Brand names: Ultravist
Radiographic Contrast Agent · X-Ray Contrast Activity
Route: Intra-Arterial, Intravenous
FDA Black Box Warning
WARNING: NOT FOR INTRATHECAL USE WARNING: NOT FOR INTRATHECAL USE See full prescribing information for complete boxed warning. Intrathecal administration, even if inadvertent, may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. ULTRAVIST is not approved for intrathecal use. (5.1)
Contraindications
4 CONTRAINDICATIONS None None
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary There are no data on ULTRAVIST use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Iopromide crosses the placenta and reaches fetal tissues in small amounts (see Data) . In animal reproduction studies, intravenous administration of iopromide to pregnant rats and rabbits during organogenesis at doses up to0.35 and 0.7 times, respectively, the maximum recommended human dose based on body surface area resulted in no relevant adverse developmental effects (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Limited case reports demonstrate that intravenously administered iodinated contrast agents, including iopromide, cross the placenta and are visualized in the digestive tract of exposed infants after birth. Animal Data Reproduction studies were performed with intravenous iopromide in rats (day 6 to 15 of gestation) and rabbits (day 6 to 18 of gestation) at dose levels of 0, 0.37, 1.11, and 3.7 g iodine per kg, corresponding to doses up to 0.35 times (rats) and 0.7 times (rabbits) the maximum human recommended dose based on body surface area. Iopromide was not teratogenic at any dose level in rats and rabbits and embryolethality was observed in rabbits that received 3.7 g iodine per kg, but this was considered to have been secondary to maternal toxicity.
2 interactions on record
Iodinated contrast agents increase risk of metformin-induced lactic acidosis, possibly by worsening renal function. Stop metformin at or prior to IOPROMIDE administration in patients with eGFR 30-60 mL/min/1.73 m2, hepatic impairment, alcoholism, heart failure, or intra-arterial contrast use.
Source: NLP:iopromide
IOPROMIDE may interfere with thyroid uptake of radioactive iodine (I-131 and I-123), decreasing therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post-IOPROMIDE.
Source: NLP:iopromide