Atracurium besylate injection contains atracurium besilate 10 mg, in each ml. Cisatracurium pretreatment with tourniquet reduces propofol injection pain. Discard unused portion of the 5 ml and 20 ml singledose vials. Cisatracurium besylate injection is a colorless to slightly yellow or greenishyellow solution. Cisatracurium besylate is one of 10 isomers of atracurium besylate.
Indian atracurium besylate injection export data covers valuable information for traders like bill of entry date, hs code, date of shipment, product description, indian exportport name, value and quantity of product. Atracurium besilate, also known as atracurium besylate, is a medication used in addition to other medications to provide skeletal muscle relaxation during surgery or mechanical ventilation. Atracurium besylate injection, usp, each ml containing 10 mg atracurium besylate is a sterile, nonpyrogenic, clear, colorless solution free from visible particles. Read all of this leaflet carefully before you start receiving. Initially 300600 microgramskg, then by intravenous injection 100200 microgramskg as required, alternatively by intravenous injection initially 300600 microgramskg, followed by by intravenous infusion 300600 microgramskghour. For continuous iv infusion, dilute atracurium besylate injection to the desired concentration usually 0. Atracurium besylate is an intermediateduration, nondepolarizing, skeletal muscle relaxant for intravenous administration. Atracurium besylate injection is available in generic form. Meitheal is an injectable drug company located in chicago, illinois. Tracrium atracurium dosing, indications, interactions. Atracurium besylate injection usp generic formulation. If you have any further questions, ask your doctor or pharmacist. Tracrium atracurium besylate injection is a sterile, nonpyrogenic aqueous solution.
If skin contact with the product formulation is likely, the use of latex or nitrile gloves is recommended. Upon removal from refrigeration to room temperature storage conditions 25c 77f, use atracurium besylate injection within 14 days even if rerefrigerated. The manufacturers of above mentioned scheduled formulations having maximum retail price higher than. To compare neuromuscular blockade and recovery characteristics of cisatracurium and atracurium in adult patients. Relaxation the dosage range recommended for adults is 0. Atracurium besylate injection fda prescribing information. It contains an amount of the transtransisomer equivalent to not less than 5. Atracurium besilate 10mgml solution for injection summary. However, we have demonstrated that separation of the main isomers of atracurium besylate. Atracurium besylate caspian tamin pharmaceutical company. Cisatracurium besilate is a bisbenzyltetrahydroisoquinolinium that has effect as a. Severe allergic reactions including fatal anaphylactic reactions may occur.
Atracurium besylate oel fastrac with ade affygility solutions. Dailymed cisatracurium cisatracurium besylate injection. Atracurium besylate injection page 6 of 19 between neuromuscular blocking agents has been reported in this class of drugs. Cisatracurium besylate injection, usp is a nondepolarizing skeletal muscle relaxant for intravenous administration. Atracurium is a nondepolarizing, intermediateduration, skeletal neuromuscular blocking agent. The solution also contains benzenesulfonic acid to adjust the ph. Dbl atracurium besylate injection package contents shelf life. Compared to other neuromuscular blocking agents, it is intermediate in its onset and duration of action. It has a role as a muscle relaxant and a nicotinic antagonist. Atracurium besylate drug information, uses, side effects.
Impurity profiling and inprocess testing of drugs for. Atracurium besylate injection is a skeletal muscle relaxant used in addition to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Atracurium besylate ab is supplied as a sterile, nonpyrogenic aqueous solution for intravenous use. Nondepolarizing agents antagonize the neurotransmitter action of acetylcholine by binding competitively to cholinergic receptor. Atracurium besylate injection, usp is a sterile, nonpyrogenic aqueous solution. Infusion solutions should be used within 24 hours of preparation. Pronunciation a tra kyoo ree um therapeutic category. Atracurium indications, dosage, side effects and precautions. Atracurium besylate all licensing, eu ctd dossiers. Lacks analgesic action and has no apparent effect on pain threshold, consciousness, or cerebration.
