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Isovue-370 Generic Name & Formulations
Legal Class
Rx
General Description
Iopamidol 755mg/mL; soln for intravascular administration; contains sodium 0.053mg, organically bound iodine 370mg per mL.
Pharmacological Class
Nonionic radiopaque contrast media.
See Also
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, 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
Manufacturer
Isovue-370 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-370 Dosage and Administration
Adults and Children
See full labeling regarding dosing based on procedure.
Isovue-370 Contraindications
Not Applicable
Isovue-370 Boxed Warnings
Boxed Warning
Not for intrathecal use.
Isovue-370 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-370 Pharmacokinetics
See Literature
Isovue-370 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-370 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-370 Clinical Trials
See Literature
Isovue-370 Note
Not Applicable
Isovue-370 Patient Counseling
See Literature
