Isovue Prescribing Information
even if inadvertent, can cause death, convulsions, cerebral hemorrhage,
coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest,
seizures, rhabdomyolysis, hyperthermia, and brain edema
Warnings and Precautions (
5.1 Risks Associated with Intrathecal AdministrationIntrathecal administration,
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 or intravenous use only and must not be administered
intrathecally
Dosage and Administration (
2.1 Important Dosingand Administration Information
- ISOVUE is for intra-arterial or intravenous use only and
must not be administered intrathecally[see Warnings and Precautions.
] - Specific concentrations of ISOVUE are recommended for each
type of imaging procedure[see Dosage and Administration ]. - Individualize the volume, concentration, and injection rate
of ISOVUE according to the specific dosing tables[see Dosage. Consider factors such as: age, body weight, blood vessel
and Administration ]
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 administration[see Warnings and Precautions ].
- Use aseptic technique for all handling and administration
of ISOVUE. - ISOVUE may be administered at either body temperature (37°C,
98.6°F) or room temperature (20°C to 25°C, 68°F to 77°F). - Visually inspect ISOVUE for particulate matter or discoloration
before administration. Do not administer ISOVUE if particulate matter
or discolorations are observed. - Do not mix ISOVUE with other drugs or inject in intravenous
lines containing other drugs or total nutritional admixtures. - ISOVUE single-dose containers are intended for one procedure
only. Discard any unused portion.
ISOVUE is a radiographic contrast agent indicated for:
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
- 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 each type of
imaging procedure
- 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 Recommended Dosage for Intra-arterial Procedures in AdultsThe recommended doses for intra-arterial procedures in adults are shown in Table 1.
Imaging Procedure | Concentration (mg Iodine/mL) | Volume to Administer per Single Injection for Selected Injection Sites | Maximum Cumulative Total Dose |
| Cerebral Arteriography | 300 | 8 mL to 12 mL by carotid puncture or transfemoral catheterization | 90 mL |
| Peripheral Arteriography | 300 |
| 250 mL |
| Selective Visceral Arteriography and Aortography | 370 |
| 225 mL |
| Coronary Arteriography and Cardiac Ventriculography | 370 |
| 200 mL |
2.3 Recommended Dosagefor Intravenous Procedures in Adults
The recommended doses for intra-arterial procedures
in adults are shown in Table 2.
Imaging Procedure | Concentration (mg Iodine/mL) | Volume to Administer |
| Excretory Urography | 250 | 50 mL to 100 mL by rapid injection |
| 300 | 50 mL by rapid injection | |
| 370 | 40 mL by rapid injection | |
| CT of the Head | 250 | 130 mL to 240 mL |
| 300 | 100 mL to 200 mL | |
| CT of the Body | 250 | 130 mL to 240 mL by rapid infusion or bolus injection |
| 300 | 100 mL to 200 mL by rapid infusion or bolus injection | |
| 370 | 80 mL to 160 mL by rapid infusion or bolus injection | |
| Peripheral Venography | 200 | 25 mL to 150 mL per lower extremity; the maximum total dose is 350 mL |
2.4 Recommended Dosage in Pediatric PatientsThe recommended doses in pediatric
patients are shown in Table 3.
Imaging Procedure | Concentration (mg Iodine/mL) | Volume per Body Weight to Administer | Maximum Dose |
Intra-arterial Procedures | |||
| Angiocardiography | 370 | 0.5 mL/kg to 2 mL/kg per single injection | Maximum Cumulative Dose by Weight
Maximum Cumulative Dose by Age
|
Intravenous Procedures | |||
| Excretory Urography | 250 | 1.2 mL/kg to 3.6 mL/kg | 120 mL |
| 300 | 1 mL/kg to 3 mL/kg | 100 mL | |
| CT of the Head and Body | 250 | 1.2 mL/kg to 3.6 mL/kg | 120 mL |
| 300 | 1 mL/kg to 3 mL/kg | 100 mL | |
- 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 Recommended Dosage for Intra-arterial Procedures in AdultsThe recommended doses for intra-arterial procedures in adults are shown in Table 1.
