Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2989
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Isovue (Injection, Solution)
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General: It is desirable that solutions of radiopaque diagnostic agents for intravascular use be at body
temperature when injected. Discard the container if crystallization of the medium has occurred. Withdrawal of contrast agents from their containers should be accomplished under aseptic
conditions with sterile syringes. Sterile techniques must be used with any intravascular injection,
and with catheters and guidewires. Parenteral drug products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit. Iopamidol solutions should be
used only if clear and within the normal colorless to pale yellow range. Patients should be well hydrated prior to and following ISOVUE (lopamidol Injection)
administration. As with all radiopaque contrast agents, only the lowest dose of ISOVUE necessary to obtain
adequate visualization should be used. A lower dose reduces the possibility of an adverse
reaction. Most procedures do not require use of either a maximum dose or the highest available
concentration of ISOVUE; the combination of dose and ISOVUE concentration to be used
should be carefully individualized, and factors such as age, body size, size of the vessel and
its blood flow rate, anticipated pathology and 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.<br/>Cerebral Arteriography: ISOVUE-300 (lopamidol Injection, 300 mgl/mL) should be used. The usual individual injection
by carotid puncture or transfemoral catheterization is 8 to 12 mL, with total multiple doses
ranging to 90 mL.<br/>Peripheral Arteriograghy: ISOVUE-300 usually provides adequate visualization. For injection into the femoral artery or
subclavian artery, 5 to 40 mL may be used; for injection into the aorta for a distal runoff, 25
to 50 mL may be used. Doses up to a total of 250 mL of ISOVUE-300 have been administered
during peripheral arteriography.<br/>Peripheral Venography (Phlebography): ISOVUE-200 (lopamidol Injection, 200 mgl/mL) should be used. The usual dose is 25 to 150 mL
per lower extremity. The combined total dose for multiple injections has not exceeded 350 mL.<br/>Selective Visceral Arteriography and Aortography: ISOVUE-370 (lopamidol Injection, 370 mgl/mL) should be used. Doses up to 50 mL may be
required for injection into the larger vessels such as the aorta or celiac artery; doses up to
10 mL may be required for injection into the renal arteries. Often, lower doses will be sufficient.
The combined total dose for multiple injections has not exceeded 225 mL.<br/>Pediatric Angiocardiography: ISOVUE-370 should be used. Pediatric angiocardiography may be performed by injection into
a large peripheral vein or by direct catheterization of the heart. The usual dose range for single injections is provided in the following table: The usual recommended dose for cumulative injections is provided in the following table:<br/>Coronary Arteriography and Ventriculography: ISOVUE-370 should be used. The usual dose for selective coronary artery injections is 2 to
10 mL. The usual dose for ventriculography, or for nonselective opacification of multiple coronary
arteries following injection at the aortic root is 25 to 50 mL. The total dose for combined
procedures has not exceeded 200 mL. EKG monitoring is essential.<br/>Excretory Urography: ISOVUE-250 ISOVUE-300 or ISOVUE-370 may be used. The usual adult dose for ISOVUE-250
is 50 to 100 mL, for ISOVUE-300 is 50 mL and for ISOVUE-370 is 40 mL administered by rapid
intravenous injection.<br/>Pediatric Excretory Urography: ISOVUE-250 or ISOVUE-300 may be used. The dosage recommended for use in children for
excretory urography is 1.2 mL/kg to 3.6 mL/kg for ISOVUE-250 and 1.0 mL/kg to 3.0 mL/kg
for ISOVUE-300. It should not be necessary to exceed a total dose of 30 grams of iodine.<br/>Computed Tomography: ISOVUE-250 or ISOVUE-300 may be used. CECT OF THE HEAD: The suggested dose for ISOVUE-250 is 130 to 240 mL and for
ISOVUE-300 is 100 to 200 mL by intravenous administration. Imaging may be performed
immediately after completion of administration. CECT OF THE BODY: The usual adult dose range for ISOVUE-250 is 130 to 240 mL and for
ISOVUE-300 is 100 to 200 mL administered by rapid intravenous infusion or bolus injection.
Equivalent doses of ISOVUE-370 based on organically bound iodine content may also be used.
