Dbl dexamethasone sodium phosphate injection nps medicinewise. The intravenous ld50 of dexamethasone sodium phosphate in female mice was 794 mgkg. Dexamethasone solution for injection contains sodium and sulphites. Dexamethasone sodium phosphate dsp is a salt of dexamethasone, a synthetic corticosteroid which possesses glucocorticoid activity. Transfer a definition portion of ophthalmic ointment, equivalent to 3 mg dexamethasone sodium phosphate ophthalmic ointment of dexamethasone phosphate, to a 150ml beaker. It is a steroid phosphate, an 11betahydroxy steroid, a 17hydroxy steroid, a 3oxodelta4 steroid, a fluorinated steroid and a tertiary alphahydroxy ketone. Dexamethasone sodium phosphate ophthalmic solution usp, 0. Jan 02, 2019 dexamethasone is a synthetic corticosteriod and possesses glucocorticoid activity. This medication is used to treat certain eye conditions due to inflammation or injury. 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. Dexamethasone sodium phosphate drug information chemocare. Absorption from localsites intraarticular,intralesionalisslowbutcomplete.
Dexamethasone sodium phosphate powder usp fagron, inc. Treatment of a wide variety of diseases and conditions principally for glucocorticoid effects as an antiinflammatory and immunosuppressant agent and for its effects on blood and lymphatic systems in the palliative treatment of various diseases. The invention provides a preparation method of dexamethasone sodium phosphate impurities i. Dexamethasone sodium phosphate api dmfs us drug master. 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. Dailymed dexamethasone sp dexamethasone sodium phosphate. Ophthalmic productsquality tests particulate and foreign. Dexamethasone sodium phosphate injection is supplied in 100 and 30 ml vials containing 4 mg of dexamethasone sodium phosphate per ml. Hexadrol phosphate injection dexamethasone sodium phosphate. Concerns continue to be raised about how the content and. Dexamethasone phosphate is a steroid phosphate that is the 21ophospho derivative of dexamethasone. The presence of accelerators, commonly used in the manufacture of rubber, mercaptobenzothiazole mbt, tetramethyl thiuram disulfide tmtd and.
Dosage of dexamethasone sodium phosphate is usually expressed in terms of dexamethasone phosphate. Dexamethasone sodium phosphate decadron, dexasone, diodex, hexadrol, maxidex glucocorticosteroid, how its given, how it works, precautions and self care tips for treatment of side effects from chemotherapy treatment. Cn106565810a preparation method of dexamethasone sodium. Dexamethasone sodium phosphate monograph for professionals. Dexamethasone sodium phosphate injection contains sodium sulfite, a sulfite that may cause allergic type reactions including anaphylactic symptoms and lifethreatening or less severe asthmatic episodes in certain susceptible people. Widelydistributed,crossestheplacenta,andappearstoenterbreast milk. Dexamethasone sodium phosphate injection drugfuture. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Phosphate injection dexamethasone sodium phosphate injection, usp description hexadrol phosphate injection dexamethasone sodium phosphate injection, usp is a watersoluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone sodium phosphate powder usp about fagron fagrons strategy is focused on the optimization and innovation of pharmaceutical compounding. Dbltm dexamethasone sodium phosphate injection 4 mgml solution for injection.
Solid dosage forms of dexamethasone sodium phosphate. Dosage of dexamethasone sodium phosphate is usually. Some medicines may increase the effects of dexamethasone phosphate solution and. The improved preparation method of the dexamethasone sodium phosphate intermediate comprises the following steps. Dsp is a white or slightly yellow crystalline powder which is particularly suitable for intravenous administration because it is highly water soluble. Dexamethasone phosphate stability and contamination of. There are two main issues with dexamethasone sodium phosphate injection. It has a role as a glucocorticoid receptor agonist. Dexamethasone sodium phosphate, c 22 h 28 fna 2 o 8 p, has a molecular weight of 516. It is also used to test for an adrenal gland disorder cushings syndrome. Dexamethasone sodium phosphate fda prescribing information. Request pdf nebulisation of dexamethasone sodium phosphate for the treatment of severe asthmatic horses background. To view the entire topic, please sign in or purchase a subscription. The oral ld 50of dexamethasone in female mice was 6.
Dexamethasone sodium phosphate chromatograms, and measure the responses for the major cream peaks. Dexamethasone is a fluorinated steroid that is 9fluoropregna1,4diene substituted by hydroxy groups at positions 11, 17 and 21, a methyl group at position 16 and oxo groups at positions 3 and 20. Dexamethasone sodium phosphate injection, usp pfizer. Dexamethasone phosphate 1 mgml eye drops, solution, preservative free dexamethasone phosphate as dexamethasone sodium phosphate read all of this leaflet carefully before you start using this medicine because it contains important information for you. Dexamethasone sodium phosphate injection, usp trade name. 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. It belongs to a class of drugs known as corticosteroids. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. The mechanism of action of dexamethasone is as a corticosteroid hormone receptor agonist.
