Sinografin (Diatrizoate Meglumine / Iodipamide Meglumine Intrauterine) - Description and Clinical Pharmacology

DESCRIPTION

Sinografin (Diatrizoate Meglumine and lodipamide Meglumine Injection) is a sterile, nonpyrogenic, essentially colorless to pale yellow, aqueous radiopaque contrast medium for intrauterine instillation. Each mL provides 527 mg diatrizoate meglumine and 268 mg iodipamide meglumine with 3.2 mg sodium citrate as a buffer, and 0.4 mg edetate disodium; pH has been adjusted to 7.0 to 7.8 with meglumine and diatrizoic acid. Each mL contains approximately 0.91 mg (0.04 mEq) sodium and 380 mg organically bound iodine. At the time of manufacture, the air in the container is replaced with nitrogen.

Diatrizoate meglumine is designated chemically as 1-deoxy-1-(methylamino)-D-glucitoI 3,5-diacetamido-2,4,6- triiodobenzoate (salt); iodipamide meglumine is 1-deoxy-1- (methylamino)-D-glucitoI 3,3´-(adipoyldiimino)bis[2,4,6- triiodobenzoate] (2:1) (salt). Structural formulas:

diatrizoate meglumine C₁₁H₉I₃N₂O₄• C₇H₁₇NO₅ MW 809.13

Organically Bound Iodine: 47.1% CAS-131-49-7

iodipamide meglumine C₂₀H₁₄I₆N₂O₆• 2C₇H₁₇NO₅ MW 1530.20

Organically Bound Iodine: 49.8% CAS-3521-84-4

CLINICAL PHARMACOLOGY

The most important characteristic of contrast media is the iodine content. The relatively high atomic weight of iodine contributes sufficient radiodensity for radiographic contrast of the uterus and uterine tubes with surrounding tissues.

Diagnostic intrauterine radiopaque agents have few known pharmacological effects. Most of the medium within the uterine cavity is discharged immediately upon termination of the procedure. Any medium retained in the uterine cavity is completely absorbed within one hour, unless there is an obstruction and large hydrosalpinx, in which case absorption is generally complete within 24 hours. Any medium spilled into the peritoneal cavity is absorbed within 20 to 60 minutes and excreted by both the hepatic and renal systems.