June 29, 2016
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Oxilan

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Oxilan

OXILAN
(ioxilan) Injection 300 mgI/mL
(Ioxilan) Injection 350 mgI/mL
(ioxilan Injection) 300 mgI/mL Pharmacy Bulk Package

Nonionic Contrast Agents

NOT FOR INTRATHECAL USE

PHARMACY BULK PACKAGE IS NOT FOR DIRECT INFUSION

DRUG DESCRIPTION

OXILAN® (Ioxilan Injection) formulations are stable, aqueous, sterile, and non- pyrogenic solutions for intravascular administration as diagnostic radiopaque media. 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:

OXILAN® (ioxilan)Structural Formula Illustration

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

OXILAN® (Ioxilan Injection) Pharmacy Bulk Package is available in two strengths: OXILAN® (Ioxilan Injection) 300 mgI/mL and OXILAN® (Ioxilan Injection) 350 mgI/mL.

Each mL of OXILAN® (Ioxilan Injection) 300 mgI/mL provides 623 mg ioxilan.

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

Each mL of OXILAN® (Ioxilan Injection) 300 mgI/mL Pharmacy Bulk Package provides 623 mg ioxilan.

Each mL of OXILAN® (Ioxilan Injection) 350 mgI/mL Pharmacy Bulk Package provides 727 mg ioxilan.

Each mL of OXILAN® solution contains 0.1 mg edetate calcium disodium (anhydrous basis), 1.0 mg tromethamine, 0.5 mg sodium chloride and a minimum of 0.2 mg (0.01 mEq) sodium. The pH is adjusted to 6.8 (5.5 to 7.5) with hydrochloric acid and sodium hydroxide. The solutions contain no preservative.

Pertinent physicochemical data are below. OXILAN® (Ioxilan Injection) is hypertonic compared to plasma (approximately 285 mOsm/kg water).

Concentration (mgI/mLclass="EmphTd" Concentration W/V
300 350
Measured Osmolality (mOsm/kg water) @ 37°C 610 721
Viscosity (cPs) @ 37°C 5.1 8.1
@ 20°C 9.4 16.3
Specific Gravity @ 37°C 1.319 1.373
@ 20°C 1.327 1.382

The OXILAN® formulations are clear, colorless to pale yellow solutions containing no undissolved solids. Crystallization does not occur at room temperature. OXILAN® solutions have osmolalities of 2.1 and 2.5 times that of plasma (285 mOsm/kg water) and are hypertonic under conditions of use.

Each bottle of OXILAN® Pharmacy Bulk Package is to be used for dispensing multiple single dose preparations utilizing a suitable transfer device.

Last reviewed on RxList: 5/2/2016
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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