Dexamethasone sodium phosphate injection, 10 mgml for intravenous and intramuscular injection only. Dexamethasone sodium phosphate injection can be given directly from the vial, or it can be added to sodium chloride injection or dextrose injection and. Injection of a steroid into an infected site is to. Dexamethasone phosphate is a steroid phosphate that is the 21ophospho derivative of dexamethasone. In addition to binding to specific nuclear steroid receptors, dexamethasone also interferes with nfkb activation and apoptotic pathways. Find patient medical information for dexamethasone sodium phosphate injection on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Dexamethasone sodium phosphate less soluble steroids better for intraarticular injection triamcinolone acetonide or. Dexamethasone sodium phosphate injection, usp 4 mgml. Dexamethasone sodium phosphate injection, usp 10 mgml drug.
Identification of the substancemixture and of the co mpany produ ct i dentifie r product name. Cn101623291a dexamethasone sodium phosphate injection. Therefore, dbl dexamethasone sodium phosphate injection. Pdf injectable dexamethasone sodium phosphate administered. Concerns continue to be raised about how the content and. The use of hexadrol phosphate injection dexamethasone sodium phosphate injection, usp in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculosis regimen. Dexamethasone sodium phosphate c22h28fna2o8p pubchem. Suspensions of dexamethasone sodium phosphate 4 mgml injection solution in a 1. Ahydrocort, see hydrocortisone sodium phosphate akineton, see biperiden alatrofloxacin mesylate, ivection 100 mg iv. There are two main issues with dexamethasone sodium phosphate injection. Dexamethasone sodium injection anda 084916 s066 fda. Dexamethasone sodium phosphate injection serious neurologic events, some resulting in death, be instituted. Dexamethasone sodium phosphate injection,usp dailymed.
Dexamethasone sodium phosphate injection, usp 10 mgml dexamethasone sodium phosphate install pdr s official, free drug information and comparison app today. Hexadrol phosphate injection dexamethasone sodium phosphate. Dbl dexamethasone sodium phosphate injection is given as a slow injection or infusion intravenous drip into the veins. It occurs as a white or slightly yellow crystalline powder, is odorless or has a slight odor of alcohol, is exceedingly hygroscopic and is freely soluble in water. Tell your doctor if you are breastfeeding or plan to breastfeed. Dosage of dexamethasone sodium phosphate is usually expressed in terms of dexamethasone phosphate. In use product safety assessment report for dexamethasone injection summary of assessment and its findings background there are two main issues with dexamethasone sodium phosphate injection 1. Some medicines may increase the effects of dexamethasone phosphate solution and. Pdf the stability of 10 mgml dexamethasone sodium phosphate injection was evaluated using a validated, stabilityindicating liquid chromatographic method during 91 days storage in glass and 55 days storage in plastic syringes with rubber plungers. Dexamethasone trichinosis with neurologic or myocardial tuberculosis in which the corticosteroid is used for the slower rate of absorption by intramuscular. The immediate pain response following tfesi was only weakly associated with successful response in pain or functional improvement at twomonth followup spearman.
Find patient medical information for dexamethasone sodium phosphate ophthalmic on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Feb 11, 2020 dexamethasone sodium phosphate injection usp is a sterile, clear, colorless solution, free from visible particles and a watersoluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Immediately flush eyes with plenty of water for at least 15 to 20 minutes. Dexamethasone sodium phosphate injection, usp intended use of the produ ct. Compatibility and stability of dexamethasone sodium. Dexamethasone sodium phosphate injection has immunosuppressive doses of corticosteroids. Dexamethasone sodium phosphate injection is a sterile solution of dexamethasone sodium phosphate in water for injection.
Dexamethasone sodium phophate a synthetic adrenocortical steroid, is a white or slightly yellow crystalline. In neonates, especially the premature infant, only preservativefree solutions should be administered. Dexamethasone sodium phosphate injection is a sterile solution of dexamethasone sodium phosphate for intravenous and intramuscular use. Dexamethasone sodium phosphate is a sodium phosphate salt form of dexamethasone, a synthetic adrenal corticosteroid with potent antiinflammatory properties. Dexamethasone phosphate stability and contamination of. The 4 mgml strength may also be used for intraarticular, intralesional and soft tissue administration. Dexamethasone sodium phosphate injection, usp 4mgml equivalent to dexamethasone 3 mgml for intravenous use in horses only. The invention provides a dexamethasone sodium phosphate injection, which consists of 0. It is used in the treatment of many conditions, including rheumatic problems, a number of skin diseases, severe allergies, asthma, chronic obstructive lung disease, croup, brain swelling, and along with antibiotics in tuberculosis.
