Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
IOTHALAMATE MEGLUMINE (UNII: XUW72GOP7W) (IOTHALAMIC ACID - UNII:16CHD79MIX)
Liebel-Flarsheim Company LLC
IOTHALAMATE MEGLUMINE
IOTHALAMATE MEGLUMINE 300 mg in 1 mL
PRESCRIPTION DRUG
New Drug Application
CONRAY 30- IOTHALAMATE MEGLUMINE INJECTION LIEBEL-FLARSHEIM COMPANY LLC ---------- MARCH 2017 CONRAY 30 (IOTHALAMATE MEGLUMINE INJECTION USP 30%) NOT FOR INTRATHECAL USE DESCRIPTION Conray 30 is a sterile aqueous solution intended for use as a diagnostic radiopaque medium. Conray 30 contains 30% w/v iothalamate meglumine which is 1-deoxy-1-(methylamino)-D-glucitol 5-acetamido- 2,4,6 triiodo-N-methylisophthalamate (salt), and has the following structural formula: Each milliliter contains 300 mg of iothalamate meglumine, 0.110 mg edetate calcium disodium as a stabilizer and 0.125 mg of monobasic sodium phosphate as a buffer. The solution contains approximately 0.04 mg sodium in each milliliter (12 mg/300 mL) and provides 14.1% (141 mg/mL) organically bound iodine (42.3 grams/300 mL). Conray 30 has an osmolarity of approximately 500 mOsmol per liter, an osmolality of approximately 600 mOsmol per kilogram and is, therefore, hypertonic under conditions of use. The viscosity (cps) is approximately 2 at 25°C and 1.5 at 37°C. The pH is 6.5 to 7.7. Conray 30 is a clear solution containing no undissolved solids. Crystallization does not occur at normal room temperatures. It is supplied in containers from which the air has been displaced by nitrogen. CLINICAL PHARMACOLOGY Following intravascular injection, Conray 30 is rapidly transported through the circulatory system to the kidneys and is excreted unchanged in the urine by glomerular filtration. The pharmacokinetics of intravascularly administered radiopaque contrast media are usually best described by a two compartment model with a rapid alpha phase for drug distribution and a slower beta phase for drug elimination. In patients with normal renal function, the alpha and beta half-lives of Conray 30 were approximately 10 and 90 minutes, respectively. Following infusion of Conray 30, the upper and lower urinary tract is opacified. Renal accumulation is sufficiently rapid that maximum radiographic density in the calyces and pelves occurs by the time the infusion is complet Olvassa el a teljes dokumentumot