Iopamidol — uses, dosing, side effects & the brands that sell it · pharmaranks
Iopamidol: uses, dosing, side effects & brands
Iopamidol is a radiographic contrast agent sold in the U.S. under 11 brand and generic names. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
By the pharmaranks editorial team·Reviewed against the FDA (openFDA label, NDC Directory & Enforcement) sources·How we research
Key facts
Drug class
Radiographic Contrast Agent
Available as
Injectable
Sold as
11 products — Iopamidol-200, Iopamidol-250 and Iopamidol-300, and others
Prescription?
Prescription only
Generic available?
Yes
How iopamidol is dosed
From the FDA label for Iopamidol-200 (application ANDA074881). Other iopamidol products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Individualize the volume and concentration of ISOVUE-M according to the specific dosing tables based on patient age, body weight, and study to be performed. ( 2.2 , 2.3 ) See full prescribing information for important dosage and administration information. ( 2.1 ) 2.1 Important Dosage and Administration Information ISOVUE-M is for intrathecal use only. Specific concentrations of ISOVUE-M are recommended for each type of imaging procedure [see Dosage and Administration ( 2.2 , 2.3 )]. Individualize the volume, concentration, and injection rate of ISOVUE-M according to the dosing tables [see Dosage and Administration ( 2.2 , 2.3 )]. Consider factors such as age, body weight, anticipated pathology and degree and extent of opacification required, structure(s) or area to be examined, concomitant medical conditions, and imaging equipment and technique to be employed. Hydrate patients prior to and following ISOVUE-M administration [see Warnings and Precautions ( 5.2) ] . Use aseptic technique for all handling and administration of ISOVUE-M. ISOVUE-M 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-M for particulate matter and discoloration prior to administration whenever the solution and container permit. Do not administer ISOVUE-M if particulate matter or discoloration are observed. Do not mix…
Iopamidol side effects
The following adverse reactions are described in greater detail in other sections: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Acute Kidney Injury [see Warnings and Precautions ( 5.2 )] Increased Risk of Seizures [see Warnings and Precautions ( 5.3 )] Cardiovascular Adverse Reactions [see Warnings and Precautions ( 5.4 )] Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age [see Warnings and Precautions ( 5.6 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (incidence > 1%) are headache, nausea, vomiting, back pain, leg pain, neck pain, and hypotension. ( 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 compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ISOVUE-M was evaluated in 686 adult patients receiving ISOVUE-M intrathecally in clinical studies. Table 3 shows the common adverse reactions (>1%). These reactions usually occur 1 to 10 hours after injection, almost all occurring within 24 hours. Table 3: Adverse Reactions Reported in >1% of…
Every iopamidol product we track (11)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
ISOVUE-M (iopamidol) injection is a radiographic contrast agent for intrathecal use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6- triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17 H 22 I 3 N 3 O 8, and the following structural formula: ISOVUE-M is a sterile, clear, colorless to pale yellow solution available in two concentrations of iodine: ISOVUE-M 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg sodium) and 1 mg tromethamine. ISOVUE-M 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg sodium) and 1 mg tromethamine. The pH of ISOVUE-M has been adjusted to 6.5 to 7.5 with hydrochloric acid and/or sodium hydroxide. Physicochemical characteristics are shown in Table 4 . ISOVUE-M is hypertonic as compared to plasma and cerebrospinal fluid (approximately 285 and 301 mOsm/kg water, respectively). Table 4: Physicochemical Characteristics of ISOVUE-M Concentration (mg Iodine/mL) 200 300 Osmolality @ 37°C (mOsm/kg water) 413 616 Viscosity (cP) @ 37°C 2.0 4.7 Viscosity (cP) @ 20°C 3.3 8.8 Specific…
What kind of drug is iopamidol?
The FDA classifies iopamidol as a radiographic contrast agent. Radiographic contrast agents are imaging dyes, not treatments. They contain dense elements like iodine that absorb X-rays strongly, so the blood vessels or organs they fill show up bright and clearly outlined on an X-ray or CT scan. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take iopamidol with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run iopamidol against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is iopamidol sold under?
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
We track 11 iopamidol-containing products in the U.S.: Iopamidol-200, Iopamidol-250, Iopamidol-300, Iopamidol-370, Isovue-128, Isovue-200, Isovue-250 and Isovue-300, and 3 more. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does iopamidol come in?
Across the brands we track, iopamidol is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic iopamidol?
Yes. Our catalog lists 4 generic iopamidol products alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.