ISOVUE 200 408 mg/mL
IOPAMIDOL · INJECTION, SOLUTION · BRACCO DIAGNOSTICS INC
ISOVUE 200 is a injection, solution containing iopamidol at 408 mg/mL, taken intravascular. Manufactured by BRACCO DIAGNOSTICS INC.
Key Facts
- Brand Name
- ISOVUE 200
- Generic Name
- IOPAMIDOL
- NDC Code (Product)
0270-1314- Manufacturer
- BRACCO DIAGNOSTICS INC
- Strength
- 408 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
New England Compounding Center
Lack of Assurance of Sterility
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 Oral Procedures † ( 1.3 ) 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. ( 2.2 , 2.3 , 2.4 , 2.5 ) 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 he…
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 , 2.5 ) See full prescribing information for important dosage and administration information and dilution instructions. ( 2.1 , 2.6 ) 2.1 Important Dosing and Administration Information ISOVUE is for intra-arterial, intravenous, or oral 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 , 2.5 )]. 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 , 2.5 )] . 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 before and after ISOVUE adm…
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described in greater detail 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 compa…
Frequently Asked Questions
What is ISOVUE 200 used for?
ISOVUE 200 contains IOPAMIDOL. It is a injection, solution taken intravascular. Consult your doctor for specific uses.
Is ISOVUE 200 a controlled substance?
ISOVUE 200 is not classified as a controlled substance by the DEA.
What is the generic name for ISOVUE 200?
The generic name for ISOVUE 200 is IOPAMIDOL. There are 11 other brand versions of IOPAMIDOL.
What is the NDC code for ISOVUE 200 408 mg/mL?
The NDC (National Drug Code) for ISOVUE 200 408 mg/mL is 0270-1314, listed by BRACCO DIAGNOSTICS INC.