ISOVUE-200 Dosage & Rx Info | Uses, Side Effects

Isovue-200 Generic Name & Formulations

Legal Class

General Description

Iopamidol 408mg/mL; soln for intravascular administration; contains sodium 0.029mg, organically bound iodine 200mg per mL.

Pharmacological Class

Nonionic radiopaque contrast media.

How Supplied

ISOVUE-200: Single dose vials (50mL)—10, Single dose bottles (200mL)—10; ISOVUE-250: Single dose vials (50mL)—10, Single dose bottles (100mL)—10; ISOVUE-300: Single dose vials (30mL, 50mL)—10, Single dose bottles (100mL, 150mL)—10; ISOVUE-370: Single dose vials (50mL)—10, Single dose bottles (75mL, 100mL, 125mL, 150mL)—10

Manufacturer

Bracco Diagnostics

Mechanism of Action

lopamidol enhances computed tomographic brain imaging through augmentation of radiographic efficiency. The degree of enhancement of visualization of tissue density is directly related to the iodine content in an administered dose; peak iodine blood levels occur immediately following rapid injection of the dose. In CECT head imaging, iopamidol does not accumulate in normal brain tissue due to the presence of the blood-brain barrier. In nonneural tissues (during computed tomography of the body), iopamidol diffuses rapidly from the vascular into the extravascular space.

Isovue-200 Indications

Indications

For angiography throughout the cardiovascular system, including cerebral and peripheral arteriography, coronary arteriography and ventriculography, pediatric angiocardiography, selective visceral arteriography and aortography, peripheral venography (phlebography), and adult and pediatric intravenous excretory urography and intravenous adult and pediatric contrast enhancement of computed tomographic (CECT) head and body imaging.

Isovue-200 Dosage and Administration

Adults and Children

See full labeling regarding dosing based on procedure.

Isovue-200 Contraindications

Not Applicable

Isovue-200 Boxed Warnings

Boxed Warning

Not for intrathecal use.

Isovue-200 Warnings/Precautions

Warnings/Precautions

Risk of serious adverse reactions due to inadvertent intrathecal administration. Should be administered by professional trained in use of radiopaque agents in appropriate facilities with emergency treatment readily available. Avoid angiography with homocystinuria. Suspected thrombosis, phlebitis, severe ischemic disease, local infection: caution with venography. Renal or hepatic impairment. Anuria. CHF. Pulmonary hypertension. Multiple myeloma or other paraproteinemia. Homozygous sickle cell disease. Pheochromocytoma. Hyperthyroidism. Thyroid dysfunction (esp. children 0–3yrs); monitor. Diabetes. Myasthenia gravis. Anesthetized patients. Severe arterial or venous disease. Avoid extravasation. Maintain hydration. Elderly. Pregnancy. Nursing mothers.

Isovue-200 Pharmacokinetics

Elimination

Renal. Half-life: ~2 hours.

Isovue-200 Interactions

Interactions

Recently received cholecystographic agents in patients with hepatic or biliary disorder; increased risk of renal toxicity. Do not mix with other drugs. Radioactive iodine uptake studies may not accurately reflect thyroid function for up to 16 days.

Isovue-200 Adverse Reactions

Adverse Reactions

Cardiovascular (eg, arrhythmia, arterial spasms, flushing, vasodilation, chest pain, cardiopulmonary arrest), CNS (eg, confusion, paresthesia, dizziness, temporary cortical blindness, temporary amnesia, convulsions, paralysis, coma), respiratory (eg, increased cough, sneezing, asthma, apnea, laryngeal edema, chest tightness, rhinitis), skin and appendages (eg, inj site pain, pallor, periorbital edema,facial edema), urogenital (eg, pain, hematuria), eye (eg, watery itchy eyes, lacrimation, conjunctivitis), musculoskeletal (eg, muscle spasm, involuntary leg movement), tremors, malaise, anaphylactoid reaction, pain, severe retching and choking, abdominal cramps, hypothyroidism.

Isovue-200 Clinical Trials

See Literature

Isovue-200 Note