Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0012833 (dizziness)
 9,689 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Twenty adult male volunteers were studied in an unblinded, ascending-dose study to evaluate the safety, tolerance, and pharmacokinetics of intravenously administered nonionic gadodiamide injection. Dosages administered were 0.05, 0.1, 0.2, and 0.3 mmol/kg. Subjects were monitored from 36 hours before, through 72 hours after administration. There were no clinically relevant changes in vital signs or electrocardiograms. No clinically significant changes occurred in blood or urine laboratory parameters, although a tendency for minor, transient elevations in serum iron levels 8 to 48 hours after administration was noted. These changes were not dose-related. Nine of 20 subjects reported at least one adverse event; all events were transient and of mild intensity, the most common being dizziness/lightheadedness and perversion of taste or smell. One subject reported discomfort consisting of mild stinging at the injection site during administration. Gadodiamide was excreted unmetabolized in the urine with greater than 95% recovery at 72 hours after administration. The serum elimination half-life was approximately 70 minutes.
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PMID:A phase I clinical trial with gadodiamide injection, a nonionic magnetic resonance imaging enhancement agent. 174 22

The development of new non-ionic magnetic resonance (MR) contrast media as gadodiamide injection increased the choice of paramagnetic contrast agents available in MR of the central nervous system (CNS). The purpose of our paper was to compare at the dose of 0.1 mmol/kg b.w. the safety of gadodiamide (Gd-DTPA-BMA) to gadopentetate dimeglumine (Gd-DTPA) and to gadoterate meglumine (Gd-DOTA) in two multicentric double-blind studies. A total of 551 patients were enrolled with 143 patients in the Gd-DTPA group, 132 patients in the Gd-DOTA group and 276 patients in the Gd-DTPA-BMA group. Safety was assessed by recording the adverse events up to 24 hours after the injection. One or more adverse events were recorded in 14% of the Gd-DTPA patients, in 15.1% of the Gd-DOTA patients and in 11.6% of the Gd-DTPA-BMA patients. These reactions were related to the contrast media in 9.1%, 13.6% and 8.7% of the cases respectively. Their intensity was defined as mild in 8.4% of the patients in the Gd-DTPA group, in 13.6% of the patients in the Gd-DOTA group and in 8.3% of the patients in the Gd-DTPA-BMA group. No severe reaction or death were recorded. An injection-site reaction (heat, coldness, pain) has been observed in 43% of the cases although an adverse event other than local reactions (headache, dizziness, nausea) has been noticed in 57% of the cases. No significant statistical difference was observed between the groups. Gadodiamide is a safe and effective contrast agent in MRI of the CNS in comparison with Gd-DTPA and Gd-DOTA currently in routine use.
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PMID:[Comparative studies of the tolerability of gadodiamide, dimeglumine gadopentetate and meglumine gadoterate in MRI tests of the central nervous system]. 747 75

The safety, tolerance, and pharmacokinetics of gadodiamide injection (Omniscan, Sanofi Winthrop Pharmaceuticals, New York, NY) were evaluated in an open, ascending-dose study in 20 healthy male volunteers. Gadodiamide injection was administered intravenously at doses of 0.05, 0.1, 0.2, and 0.3 mmol/kg. Mild adverse events were experienced by nine subjects. These events included, but were not limited to, light-headedness, dizziness, and perversion of taste or smell. There was one occurrence of injection-associated discomfort that resolved within seconds. Vital sign and electrocardiogram measurements did not show any clinically relevant changes. There were no clinically significant changes in laboratory parameters, but minor transient elevations in serum iron were detected. These elevations typically occurred 8 and 48 hours after administration of gadodiamide injection and were not dose related. The pharmacokinetics of gadodiamide injection were evaluated in the 0.1-mmol/kg and 0.3-mmol/kg dose groups with the serum time-concentration data fitted to an open two-compartment model and the urine time-concentration data fitted to a one-compartment model. The serum elimination half-life was approximately 70 minutes, and urinary recovery was greater than 95% by 72 hours after administration.
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PMID:Gadodiamide injection. First human experience with the nonionic magnetic resonance imaging enhancement agent. 848 3

Gadolinium-based magnetic resonance imaging (MRI) contrast agents (Gad-CA) were formerly considered as alternatives to X-ray-employed iodinated media. Although originally thought to be nonnephrotoxic and proven to be nonhazardous in a healthy population, the Gad-CA safety issue is progressively more controversial in the high-risk group of end-stage renal disease (ESRD) patients. Recently, Gad-CAs have not only been blamed for harmless side effects such as dizziness or nausea but also for much more severe complications such as acute renal failure, pancreatitis, or even the development of so-called "nephrogenic systemic fibrosis" in patients with renal failure, culminating in the prohibition of gadodiamide (Omniscan) administration in ESRD patients and, due to renal-organ immaturity, in newborns and infants up to 1 year old. This editorial is written to give insights into the molecular structure of Gad-CAs as well as into the potential biochemical pathomechanisms underlying the aforementioned severe clinical manifestations. Furthermore, a review about the latest literature on Gad-CA nephrotoxicity is provided. Potential risk factors are mentioned and strategies to avoid deterioration of renal function are presented. Cases with Gad-CA-associated adverse events should be adequately documented and reported appropriately. MRI professionals should collaborate closely with their colleagues from other medical specialties to identify patients with adverse events.
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PMID:Good MRI images: to Gad or not to Gad? 1757 78