Generic Name and Formulations:
Iopamidol 612mg/mL; soln for intravascular administration; contains sodium 0.043mg, organically bound iodine 300mg per mL.
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Indications for ISOVUE-300:
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.
Adults and Children:
See full labeling regarding dosing based on procedure.
Not for intrathecal use.
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. Thyroid disorder. Diabetes. Myasthenia gravis. Anesthetized patients. Severe arterial or venous disease. Avoid extravasation. Maintain hydration. Elderly. Pregnancy (Cat.B). Nursing mothers.
Nonionic radiopaque contrast media.
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.
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: Single dose vials (50mL)—10, Single dose bottles (200mL)—10; ISOVUE-250: Single dose vials (50mL)—10, Single dose bottles (100mL, 150mL)—10; ISOVUE-300: Single dose vials (30mL, 50mL)—10, Single dose bottles (75mL, 100mL, 150mL)—10; ISOVUE-370: Single dose vials (50mL)—10, Single dose bottles (50mL, 75mL, 100mL, 125mL, 150mL)—10
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