Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1304
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ROXICET 5/500 (Capsule)
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General: As with all radiopaque contrast agents, only the lowest dose necessary to obtain adequate visualization should be used. A lower dose may reduce the possibility of an adverse reaction. Most procedures do not require use of either the maximum volume or the highest concentration of OPTIRAY. The combination of volume and concentration of OPTIRAY to be used should be carefully individualized accounting for factors such as age, body weight, size of the vessel and the rate of blood flow within the vessel. Other factors such as anticipated pathology,degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed should be considered. It is desirable that intravascularly administered iodinated contrast agents be at or close to body temperature when injected. If during administration a reaction occurs, the injection should be stopped until the reaction has subsided. Patients should be well hydrated prior to and following OPTIRAY (ioversol injection) administration. As with all contrast media, other drugs should not be mixed with ioversol solutions because of the potential for chemical incompatibility. Sterile technique must be used in all vascular injections involving contrast media. If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents. Withdrawal of contrast agents from their containers should be accomplished under strict aseptic conditions using only sterile syringes and transfer devices. Contrast agents which have been transferred into other delivery systems should be used immediately. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration and should not be used if particulates are observed or marked discoloration has occurred. The OPTIRAY formulations are supplied in single dose containers. Discard unused portion.
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OPTIRAY (ioversol injection) formulations are sterile, nonpyrogenic, aqueous solutions intended for intravascular administration as diagnostic radiopaque media. Ioversol is designated chemically as N,N'-Bis (2,3-dihydroxypropyl)-5-[N-(2-hydroxyethyl) -glycolamido] -2,4,6-triiodoisophthalamide and has the following structural formula: The molecular weight of ioversol is 807.11 and the organically bound iodine content is 47.2%. Ioversol is nonionic and does not dissociate in solution. Each milliliter of OPTIRAY 350 (ioversol injection 74%) contains 741 mg of ioversol with 3.6 mg of tromethamine as a buffer and 0.2 mg of edetate calcium disodium as a stabilizer. OPTIRAY 350 provides 35% (350 mg/mL) organically bound iodine. Each milliliter of OPTIRAY 320 (ioversol injection 68%) contains 678 mg of ioversol with 3.6 mg of tromethamine as a buffer and 0.2 mg of edetate calcium disodium as a stabilizer. OPTIRAY 320 provides 32% (320 mg/mL) organically bound iodine. Each milliliter of OPTIRAY 300 (ioversol injection 64%) contains 636 mg of ioversol with 3.6 mg of tromethamine as a buffer and 0.2 mg of edetate calcium disodium as a stabilizer. OPTIRAY 300 provides 30% (300 mg/mL) organically bound iodine. Each milliliter of OPTIRAY 240 (ioversol injection 51%) contains 509 mg of ioversol with 3.6 mg of tromethamine as a buffer and 0.2 mg of edetate calcium disodium as a stabilizer. OPTIRAY 240 provides 24% (240 mg/mL) organically bound iodine. Each milliliter of OPTIRAY 160 (ioversol injection 34%) contains 339 mg of ioversol with 3.6 mg of tromethamine as a buffer and 0.2 mg of edetate calcium disodium as a stabilizer. OPTIRAY 160 provides 16% (160 mg/mL) organically bound iodine. The pH of the OPTIRAY formulations has been adjusted to 6.0 to 7.4 with hydrochloric acid or sodium hydroxide. All solutions are sterilized by autoclaving and contain no preservatives. Unused portions should be discarded. OPTIRAY solutions are sensitive to light and therefore should be protected from exposure. Some physical and chemical properties of these formulations are listed below: The OPTIRAY formulations are clear, colorless to pale yellow solutions containing no undissolved solids. Crystallization does not occur at room temperature. The products are supplied in containers from which the air has been displaced by nitrogen. OPTIRAY solutions have osmolalities 1.2 to 2.8 times that of plasma (285 mOsm/kg water) as shown in the above table and are hypertonic under conditions of use.
