ISOVUE 370 755 mg/mL
IOPAMIDOL · INJECTION, SOLUTION · BRACCO DIAGNOSTICS INC
ISOVUE 370 is a injection, solution containing iopamidol at 755 mg/mL, taken intravascular. Manufactured by BRACCO DIAGNOSTICS INC.
Key Facts
- Brand Name
- ISOVUE 370
- Generic Name
- IOPAMIDOL
- NDC Code (Product)
0270-1316- Manufacturer
- BRACCO DIAGNOSTICS INC
- Strength
- 755 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVASCULAR
- Marketing Status
- Application #
- NDA018735
- Drug Class
- Radiographic Contrast Agent [EPC]
- Marketing Start
- 12/31/1985
Recall History
Bracco Diagnostic Inc
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ISOVUE is a radiographic contrast agent indicated for: Intra-arterial Procedures † ( 1.1 ) 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 † ( 1.2 ) Excretory urography in adults and pediatric patients Computed tomography (CT) of head and body in adults and pediatric patients Peripheral venography in adults † Specific concentrations are recommended for each type of imaging procedure. ( 2.2 , 2.3 , 2.4 ) 1.1 Intra-arterial Procedures † ISOVUE is indicated for: 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 1.2 Intravenous Procedures † ISOVUE is indicated for: Excretory urography in adults and pediatric patients Computerized tomography (CT) of the head and body in adults and pediatric patients Peripheral venography in adults † Specific concentrations of ISOVUE are recommended for e…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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 ) See full prescribing information for important dosage and administration information and directions for use of imaging bulk packages. ( 2.1 , 2.5 ) 2.1 Important Dosing and Administration Information ISOVUE Imaging Bulk Package (IBP) is for intra-arterial or intravenous use only. Do not administer intrathecally [see Warnings and Precautions ( 5.1 )] . Specific concentrations of ISOVUE are recommended for each type of imaging procedure [see Dosage and Administration ( 2.2 , 2.3 , 2.4 )]. Individualize the volume, concentration, and rate of administration of ISOVUE according to the specific dosing tables [see Dosage and Administration ( 2.2 , 2.3 , 2.4 )] . Consider factors such as: age, body weight, blood vessel size and blood flow rate, anticipated pathology and degree and extent of opacification required, structures or area to be examined, concomitant medical conditions, imaging equipment, and technique to be employed. Hydrate patients bef…
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in elsewhere in the labeling: Risks Associated with Intrathecal Administration [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] Acute Kidney Injury [see Warnings and Precautions ( 5.3 )] Cardiovascular Adverse Reactions [see Warnings and Precautions ( 5.4 )] Thromboembolic Events [see Warnings and Precautions ( 5.5 )] Extravasation and Injection Site Reactions [see Warnings and Precautions ( 5.6 )] Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age [see Warnings and Precautions ( 5.8 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.11 )] Most common adverse reactions (incidence >1%) from intra-arterial or intravenous use are pain, hot flashes, burning sensation, nausea, and warmth. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc. at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly c…
Frequently Asked Questions
What is ISOVUE 370 used for?
ISOVUE 370 contains IOPAMIDOL. It is a injection, solution taken intravascular. Consult your doctor for specific uses.
Is ISOVUE 370 a controlled substance?
ISOVUE 370 is not classified as a controlled substance by the DEA.
What is the generic name for ISOVUE 370?
The generic name for ISOVUE 370 is IOPAMIDOL. There are 11 other brand versions of IOPAMIDOL.
What is the NDC code for ISOVUE 370 755 mg/mL?
The NDC (National Drug Code) for ISOVUE 370 755 mg/mL is 0270-1316, listed by BRACCO DIAGNOSTICS INC.