Table 1: Recommended Concentrations and Volumes of ISOVUE for Intra-arterial Procedures in Adults Imaging ProcedureConcentration (mg Iodine/mL)Volume to Administer per Single Injection for Selected Injection SitesMaximum Cumulative Total DoseCerebral Arteriography 300 8 mL to 12 mL by carotid puncture or transfemoral catheterization 90 mL Peripheral Arteriography 300 - 5 mL to 40 mL into the femoral artery or subclavian artery
- 25 mL to 50 mL into the aorta for a distal runoff
250 mL Selective Visceral Arteriography and Aortography 370 - Up to 10 mL for the renal arteries
- Up to 50 mL into the larger vessels such as the aorta or celiac artery
225 mL Coronary Arteriography and Cardiac Ventriculography 370 - 2 mL to 10 mL for selective coronary artery injection
- 25 mL to 50 mL for cardiac ventriculography or for nonselective opacification of multiple coronary arteries following injection at the aortic root
200 mL ,2.3 Recommended Dosage
for Intravenous Procedures in AdultsThe recommended doses for intra-arterial procedures
in adults are shown in Table 2.Table 2: Recommended Concentrations and Volumes of
ISOVUE for Intravenous Procedures in AdultsImaging ProcedureConcentration (mg Iodine/mL)Volume to AdministerExcretory Urography 250 50 mL to 100 mL by rapid injection 300 50 mL by rapid injection 370 40 mL by rapid injection CT of the Head 250 130 mL to 240 mL 300 100 mL to 200 mL CT of the Body 250 130 mL to 240 mL by rapid infusion or bolus injection 300 100 mL to 200 mL by rapid infusion or bolus injection 370 80 mL to 160 mL by rapid infusion or bolus injection Peripheral Venography 200 25 mL to 150 mL per lower extremity; the maximum total dose is
350 mL)2.4 Recommended Dosage in Pediatric PatientsThe recommended doses in pediatric
patients are shown in Table 3.Table 3: Recommended Concentrations and Volumes per
Body Weight of ISOVUE for Intra- arterial and Intravenous Procedures
in Pediatric PatientsImaging
ProcedureConcentration
(mg Iodine/mL)Volume
per Body Weight to AdministerMaximum
DoseIntra-arterial
ProceduresAngiocardiography 370 0.5 mL/kg to 2
mL/kg per single injectionMaximum Cumulative
Dose by Weight- Neonates: 5 mL/kg
- Aged 4 weeks and older: 8 mL/kg
- Do not exceed maximum cumulative doses by age below.
Maximum Cumulative
Dose by Age- <2 years 40 mL
- 2 years to 4 years 50 mL
- 5 years to 9 years 100 mL
- 10 years to 18 years 125 mL
Intravenous
ProceduresExcretory Urography 250 1.2 mL/kg to 3.6 mL/kg 120 mL 300 1 mL/kg to 3 mL/kg 100 mL CT of the Head
and Body250 1.2 mL/kg to 3.6 mL/kg 120 mL 300 1 mL/kg to 3 mL/kg 100 mL - See full prescribing information for important dosage and
administration information. ()2.1 Important Dosing
and Administration Information- ISOVUE is for intra-arterial or intravenous use only and
must not be administered intrathecally[see Warnings and Precautions.
] - Specific concentrations of ISOVUE are recommended for each
type of imaging procedure[see Dosage and Administration ]. - Individualize the volume, concentration, and injection rate
of ISOVUE according to the specific dosing tables[see Dosage. Consider factors such as: age, body weight, blood vessel
and Administration ]
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 administration[see Warnings and Precautions ].
- Use aseptic technique for all handling and administration
of ISOVUE. - ISOVUE may be administered at either body temperature (37°C,
98.6°F) or room temperature (20°C to 25°C, 68°F to 77°F). - Visually inspect ISOVUE for particulate matter or discoloration
before administration. Do not administer ISOVUE if particulate matter
or discolorations are observed. - Do not mix ISOVUE with other drugs or inject in intravenous
lines containing other drugs or total nutritional admixtures. - ISOVUE single-dose containers are intended for one procedure
only. Discard any unused portion.
- ISOVUE is for intra-arterial or intravenous use only and
Injection: Clear, colorless
to pale yellow solution available in the following concentrations
of iodine:
Concentration (mg Iodine/mL) | Package Size | Package Type |
| 200 | 200 mL | Single-Dose Bottle |
| 250 | 100 mL | Single-Dose Bottle |
| 300 | 30 mL and 50 mL | Single-Dose Vial |
| 100 mL and 150 mL | Single-Dose Bottle | |
| 370 | 50 mL | Single-Dose Vial |
| 75 mL, 100 mL, 125 mL, and 150 mL | Single-Dose Bottle |
Lactation: A lactating woman may
pump and discard breast milk for 10 hours after ISOVUE administration.
(
8.2 LactationThere are no data
on the presence of iopamidol in human milk, the effects on the breastfed
infant, or the effects on milk production. Iodinated contrast agents
are present unchanged in human milk in very low amounts, with poor
absorption from the gastrointestinal tract of a breastfed infant.
The developmental and health benefits of breastfeeding should be considered
along with the mother's clinical need for ISOVUE and any potential
adverse effects on the breastfed infant from ISOVUE or from the underlying
maternal condition.
Interruption of breastfeeding after exposure
to iodinated contrast agents is not necessary because the potential
exposure of the breastfed infant to iodine is small. However, a lactating
woman may consider interrupting breastfeeding and pumping and discarding
breast milk for 10 hours (approximately 5 half- lives) after ISOVUE
administration in order to minimize drug exposure to a breastfed infant.
None.