The total dose for either CECT procedure should not exceed 60 grams of iodine.<br/>Pediatric Computed Tomography: ISOVUE-250 or ISOVUE-300 may be used. The dosage recommended for use in children
for contrast enhanced computed tomography is 1.2 mL/kg to 3.6 mL/kg for ISOVUE-250 and
1.0 mL/kg to 3.0 mL/kg for ISOVUE-300. It should not be necessary to exceed a total dose of
30 grams of iodine.<br/>Drug Incompatibilities: Many radiopaque contrast agents are incompatible in vitro with some antihistamines and many
other drugs; therefore, no other pharmaceuticals should be admixed with contrast agents.
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ISOVUE (lopamidol Injection) formulations are stable, aqueous, sterile, and nonpyrogenic
solutions for intravascular administration. Each mL of ISOVUE-200 (lopamidol Injection 41%) provides 408 mg iopamidol with 1 mg
tromethamine and 0.26 mg edetate calcium disodium. The solution contains approximately
0.029 mg (0.001 mEq) sodium and 200 mg organically bound iodine per mL. Each mL of ISOVUE-250 (lopamidol Injection 51%) provides 510 mg iopamidol with 1 mg
tromethamine and 0. 33 mg edetate calcium disodium. The solution contains approximately
0.036 mg (0.002 mEq) sodium and 250 mg organically bound iodine per mL. Each mL of ISOVUE-300 (lopamidol Injection 61%) provides 612 mg iopamidol with 1 mg
tromethamine and 0.39 mg edetate calcium disodium. The solution contains approximately
0.043 mg (0.002 mEq) sodium and 300 mg organically bound iodine per mL. Each mL of ISOVUE-370 (lopamidol Injection 76%) provides 755 mg iopamidol with 1 mg
tromethamine and 0.48 mg edetate calcium disodium. The solution contains approximately
0.053 mg (0.002 mEq) sodium and 370 mg organically bound iodine per mL. The pH of ISOVUE contrast media has been adjusted to 6.5-7.5 with hydrochloric acid and/or
sodium hydroxide. Pertinent physicochemical data are noted below. ISOVUE (lopamidol Injection)
is hypertonic as compared to plasma and cerebrospinal fluid (approximately 285 and
301 mOsm/kg water, respectively). lopamidol is designated chemically as (S)-N,N'-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-
triiodo-5-lactamidoisophthalamide. Structural formula:
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Intravascular injection of a radiopaque diagnostic agent opacifies those vessels in the path of
flow of the contrast medium, permitting radiographic visualization of the internal structures of
the human body until significant hemodilution occurs. Following intravascular injection, radiopaque diagnostic agents are immediately diluted in the
circulating plasma. Calculations of apparent volume of distribution at steady-state indicate that
iopamidol is distributed between the circulating blood volume and other extracellular fluid; there
appears to be no significant deposition of iopamidol in tissues. Uniform distribution of iopamidol
in extracellular fluid is reflected by its demonstrated utility in contrast enhancement of computed
tomographic imaging of the head and body following intravenous administration. The pharmacokinetics of intravenously administered iopamidol in normal subjects conform
to an open two-compartment model with first order elimination (a rapid alpha phase for drug
distribution and a slow beta phase for drug elimination). The elimination serum or plasma
half-life is approximately two hours; the half-life is not dose dependent. No significant metabolism,
deiodination, or biotransformation occurs. Iopamidol is excreted mainly through the kidneys following intravascular administration. In
patients with impaired renal function, the elimination half-life is prolonged dependent upon the
degree of impairment. In the absence of renal dysfunction, the cumulative urinary excretion
for Iopamidol, expressed as a percentage of administered intravenous dose is approximately
35 to 40 percent at 60 minutes, 80 to 90 percent at 8 hours, and 90 percent or more in the
72-to 96-hour period after administration. In normal subjects, approximately one percent or
less of the administered dose appears in cumulative 72- to 96-hour fecal specimens. ISOVUE may be visualized in the renal parenchyma within 30-60 seconds following rapid
intravenous administration. Opacification of the calyces and pelves in patients with normal
renal function becomes apparent within 1 to 3 minutes, with optimum contrast occurring between
