IOPAMIDOL
INJECTION, USP
PRODUCT DETAILS
- RLD: ISOVUE®
- Concentration:
51% (510 mg/mL)
61% (612 mg/mL)
76% (755 mg/mL) - Fill Volume: Sterile Solution in a
50 mL vial (51%)
30 or 50 or 100 mL vial (61%)
100 mL vial (76%) - Therapeutic Class: Contrast Agent
- Closure does not contain any natural rubber or latex.
- Preservative Free
NDC Numbers:
51%, 50 mL | Box of 10 vials: 70436-125-82
61%, 30 mL | Box of 10 vials: 70436-219-52
61%, 50 mL | Box of 10 vials: 70436-219-62
61%, 100 mL | Box of 10 vials: 70436-219-82
76%, 100 mL | Box of 10 vials: 70436-127-82
Available through your wholesaler:
NDC: 70436-125-82
FFF: IOP012582
Cardinal Health: 5936513
McKesson: 2974806
Amerisource: 10291505
FFF: IOP012582
NDC: 70436-219-52
FFF: IOP021952
Cardinal Health: 5936521
McKesson: 2974814
Amerisource: 10291560
NDC: 70436-219-62
FFF: IOP021962
Cardinal Health: 5936539
McKesson: 2974780
Amerisource: 10291504
NDC: 70436-219-82
FFF: IOP021982
Cardinal Health: 5936547
McKesson: 2974863
Amerisource: 10291562
NDC: 70436-127-82
FFF: IOP012782
Cardinal Health: 5936554
McKesson: 2974871
Amerisource: 10291503
| Strength | NDC | Saleable Unit |
|---|---|---|
| 51 % (510 mg/mL) | 70436-125-82 | Box of 10 vials Sterile Solution (50 mL) |
| 61 % (612 mg/mL) | 70436-219-52 | Box of 10 vials Sterile Solution (30 mL) |
| 61 % (612 mg/mL) | 70436-219-62 | Box of 10 vials Sterile Solution (50 mL) |
| 61 % (612 mg/mL) | 70436-219-82 | Box of 10 vials Sterile Solution (100 mL) |
| 76% (755 mg/mL) | 70436-127-82 | Box of 10 vials Sterile Solution (100 mL) |
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light.
Discard unused portion.
IMPORTANT SAFETY INFORMATION FOR:
IOPAMIDOL INJECTION
WARNING: RISKS ASSOCIATED WITH INTRATHECAL USE
Intrathecal administration, even if inadvertent, can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Iopamidol Injection, USP is for intra-arterial or intravenous use only.
Iopamidol injection can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock. Most severe reactions develop shortly after the start of injection (e.g., within 1 to 3 minutes), but delayed reactions can also occur. Obtain a history of allergy, hypersensitivity, or hypersensitivity reactions to iodinated contrast agents and always have emergency resuscitation equipment and trained personnel available prior to iopamidol injection administration. Monitor all patients for hypersensitivity reactions.
Acute kidney injury, including renal failure, may occur after iopamidol injection administration. Use the lowest necessary dose of iopamidol injection in patients with renal impairment. Adequately hydrate patients prior to and following iopamidol injection administration. Do not use laxatives, diuretics, or preparatory dehydration prior to iopamidol injection administration.
Iopamidol injection increases the circulatory osmotic load and may induce acute or delayed hemodynamic disturbances in patients with congestive heart failure, severely impaired renal function, combined renal and hepatic disease, and combined renal and cardiac disease, particularly when repetitive or large doses are administered. Fatal cardiovascular reactions have occurred mostly within 10 minutes of iopamidol injection; the main feature was cardiac arrest with cardiovascular disease as the main underlying factor. Monitor all patients for severe cardiovascular reactions.
Serious, in some cases fatal, thromboembolic events, including myocardial infarction and stroke, can occur during angiographic procedures. During these procedures, increased thrombosis and activation of the complement system occurs. To minimize thromboembolic events, use meticulous angiographic techniques and minimize the length of the procedure. Avoid blood remaining in contact with syringes containing iodinated contrast agents, which increases risk of clotting. Avoid angiocardiography in patients with homocystinuria because of the risk of inducing thrombosis and embolism.
Extravasation can occur with iopamidol injection administration, particularly in patients with severe arterial or venous disease. Inflammation, blistering, skin necrosis, and compartment syndrome have been reported following extravasation. In addition, injection site reactions such as pain and swelling at the injection site can also occur. Ensure intravascular placement of catheters prior to injection. Monitor patients for extravasation and advise patients to seek medical care for progression of symptoms.
Thyroid storm has occurred after the intravascular use of iodinated agents in patients with hyperthyroidism or with an autonomously functioning thyroid nodule. Evaluate the risk in such patients before use of iopamidol injection.
The most frequent adverse reactions are: hot flashes, angina pectoris, flushing, bradycardia, hypotension, and hives.
Please see the package insert for Iopamidol Injection, USP for full prescribing information.