Iopamidol

Generic Name: iopamidol

Radiographic Contrast Agent [EPC]Over-the-Counter (OTC)

Brand Names:

Isovue-m

11 DESCRIPTION ISOVUE-M (iopamidol) injection is a radiographic contrast agent for intrathecal use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6- triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17 H 22 I 3 N 3 O 8, and the following structural formula: ISOVUE-M is a sterile, clear, colorless to pale yellow solution available in two concentrations of iodine: ISOVUE-M 200 mg iodine/mL: Each mL contains 40...

Overview

Uses

1 INDICATIONS AND USAGE ISOVUE-M is indicated for: Lumbar and thoracic myelography, and computed tomography (CT) myelography in adults and pediatric patients aged 2 years and older Cervical and total columnar myelography and CT myelography in adults CT cisternography in adults Specific concentrations of ISOVUE-M are recommended for each type of imaging procedure [see Dosage and Administration ( 2.2 , 2.3 )]. ISOVUE-M is a radiographic contrast agent indicated for: Lumbar and thoracic myelography and computed tomography (CT) myelography in adults and pediatric patients aged 2 years and older Cervical and total columnar myelography in adults CT cisternography in adults ( 1 ) Specific concentrations of ISOVUE-M are recommended for each type of imaging procedure. ( 2.2 , 2.3 )

Dosage

2 DOSAGE AND ADMINISTRATION Individualize the volume and concentration of ISOVUE-M according to the specific dosing tables based on patient age, body weight, and study to be performed. ( 2.2 , 2.3 ) See full prescribing information for important dosage and administration information. ( 2.1 ) 2.1 Important Dosage and Administration Information ISOVUE-M is for intrathecal use only. Specific concentrations of ISOVUE-M are recommended for each type of imaging procedure [see Dosage and Administration ( 2.2 , 2.3 )]. Individualize the volume, concentration, and injection rate of ISOVUE-M according to the dosing tables [see Dosage and Administration ( 2.2 , 2.3 )].

Side Effects

6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Acute Kidney Injury [see Warnings and Precautions ( 5.2 )] Increased Risk of Seizures [see Warnings and Precautions ( 5.3 )] Cardiovascular Adverse Reactions [see Warnings and Precautions ( 5.4 )] Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age [see Warnings and Precautions ( 5.6 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (incidence > 1%) are headache, nausea, vomiting, back pain, leg pain, neck pain, and hypotension. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc.

Warnings

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency resuscitation equipment and trained personnel available. ( 5.1 ) Acute Kidney Injury: Acute injury including renal failure can occur. Use the lowest dose and maintain adequate hydration to minimize risk. ( 5.2 ) Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after ISOVUE-M administration. ( 5.4 ) Thyroid Dysfunction in Pediatric Patients 0 Years to 3 Years of Age: Individualize thyroid function monitoring based on risk factors such as prematurity. ( 5.6 ) 5.1 Hypersensitivity Reactions ISOVUE-M can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis. 4 CONTRAINDICATIONS None. None ( 4 )

Storage

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ISOVUE-M (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 10 mL Single-Dose Vial Carton of 10 0270-1411-11 300 15 mL Single-Dose Vial Carton of 10 0270-1412-15 Storage and Handling Store at 20°C to 25°C (68°F to 77°F...

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.