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The pharmacokinetics of ioversol intravascularly administered in normal subjects conform to an open two compartment model with first order elimination (a rapid alpha phase for drug distribution and a slower beta phase for drug elimination). Based on the blood clearance curves for 12 healthy volunteers (6 receiving 50 mL and 6 receiving 150 mL of OPTIRAY 320), the biological half-life was 1.5 hours for both dose levels and there was no evidence of any dose related difference in the rate of elimination. Ioversol is excreted mainly through the kidneys following intravascular administration. In patients with impaired renal function, the elimination half-life is prolonged. In the absence of renal dysfunction, the mean half-life for urinary excretion following a 50 mL dose was 118 minutes (105 to 156) and following a 150 mL dose was 105 minutes (74 to 141). Greater than 95% of the administered dose was excreted within the first 24 hours, with the peak urine concentration occurring in the first 2 hours after administration. Fecal elimination was negligible. Ioversol does not bind to serum or plasma proteins to any extent and nosignificant metabolism, deiodination or biotransformation occurs. OPTIRAY probably crosses the placental barrier in humans by simple diffusion. It is not known to what extent ioversol is excreted in human milk. Intravascular injection of ioversol opacifies those vessels in the path of the flow of the contrast medium, permitting radiographic visualization of the internal structures until significant hemodilution occurs. Ioversol may be visualized in the renal parenchyma within 30 to 60 seconds following rapid intravenous injection. Opacification of the calyces and pelves in patients with normal renal function becomes apparent within 1 to 3 minutes, with optimum contrast occurring within 5 to 15 minutes. Animal studies indicate that ioversol does not cross the blood-brain barrier or cause endothelial damage to any significant extent. OPTIRAY enhances computed tomographic imaging through augmentation of radiographic efficiency. The degree of density enhancement is directly related to the iodine content in an administered dose; peak iodine blood levels occur immediately following rapid intravenous injection. Blood levels fall rapidly within 5 to 10 minutes and the vascular compartment half-life is approximately 20 minutes. This can be accounted for by the dilution in the vascular and extravascular fluid compartments which causes an initial sharp fall in plasma concentration. Equilibration with the extracellular compartments is reached in about 10 minutes; thereafter, the fall becomes exponential. The pharmacokinetics of ioversol in both normal and abnormal tissue have been shown to be variable. Contrast enhancement appears to be greatest immediately after bolus administration (15 seconds to 120 seconds). Thus, greatest enhancement may be detected by a series of consecutive two-to-three second scans performed within 30 to 90 seconds after injection (i.e., dynamic computed tomographic imaging). Utilization of a continuous scanning technique (i.e., dynamic CT scanning) may improve enhancement and diagnostic assessment of tumor and other lesions such as abscess, occasionally revealing unsuspected or more extensive disease. For example, a cyst may be distinguished from a vascularized solid lesion when precontrast and enhanced scans are compared; the nonperfused 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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None.
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This information is for Ultrajectsyringes containing OPTIRAY that have been labeled with a Radio Frequency Identification (RFID) tag. When used with an RFID-enabled Optivantageinjector, this tag allows for the exchange of product information such as lot number, expiration, concentration, and identification of the syringe as being "unused" prior to use and "used" after product administrations. Patient information is not utilized in any form with this RFID technology. OPTIRAY product quality isnot impacted with the use of this RFID tag. OPTIRAY RFID-tagged syringes require no special handling and should be stored at the conditions listed for the drug product.