5 and 15 minutes. In patients with renal impairment, contrast visualization may be delayed. Iopamidol displays little tendency to bind to serum or plasma proteins. No evidence of in vivo complement activation has been found in normal subjects. Animal studies indicate that iopamidol does not cross the blood-brain barrier to any significant
extent following intravascular administration. ISOVUE (lopamidol Injection) enhances computed tomographic brain imaging through
augmentation of radiographic efficiency. The degree of enhancement of visualization of tissue
density is directly related to the iodine content in an administered dose; peak iodine blood
levels occur immediately following rapid injection of the dose. These levels fall rapidly within
five to ten minutes. This can be accounted for by the dilution in the vascular and extracellular
fluid compartments which causes an initial sharp fall in plasma concentration. Equilibration
with the extracellular compartments is reached in about ten minutes, thereafter the fall becomes
exponential. Maximum contrast enhancement frequently occurs after peak blood iodine levels
are reached. Thedelay in maximum contrast enhancement can range from five to forty minutes
depending on the peak iodine levels achieved and the cell type of the lesion. This lag suggests
that radiographic contrast enhancement is at least in part dependent on the accumulation of
iodine within the lesion and outside the blood pool, although the mechanism by which this
occurs is not clear. The radiographic enhancement of nontumoral lesions, such as arteriovenous
malformations and aneurysms, is probably dependent on the iodine content of the circulating
blood pool. In CECT head imaging, ISOVUE (lopamidol Injection) does not accumulate in normal brain
tissue due to the presence of the blood-brain barrier. The increase in x-ray absorption in normal
brain is due to the presence of contrast agent within the blood pool. A break in the blood-brain
barrier such as occurs in malignant tumors of the brain allows the accumulation of the contrast
medium within the interstitial tissue of the tumor. Adjacent normal brain tissue does not contain
the contrast medium. In nonneural tissues (during computed tomography of the body), iopamidol diffuses rapidly
from the vascular into the extravascular space. Increase in x-ray absorption is related to blood
flow, concentration of the contrast medium, and extraction of the contrast medium by interstitial
tissue of tumors since no barrier exists. Contrast enhancement is thus due to the relative
differences in extravascular diffusion between normal and abnormaltissue, quite different from
that in the brain. The pharmacokinetics of iopamidol in both normal and abnormal tissue have been shown
to be variable. Contrast enhancement appears to be greatest soon after administration of the
contrast medium, and following intraarterial rather than intravenous administration. Thus, greatest
enhancement can be detected by a series of consecutive two- to three-second scans performed
just after injection (within 30 to 90 seconds), i.e., dynamic computedtomographic imaging.
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None.
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ISOVUE-200 (lopamidol Injection 41%)Ten 50 mL single dose vials (NDC 0270-1314-30)Ten 100 mL single dose bottles (NDC 0270-1314-34)Ten 200 mL single dose bottles (NDC 0270-1314-15) ISOVUE-250 (lopamidol Injection 51%)Ten 50 mL single dose vials (NDC 0270-1317-05)Ten 100 mL single dose bottles (NDC 0270-1317-02)Ten 150 mL single dose bottles (NDC 0270-1317-09)Ten 200 mL single dose bottles (NDC 0270-1317-39) ISOVUE-300 (lopamidol Injection 61%)Ten 30 mL single dose vials (NDC 0270-1315-25)Ten 50 mL single dose vials (NDC 0270-1315-30)Ten 75 mL single dose bottles (NDC 0270-1315-47)Ten 100 mL single dose bottles (NDC 0270-1315-35)Ten 150 mL single dose bottles (NDC 0270-1315-50) ISOVUE-370 (lopamidol Injection 76%)Ten 20 mL single dose vials (NDC 0270-1316-07)Ten 30 mL single dose vials (NDC 0270-1316-47)Ten 50 mL single dose vials (NDC 0270-1316-30)Ten 50 mL single dose bottles (NDC 0270-1316-01)Ten 75 mL single dose bottles (NDC 0270-1316-52)Ten 100 mL single dose bottles (NDC 0270-1316-35)Ten 125 mL single dose bottles (NDC 0270-1316-04)Ten 150 mL single dose bottles (NDC 0270-1316-37)Ten 175 mL single dose bottles (NDC 0270-1316-44)Ten 200 mL single dose bottles (NDC 0270-1316-40)<br/>Storage: Store at 20-25��C (68-77��F). [See USP]. Protect from light.<br/>Also Available: lopamidol Injection is also available as ISOVUE-M for intrathecal administration.