Water for injection reach annex iv exemptions from the obligations of register. A solid pharmaceutical composition comprising cisatracurium or a. M is the concentration of atracurium besylate, in mg per ml, in the test preparation. Inhibits neuromuscular transmission by binding competitively with acetylcholine to muscle end plate receptors. Pharmaceutical form dbl atracurium besylate injection is a clear, colourless or faint yellow, sterile solution for injection. Atracurium besilate injection should be used only by those skilled in the management of artificial respiration and only when facilities are immediately available for endotracheal intubation and.
Atracurium besylate, atracurium besylate manufacturers. Side effects of atracurium besylate injection atracurium. Atracurium besylate is indicated for induction of neuromuscular blockade, as an adjunct to general anesthesia, to facilitate endotracheal intubation, and to provide skeletal muscle relaxation during. Common side effects of atracurium besylate injection include. Atracurium besilate 10 mgml solution for injection is administered by intravenous injection and must not be administered intramuscularly. Atracurium by injection national library of medicine. Atracurium besylate finished formulations export data. Atracurium besylate infusion solutions may be prepared by admixing atracurium besylate injection with an appropriate diluent such as 5% dextrose injection, 0. Dbl atracurium besylate injection contains atracurium besilate 10 mg, in each ml. Pharmacology, adverse reactions, warnings and side effects. Indications and dosages adjunct to general anesthesia, to facilitate endotracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Generic atracurium besylate inn entry, pharmaceutical. It can also be used to help with endotracheal intubation but suxamethonium succinylcholine is generally preferred if this needs to be done quickly. Using a twocompartment pharmacokinetic model, the elimination half life was found to be 28. Sagent pharmaceuticals recalls atracurium besylate injection. Nondepolarising agents antagonise the neurotransmitter action of acetylcholine by binding competitively with cholinergic receptor sites on the motor endplate. Summaries for consumers techniques of intrauterine fetal transfusion for women with red. You can analyse the data and generate an analysis report like top exporters, buyers, and country of destination. Pdf impurity profiling and inprocess testing of drugs. Atracurium besylate injection is a sterile solution containing not less than 90. Given in general anesthesia only after unconsciousness has been induced by other drugs. Benzenesulfonic acid water for injections this medicine does not contain.
Atracurium besylate is indicated for induction of neuromuscular blockade, as an adjunct to general anesthesia, to facilitate endotracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. The lyophilized preparation contains benzene sulfonic acid cisatracurium besylate and a lyophilization excipient, a weight ratio of the lyophilization excipient to the benzene sulfonic acid cisatracurium besylate. Allergic reactions to atracurium or any component of the formulation. Atracurium medicines sps specialist pharmacy service. The plasma concentration values were obtained by high performance liquid chromatography.
Webmd provides common contraindications for atracurium intravenous. Atracurium besylate injection is a solution containing atracurium besylate, an intermediateduration, nondepolarizing, skeletal muscle relaxant for intravenous. Dosage depends on anesthetic used, individual needs, and response. Atracurium besylate injection, uspfor intravenous injection. Wo20189800a9 cisatracurium and betacyclodextrin derivative. Atracurium besylate injection atracurium besylate injection. The 5 ml and 10 ml vials each contain cisatracurium besylate, equivalent to 2 mgml cisatracurium. Jan 31, 2017 atracurium besilate injection should be used only by those skilled in the management of artificial respiration and only when facilities are immediately available for endotracheal intubation and for providing adequate ventilation support, including the administration of oxygen under positive pressure and the elimination of carbon dioxide. This drug should be used only by adequately trained individuals familiar with its actions, characteristics. Oct 01, 2019 atracurium besylate injection is a skeletal muscle relaxant used in addition to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Cisatracurium besylate injection, usp is a sterile, nonpyrogenic aqueous solution provided in 5 ml, 10 ml, and 20 ml vials. Drug name active ingredients strength dosage formroute marketing status te code rld rs. Eu einecselincs list 2317912 cerclasara 3 emission reporting atracurium besylate.
