iopamidol 612 mg/mL
iopamidol · INJECTION, SOLUTION · Slate Run Pharmaceuticals
iopamidol is a injection, solution containing iopamidol at 612 mg/mL, taken intrathecal. Manufactured by Slate Run Pharmaceuticals.
Key Facts
- Brand Name
- iopamidol
- Generic Name
- iopamidol
- NDC Code (Product)
70436-126- Manufacturer
- Slate Run Pharmaceuticals
- Strength
- 612 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRATHECAL
- Marketing Status
- Application #
- ANDA215382
- Drug Class
- Radiographic Contrast Agent [EPC]
- Marketing Start
- 07/20/2023
Recall History
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Bracco Diagnostic Inc
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
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
INDICATIONS AND USAGE Iopamidol Injection is indicated for intrathecal administration in adult neuroradiology including myelography (lumbar, thoracic, cervical, total columnar), and for contrast enhancement of computed tomographic (CECT) cisternography and ventriculography. Iopamidol Injection, 41% is indicated for thoraco-lumbar myelography in children over the age of two years.
Dosage & Administration
DOSAGE AND ADMINISTRATION In adults a solution that is approximately isotonic (Iopamidol Injection, 41%) is recommended for examination of the lumbar region. For movement of the contrast medium to distant target areas the more concentrated Iopamidol Injection, 61% preparation should be used to compensate for dilution of Iopamidol Injection with cerebrospinal fluid. The usual recommended adult dose range for iopamidol is 2000-3000 mg iodine. Iopamidol formulated to contain more than 300 mgI/mL should not be used intrathecally in adults. The minimum dose needed to perform a procedure should always be used. In pediatric patients , a solution that is approximately isotonic (Iopamidol Injection, 41%) is recommended for all intrathecal procedures. In children, loss of contrast due to mixing on movement of the medium is less apt to occur because of their shorter spinal cord. The usual recommended pediatric dose range for iopamidol is 1400-2400 mg iodine. Iopamidol formulated to contain more than 200 mgI/mL should not be used intrathecally in children. The minimum dose needed to perform a procedure should always be used. See pediatric dosage table for recommended dosage . Anesthesia is not…
Warnings
WARNINGS The need for myelographic examination should be carefully evaluated. Iopamidol should be administered with caution in patients with increased intracranial pressure or suspicion of intracranial tumor, abscess or hematoma, those with a history of convulsive disorder, severe cardiovascular disease, chronic alcoholism, or multiple sclerosis, and elderly patients. Particular attention must be given to state of hydration, concentration of medium, dose, and technique used in these patients. Contrast media may promote sickling in individuals who are homozygous for sickle cell disease when injected intravenously or intra-arterially. Although Iopamidol Injection is not injected intravascularly, measurable plasma levels are attained after intrathecal administration of iopamidol. If frankly bloody cerebrospinal fluid is observed, the possible benefits of a myelographic examination should be considered in terms of risk to the patient. Patients on anticonvulsant medication should be maintained on this therapy. Direct intracisternal or ventricular administration for standard radiography (without computerized tomographic enhancement) is not recommended. Inadvertent intracranial entry of a…
Contraindications
CONTRAINDICATIONS Intrathecal administration of corticosteroids with iopamidol is contraindicated. Because of overdosage considerations, immediate repeat myelography in the event of technical failure is contraindicated (see interval recommendation under DOSAGE AND ADMINISTRATION ). Myelography should not be performed in the presence of significant local or systemic infection where bacteremia is likely.
Drug Interactions
Drug Interactions Other drugs should not be admixed with iopamidol (see CONTRAINDICATIONS , and DOSAGE AND ADMINISTRATION : Drug Incompatibilities ).
Adverse Reactions
ADVERSE REACTIONS The most frequently reported adverse reactions following intrathecal administration of iopamidol are headache, nausea, vomiting, and musculoskeletal pain. These reactions usually occur 1 to 10 hours after injection, almost all occurring within 24 hours. They are usually mild to moderate in degree, lasting for a few hours and usually disappearing within 24 hours. Rarely, headaches may be severe or persist for days. Headache is often accompanied by nausea and vomiting, and tends to be more frequent and persistent in patients not optimally hydrated. Backache, neck stiffness, numbness and paresthesias, leg or sciatic-type pain occurred less frequently, often in the form of a transient exacerbation of pre-existing symptomatology. Transient alterations in vital signs may occur and their significance must be assessed on an individual basis. The following table of incidence of reactions is based on clinical studies with Iopamidol Injection in about 686 patients. Adverse Reactions Estimated Overall Incidence System > 1% ≤ 1% Body as a Whole headache (16.4%) pyrexia muscle weakness hot flashes malaise fatigue weakness Digestive nausea (7.3%) diarrhea vomiting (3.6%) heartbu…
Frequently Asked Questions
What is iopamidol used for?
iopamidol contains iopamidol. It is a injection, solution taken intrathecal. Consult your doctor for specific uses.
Is iopamidol a controlled substance?
iopamidol is not classified as a controlled substance by the DEA.
What is the generic name for iopamidol?
The generic name for iopamidol is iopamidol. There are 6 other brand versions of iopamidol.
What is the NDC code for iopamidol 612 mg/mL?
The NDC (National Drug Code) for iopamidol 612 mg/mL is 70436-126, listed by Slate Run Pharmaceuticals.