Iopamidol

⛔ FDA Black Box Warning

WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION Intrathecal administration, even if inadvertent, can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema [see Warnings and Precautions ( 5.1 )] . Iopamidol Injection, USP is for intra-arterial or intravenous use only [see Dosage and Administration ( 2.1 )] . WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION See full prescribing information for complete boxed warning.

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.

Pregnancy & Breastfeeding

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.