Dexamethasone sodium phosphate injection can be given directly from the vial, or it can be added to sodium chloride injection or dextrose injection and administered by intravenous drip. Dexamethasone sodium phosphate should be kept in a tightly closed container, 59 protected from light. Dexamethasone mylan may be administered intravenously or intramuscularly for systemic effect, or as an intrasynovial or soft tissue injection for local effect. Aug 01, 2019 dexamethasone sodium phosphate injection usp is a sterile, clear, colorless solution, free from visible particles and a watersoluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. In use product safety assessment report for dexamethasone injection. The other ingredients are glycerol, disodium edetate, water for injections and sodium hydroxide or phosphoric acid. Decadron phosphate injection prednisolone sodium phosphate 20 4. Dexamethasone sodium phosphate injection, 4 mg per ml.
Pipet 5 ml of internal standard solution into the flask, and curr s mix to dissolve. Dexiumsp 4mg injection dexamethasone sodium phosphate injection safety data sheet according to federal register vol. Important information about this medicine dexamethasone is a steroid medicine, prescribed for many different conditions including serious illnesse s. Dexamethasone sodium phosphate injection, usp 10 mgml.
Injection of a steroid into an infected site is to conventional. Dexamethasone sodium phosphate phosphate reagent bdissolve 350 mg of pmethylaminophenol sulfate in 50 ml of water, add 20 g of sodium bisulfite, mix to dissolve, and dilute with water to 100 ml. Alternatively, it can be added, without loss of potency, to sodium chloride, or dextrose, injection and given by intravenous infusion. Each ml dexamethasone sodium phosphate injection, usp preservedcontains dexamethasone sodium phosphate, usp equivalent to 10 mg dex. Dexamethasone phosphate as sodium is soluble 1 in 2 of water, slightly soluble in alcohol, practically. The stability of 10 mgml dexamethasone sodium phosphate injection was evaluated using a validated, stabilityindicating liquid chromatographic method during 91 days storage in glass and 55 days storage in plastic syringes with rubber plungers. Dexamethasone solution for injection contains sodium and sulphites. The presence of accelerators, commonly used in the manufacture of rubber, mercaptobenzothiazole mbt, tetramethyl thiuram disulfide tmtd and. Epidural steroid injections medications and dosages. Serious neurologic events, some resulting in death.
Dexamethasone sodium phosphate contains not less than 9796. Dexamethasone sodium phosphate injection, usp 4 mgml is a sterile solution for intravenous, intramuscular, intraarticular, intralesional and soft tissue administration. Even in the 61 absence of light it is gradually degraded on exposure to a humid atmosphere, the decomposition 62 being faster at higher temperatures. Dexamethasone sodium phosphate injection usp can be given directly.
Dbl dexamethasone sodium phosphate injection nps medicinewise. Forced degradation of dexamethasone sodium phosphate and ketamine hydrochloride dexamethasone sodium phosphate injection 10 mg2 ml was diluted to 1 mgml, and the diluted sample was acidified with concentrated hydrochloric acid to a ph of 1. Other preparations such as triamcinolone or dexamethasone may be used. These samples were analyzed for identification, ph, and strength. Diagnostic and therapeutic injection of the shoulder region. An approach to injection therapy internal medicine acp. Ophthalmic productsquality tests particulate and foreign. What dexamethasone solution for injection looks like and contents of the pack. It does not take the place of talking to your doctor or pharmacist. Dexamethasone sodium phosphate injection, usp, is a watersoluble inorganic ester of dexamethasone which produces a rapid response even when injected. Dailymed dexamethasone sodium phosphate injection, solution. Dexiumsp 4mg injection dexamethasone sodium phosphate. Dexamethasone sodium phosphate injection, usp dailymed.
Dexamethasone sodium phosphate is very hygroscopic. Dexamethasone sodium phosphate injection, usp, is a watersoluble inorganic ester of dexam ethasone which produces a rapid response even when injected intramuscularly. There is no evidence for complete clinical similarity between. Dexamethasone sodium phosphate should be administered at a rate of 24 mgkg i. Dexamethasone sodium phosphate injection, usp is a sterile solution of dexamethasone sodium phosphate, and is supplied in 4 mg ml and 10 mg ml. Dexamethasone sodium phosphate european pharmacopoeia 6. This medication is used to treat various conditions such as severe allergic reactions, arthritis, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders, and skin diseases. Important information about this medicine dexamethasone is a steroid medicine, prescribed for many different conditions including serious illnesse s you need to take it regularly to get the maximum benefit. Dexamethasone sodium phosphate injection, the management of the disease in conjunction with administration should be recognized. This leaflet answers some common questions about dbl dexamethasone sodium phosphate injection. Route onset peak duration dexamethasone dexamethasone. Dexlido kit dexamethasone sodium phosphate, lidocaine hydrochloride, povidine iodine. Dexamethasone sodium phosphate injection, usp safety data sheet according to federal register vol. Dexamethasone phosphate as sodium is a white or slightly yellow, very hygroscopic, crystalline powder.
