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Reno-60 (Diatrizoate Meglumine) - Summary

 
 



NOT FOR INTRATHECAL USE

 

RENO-60 SUMMARY

RENO-60®
Diatrizoate Meglumine
Injection USP 60%

Reno-60 is a radiopaque contrast agent supplied as a sterile, aqueous solution for parenteral use.

Reno-60 is indicated in excretion urography (by direct I.V. or drip infusion); cerebral angiography; peripheral arteriography; venography; operative, T-tube, or percutaneous transhepatic cholangiography; splenoportography; arthrography; and discography.

Computed Tomography

Reno-60 (Diatrizoate Meglumine Injection USP 60%) is also indicated for radiographic contrast enhancement in computed tomography (CT) of the brain and body. Contrast enhancement may be advantageous in delineating or ruling out disease in suspicious areas which may otherwise not have been satisfactorily visualized.

Brain Tumors

Reno-60 may be useful to demonstrate the presence and extent of certain malignancies such as: gliomas including malignant gliomas, glioblastomas, astrocytomas, oligodendrogliomas and gangliomas; ependymomas; medulloblastomas; meningiomas; neuromas; pinealomas; pituitary adenomas; craniopharyngiomas; germinomas; and metastatic lesions.

The usefulness of contrast enhancement for the investigation of the retrobulbar space and in cases of low grade or infiltrative glioma has not been demonstrated. In cases where lesions have calcified, there is less likelihood of enhancement. Following therapy, tumors may show decreased or no enhancement.

Non-Neoplastic Conditions of The Brain

The use of Reno-60 may be beneficial in the enhancement of images of lesions not due to neoplasms. Cerebral infarctions of recent onset may be better visualized with the contrast enhancement, while some infarctions are obscured if a contrast medium is used. The use of Reno-60 (Diatrizoate Meglumine Injection USP 60%) improved the contrast enhancement in approximately 60 percent of cerebral infarctions studied from one week to four weeks from the onset of symptoms.

Sites of active infection also will produce contrast enhancement following contrast medium administration.

Arteriovenous malformations and aneurysms will show contrast enhancement. In the case of these vascular lesions, the enhancement is probably dependent on the iodine content of the circulating blood pool.

Hematomas and intraparenchymal bleeders seldom demonstrate any contrast enhancement. However, in cases of intraparenchymal clot, for which there is no obvious clinical explanation, contrast medium administration may be helpful in ruling out the possibility of associated arteriovenous malformation.

The opacification of the inferior vermis following contrast medium administration has resulted in false-positive diagnoses in a number of normal studies.

Body Scanning

Reno-60 (Diatrizoate Meglumine Injection USP 60%) may be used for enhancement of computed tomographic scans performed for detection and evaluation of lesions in the liver, pancreas, kidneys, aorta, mediastinum, abdominal cavity, pelvis and retroperitoneal space.

Enhancement of computed tomography with Reno-60 may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone, and in supplying additional features of the lesions (e.g., hepatic abscess delineation prior to percutaneous drainage). In other cases, the contrast agent may allow visualization of lesions not seen with CT alone (e.g., tumor extension), or may help to define suspicious lesions seen with unenhanced CT (e.g., pancreatic cyst).

Contrast enhancement appears to be greatest within 60-90 seconds after bolus administration of the contrast agent. Therefore, utilization of a continuous scanning technique (“dynamic CT scanning”) may improve enhancement and diagnostic assessment of tumor and other lesions such as an abscess, occasionally revealing unsuspected or more extensive disease. For example, a cyst may be distinguished from a vascularized solid lesion when pre-contrast and enhanced scans are compared; the non-perfused mass shows unchanged X-ray absorption (CT number). A vascularized lesion is characterized by an increase in CT number in the few minutes after a bolus of intravascular contrast agent; it may be malignant, benign or normal tissue, but would probably not be a cyst, hematoma, or other nonvascular lesion.

Because unenhanced scanning may provide adequate diagnostic information in the individual patient, the decision to employ contrast enhancement, which may be associated with risk and increased radiation exposure, should be based upon a careful evaluation of clinical, other radiological, and unenhanced CT findings.


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NEWS HIGHLIGHTS

Published Studies Related to Reno-60 (Diatrizoate)

Prospective randomized trial of iohexol 350 versus meglumine sodium diatrizoate as an oral contrast agent for abdominopelvic computed tomography. [2011.03]
CONCLUSION: Iohexol 350 is a satisfactory oral contrast agent for abdominopelvic CT. It opacifies the gastrointestinal tract as well as meglumine sodium diatrizoate does, and patients prefer the taste of iohexol to that of diatrizoate.

Oral contrast media for body CT: Comparison of diatrizoate sodium and iohexol for patient acceptance and bowel opacification. [2010.11]
CONCLUSION: Patents preferred dilute iohexol over dilute diatrizoate sodium for oral contrast for abdominal-pelvic CT. There was no significant difference in bowel opacification or adverse effect profile.

