IODIXANOL injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IODIXANOL (UNII: HW8W27HTXX) (IODIXANOL - UNII:HW8W27HTXX)

Available from:

FRESENIUS KABI USA, LLC

Administration route:

INTRAVASCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Iodixanol injection is indicated in for: Adult and pediatric patients 12 years of age and older - (270 mg Iodine/mL and 320 mg Iodine/mL) intra-arterial digital subtraction angiography (IA-DSA). - (320 mg Iodine/mL) angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography. Pediatric patients less than 12 years of age - (320 mg Iodine/mL) angiocardiography, cerebral arteriography, and visceral arteriography. Adult and pediatric patients 12 years of age and older - (270 mg Iodine/mL and 320 mg Iodine/mL) CT imaging of the head and body. - (270 mg Iodine/mL and 320 mg Iodine/mL) excretory urography. - (270 mg Iodine/mL) peripheral venography. - (320 mg Iodine/mL) coronary computed tomography angiography (CCTA) to assist in the diagnostic evaluation of patients with suspected coronary artery disease. Pediatric patients less than 12 years of age - (270 mg Iodine/mL) CT imaging of the head and body. - (270 mg Iodine/

Product summary:

Iodixanol injection, USP is a ready-to-use sterile, pyrogen-free, preservative free, colorless to pale yellow solution available in two (2) strengths. It is supplied in the following configurations: Iodixanol Injection, USP, 270 mg Iodine/mL: Iodixanol Injection, USP, 320 mg Iodine/mL: Protect iodixanol injection, USP from direct exposure to sunlight. Store iodixanol injection, USP at controlled room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Iodixanol injection, USP may be stored in a contrast media warmer for up to one month at 37°C (98.6°F). Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container. DO NOT USE IF TAMPER-EVIDENT RING IS BROKEN OR MISSING.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IODIXANOL- IODIXANOL INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IODIXANOL INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR IODIXANOL
INJECTION.
IODIXANOL INJECTION, FOR INTRA-ARTERIAL OR INTRA-VENOUS USE
INITIAL U.S. APPROVAL: 1996
WARNING: NOT FOR INTRATHECAL USE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
INADVERTENT INTRATHECAL ADMINISTRATION MAY CAUSE DEATH,
CONVULSIONS/SEIZURES, CEREBRAL
HEMORRHAGE, COMA, PARALYSIS, ARACHNOIDITIS, ACUTE RENAL FAILURE,
CARDIAC ARREST,
RHABDOMYOLYSIS, HYPERTHERMIA, AND BRAIN EDEMA. (4, 5.1)
RECENT MAJOR CHANGES
Warnings and Precautions, Thyroid Dysfunction in Pediatric Patients 0
to 3 Years of Age (5.8)
04/2023
INDICATIONS AND USAGE
Iodixanol injection is a radiographic contrast agent indicated for the
following:
INTRA-ARTERIAL PROCEDURES ( 1.1)
Adults and pediatric patients 12 years of age and over
Intra-arterial digital subtraction angiography (270 mg Iodine/mL and
320 mg Iodine/mL).
Angiocardiography (left ventriculography and selective coronary
arteriography), peripheral
arteriography, visceral arteriography, and cerebral arteriography (320
mg Iodine/mL).
Pediatric patients less than 12 years of age
Angiocardiography, cerebral arteriography, and visceral arteriography
(320 mg Iodine/mL).
INTRAVENOUS PROCEDURES ( 1.2)
Adults and pediatric patients 12 years of age and over
Computed tomography (CT) imaging head and body (270 mg Iodine/mL and
320 mg Iodine/mL).
Excretory urography (270 mg Iodine/mL and 320 mg Iodine/mL).
Peripheral venography (270 mg Iodine/mL).
Coronary computed tomography angiography (CCTA) to assist diagnostic
evaluation of patients with
suspected coronary artery disease (320 mg Iodine/mL).
Pediatric patients less than 12 years of age
CT imaging of the head and body (270 mg Iodine/mL).
Excretory urography (270 mg Iodine/mL).
DOSAGE AND ADMINISTRATION
Individualize the combination of volume and concentrat