Description

VISIPAQUE is a specialized radiographic contrast medium designed for intravascular use, featuring the active ingredient iodixanol. This nonionic, dimeric, water-soluble compound is known for its isosmolar properties, making it suitable for a wide range of radiographic imaging procedures in both adults and pediatric patients, including neonates.

Formulation

• Concentrations Available:
• 150 mg iodine/mL (in some markets)
• 270 mg iodine/mL
• 320 mg iodine/mL
• Excipients Include: Sodium chloride, calcium chloride dihydrate, tromethamine, edetate calcium disodium, sodium hydroxide, and hydrochloric acid for pH adjustment.
• pH Range: 6.8 to 7.7
• Osmolality: 290 mOsm/kg H₂O, isotonic with plasma
• Viscosity at 37°C: 3.2 mPa·s (270 mg I/mL) and 11.4 mPa·s (320 mg I/mL)

This formulation is supplied as a sterile, pyrogen-free, colorless to pale yellow injectable solution, with no preservatives, ensuring safety and efficacy.

Indications

VISIPAQUE is intended for use in various imaging procedures such as:

• Angiocardiography
• Cerebral and visceral arteriography
• Peripheral arteriography and venography
• Excretory urography
• Contrast-enhanced computed tomography (CT) of the head and body
• Coronary CT angiography (CCTA)
• Digital subtraction angiography
• Gastrointestinal studies in children

Administration

Administered via intravascular injection, VISIPAQUE requires careful dosage management. For adults, the dose typically aligns with 1 mL/kg, not exceeding 100 mL for certain procedures. Pediatric dosing is weight-based, with specific recommendations varying by age and procedure.

• Use: Single-dose containers, with solutions to be used within 4 hours of opening.
• Preparation: May be warmed to body or room temperature before use.
• Mixing: Avoid mixing with other drugs in the same syringe or infusion.

Pharmacokinetics

VISIPAQUE is not metabolized and is primarily excreted unchanged in urine, with about 97% eliminated within 24 hours in adults. It has an elimination half-life of approximately 2 hours in adults and 2 to 4 hours in children, varying by age.

Storage

Store VISIPAQUE at controlled room temperature (20°C to 25°C), protect from light, and do not freeze. Inspect the solution for particulate matter and discoloration before use. The product may be warmed to body temperature prior to administration, with a shelf life of up to 3 years, depending on packaging and storage conditions.

Contraindications and Precautions

Contraindications include hypersensitivity to iodixanol, iodine, or any excipients, manifest thyrotoxicosis, and intrathecal administration. Precautions should be taken to manage risks such as hypersensitivity reactions, acute kidney injury, and thyroid dysfunction, particularly in vulnerable populations.

Adverse Effects

Common adverse effects include headache, dizziness, nausea, and injection site discomfort. Serious reactions may involve hypersensitivity, severe skin reactions, and cardiovascular events. Special care is advised for pediatric patients, pregnant or lactating women, and the elderly.

Drug Interactions

Interactions may occur with medications such as metformin, beta-blockers, and nephrotoxic drugs, affecting outcomes and necessitating careful management.

Overdose Management

In case of overdose, supportive care is essential, particularly for pulmonary and cardiovascular effects. VISIPAQUE is dialyzable, providing an option for management in such scenarios.