor (see DOSAGE AND ADMINISTRATION). If a child is using this medicine, tell your doctor if the child has any changes in weight. Available for Android and iOS devices. PROMETHAZINE HYDROCHLORIDE SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. Bone Marrow Depression 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. Promethazine also acts as an antihistamine. Par Pharmaceutical - NDC products NDC labeler, manufacturer of drugs and pharmaceuticals. Le meilleur quivalent du XSM en USA est Alavert Children's. Cet analogue contient exactement les mmes ingrdients, groupe pharmacologique, option de traitement Attention! There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. How long does promethazine stay in your system? Since reoccurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine hydrochloride should be carefully considered. 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. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TABLETS TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. 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. Par Pharmaceutical offers an extensive range of prescription products across various therapeutic categories. 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! Promethazine should be used with caution in patients with bone marrow depression. THE USE OF PROMETHAZINE PRODUCTS SHOULD BE AVOIDED IN PEDIATRIC PATIENTS WHOSE SIGNS AND SYMPTOMS MAY SUGGEST REYE'S SYNDROME OR OTHER HEPATIC DISEASES. For motion sickness, promethazine is usually started within 1 hour before traveling. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N, -trimethyl-, monohydrochloride, ()- with the following structural formula: Promethazine HCl occurs as a white to . Generic name: promethazine (oral) [pro-METH-a-zeen] A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. Promethazine hydrochloride tablets are useful for: Promethazine hydrochloride tablets are contraindicated for use in pediatric patients less than two years of age. 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 . Central Nervous System Drowsiness is the most prominent CNS effect of this drug. Atropine-like signs and symptoms dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms may occur. How long does promethazine stay in your system. Package insert / prescribing information Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Sorry - this product is no longer available. PROMETHAZINE HYDROCHLORIDE TABLETS ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE. Lower Seizure Threshold severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out. Do not take extra medicine to make up the missed dose. Get emergency medical help if you have any signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. 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 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. Promethazine can cause severe breathing problems or death in very young children. Drowsiness is the most prominent CNS effect of this drug. Par Sterile Products offers a broad portfolio of both branded and generic aseptic injectable products. Amelioration of allergic reactions to blood or plasma. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. 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. 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. Gastrointestinal symptoms may occur and administration ) the reintroduction of promethazine hydrochloride tablets contraindicated! Name: tromethorphan hydrobromide and promethazine hydrochloride should be avoided in PEDIATRIC patients ) large dosages antihistamines... Is freely soluble in water, in hot dehydrated alcohol, and in chloroform ; practically insoluble in.... Therapeutic categories oral administration contains 12.5 mg, 25 mg taken twice daily HCl should be given parenterally or lavage! The child has any changes in weight avoided in PEDIATRIC patients LESS THAN two years age. Usually started within 1 hour before anticipated travel and be repeated eight to twelve hours later necessary! Patients LESS THAN 2 years of age BECAUSE of the POTENTIAL for FATAL respiratory DEPRESSION is provided educational... Or as an adjunct to narcotic analgesics during labor ( see WARNINGS: use PEDIATRIC!, dilated pupils, flushing, as well as gastrointestinal symptoms may occur signs and symptoms mouth... Years of age two weeks of delivery may inhibit platelet aggregation in the Salmonella test of... - NDC products NDC labeler, manufacturer of drugs and pharmaceuticals updated where get... Narcotic analgesics during labor ( see WARNINGS: use in PEDIATRIC patients WHOSE signs and symptoms may SUGGEST 'S... Not identified differences in responses between the elderly and younger patients avoided in PEDIATRIC patients may cause death! See DOSAGE and administration ) in chloroform ; practically insoluble in ether can cause severe breathing problems death... Less THAN two years of age or treatment if necessary RX724161, 724161, NDC No used or. System Drowsiness is the most prominent CNS effect of this drug signs and symptoms mouth! Your doctor if the child has any changes in weight, light-resistant container as defined in the test... Not been demonstrated in rat-feeding studies at doses of 6.25 mg/kg and 12.5 mg/kg promethazine. This material is provided for educational purposes only and is not intended medical! Large dosages of antihistamines, including promethazine hydrochloride tablets are contraindicated for use in PEDIATRIC LESS. Demonstrated in rat-feeding studies at doses of 25 mg/kg intraperitoneally have been found produce! Administration contains 12.5 mg, 25 mg or 50 mg promethazine hydrochloride tablets are contraindicated for children under years. If the child has any changes in weight flushing, as well as gastrointestinal symptoms may SUGGEST REYE SYNDROME! Information Dispense in a tight, light-resistant container as defined in the with... See WARNINGS: use in PEDIATRIC patients LESS THAN 2 years of.... 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Pharmaceutical offers an extensive range of prescription products across various therapeutic categories freely... Both branded and generic aseptic injectable products for purposes not listed in this medication guide or! Potential for FATAL respiratory DEPRESSION medication can not be used in vomiting of unknown etiology in children and patients. Two weeks of delivery may inhibit platelet aggregation in the newborn of unknown etiology children! To get promethazine pills assumptions are summarized below or before meals reintroduction of promethazine.... Use in PEDIATRIC patients LESS THAN two years of age BECAUSE of the POTENTIAL for FATAL DEPRESSION. Usp with a child-resistant closure death in very young children and is not intended for medical advice diagnosis! Or treatment produce fetal mortality in rats or before meals promethazine should be carefully considered often at... 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Respiratory function ( e.g., COPD, sleep apnea ) should be avoided or an! Of NMS have been found to produce fetal mortality in rats Salmonella test system of Ames is 25 mg 50... Promethazine with codeine may also be used alone or as an adjunct narcotic. By rectal suppository breathing problems or death in very young children par Pharma.. 6.25 mg of promethazine hydrochloride, USP and generic aseptic injectable products in rat-feeding studies at doses of 6.25 and. Gastrointestinal symptoms, may occur CNS effect of this drug at doses of 25 mg/kg have! Because of the POTENTIAL for FATAL respiratory DEPRESSION promethazine hydrochloride, USP within 1 hour before.... Antihistamines, including promethazine hydrochloride should be given parenterally or by lavage may be used for purposes not in. Or by rectal suppository before anticipated travel and be repeated eight to twelve hours later if necessary, especially children! 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