Randomised clinical trial investigating the effects of combined administration of octreotide and methylglucamine diatrizoate in the older persons with adhesive small bowel obstruction. [2006.03]
OBJECTIVE: To investigate the effects of combined administration of octreotide and methylglucamine diatrizoate in the older persons with adhesive small bowel obstruction... CONCLUSIONS: Combined administration of octreotide and methylglucamine diatrizoate accelerates resolution of small bowel obstruction by a specific therapeutic effect and is safe for the older persons.

Preoperative bowel preparation with meglumine and sodium diatrizoate (Gastrografin): a prospective randomised comparison. [2001.12]
OBJECTIVE: To test the use of meglumine and sodium diatrizoate (Gastrografin) as an agent for preoperative mechanical bowel preparation... CONCLUSIONS: Gastrografin can be used successfully as an agent for mechanical bowel preparation before elective colorectal surgery, as it gives equally good cleansing results compared with the established method of whole gut irrigation. It also seems to be better tolerated and accepted by patients.

Effects in vivo of iohexol and diatrizoate on human plasma acetyl- and butyryl-cholinesterase activity. [2001.03]
CONCLUSIONS: Iohexol and diatrizoate induce in vivo a significant decrease of AC and BC plasma activities. The decrease is more pronounced for iohexol, a non ionic CA, which has a lower pharmacotoxicity than diatrizoate and adverse effects rate. No inference can be drawn about the relationship between plasma cholinesterase activity and adverse effects.

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Clinical Trials Related to Reno-60 (Diatrizoate)

Diagnostic Relevance of Laser Confocal Microscopy for the Screening of Upper Urinary Tract Tumors [Recruiting]
Upper Urinary Tract Tumors have an incidence of 1 to 2 cases for 100 000 persons per year. The standard treatment for these tumors is the ablation of the kidney, ureter and a part of the bladder surrounding the ureteral orifice. The development of new diagnosis and treatment techniques through natural routes opens the possibility to use conservative treatments. The investigators hypothesis is that during a reno-ureteroscopy, laser confocal microscopy will allow the discrimination between normal and pathologic urothelium by microscopic analysis. This will prevent the systematic use of biopsies which are often difficult and iatrogenic.

Effects of Aliskiren, Irbesartan, and the Combination in Hypertensive Patients With Type 2 Diabetes and Diabetic Nephropathy [Completed]
This study will assess the reno-protective effect of renin inhibition with aliskiren as an alternative to irbesartan in type 2 diabetes patients with incipient/overt diabetic nephropathy.

Reno- and Vascular Protective Effect of a Vitamin-D-analogue in Moderate to Severe Chronic Kidney Disease [Completed]
Recently it has been documented that vitamin D has important functions in the human body that are unrelated to its primary effects in calcium homeostasis and bone mineralization. In

clinical studies, paricalcitol - a low-calcemic vitamin D analogue - has been shown to

decrease proteinuria, a marker of disease progression and cardiovascular risk in patients with chronic kidney disease (CKD). The purpose of this study is to investigate the effect of a paricalcitol on renal and cardiovascular variables in patients with moderate to severe CKD.

Effect of Renal Denervation on NO-mediated Sodium Excretion and Plasma Levels of Vasoactive Hormones [Recruiting]
Catheter based renal denervation (CRD) in humans represents a promising new treatment of resistant hypertension. CRD is currently investigated as a treatment option in patients with resistant hypertension defined as at least 3 antihypertensive drugs (including a diuretic) in a randomized, sham-controlled, multicenter trial in Denmark (ReSet). In ReSet, patients are randomized to either CRD or a sham procedure with 6 months follow up. The mechanisms by which CRD reduce blood pressure are only partly understood and the interaction between renal sympathetic nerves and nitric oxide (NO) has not been investigated in humans. To Study the interaction between NO and renal sympathetic nerves, we designed the present substudy, where the effects of NO-inhibition on renal, hemodynamic and hormonal variables are studied before and after CRD.

Cardio- and Renoprotective Effect of Remote Ischemic Preconditioning in Patients Undergoing Percutaneous Coronary Intervention [Completed]
Myocyte necrosis occurs frequently in elective percutanious percutaneous coronary intervention (PCI) and is associated with subsequent cardiovascular events. This study assessed the cardio- and reno-protective effect of remote ischemic preconditioning (RIPC) in patients undergoing elective PCI. 200 patients were randomized into 2 groups: 100 patients received RIPC (created by three 5-minute inflations of a blood pressure cuff to 200 mm Hg around the upper arm, separated by 5-minute intervals of reperfusion) < 2 hours before the PCI procedure, and the control group (n = 100).

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Page last updated: 2011-12-09

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