Oxilan

DRUG DESCRIPTION

OXILANŽ (ioxilan (ioxilan) ) (loxilan (ioxilan (ioxilan) ) Injection) formulations are stable, aqueous, sterile, and non-pyrogenic solutions for intravascular administration as diagnostic radiopaque media. Ioxilan (ioxilan (ioxilan) ) is designated chemically as N-(2,3-dihydroxypropyl)-N'-(2-hydroxyethyl)-5-[N-(2,3-dihydroxypropyl) acetamido]-2,4,6-triiodoisophthal-amide and has the following structural formula:

OXILANŽ (loxilan) structural formula illustration

The molecular weight of Ioxilan (ioxilan (ioxilan) ) is 791.12 and the organically bound iodine content is 48.1%. loxilan (ioxilan (ioxilan) ) is nonionic and does not dissociate in solution.

Each mL of OXILAN (ioxilan (ioxilan) ) Ž (loxilan Injection) 300 mgl/mL provides 623 mg ioxilan.

Each mL of OXILANŽ (Ioxilan Injection) 350 mgI/mL provides 727 mg ioxilan.

Each mL of OXILANŽ (ioxilan (ioxilan (ioxilan) ) ) solution contains 0.576 mg citric acid anhydrous, 0.561 mg edetate calcium disodium, and a minimum of 0.22 mg (0.01 mEq) sodium. The pH is adjusted to 6.8 (6.0 to 7.5) with sodium hydroxide and carbon dioxide. The solutions contain no preservative.

Pertinent physicochemical data are below. OXILANŽ (Ioxilan (ioxilan (ioxilan) ) Injection) is hypertonic compared to plasma (approximately 285 mOsnVkg water).

Concentration (mgI/mL) Concentration W/V
300 350
Measured Osmolality (mOsm/kg water) @ 37°C 585 695
Viscosity (cPs)
    @ 37°C
    @ 20°C

5.1
9.4

8.1
16.3
Specific Gravity @ 37°C 1.303 1.372

The OXILANŽ (ioxilan (ioxilan (ioxilan) ) ) formulations are clear, colorless to pale yellow solutions containing no undissolved solids. Crystallization does not occur at room temperature. OXILANŽ (ioxilan (ioxilan (ioxilan) ) ) solutions have osmolalities of 2.1 and 2.4 times that of plasma (285 mOsm/kg water) and are hypertonic under conditions of use.



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