Iodixanol is a radiographic contrast agent sold in the U.S. under 2 brand and generic names. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Visipaque 270 (application NDA020351). Other iodixanol products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Individualize the combination of volume and concentration of VISIPAQUE Injection considering age, body weight, size of the vessel, rate of blood flow within the vessel, and other applicable factors. ( 2.1 , 2.2 , 2.3 , 2.4 ) For CT of the head and body, VISIPAQUE may be used with an automated contrast injection system or contrast media management system cleared for use with VISIPAQUE. ( 2.5 ) For the adult patients, the maximum recommended total dose of iodine is 80 grams. ( 2.1 ) Patients should be adequately hydrated prior to and following the intravascular administration of iodinated contrast agents. ( 2.1 , 5.3 ) See full prescribing information for complete dosing and administration information. ( 2 ) 2.1 Important Dosage and Administration Instructions VISIPAQUE is for intravascular use only [see Boxed Warning , Contraindications (4) , and Warnings and Precautions (5.1) ] Use sterile technique for all handling and administration of VISIPAQUE. Do not use if tamper-evident ring is broken or missing. Warm VISIPAQUE and administer at body or room temperature. Inspect VISIPAQUE for particulate matter or discoloration before administration, whenever solution and container permit. Do not administer if VISIPAQUE contains particulate matter or is discolored. Do not mix VISIPAQUE with, or inject in intravenous lines containing, other drugs or total nutritional admixtures. Use the…
The following clinically significant adverse reactions are described elsewhere in the labeling: Risks Associated with Inadvertent Intrathecal Administration [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Contrast-Induced Kidney Injury [see Warnings and Precautions (5.3) ] Cardiovascular Adverse Reactions [see Warnings and Precautions (5.4) ] Thromboembolic Events [see Warnings and Precautions (5.5) ] Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age [see Warnings and Precautions (5.8) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.11) ] Most common adverse reactions (incidence greater than 0.5%) in adult patients after VISIPAQUE injection: Discomfort, warmth, pain; Cardiovascular: angina. Gastrointestinal: diarrhea, nausea, vomiting. Nervous System: agitation, anxiety, insomnia, nervousness, dizziness, headache, migraine, unusual skin sensations, sensory disturbance, fainting, sensation of spinning. Skin: itchy rash, severe itching, hives. Special Senses: Smell, taste, and vision alteration. ( 6.1 ) Pediatric patients experienced similar adverse reactions. ( 6.3 ) To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 1-800-654-0118 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…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
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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.
VISIPAQUE is contraindicated for intrathecal use [see Warnings and Precautions (5.1) ]. Not indicated for intrathecal use. ( 4 )
Drug-Drug Interactions Metformin In patients with renal impairment, metformin can cause lactic acidosis. Iodinated contrast agents appear to increase the risk of metformin-induced lactic acidosis, possibly as a result of worsening renal function. Stop metformin at the time of, or prior to, VISIPAQUE administration in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ; in patients with a history of hepatic impairment, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure, and reinstitute metformin only after renal function is stable. Radioactive Iodine Administration of iodinated contrast agents may interfere with thyroid uptake of radioactive iodine (I-131 and I-123) and decrease therapeutic and diagnostic efficacy in patients with carcinoma of the thyroid. The decrease in efficacy lasts for 6 to 8 weeks. Beta-adrenergic Blocking Agents The use of beta-adrenergic blocking agents lowers the threshold for and increases the severity of contrast reactions, and reduces the responsiveness of treatment of hypersensitivity reactions with epinephrine. Because of the risk of hypersensitivity reactions, use caution when administering VISIPAQUE to patients taking beta-blockers. Oral Cholecystographic Contrast Agents Renal toxicity has been reported in patients with liver…
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