Finished product reference
Iopamidol
Injection · Parenteral · 370 mg/1mL · 20 mL
- List code
- 13413
- Pharmacologic class
- Radiographic Contrast Agent
WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION Intrathecal administration of ISOVUE, even if inadvertent, can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema . ISOVUE is for intra-arterial, intravenous, or oral use only .
What it is and how it works
Mechanism class: X-Ray Contrast Activity
Indications
is a radiographic contrast agent indicated for: Intra-arterial Procedures † Cerebral arteriography in adults Peripheral arteriography in adults Selective visceral arteriography and aortography in adults Coronary arteriography and cardiac ventriculography in adults Angiocardiography in pediatric patients Intravenous Procedures † Excretory urography in adults and pediatric patients Computed tomography (CT) of head and body in adults and pediatric patients Peripheral venography in adults Oral Procedures † CT of the abdomen and pelvis to delineate the gastrointestinal tract in adults and pediatric patients † Specific concentrations are recommended for each type of imaging procedure.
Dosage and administration (summary)
Individualize the volume and concentration according to the specific dosing tables accounting for factors such as age, body weight, size of the vessel, and the rate of blood flow within the vessel. ( 2.2 , 2.3 , 2.4 , 2.5 ) See full prescribing information for important dosage and administration information and dilution instructions. ( 2.1 , 2.6 ) Important Dosing and Administration Information ISOVUE is for intra-arterial, intravenous, or oral use only. Do not administer intrathecally . Specific concentrations of ISOVUE are recommended for each type of imaging procedure . Individualize the volume, concentration, and rate of administration of ISOVUE according to the specific dosing tables .
Contraindications
None. None
Warnings and precautions
Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency resuscitation equipment and trained personnel available. Acute Kidney Injury: Acute injury including renal failure can occur. Use the lowest dose and maintain adequate hydration to minimize risk. Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after ISOVUE administration. Thyroid Dysfunction in Pediatric Patients 0 Years to 3 Years of Age: Individualize thyroid function monitoring based on risk factors such as prematurity.
Pregnancy
Pregnancy Risk Summary Available data from published literature and postmarketing cases from decades of use with iopamidol during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
Storage and supply
How Supplied ISOVUE (iopamidol) injection is a clear, colorless to pale yellow solution available in the following presentations: Concentration (mg Iodine/mL) Package Size Package Type Sale Unit NDC 200 200 mL Single-Dose Bottle Carton of 10 0270-1314-15 250 100 mL Single-Dose Bottle Carton of 10 0270-1317-02 300 30 mL Single-Dose Vial Carton of 10…
Source: Iopamidol (Isovue 200) — US FDA prescribing information, 2026-03-10, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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