MD-76R diatrizoate meglumine and sodium solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIATRIZOATE MEGLUMINE (UNII: 3X9MR4N98U) (DIATRIZOIC ACID - UNII:5UVC90J1LK)

Available from:

Liebel-Flarsheim Company LLC

INN (International Name):

DIATRIZOATE MEGLUMINE

Composition:

DIATRIZOATE MEGLUMINE 660 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

MD-76R- DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM SOLUTION
LIEBEL-FLARSHEIM COMPANY LLC
----------
MARCH 2017
MD-76
R
[DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM INJECTION USP]
NOT FOR INTRATHECAL USE
DESCRIPTION
MD-76R (Diatrizoate Meglumine and Diatrizoate Sodium Injection USP) is
a radiopaque contrast agent
supplied as a sterile, aqueous solution. Intended for intravascular
administration, MD-76R contains 66%
w/v 1-deoxy-1-(methylamino)-D-glucitol 3,5-diacetamido-2,4,6,
triiodobenzoate (salt) and 10% w/v
monosodium 3,5-diacetamido-2,4,6, triiodobenzoate. The two salts have
the following structural
formulae:
Each mL provides 660 mg diatrizoate meglumine and 100 mg diatrizoate
sodium, 0.125 mg monobasic
sodium phosphate as a buffer and 0.11 mg edetate calcium disodium as a
sequestering agent. The pH has
been adjusted between 6.5 to 7.7 with either a meglumine and sodium
hydroxide combination, or
®
diatrizoic acid. Each mL contains approximately 3.65 mg (0.16 mEq)
sodium and 370 mg of organically
bound iodine. The viscosity of the solution is 16.4 cps at 25°C and
10.5 cps at 37°C. It is hypertonic to
blood with an osmolality of 1551 m0sm/Kg. At the time of manufacture,
the air in the container is
replaced by nitrogen.
CLINICAL PHARMACOLOGY
Following intravascular injection, MD-76R is rapidly transported
through the bloodstream 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
MD-76R were approximately 10 and
100 minutes, respectively.
Renal accumulation is sufficiently rapid that the period of maximal
opacification of the renal passages
may begin as early as 5 minutes after injection. In infants and small
children, excretion takes place
somewhat more promptly than in adults, so that