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NOT FOR INTRATHECAL USE
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General: Diagnostic procedures which involve the use of any radiopaque agent should be carried out
under the direction of personnel with the prerequisite training and with a thorough knowledge
of the particular procedure to be performed. Appropriate facilities should be available for coping
with any complication of the procedure, as well as for emergency treatment of severe reaction
to the contrast agent itself. After parenteral administration of a radiopaque agent, competent
personnel and emergency facilities should be available for at least 30 to 60 minutes since
severe delayed reactions may occur. Caution should be exercised in hydrating patients with
underlying conditions that may be worsened by fluid overload, such as congestive heart failure. Diabetic nephropathy may predispose to acute renal impairment following intravascular
contrast media administration. Acute renal impairment following contrast media administration
may precipitate lactic acidosis in patients who are taking biguanides. The administration of iodinated contrast media may aggravate the symptoms of myasthenia gravis. 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 preexisting renal disease). Patients should be well hydrated prior to and
following iopamidol administration. The possibility of a reaction, including serious, life-threatening,
fatal, anaphylactoid or cardiovascular reactions, should always be considered (see ADVERSE
REACTIONS). Patients at increased risk include those with a history of a previous reaction
to a contrast medium, patients with a known sensitivity to iodine per se, and patients with a
known clinical hypersensitivity (bronchial asthma, hay fever, and food allergies). 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 for
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 where 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. Recent reports indicate that such pretreatmentdoes not prevent serious life-threatening
reactions but may reduce both their incidence and severity. Pre-existing conditions, such as pacemakers or cardiac medications, specifically beta-blockers,
may mask or alter the signs or symptoms of an anaphylactoid reaction, as well as masking
or altering the response to particular medications used for treatment. For example, beta-blockers inhibit a tachycardiac response, and can lead to the incorrect diagnosis of a vasovagal
rather than an anaphylactoid reaction. Special attention to this possibility is particularly critical
in patients suffering from serious, life-threatening reactions. General anesthesia may be indicated in the performance of some procedures in selected
patients; however, a higher incidence of adverse reactions has been reported with radiopaque
media in anesthetized patients, which may be attributable to the inability of the patient to identify
untoward symptoms, or to the hypotensive effect of anesthesia which can reduce cardiac output
and increase the duration of exposure to the contrast agent. Even though the osmolality of iopamidol is low compared to diatrizoate or iothalamate based
ionic agents of comparable iodine concentration, the potential transitory increase in the circulatory
osmotic load in patients with congestive heart failure requires caution during injection. These
patients should be observed for several hours following the procedure to detect delayed
hemodynamic disturbances. Injection site pain and swelling may occur. In the majority of cases
it is due to extravasation of contrast medium. Reactions are usually transient and recover without
sequelae. However, inflammation and even skin necrosis have been seen on very rare occasions. In angiographic procedures, the possibility of dislodging plaques or damaging or perforating
the vessel wall, or inducing vasospasm, and or subsequent ischemic events, should be borne
in mind during catheter manipulations and contrast medium injection. Test injections to ensure
proper catheter placement are suggested. 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 pulmonary hypertension must be weighed against the
necessity for performing this procedure. Angiography should be avoided whenever possible
in patients with homocystinuria, because of the risk of inducing thrombosis and embolism.
See also Pediatric Use. In addition to the general precautions previously described, special care is required when
venography is performed in patients with suspected thrombosis, phlebitis, severe ischemic
disease, local infection or a totally obstructed venous system. Extreme caution during injection
of contrast media is necessary to avoid extravasation and fluoroscopy is recommended. This
is especially important in patients with severe arterial or venous disease.<br/>Information for Patients: Patients receiving injectable radiopaque diagnostic agents should be instructed to:<br/>Drug Interactions: Renal toxicity has been reported in a few patients with liver dysfunction who were given oralcholecystographic agents followed by intravascular contrast agents. Administration of intravascular
agents should therefore be postponed in any patient with a known or suspected hepatic or
biliary disorder who has recently received a cholecystographic contrast agent. Other drugs should not be admixed with iopamidol.<br/>Drug/Laboratory Test Interactions: The results of PBI and radioactive iodine uptake studies, which depend on iodine estimations,
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. Any test which might be affected by contrast media should be performed prior to administration
of the contrast medium.<br/>Laboratory Test Findings: In vitro studies with animal blood showed that many radiopaque contrast agents, including
iopamidol, produced a slight depression of plasma coagulation factors including prothrombin
time, partial thromboplastin time, and fibrinogen, as well as a slight tendency to cause plateletand/or red blood cell aggregation . Transitory changes may occur in red cell and leucocyte counts, serum calcium, serum
creatinine, serum glutamic oxaloacetic transaminase (SGOT), and uric acid in urine; transient
albuminuria may occur. These findings have not been associated with clinical manifestations.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals have not been performed to evaluate carcinogenic potential.
