pharmacopeia
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Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Imaging Contrast Activity; X-Ray Contrast Activity.

Indications

Sourced from openFDA
  • 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.

Contraindications

Sourced from openFDA
  • 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 ).contraindicated

Dosage & administration

Sourced from openFDA

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 necessary. However, young children may require general anesthesia for technical reasons. Premedication with sedatives or tranquillizers is usually not needed. In patients with a history of seizure activity who are not on anticonvulsant therapy, premedication with barbiturates or phenytoin should be considered.

Warnings & precautions

Sourced from openFDA

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 large or concentrated bolus of the contrast medium, which increases the risk of neurotoxicity, can be prevented by careful patient management. Also, effort should be directed to avoid rapid dispersion of the medium causing inadvertent rise to intracranial levels (e.g., by active patient movement).

Adverse reactions

Sourced from openFDA

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.

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects Reproduction studies have been performed in rats and rabbits at doses up to 2.7 and 1.4 times the maximum recommended human dose (1.48 gI/kg in a 50 kg individual), respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to iopamidol. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Overdosage

Sourced from openFDA

A dose of 3000 mgI in adults and 2400 mgI in children is sufficient for most myelographic procedures. Doses above these levels may result in an increased frequency and severity of adverse reactions including seizures. However, in myelography, even use of a recommended dose can produce mental aberrations tantamount to overdosage, if incorrect management of the patient during or immediately following the procedure permits inadvertent early intracranial entry of a large portion of the medium. Treatment of an overdose of an injectable radiopaque contrast medium is directed toward the support of all vital functions, and prompt institution of symptomatic therapy.

Approval history

Sourced from openFDA
  • Dec 31, 1985NDANDA018735Bracco
  • Oct 12, 1994NDANDA020327Bracco
  • Feb 27, 2023ANDAANDA215382Hainan Poly
  • Sep 27, 2023ANDAANDA217134Hainan Poly

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
2,855 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Anaphylactic Reaction1826.4%
  2. 2Urticaria1796.3%
  3. 3Dyspnoea1776.2%
  4. 4Nausea1575.5%
  5. 5Pruritus1505.3%
  6. 6Contrast Media Reaction1404.9%
  7. 7No Adverse Event1404.9%
  8. 8Vomiting1224.3%
  9. 9Acute Kidney Injury1123.9%
  10. 10Hypersensitivity1033.6%
  11. 11Off Label Use943.3%
  12. 12Anaphylactic Shock772.7%
  13. 13Dizziness772.7%
  14. 14Erythema762.7%
  15. 15Cough742.6%

Literature

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Recent PubMed references pinned to Iopamidol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 52 ClinicalTrials.gov registrations naming Iopamidol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Iopamidol work?
Mechanism-of-action classes: Imaging Contrast Activity; X-Ray Contrast Activity.
What is Iopamidol used for?
According to FDA labeling, Iopamidol carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Iopamidol?
Iopamidol is classified as Watersoluble, nephrotropic, low osmolar X-ray contrast media, Radiographic Contrast Agent, Imaging Contrast Activity, X-Ray Contrast Activity.
What are the contraindications for Iopamidol?
Iopamidol labeling lists contraindications including: 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 ).. Always consult the full prescribing information and a clinician.
Note. Data for iopamidol is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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