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WARNING: NOT FOR INTRATHECAL USE
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General: Diagnostic procedures which involve the use of iodinated intravascular contrast agents should be carried out under the direction of personnel skilled and experienced in the particular procedure to be performed. A fully equipped emergency cart, or equivalent supplies and equipment, and personnel competent in recognizing and treating adverse reactions of all types should always be available. Since severe delayed reactions have been known to occur, emergency facilities and competent personnel should be available for at least 30 to 60 minutes after administration. Preparatory dehydration is dangerous and may contribute to acute renal failure in patients with advanced vascular disease, diabetic patients, and in susceptible nondiabetic patients (often elderly with pre-existing renal disease). Patients should be well hydrated prior to and following the administration of OPTIRAY. The possibility of a reaction, including serious, life-threatening, fatal, anaphylactoid or cardiovascular reactions, should always be considered (See Adverse Reactions). Increased risk is associated with a history of previous reaction to a contrast medium, a known sensitivity to iodine and known allergies (i.e., bronchial asthma, hay fever and food allergies) or hypersensitivities. The occurrence of severe idiosyncratic reactions has prompted the use of several pretesting methods. However, pretesting cannot be relied upon to predict severe reactions and may itself be hazardous to the patient. It is suggested that a thorough medical history with emphasis on allergy and hypersensitivity, prior to the injection of any contrast medium, may be more accurate than pretesting in predicting potential adverse reactions. A positive history of allergies or hypersensitivity does not arbitrarily contraindicate the use of a contrast agent when a diagnostic procedure is thought essential, but caution should be exercised. Premedication with antihistamines or corticosteroids to avoid or minimize possible allergic reactions in such patients should be considered. Reports indicate that such pretreatment does not prevent serious life-threatening reactions, but may reduce both their incidence and severity. General anesthesia may be indicated in the performance of some procedures in selected patients; however, a higher incidence of adverse reactions has been reported in these patients, and may be attributable to the inability of the patient to identify untoward symptoms or to the hypotensive effect of anesthesia which can prolong the circulation time and increase the duration of exposure to the contrast agent. In angiographic procedures, the possibility of dislodging plaques or damaging or perforating the vessel wall should be considered during catheter manipulations and contrast medium injection. Test injections to insure proper catheter placement are suggested. Angiography should be avoided whenever possible in patients with homocystinuria because of the risk of inducing thrombosis and embolism. Patients with congestive heart failure should be observed for several hours following the procedure to detect delayed hemodynamic disturbances which may be associated with a transitory increase in the circulating osmotic load. Selective coronary arteriography should be performed only in selected patients and those in whom the expected benefits outweigh the procedural risk. The inherent risks of angiocardiography in patients with chronic pulmonary emphysema must be weighed against the necessity for performing this procedure. Extreme caution during injection of a contrast medium is necessary to avoid extravasation. This is especially important in patients with severe arterial or venous disease.<br/>Information for Patients: Patients receiving iodinated intravascular contrast agents should be instructed to:<br/>Drug Interactions: Renal toxicity has been reported in a few patients with liver dysfunction who were given oral cholecystographic agents followed by intravascular contrast agents. Administration of any intravascular contrast agent should therefore be postponed in patients who have recently received a cholecystographic contrast agent. Other drugs should not be mixed with ioversol injection.<br/>Drug / Laboratory Test Interactions: The results of PBI and radioactive iodine uptake studies, which depend on iodine estimation, will not accurately reflect thyroid function for up to 16 days following administration of iodinated contrast media. However, thyroid function tests not depending on iodine estimations, e.g., T3 resin uptake and total or free thyroxine (T4) assays are not affected.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: No long term animal studies have been performed to evaluate carcinogenic potential. However, animal studies suggest that this drug is not mutagenic and does not affect fertility.<br/>Pregnancy Category B: No teratogenic effects attributable to ioversol have been observed in teratology studies performed in animals. There are, however, no adequate and well controlled studies in pregnant women. It is not known whether ioversol crosses the placental barrier or reaches fetal tissues. However, many injectable contrast agents cross the placental barrier in humans and appear to enter fetal tissue passively. Because animal teratology studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. X-ray procedures involve a certain risk related to the exposure of the fetus.<br/>Nursing Mothers: It is not known whether ioversol is excreted in human milk. However, many injectable contrast agents are excreted unchanged in human milk. Although it has not been established that serious adverse reactions occur in nursing infants, caution should be exercised when intravascular contrast media are administered to nursing women because of potential adverse reactions, and consideration should be given to temporarily discontinuing nursing.<br/>Pediatric Use: Safety and effectiveness in children have been established for the use of OPTIRAY 350 and OPTIRAY 320 in angiocardiography, and for OPTIRAY 320 in contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography. Safety and effectiveness in newborns have not been established.
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The adverse effects of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular system. Treatment of an overdosage is directed toward the support of all vital functions and prompt institution of symptomatic therapy. Ioversol does not bind to plasma or serum protein and is, therefore, dialyzable. The intravenous LDvalues (gI/kg) for ioversol in animals were: 17 (mice), and 15 (rats).
