Reno-60 (Diatrizoate Meglumine) - Summary

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)

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.

Iopentol (Imagopaque 350) compared with diatrizoate (Urografin 370) in cerebral CT. A clinical trial assessing immediate and late (7 days) adverse events and diagnostic information (visualization quality and Hounsfield unit measurements). [1997]
The non-ionic contrast medium iopentol (Imagopaque, Nycomed Imaging AS, Oslo, Norway) 350 mg I/ml was compared for safety and efficacy with the ionic contrast medium diatrizoate (Urografin, Schering AG, Berlin, Germany) 370 mg I/ml in a randomized, double-blind, parallel-group clinical trial in cerebral computed tomography (CT)...

Iopentol (Imagopaque 250) compared with diatrizoate (Urografin 219) in endoscopic retrograde cholangio-pancreatography (ERCP). A clinical trial assessing safety (adverse events and S-pancreatic iso-amylase) and diagnostic information (VAS). [1997]
The efficacy and safety of the non-ionic contrast medium iopentol, 250 mg I/ml (Imagopaque, Nycomed Imaging AS, Oslo, Norway) were evaluated and compared to those of the ionic contrast medium diatrizoate 219 mg I/ml (Urografin, Schering AG, Berlin, Germany)... In conclusion, the study did not show any statistically significant differences between the two contrast media as regards safety or efficacy in ERCP.

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Clinical Trials Related to Reno-60 (Diatrizoate)

Impact of Early Renal Involvement on the Development of Severe In-Hospital Renal Failure [Recruiting]
The purpose of this study is to determine whether renal team involvement early at the onset of kidney injury will prevent further developement of more severe renal failure and worse hospitalization outcomes.

A Clinical Study of the Living Renal Transplantation With Restored Kidneys Between Third Parties [Recruiting]
Approximately 30,000 new patients are introduced into dialysis and about 20,000 of them die every year in Japan. At present, about 300,000 patients are on dialysis and more than 10,000 patients are registered to the Japan Organ Transplant Network (JOTN) with the hope for a renal transplantation. If the renal function is restored by transplantation, the quality of life (QOL) improves and more than 90% are reportedly come back to their normal life activities and get relieved from the burden of dialysis. Furthermore, it can reduce the dialysis related medical cost by as much as 50%. However, only about 1,000 renal transplantation cases are annually carried out in Japan. Among them, 80-85% are living renal transplantations offered by family members or relatives, and the rest are from deceased donors.

Due to the fact that the number of deceased donors are scarce and renal transplantations between non-relatives (third parties) are currently not allowed in Japan, the approximate waiting time to receive a renal transplantation is 16 years. For that reason, many patients travel abroad to receive a renal transplantation.

There are reports that total nephrectomies are performed as a treatment for small size (4 cm or less) renal tumors in many cases and that many of these nephrectomized kidneys can be successfully transplanted after surgical restoration with satisfactory results. However, due to the lack of necessary evidence it is currently not allowed in Japan.

Therefore, the investigators planned the present clinical study to evaluate the curative efficacy (renal function, QOL) and safety (side effects, complications or occurence of renal cancer) of living renal transplantations between third parties (non-relatives) with restored donor kidneys after the surgical removal of a small size (4 cm or less) renal tumor, in order to acquire necessary clinical data for potential enrichment of the renal donor pool in Japan as well as to develop useful medical care for our patients who are on dialysis for many years due to the renal failure.

A Clinical Study of the Living Renal Transplantation With Restored Kidneys Between Family Members [Recruiting]
Approximately 30,000 new patients are introduced into dialysis and about 20,000 of them die every year in Japan. At present, about 300,000 patients are on dialysis and more than 10,000 patients are registered with the Japan Organ Transplant Network (JOTN) with the hope for a renal transplantation. If the renal function is restored by transplantation, the quality of life (QOL) improves and more than 90% are reportedly comeback to their normal life activities and get relieved from the burden of dialysis. Furthermore, it can reduce the dialysis related medical cost by as much as 50%. However, only about 1,000 renal transplantation cases are annually carried out in Japan. Among them, 80-85% are living renal transplantations offered by family members or relatives, and the rest are from deceased donors.

Due to the fact that the number of deceased donors are scarce and only living renal transplantations between the family members or relatives are currently allowed in Japan, the approximate waiting time to receive a renal transplantation is 16 years. For that reason, many patients travel abroad to receive a renal transplantation.

There are reports that total nephrectomies are performed as a treatment for small size (4 cm or less) renal tumors, renal stones, ureteral tumors and ureteral strictures in many cases and that many of these nephrectomized kidneys can be successfully transplanted after surgical restoration with satisfactory results. However, due to the lack of necessary evidence it is currently not allowed in Japan.

Therefore, the investigators planned the present clinical study to evaluate the curative efficacy (renal function, QOL) and safety (side effects, complications or occurrence of renal cancer) of living renal transplantations between family members and relatives with restored donor kidneys after the surgical removal or repairment of a small size (4 cm or less) renal tumor or renal stone, ureteral tumor or ureteral stricture, in order to acquire necessary clinical data for potential enrichment of the renal donor pool in Japan as well as to develop useful medical care for our patients who are on dialysis for many years due to the renal failure.

Does An Abnormal PFA 100 Predict Bleeding After Renal Biopsy? [Recruiting]

- The kidneys are highly vascular organs and any trauma or surgery poses risk of severe

bleeding. Platelet function is an integral part of the blood clotting during the initial, so-called vascular phase. So far no universally accepted, easy test has been available to measure platelet functions. Renal failure is a condition generally associated with bleeding due to platelet dysfunctions. This study is exploring the utility of a novel platelet function test, called PFA-100 to predict bleed after percutaneous kidney biopsy. PFA-100 will be measure before kidney biopsy along with routine blood tests. Subjects will undergo renal ultrasound before and after renal biopsy to verify post-biopsy bleeding events.

Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function [Recruiting]
The purpose of this study is to assess whether a dosing adjustment is needed in patients with renal impairment.

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