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Search results for "Established Pharmacologic Class [EPC]|Radiographic Contrast Agent [EPC]" in comments (approximate match)
Status:
US Approved Rx
(1996)
Source:
NDA020351
(1996)
Source URL:
First approved in 1996
Source:
NDA020351
Source URL:
Class (Stereo):
CHEMICAL (MIXED)
Conditions:
Iodixanol (brand name VISIPAQUE) is an iodine-containing nonionic dimeric hydrophilic contrast agent for intravascular (intravenous and intra-arterial) use during coronary angiography. Pharmacodynamics studies indicated that iodixanol had fewer cardiovascular effects, caused less renal damage and were associated with similar or smaller changes to the blood-brain barrier and neurological function when compared with nonionic contrast media. It is known, that the organic iodine compounds attenuate x-rays as they pass through the body, thereby allowing the body structures containing iodine to be delineated in contrast to those structures that do not contain iodine. The degree of opacity produced by these compounds is directly proportional to the total amount (concentration and volume) of the iodinated contrast agent in the path of the x-rays. Thus, after intravascular administration, iodixanol makes opaque those internal structures in its path of flow, allowing their visualization until significant hemodilution and elimination occur.
Status:
US Approved Rx
(2002)
Source:
NDA021425
(2002)
Source URL:
First approved in 1995
Source:
NDA020220
Source URL:
Class (Stereo):
CHEMICAL (MIXED)
Targets:
Iopromide is a molecule used as a contrast medium. It is a low osmolar, non-ionic contrast agent for intravascular use. It is commonly used in radiographic studies such as intravenous urograms, brain computer tomography (CT) and CT pulmonary angiograms (CTPAs). It appears to increase the risk of biguanide induced lactic acidosis. Interleukins are associated with an increased prevalence of delayed hypersensitivity reactions after iodinated contrast agent administration. Most common adverse reactions (>1%) are headache, nausea, injection site and infusion site reactions, vasodilatation, vomiting, back pain, urinary urgency, chest pain, pain, dysgeusia, and abnormal vision.
Status:
US Approved Rx
(1988)
Source:
NDA019710
(1988)
Source URL:
First approved in 1988
Source:
NDA019710
Source URL:
Class (Stereo):
CHEMICAL (UNKNOWN)
Ioversol is an organoiodine compound that used as a contrast medium. It features both a high iodine content, as well as several hydrophilic groups. It is indicated in adults for peripheral and coronary arteriography and left ventriculography, for excretory urography and computed tomography. Injections of contrast media are often associated with sensations of warmth and pain. Renal toxicity has been reported in a few patients with liver dysfunction who were given oral cholecystographic agents followed by intravascular contrast agents.
Status:
US Approved Rx
(1985)
Source:
NDA018956
(1985)
Source URL:
First approved in 1985
Source:
NDA018956
Source URL:
Class (Stereo):
CHEMICAL (MIXED)
Conditions:
Iohexol is a nonionic, water-soluble radiographic contrast medium. Organic iodine compounds block x-rays as they pass through the body, thereby allowing body structures containing iodine to be delineated in contrast to those structures that do not contain iodine. It is used in myelography, arthrography, nephroangiography, arteriography, and other radiographic procedures. Drugs which lower seizure threshold, especially phenothiazine derivatives including those used for their antihistaminic or antinauseant properties, are not recommended for use with Iohexol. Others include monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, CNS stimulants, psychoactive drugs described as analeptics, major tranquilizers, or antipsychotic drugs. The most frequently reported adverse reactions are headache, mild to moderate pain including backache, neckache and stiffness, nausea, and vomiting.
Status:
US Approved Rx
(2023)
Source:
ANDA215382
(2023)
Source URL:
First approved in 1985
Source:
NDA018735
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Iopamidol is a nonionic, low-osmolar iodinated contrast agent. Iopamidol is indicated for angiography, pediatric angiocardiography, selective visceral arteriography and aortography, peripheral venography, and adult and pediatric intravenous excretory urography and intravenous adult and pediatric contrast enhancement of computed tomographic. Renal toxicity has been reported in a few patients with liver dysfunction who were given oral cholecystographic agents followed by intravascular contrast agents. Intravascular injection of contrast media is frequently associated with the sensation of warmth and pain especially in peripheral arteriography and venography. In angiocardiography the adverse reactions are: hot flashes, angina pectoris, flushing, bradycardia, hypotension, hives.