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Ioversol
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ROXICET 5/500 (Capsule)
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Adverse reactions following the use of OPTIRAY formulations are usually mild to moderate, of short duration and resolve spontaneously (without treatment). However, serious, life-threatening and fatal reactions, mostly of cardiovascular origin, have been associated with the administration of iodine-containing contrast media. Injections of contrast media are often associated with sensations of warmth and pain. In controlled double-blind clinical studies, significantly less warmth and pain were associated with the injection of OPTIRAY than with iothalamate meglumine, diatrizoate meglumine, and diatrizoate meglumine and diatrizoate sodium. When OPTIRAY was used for coronary arteriography and ventriculography in double-blind clinical trials, electrocardiographic and hemodynamic changes occurred with less frequency and severity with ioversol injection than with diatrizoate meglumine and diatrizoate sodium. Following coronary artery and left ventricular injection, electro-cardiographic parameters were affected less with OPTIRAY (ioversol injection) than with diatrizoate meglumine and diatrizoate sodium injection. These parameters included the following: bradycardia, tachycardia, T-wave amplitude, ST depression and ST elevation. OPTIRAY has also been shown to cause fewer changes in cardiac function and systemic blood pressure than conventional ionic media. These include cardiac output, left ventricular systolic and end-diastolic pressure, right ventricular systolic and pulmonary artery systolic pressures and decreases in systolic and diastolic blood pressures. The following table of incidence of reactions is based upon clinical trials with OPTIRAY formulations in 2,098 patients. This listing includes all adverse reactions which were coincidental to the administration of ioversol regardless of their direct attributability to the drug or the procedure. Adverse reactions are listed by organ system and in decreasing order of occurrence. Significantly more severe reactions are listed before others in a system regardless of frequency. Regardless of the contrast medium employed, the overall incidence of serious adverse reaction is higher with coronary arteriography than with other procedures. Cardiac decompensation, serious arrhythmias, myocardial ischemia or myocardial infarction may occur during coronary arteriography and left ventriculography.<br/>Pediatrics: In controlled clinical trials involving 159 patients for pediatric angiocardiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography, adverse reactions reported were as follows: fever (1.3%), nausea (0.6%), muscle spasm (0.6%), LV pressure changes (0.6%).<br/>General Adverse Reactions to Contrast Media: The following adverse reactions are possible with any parenterally administered iodinated contrast medium. Severe life-threatening reactions and fatalities, mostly of cardiovascular origin, have occurred. Most deaths occur during injection or 5 to 10 minutes later; the main feature being cardiac arrest with cardiovascular disease as the main aggravating factor. Isolated reports of hypotensive collapse and shock are found in the literature. Based upon clinical literature, reported deaths from the administration of conventional iodinated contrast agents range from 6.6 per 1 million (0.00066 percent) to 1 in 10,000 patients (0.01 percent). The reported incidence of adverse reactions to contrast media in patients with a history of allergy is twice that of the general population. Patients with a history of previous reactions to a contrast medium are three times more susceptible than other patients. However, sensitivity to contrast media does not appear to increase with repeated examinations. Adverse reactions to injectable contrast media fall into two categories: chemotoxic reactions and idiosyncratic reactions. Chemotoxic reactions result from the physiochemical properties of the contrast medium, the dose and the speed of injection. All hemodynamic disturbances and injuries to organs or vessels perfused by the contrast medium are included in this category. Idiosyncratic reactions include all other reactions. They occur more frequently in patients 20 to 40 years old. Idiosyncratic reactions may or may not be dependent on the dose injected, the speed of injection, the mode of injection and the radiographic procedure. Idiosyncratic reactions are subdivided into minor, intermediate and severe. The minor reactions are self-limited and of short duration; the severe reactions are life-threatening and treatment is urgent and mandatory. In addition to the adverse reactions reported for ioversol, the following additional adverse reactions have been reported with the use of other contrast agents and are possible with any water soluble, iodinated contrast agent. Nervous: convulsions, aphasia, paralysis, visual field losses which are usually transient but may be permanent, coma and death. Cardiovascular: angioneurotic edema, peripheral edema, vasodilation, thrombosis and rarely thrombophlebitis, disseminated intravascular coagulation and shock. Skin: maculopapular rash, erythema, conjunctival symptoms, ecchymosis and tissue necrosis. Respiratory: choking, dyspnea, wheezing which may be an initial manifestation of more severe and infrequent reactions including asthmatic attack, laryngospasm and bronchospasm, apnea and cyanosis. Rarely these allergic-type reactions can progress into anaphylaxis with loss of consciousness, coma, severe cardiovascular disturbances and death. Miscellaneous: hyperthermia, temporary anuria or other nephropathy. Other reactions may also occur with the use of any contrast agent as a consequence of the procedural hazard; these include hemorrhage or pseudoaneurysms at the puncture site, brachial plexus palsy following axillary artery injections, chest pain, myocardial infarction, and transient changes in hepatorenal chemistry tests. Arterial thrombosis, displacement of arterial plaques, venous thrombosis, dissection of the coronary vessels and transient sinus arrest are rare complications. (Adverse reactions for specific procedures receive comment in the Indications, Usage and Procedural Information section).