No evidence of genetic toxicity was obtained in in vitro tests. Pregnancy:Teratogenic Effects Pregnancy Category B Reproduction studies have been performed in rats and rabbits at doses
up to 2.7 and 1.4 times the maximum recommended human dose (1.48 gl/kg in a 50 kg
individual), respectively, and have revealed no evidence of impaired fertility or harm to the fetus
due to iopamidol. There are, however, no adequate and well-controlled studies in pregnant
women. Because animal reproduction studies are not always predictive of human response,
this drug should be used during pregnancy only if clearly needed.<br/>Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted
in human milk, caution should be exercised when iopamidol is administered to a nursing woman.<br/>Pediatric Use: Safety and effectiveness in children has been established in pediatric angiocardiography,
computed tomography (head and body) and excretory urography. Pediatric patients at higher
risk of experiencing adverse events during contrast medium administration may include those
having asthma, a sensitivity to medication and/or allergens, cyanotic heart disease, congestive
heart failure, a serum creatinine greater than 1.5 mg/dL or those less than 12 months of age.
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Treatment of an overdose of an injectable radiopaque contrast medium is directed toward the
support of all vital functions, and prompt institution of symptomatic therapy.
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iopamidol
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Isovue (Injection, Solution)
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Adverse reactions following the use of iopamidol are usually mild to moderate, self-limited, and
transient. In angiocardiography (597 patients), the adverse reactions with an estimated incidence of
one percent or higher are: hot flashes 3.4%; angina pectoris 3.0%; flushing 1.8%; bradycardia
1.3%; hypotension 1.0%; hives 1.0%. In a clinical trial with 76 pediatric patients undergoing angiocardiography, 2 adverse reactions
(2.6%) both remotely attributed to the contrast media were reported. Both patients were less
than 2 years of age, both had cyanotic heart disease with underlying right ventricular abnormalities
and abnormal pulmonary circulation. In one patient preexisting cyanosis was transiently
intensified following contrast media administration. In the second patient preexisting decreased
peripheral perfusion was intensified for 24 hours following the examination.(See���PRECAUTIONS���Section for information on high risk nature of these patients.) Intravascular injection of contrast media is frequently associated with the sensation of warmth
and pain especially in peripheral arteriography and venography; pain and warmth are less
frequent and less severe with ISOVUE (lopamidol Injection) than with diatrizoate meglumine
and diatrizoate sodium injection. The following table of incidence of reactions is based on clinical studies with ISOVUE in about
2246 patients. Adverse Reactions Regardless of the contrast agent employed, the overall estimated incidence of serious adverse
reactions is higher with coronary arteriography than with other procedures. Cardiac
decompensation, serious arrhythmias, or myocardial ischemia or infarction have been reported
with Isovue and may occur during coronary arteriography and left ventriculography. Following coronary and ventricular injections, certain electrocardiographic changes (increased
QTc, increased R-R, T-wave amplitude) and certain hemodynamic changes (decreased systolic
pressure) occurred less frequently with ISOVUE (lopamidol Injection) than with diatrizoate
meglumine and diatrizoate sodium injection; increased LVEDP occurred less frequently after
ventricular iopamidol injections. In aortography, the risks of procedures also include injury to the aorta and neighboring organs,
pleural puncture, renal damage including infarction and acute tabular necrosis with oliguria and
anuria, accidental selective filling of the right renal artery during the translumbar procedure in the
presence of preexisting renal disease, retroperitoneal hemorrhage from the translumbar approach,
and spinal cord injury and pathology associated with the syndrome of transverse myelitis. The following adverse reactions have been reported for lopamidol: Cardiovascular: arrhythmia,
arterial spasms, flushing, vasodilation, chest pain, cardiopulmonary arrest; Nervous: confusion,
paresthesia, dizziness, temporary cortical blindness, temporary amnesia, convulsions, paralysis,
coma; Respiratory: increased cough, sneezing, asthma, apnea, laryngeal edema, chest tightness,
rhinitis; Skin and Appendages: injection site pain usually due to extravasation and/or erythematous
swelling, pallor, periorbital edema, facial edema; Urogenital: pain, hematuria; Special Senses:
watery itchy eyes, lacrimation, conjunctivitis; Musculoskeletal: muscle spasm, involuntary leg
movement; Body as a whole: tremors, malaise, anaphylactoid reaction (characterized by