To address this issue, a program was initiated to investigate the individual isomer. Cisatracurium besylate injection may be diluted to 0. If you get any side effects, talk to your doctor or pharmacist. The generic name cisatracurium was conceived by scientists at burroughs wellcome co. Find out what health conditions may be a health risk when taken with atracurium intravenous. After administration of a recommended initial bolus dose of atracurium besylate injection 0. A pharmacokinetic study of atracurium besylate was performed in the pig after a single i. The ndc code 0409110502 is assigned to atracurium besylate also known as. Atracurium drug monograph pediatric care online aap. Atracurium besilate 10 mgml solution for injection vial. Atracurium besylate injection export data india with hs code. Atracurium besylate injection atracurium besylate injection rxlist. Chemical stability and adsorption of atracurium besylate injections in disposable plastic syringes. Atracurium besylate injection within 14 days even if rerefrigerated.
Find patient medical information for atracurium intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Tracrium injection is a clear, faintly yellow, sterile, aqueous solution in a glass ampoule containing 10 mgml atracurium besylate. Children may need more frequent maintenance doses than adult. M2 pharmamay 21, 2012sagent pharmaceuticals inc unveils skeletal muscle relaxant drug atracurium besylate injection c2012 m2 communications. Initially 300600 microgramskg, initial dose is optional, then by intravenous infusion 2701770 microgramskghour. Drug interactions atracurium besylate is potentiated by isoflurane and by enflurane anaesthesia, and marginally potentiated by halothane see dosage and administration. This medication provides relaxation of skeletal muscles during surgery. Atracurium besilate injection should be used only by those skilled in the management of artificial respiration and only when facilities are immediately available for endotracheal intubation and for providing adequate ventilation support, including the administration of oxygen under positive pressure and the elimination of carbon dioxide. Atracurium besylate is designated as 22carboxyethyl1, 2, 3, 4tetrahydro6,7dimethoxy2methyl1veratrylisoquinolinium b. After induction agent, dose of neuromuscular blocking drug nmba atracurium. Page 1 of 38 commentary second supplement to usp 35nf 30. Atracurium is a diester compound consisting of pentane1,5diol with both hydroxyls bearing 3,4dimethoxybenzyl6,7dimethoxy2methyl3,4dihydroisoquinolinium21hylpropanoyl groups.
The invention relates to a cisatracurium besylate lyophilized preparation composition stable at room temperature and a preparation method thereof. Dbl atracurium besylate injection atracurium besilate attracureeum consumer medicine information dbl atracurium besylate injection published by mims august 2019 1 what is in this leaflet please read this leaflet carefully before you are given dbl atracurium besylate injection atracurium. Atracurium atracurium besylate injection generic is a neuromuscularblocking agent, used as an adjuvant in anesthesia. Atracurium besylate injection usp generic formulation this drug should be used only by adequately trained individuals familiar with its actions, characteristics, and hazards. Atracurium besylate is a complex molecule containing four sites at which different stereochemical configurations can occur. Dbl atracurium besylate injection is a clear, colourless or faint yellow solution and comes in a glass ampoule. Atracurium besylate injection prescription and dosage sizes information for physicians and healthcare professionals. Dbl atracurium besylate injection atracurium besilate attracureeum consumer medicine information dbl atracurium besylate injection published by mims august 2019 1 what is in this leaflet please read this leaflet carefully before you are given dbl atracurium besylate injection atracurium, even if you have had this medicine before. In the event of an inadvertent temperature excursion the following data may be used. Atracurium is a nondepolarizing, intermediateduration, skeletal neuromuscular. Mar 30, 2018 atracurium besylate injection should be refrigerated at 2 to 8c 36 to 46f to preserve potency.
Atracurium besilate drug bnf content published by nice. Canada vigilance program by one of the following 3 ways. Chemical stability and adsorption of atracurium besylate. Atracurium besylate is the generic ingredient in four branded drugs marketed by aurobindo pharma ltd, baxter hlthcare, baxter hlthcare corp, hospira, hospira inc, meitheal, mylan. Atracurium 10 mgml solution for injection or infusion. Rate of loss in potency increases to approximately 5% per month at 25c 77f. Dbl atracurium besylate injection contains atracurium besylate as the active ingredient.
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