A colourless solution when examined under suitable conditions of visibility, practically clear and practically free from particles. When given intramuscularly, dexamethasone sodium phosphate is absorbed much faster from the injection site than dexamethasone acetate. Dexamethasone sodium phosphate injection, usp dailymed. Dexamethasone sodium phosphate 2393234 whmis classification class d division 2 subdivision a very toxic material causing other toxic effects this product has been classified in accordance with the hazard criteria of the controlled products regulations cpr and the msds contains all of the information required by cpr. Jun 21, 2017 hexadrol phosphate injection dexamethasone sodium phosphate injection, usp is a watersoluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone sodium phosphate injection, usp, is a watersoluble inorganic ester of dexamethasone which produces a rapid response even when injected. Calculate the quantity, in mg, of c22h30fo8p in the portion of cream taken by the formula. Mylan manufactures dexamethasone sodium phosphate injection, usp dexamethasone sodium phosphate in strengths of 4 mg1 ml 4 mgml20 mg5 ml 4 mgml100 mg10 ml 10 mgml120 mg30 ml 4 mgml. Dexamethasone is a type of corticosteroid medication. Dexamethasone sodium phosphate cream contains an taining 45ml of isooctane.
Dexamethasone phosphate sodium salt safety data sheet according to regulation ec no. Dexamethasone sodium phosphate caution federal law restricts this drug to use by or on the order of a licensed. List of drug master files dmf of dexamethasone sodium phosphate active pharmaceutical ingredient api submitted to the u. A decrease in the morning cortisol of 20% or more from baseline had a 97. Dexamethasone sodium phosphate injection, usp 10 mgml drug. Dexamethasone works by relieving symptoms such as swelling, redness, and itching. Find patient medical information for dexamethasone sodium phosphate injection on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. It does not take the place of talking to your doctor or pharmacist. Pdf injectable dexamethasone sodium phosphate administered. Hexadrol dexamethasone sodium phosphate injection, usp. Pipet 5 ml of internal standard solution into the flask, and curr s mix to dissolve. Pemphigus ficiency may result from too rapid withdrawal of corticosteroids should be advised not. Sodium phosphate salt is rapidly absorbed after im administration.
Suspensions of dexamethasone sodium phosphate 4 mgml injection solution in a 1. Physical and chemical stability of dexamethasone sodium. The preparation method comprises the following steps that a mixture water solution of a compound 1 dexamethasone sodium phosphate and nahso3 is prepared according to the proportion of the mol ratio of 1. Dexamethasone sodium phosphate injection, the management of the disease in conjunction with administration should be recognized. 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. 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. Solutions used for intravenous administration or further dilution of this product should be preservativefree when used in the neonate, especially the. This leaflet answers some common questions about dbl dexamethasone sodium phosphate injection. Early sodium phosphate salt is rapidly absorbed after im administration.
Dexamethasone sodium phosphate injection, usp 10 mgml. Dexamethasone sodium phosphate usp, c22h28fna2o8p, has a molecular weight of 516. Dexamethasone sodium phosphate, j1100 dextran, j7100 dextrose saline normal, j7042 water, j7060, j7070 dextrostick, a4772 diagnostic radiology services, r0070r0076 dialysate concentrate additives, a4765 dialysate solution, a4728 dialysate testing solution, a4760 dialysis. Side effects of hexadrol dexamethasone sodium phosphate. 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.
Dexamethasone sodium phosphate usp chemical family. The invention provides an improved preparation method of a dexamethasone sodium phosphate intermediate. Dailymed dexamethasone sodium phosphate injection, solution. In use product safety assessment report for dexamethasone injection. Feb 11, 2020 dexamethasone sodium phosphate injection contains sodium sulfite, a sulfite that may cause allergic type reactions including anaphylactic symptoms and lifethreatening or less severe asthmatic episodes in certain susceptible people.
Concurrent use ofcorticosteroids with sodium phosphate may re. Dexamethasone sodium phosphate injection, usp 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 is a salt of dexamethasone that is particularly suitable for intravenous administration because it is highly water soluble, permitting administration of relatively large doses in a small volume of diluent. 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, ocular pain following ophthalmic surgery, and along with antibiotics in tuberculosis.
Route onset peak duration dexamethasone dexamethasone. Dexamethasone sodium phosphate an overview sciencedirect. Dexamethasone sodium phosphate injection has immunosuppressive doses of corticosteroids. Dexamethasone is a synthetic corticosteriod and possesses glucocorticoid activity. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication. Dexamethasone sodium phosphate injection, 10 mgml for intravenous and intramuscular injection only. Jun 21, 2017 hexadrol phosphate injection dexamethasone sodium phosphate is a corticosteroid used to treat a number of conditions including arthritis, bloodhormoneimmune system disorders, allergic reactions, certain skin and eye conditions, breathing problems, certain bowel disorders, and certain cancers.
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