Description

VISIPAQUE is a specialized radiographic contrast medium designed for intravascular administration, utilizing the active ingredient Iodixanol. This nonionic, isosmolar, water-soluble solution is available in concentrations of 270 mg iodine/mL and 320 mg iodine/mL, providing versatility for various imaging needs.

Composition

Each milliliter of VISIPAQUE includes:

• Iodixanol
• Sodium chloride
• Calcium chloride dihydrate
• Tromethamine
• Edetate calcium disodium
• Water for injection

The solution's pH is carefully adjusted to between 6.8 and 7.7, ensuring compatibility with body fluids. It is free from preservatives, maintaining sterility and pyrogen-free quality.

Physical Characteristics

VISIPAQUE is characterized by its colorless to pale yellow appearance, with viscosity and osmolality closely resembling that of plasma. Its molecular formula is C35H44I6N6O15, with a molecular weight of 1550.20, and an iodine content of 49.1%.

Indications

This contrast agent is indicated for a wide range of radiographic imaging procedures in both adults and pediatric patients, including:

• Angiocardiography
• Cerebral arteriography
• Peripheral arteriography
• Contrast-enhanced computed tomography (CT)
• Digital subtraction angiography

Administration Guidelines

VISIPAQUE is intended for intravascular use only and should be administered using sterile techniques. It is contraindicated for intrathecal administration. The solution should be warmed to body or room temperature prior to use, and any unused portion must be discarded after a single procedure.

Pharmacokinetics

The agent is not metabolized and does not bind to plasma proteins, with primary excretion occurring through urine. In healthy adults, approximately 97% is excreted unchanged within 24 hours.

Contraindications and Precautions

Contraindications include hypersensitivity to iodixanol or iodine, and manifest thyrotoxicosis. Precautions should be taken for patients with renal impairment, cardiovascular conditions, or a history of hypersensitivity reactions.

Storage Instructions

VISIPAQUE should be stored below 30°C, protected from light, and not frozen. It can be kept in a contrast media warmer at 37°C for specified durations depending on the container type. The product is packaged in various formats, including glass vials and polypropylene bottles, with tamper-proof features to ensure integrity.

Mechanism of Action

Iodixanol functions by opacifying blood vessels and internal structures, enhancing radiographic imaging through its iodine content. This enhancement is crucial for accurate visualization during diagnostic procedures.