Diagnostic and therapeutic injection of the shoulder. Dexamethasone sodium phosphate usp, c22h28fna2o8p, has a molecular weight of 516. Dbltm dexamethasone sodium phosphate injection 4 mgml solution for injection. Chondroitin sulfate sodium, shark dexamethasone sodium phosphate exenatide fluticasone propionate lotion hydrocodone bitartrate hydroflumethiazide tablets hydrogenated castor oil indomethacin sodium insulin glargine isoxsuprine hydrochloride injection meglumine methyldopa monoglyceride citrate nimodipine ondansetron orally disintegrating tablets. Transfer a definition portion of ophthalmic ointment, equivalent to 3 mg dexamethasone sodium phosphate ophthalmic ointment of dexamethasone phosphate, to a 150ml beaker. Presentation a clear aqueous solution for injection. Dexamethasone sodium phosphate solution for injection 4 mgml or 10 mgml may be added to 5% dextrose injection or 0. Obtain baseline 24hr urine for 17hydroxycorticosteroid. Mylan manufactures dexamethasone sodium phosphate injection, usp dexamethasone sodium phosphate in strengths of 4 mg1 ml 4 mgml20 mg5. Dexamethasone injection fda prescribing information.
Dexamethasone sodium phosphate usp dexamethasone rs injection usp dexamethasone phosphate rs identificationprepare a ph 9. Dbl dexamethasone sodium phosphate injection may pass into breast milk, and there is a possibility that the breastfed baby may be affected. Dexamethasone is a type of corticosteroid medication. Dexamethasone sodium phosphate injection, usprx only. To perform an lddst, dexamethasone or dexamethasone sodium phosphate can be used as long as calculations are based on the concentration of the active ingredient. Dexamethasone sodium phosphate injection usp is a sterile, clear, colorless solution, free from visible particles and a watersoluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Site syringe needle anesthetic corticosteroid injection mg glenohumeral joint 10 ml 25 gauge, 5 to 7 ml of 1% 1 to 2ml betamethasone sodium phosphate 150 to. It is also used to test for an adrenal gland disorder cushings syndrome. The other ingredients are sodium citrate, creatinine and water for injections. In treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day or 48 mg dexamethasone every other day for 1 month have been shown to be effective.
Dexamethasone injection different injection strengths. Stability of sterile dexamethasone acetate suspensions and. Dexamethasone sodium phosphate injection, usp pfizer. Dexamethasone injection fda prescribing information, side. Proceduredissolve about 50 mg of dexamethasone sodium phosphate, accurately weighed, in a mixture of 10 ml of water. Based on the responses, fda selected 21 samples of sterile dexamethasone acetate suspensions representing two manufacturers and 114 samples of dexamethasone sodium phosphate injection representing 11 manufacturers. Dbl dexamethasone sodium phosphate injection may be administered intravenously or intramuscularly for systemic effect, or as an intrasynovial or soft tissue injection for local effect.
Gubanich, md, mph kelsey logan, md, mph, faap, facp. Dexamethasone sodium phosphate injection market growth by top. It has a role as a glucocorticoid receptor agonist. Phosphate injection 4 mgml, contains dexamethasone sodium phosphate, usp equivalent to 4 mg dexamethasone phosphate. Dexamethasone sodium phosphate is a water ment of hypokalemia.
An approach to injection therapy ohio acp meeting october 17, 2014 columbus, oh paul j. Dexamethasone sodium phosphate, usp chemically is pregna1,4diene3,20dione, 9fluoro 11,17dihydroxy16methyl21phosphonooxy, disodium salt, 11 b, 16 a. Press release qy research, inc dexamethasone sodium phosphate injection market growth by top companies, trends by types and application, forecast to 2026fresenius kabi, hikma, mylan. If an immediate effect is required, dexamethasone sodium phosphate should be administered intravenously because it has a more rapid effect than the same preparation given intramuscularly. Concerns continue to be raised about how the content and dose of dexamethasone are. Patient safety is our primary concern, and we are committed to taking the necessary steps to protect. Dexamethasone sodium phosphate injection, usp mylan.
Intravenous administration includes all methods, such as gravity infusion, injections, and timed pushes. Dbl dexamethasone sodium phosphate injection should only. The var posting denotes various routes of administration and is used for drugs that are. Dexamethasone sodium phosphate an overview sciencedirect. Sodium phosphate salt is rapidly absorbed after im administration. To diagnose cushings syndrome, obtain baselinecortisollevel. It is a steroid phosphate, an 11betahydroxy steroid, a 17hydroxy steroid, a 3oxodelta4 steroid, a fluorinated steroid and a tertiary alphahydroxy ketone. It may also be given as an injection into an injured muscle or joint. Nonhazardous ingredients include water for injection and sodium citrate. When given intramuscularly, dexamethasone sodium phosphate is absorbed much faster from the injection site than dexamethasone acetate.
If preferred, it can be added to sodium chloride injection, or dextrose injection, or compatible blood for transfusion, without loss of potency, and administered by i. Use diluted solutions within 24 hours, as infusion solutions generally do not contain preservatives. Dbl dexamethasone sodium phosphate injection during pregnancy. Lidocaine may be administered if arrhythmias are present.
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