Iohexol

FDA Drug Profile — Iohexol, Omnipaque, OMNIPAQUE

Drug Details

Generic Name
Iohexol
Brand Names
Iohexol, Omnipaque, OMNIPAQUE
Application Number
ANDA217737
Sponsor
Divi's Laboratories Limited
NDC Codes
17
Dosage Forms
POWDER, SOLUTION, INJECTION, SOLUTION
Routes
INTRA-ARTICULAR, INTRATHECAL, INTRAVASCULAR, INTRAVENOUS, ORAL, RECTAL
Active Ingredients
IOHEXOL

Indications and Usage

1 INDICATIONS AND USAGE OMNIPAQUE 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 ‡ OMNIPAQUE 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 ‡ OMNIPAQUE 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 ‡ OMNIPAQUE 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 ‡ OMNIPAQUE is indicated for: Radiographic examination of the gastrointestinal (GI) tract by oral administration in adult patients and by oral or rectal administration in pediatric patients CT of the abdomen and pelvis by oral administration in adult and pediatric patients, in conjunction with intravenous administration of OMNIPAQUE 1.5 Intraarticular Procedures ‡ OMNIPAQUE is indicated for: Arthrography in adults 1.6 Body Cavity Procedures ‡ OMNIPAQUE 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 OMNIPAQUE 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) ].