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SEVERE ADVERSE EVENTS��� INADVERTENT INTRATHECAL ADMINISTRATION: Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use. These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Special attention must be given to insure that this drug product is not administered intrathecally. Nonionic iodinated contrast media inhibit blood coagulation, in vitro, less thanionic contrast media. Clotting has been reported whenblood remains in contact with syringes containing nonionic contrast media. Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. Numerous factors, including length of procedure, catheter and syringe material,underlying disease state, and concomitant medications may contribute to the development of thromboembolic events. For these reasons, meticulous angiographic techniques are recommended including close attention to guidewire and catheter manipulation, use of manifold systems and/or three-way stopcocks, frequent catheter flushing with heparinized saline solutions and minimizing the length of the procedure. The use of plastic syringes in place of glass syringes has been reported to decrease but not eliminate the likelihood of in vitro clotting. Serious or fatal reactions have been associated with the administration of iodine-containing radiopaque media. It is of utmost importance to be completely prepared to treat any contrast medium reaction. As with any contrast medium, serious neurologic sequelae, including permanent paralysis, can occur following cerebral arteriography, selective spinal arteriography and arteriography of vessels supplying the spinal cord. A cause-effect relationship to the contrast medium has not been established since the patients' pre-existing condition and procedural technique are causative factors in themselves. The arterial injection of a contrast medium should never be made following the administration of vasopressors since they strongly potentiate neurologic effects. Caution must be exercised in patients with severely impaired renal function, combined renal and hepatic disease, severe thyrotoxicosis, myelomatosis, or anuria, particularly when large doses are administered. Intravascularly administered iodine-containing radiopaque media are potentially hazardous in patients with multiple myeloma or other paraproteinemia, particularly in those with therapeutically resistant anuria. Myeloma occurs most commonly in persons over age 40. Although neither the contrast agent nor dehydration has been proved separately to be the cause of anuria in myelomatous patients, it has been speculated that the combinationof both may be causative. The risk in myelomatous patients is not a contraindication to the procedure; however, special precautions, including maintenance of normal hydration and close monitoring, are required. Partial dehydration in the preparation of these patients prior to injection is not recommended since this may predispose the patient to precipitation of the myeloma protein. Administration of radiopaque materials to patients known or suspected of having pheochromocytoma should be performed with extreme caution. If, in the opinion of the physician, the possible benefits of such procedures outweigh the considered risks, the procedures may be performed; however, the amount of radiopaque medium injected should be kept to an absolute minimum. The blood pressure should be assessed throughout the procedure, and measures for treatment of a hypertensive crisis should be available. Contrast media may promote sickling in individuals who are homozygous for sickle cell disease when administered intravascularly. Reports of thyroid storm following the intravascular use of iodinated radiopaque agents in patients with hyperthyroidism or with an autonomously functioning thyroid nodule, suggest that this additional risk be evaluated in such patients before use of any contrast medium.
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OPTIRAY 350 is indicated in adults for peripheral and coronary arteriography and left ventriculography. OPTIRAY 350 is also indicated for contrast enhanced computed tomographic imaging of the head and body, intravenous excretory urography, intravenous digital subtraction angiography and venography. OPTIRAY 350 is indicated in children for angiocardiography. OPTIRAY 320 is indicated in adults for angiography throughout the cardiovascular system. The uses include cerebral, coronary, peripheral, visceral and renal arteriography, venography, aortography, and left ventriculography. OPTIRAY 320 is also indicated for contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography. OPTIRAY 320 is indicated in children for angiocardiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography. OPTIRAY 300 is indicated for cerebral angiography and peripheral arteriography. OPTIRAY 300 is also indicated for contrast enhanced computed tomographic imaging of the head and body, venography, and intravenous excretory urography. OPTIRAY 240 is indicated for cerebral angiography and venography. OPTIRAY 240 is also indicated for contrast enhanced computed tomographic imaging of the head and body and intravenous excretory urography. OPTIRAY 160 is indicated for intra-arterial digital subtraction angiography (IA-DSA).
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ROXICET 5/500
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