cardiovascular,respiratory and cutaneous symptoms), pain; Digestive: severe retching and
choking, abdominal cramps. Some of these may occur as a consequence of the procedure. 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.<br/>General Adverse Reactions To Contrast Media: Reactions known to occur with parenteral administration of iodinated ionic contrast agents (see
the listing below) are possible with any nonionic agent. Approximately 95 percent of adverse
reactions accompanying the use of other water-soluble intravascularly administered contrast
agents are mild to moderate in degree. However, life-threatening reactions and fatalities, mostly
of cardiovascular origin, have occurred. Reported incidences of death from the administration
of other iodinated contrast media range from 6.6 per 1 million(0.00066 percent) to 1 in 10,000
patients (0.01 percent). 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. The incidence of shock
is estimated to be 1 out of 20,000 (0.005 percent) patients. Adverse reactions to injectable contrast media fall into two categories: chemotoxic reactions
and idiosyncratic reactions. Chemotoxic reactions result from the physicochemical 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. Experience with iopamidol suggests there is much less discomfort (e.g. pain and/or warmth)
with peripheral arteriography. Fewer changes are noted in ventricular function after ventriculography
and coronary arteriography. 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 amount of drug
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. The reported incidence of adverse reactions to contrast media in patients with a history of
allergy is twice that for 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. Most adverse
reactions to intravascular contrast agents appear within one to three minutes after the start
ofinjection, but delayed reactions may occur. Delayed reactions, usually involving the skin,
may uncommonly occur within 2-3 days (range 1-7 days) after the administration of contrast
. Delayed allergic reactions are more frequent in patients treated
with immunostimulants, such as interleukin-2. In addition to the adverse drug reactions reported for iopamidol, the following additional
adverse reactions have been reported with the use of other intravascular contrast agents and
are possible with the use of any water-soluble iodinated contrast agent: Cardiovascular: cerebral hematomas, petechiae; Hematologic: neutropenia; Skin and
Appendages: skin necrosis; Urogenital: osmotic nephrosis of proximal tubular cells, renal failure;Special Senses: conjunctival chemosis with infection.
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ISOVUE (lopamidol Injection) is indicated for angiography throughout the cardiovascular system,
including cerebral and peripheral arteriography, coronary arteriography and ventriculography,
pediatric angiocardiography, selective visceral arteriography and aortography, peripheral
venography (phlebography), and adult and pediatric intravenous excretory urography and
intravenous adult and pediatric contrast enhancement of computed tomographic (CECT) head
and body imaging (see below).<br/>CECT Head Imaging: ISOVUE may be used to refine diagnostic precision in areas of the brain which may not
otherwise have been satisfactorily visualized.<br/>Tumors: ISOVUE may be useful to investigate 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 calcified lesions, there is less likelihood of enhancement. Following therapy, tumors may
show decreased or no enhancement. The opacification of the inferior vermis following contrast media administration has resulted
in false-positive diagnosis in a number of otherwise normal studies.<br/>Nonneoplastic Conditions: ISOVUE may be beneficial in the image enhancement of nonneoplastic lesions. Cerebral
infarctions of recent onset may be better visualized with contrast enhancement, while some
infarctions are obscured if contrast media are used. The use of iodinated contrast media results
in contrast enhancement in about 60 percent of cerebral infarctions studied from one to four
weeks from the onset of symptoms. Sites of active infection may also be enhanced following contrast media administration. Arteriovenous malformations and aneurysms will show contrast enhancement. For 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 media administration may be helpful in ruling out the possibility of associated
arteriovenous malformation.<br/>CECT Body Imaging: ISOVUE (lopamidol Injection) may be used for enhancement of computed tomographic images
for detection and evaluation of lesions in the liver, pancreas, kidneys, aorta, mediastinum,
abdominal cavity, pelvis and retroperitoneal space. Enhancement of computed tomography with ISOVUE 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 to 90 seconds after bolus administration
of 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 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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Isovue
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