Status:
US Approved Rx
(1972)
Source:
NDA017057
(1972)
Source URL:
First approved in 1962
Source:
NDA013295
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Iothalamic Acid is an iodine-containing organic anion used as a radiocontrast agent. It is available as sodium iothalamate (Iothalamate sodium) and meglumine iothalamate (Iothalmate meglumine). It can be administered intravenously or intravesically (into the urinary bladder). Iothalamate is indicated to visualize specific regions of the vascular system and blood flow in these areas to help in the diagnosis and evaluation of neoplasms (known or suspected) or vascular diseases (congenital or acquired) that may cause changes in normal vascular anatomy or physiology. Iothalamate meglumine injection is indicated for use in cerebral angiography, peripheral arteriography or venography, arterial digital subtraction angiography1 , and intravenous digital subtraction angiography. Iothalamate meglumine and iothalamate sodium injection is indicated for use in selective coronary arteriography, selective renal arteriography, and in intravenous digital subtraction angiography. othalamate meglumine and iothalamate sodium injection and iothalamate sodium injection are indicated to visualize the aorta and its major branches. However, the injection of iothalamate meglumine and iothalamate sodium is preferred because it generally causes less severe hemodynamic, neurotoxic, and cardiotoxic effects than the individual injection of iothalamate sodium. Radioactive formulation is also available as sodium iothalamate I-125 Injection (GLOFIL-125). It is indicated for evaluation of glomerular filtration in the diagnosis or monitoring of patients with renal disease.
Status:
US Approved Rx
(1955)
Source:
NDA010040
(1955)
Source URL:
First approved in 1954
Source:
HYPAQUE by GE HEALTHCARE
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
This compound belongs to the class of organic compounds known as aminobenzoic acids. These are benzoic acids containing an amine group attached to the benzene moiety. A commonly used x-ray contrast medium. Used, alone or in combination, for a wide variety of diagnostic imaging methods, including angiography, urography, cholangiography, computed tomography, hysterosalpingography, and retrograde pyelography. It can be used for imaging the gastrointestinal tract in patients allergic to barium. Radiopaque agents are drugs used to help diagnose certain medical problems. They contain iodine, which blocks x-rays. Depending on how the radiopaque agent is given, it localizes or builds up in certain areas of the body. The resulting high level of iodine allows the x-rays to make a "picture" of the area. The areas of the body in which the radiopaque agent localizes will appear white on the x-ray film. This creates the needed distinction, or contrast, between one organ and other tissues.
Status:
US Approved Rx
(2013)
Source:
NDA205815
(2013)
Source URL:
First marketed in 1925
Class (Stereo):
CHEMICAL (ACHIRAL)
Carbon dioxide is a colorless gas occurring naturally in Earth's atmosphere. Carbon dioxide is a primary carbon source for life on Earth. It is produced by all aerobic organisms during metabolism of carbohydrates and lipids. Carbon dioxide is used in food industry as an acidity regulator and for production of carbonated soft drinks and soda water. In medicine, carbon dioxide is commonly used as an insufflation gas for minimally invasive surgery (laparoscopy, endoscopy, and arthroscopy) to enlarge and stabilize body cavities to provide better visibility of the surgical area. A mixture of carbon dioxide and oxygen is used for stimulation of breathing after apnea, in anesthetic procedures to increase the depth of respiration, to facilitate blind intubations in anesthetic practice.
Status:
US Approved Rx
(2016)
Source:
NDA208036
(2016)
Source URL:
First marketed in 1912
Source:
Barium Sulphate
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Barium sulfate, an insoluble in water substance, which was approved under the brand name E-Z-HD for use in double-contrast radiographic examinations of the esophagus, stomach and duodenum to visualize the gastrointestinal (GI) tract in patients 12 years and older. Due to its high atomic number, barium is opaque to x-rays and therefore acts as a positive contrast agent for radiographic studies.
Status:
US Previously Marketed
Source:
OXILAN-300 by GUERBET
(1995)
Source URL:
First approved in 1995
Source:
OXILAN-300 by GUERBET
Source URL:
Class (Stereo):
CHEMICAL (MIXED)
Conditions:
Ioxilan is a nonionic X-ray contrast agent approved by the United States Food and Drug Administration for X-ray imaging contrast enhancement. Ioxilan can be administered intravenously for excretory urography and contrast-enhanced computed tomography (CT) imaging of the head and body. Ioxilan can also be given intraarterially for cerebral arteriograpy, coronary arteriography and left ventriculography, visceral angiography, aortography, and peripheral arteriography.