Iohexol

FDA Drug Profile — OMNIPAQUE, Omnipaque, Iohexol

Drug Details

Generic Name
Iohexol
Brand Names
OMNIPAQUE, Omnipaque, Iohexol
Application Number
NDA018956
Sponsor
GE Healthcare Inc.
NDC Codes
17
Dosage Forms
SOLUTION, INJECTION, SOLUTION, POWDER
Routes
ORAL, INTRATHECAL, RECTAL, INTRA-ARTICULAR, INTRAVASCULAR, INTRAVENOUS
Active Ingredients
IOHEXOL

Indications and Usage

1 INDICATIONS AND USAGE Iohexol is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular and body cavity imaging procedures in adults and pediatric patients. ( 1 ) 1.1 Intrathecal Procedures ‡ Iohexol injection is indicated for: Myelography and computerized tomography (CT) myelography (lumbar, thoracic, cervical, total columnar) in adults and pediatric patients aged 2 weeks and older CT cisternography in adults and pediatric patients aged 2 weeks and older 1.2 Intra-arterial Procedures ‡ Iohexol injection is indicated for: Cardiac ventriculography in adults and pediatric patients Aortography including studies of aorta and its branches in adults and pediatric patients Selective coronary arteriography in adults Cerebral arteriography in adults Peripheral arteriography in adults Intra-arterial digital subtraction angiography (IA-DSA) of the head, neck, abdominal, renal and peripheral vessels in adults Pulmonary angiography in pediatric patients 1.3 Intravenous Procedures ‡ Iohexol injection is indicated for: Excretory urography in adults and pediatric patients CT of the head and body in adults and pediatric patients Peripheral venography (phlebography) in adults Intravenous digital subtraction angiography (IV-DSA) of the head, neck, abdominal, renal and peripheral vessels in adults 1.4 Oral or Rectal Procedures ‡ Iohexol injection is indicated for: Radiographic examination of the gastrointestinal (GI) tract in adults and pediatric patients CT of the abdomen and pelvis in conjunction with intravenous administration of iohexol injection in adults and pediatric patients 1.5 Intraarticular Procedures ‡ Iohexol injection is indicated for: Arthrography in adults 1.6 Body Cavity Procedures ‡ Iohexol injection is indicated for: Endoscopic retrograde pancreatography (ERP) and cholangiopancreatography (ERCP) in adults Herniography in adults Hysterosalpingography in adults Voiding cystourethrography (VCU) in pediatric patients ‡ Specific dosage forms, concentrations and presentations of iohexol are recommended for each type of imaging procedure [see Dosage and Administrations (2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 , 2.9 ) and Warnings and Precautions (5.1 , 5.2) ].