RenoCal-76® Diatrizoate Meglumine and
Diatrizoate Sodium Injection USP
NOT FOR INTRATHECAL USE
RenoCal-76 (Diatrizoate Meglumine and Diatrizoate Sodium
Injection USP) is a radiopaque contrast agent for intravascular use
supplied as a sterile, aqueous solution. Each mL provides 660 mg
diatrizoate meglumine and 100 mg diatrizoate sodium with 0.1 mg
edetate calcium disodium as a sequestering agent. The pH has
been adjusted to 6.0-7.7 with sodium carbonate and sodium
hydroxide or hydrochloric acid. Each mL contains approximately
3.69 mg (0.16 mEq) sodium and 370 mg of organically bound
iodine. The viscosity of the solution is 15 cps at 25°C and 9.1 cps
at 37°C. It is hypertonic to blood with an osmolality of
1870 mOsm/kg. At the time of manufacture, the air in the
container is replaced by nitrogen.
Following intravascular injection, RenoCal-76 is rapidly transported
through the bloodstream to the kidneys and is excreted unchanged
in the urine by glomerular filtration. When urinary tract obstruction
is severe enough to block glomerular filtration, the agent appears
to be excreted by the tubular epithelium.
Renal accumulation is sufficiently rapid so that the period of
maximal opacification of the renal passages may begin as early as
five minutes after injection. In infants and small children excretion
takes place somewhat more promptly than in adults, so that
maximal opacification occurs more rapidly and is less sustained.
The normal kidney eliminates the contrast medium almost
immediately. In nephropathic conditions, particularly when
excretory capacity has been altered, the rate of excretion varies
unpredictably, and opacification may be delayed for 30 minutes or
more after injection; with severe impairment opacification may not
occur. Generally, however, the medium is concentrated in sufficient
amounts and promptly enough to permit a thorough evaluation of
the anatomy and physiology of the urinary tract. After intramuscular
injection, the contrast agent is promptly absorbed and
normally reaches the renal passages within 20 to 60 minutes.
Intravascular injection of diatrizoate also opacifies those vessels in
the path of flow of the medium, permitting visualization until the
circulating blood dilutes the concentration of the medium. Thus
selective angiography may be performed following injection
directly into veins or arteries.
RenoCal-76 enhances computed tomographic brain scanning
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. The delay 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.
RenoCal-76 is indicated in excretion urography,
nephrotomography, aortography, pediatric angiocardiography,
peripheral arteriography, selective renal arteriography, selective
visceral arteriography, selective coronary arteriography, selective
coronary arteriography combined with left ventriculography, and
intravenous digital subtraction angiography (DSA).
RenoCal-76 is also indicated for radiographic contrast
enhancement in computed tomography (CT) of the brain. Contrast
enhancement is advantageous in delineating or ruling out disease
in suspicious areas which may otherwise not have been
RenoCal-76 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
The use of RenoCal-76 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 RenoCal-76 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.
RenoCal-76 is contraindicated for use in intrathecal procedures.
This preparation is contraindicated in patients with a
hypersensitivity to salts of diatrizoic acid.
Urography and nephrotomography are contraindicated in patients
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 inadvertentlyadministered intrathecally.
The possibility exists for inadvertent administration into the
intrathecal space during epidural administrations. Therefore,
epidural administration procedures, such as pain management
catheter placement, should not be performed with use of this
Ionic iodinated contrast media inhibit blood coagulation, in vitro,
more than nonionic contrast media. Nonetheless, it is prudent to
avoid prolonged contact of blood with syringes containing ionic
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.
A definite risk exists in the use of intravascular contrast agents
in patients who are known to have multiple myeloma. In such
instances there has been anuria resulting in progressive
uremia, renal failure and eventually death. Although neither the
contrast agent nor dehydration has separately proved to be the
cause of anuria in myeloma, it has been speculated that the
combination of both may be the causative factor. The risk in
myelomatous patients is not a contraindication to the
procedures; however, partial dehydration in the preparation of
these patients for the examination is not recommended since
this may predispose to the precipitation of myeloma protein in
the renal tubules. No form of therapy, including dialysis, has
been successful in reversing this effect. Myeloma, which occurs
most commonly in persons over age 40, should be considered
before intravascular administration of a contrast agent.
Administration of radiopaque materials to patients known or
suspected to have 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
Contrast media have been shown to promote the phenomenon of
sickling in individuals who are homozygous for sickle cell disease
when the material is injected intravenously or intra-arterially.
Since iodine-containing contrast agents may alter the results of
thyroid function tests, such tests, if indicated, should be
performed prior to the administration of this preparation.
A history of sensitivity to iodine per se or to other contrast agents
is not an absolute contraindication to the use of diatrizoate, but
calls for extreme caution in administration.
In patients with subarachnoid hemorrhage, a rare association
between contrast administration and clinical deterioration,
including convulsions and death, has been reported; therefore,
administration of intravascular iodinated ionic contrast media in
these patients should be undertaken with caution.
The inherent risks of angiocardiography in cyanotic infants and
patients with chronic pulmonary emphysema must be weighed
against the necessity for performing this procedure. In pediatric
angiocardiography, a dose of 10 to 20 mL may be particularly
hazardous in infants weighing less than 7 kg. This risk is probably
significantly increased if these infants have preexisting right heart“strain,” right heart failure, and effectively decreased or obliterated
pulmonary vascular beds.
Urography and nephrotomography should be performed with
extreme caution in patients with severe concomitant hepatic and
Selective visceral arteriography should be performed with extreme
caution in patients with severe generalized atherosclerosis,
specifically with plaques or aneurysms at the level of the iliac or
Selective coronary arteriography should be performed only in
selected patients and those in whom the expected benefits
outweigh the procedural risk.
Diagnostic procedures which involve the use of diagnostic
radiopaque contrast agents 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 reactions 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 have occurred (seeADVERSE REACTIONS).
Severe, life-threatening reactions suggest hypersensitivity to the
radiopaque agent, which has prompted the use of several
pretesting methods, none of which can be relied upon to predict
severe reactions. Many authorities question the value of any
pretest. A history of bronchial asthma or allergy, a family history
of allergy, or a previous reaction to a contrast agent warrant
special attention. Such a history, by suggesting histamine
sensitivity and a consequent proneness to reactions, may be more
accurate than pretesting in predicting the likelihood of a reaction,
although not necessarily the severity or type of reaction in the
The sensitivity test most often performed is the slow injection of
0.5 to 1.0 mL of the radiopaque medium, administered
intravenously, prior to injection of the full diagnostic dose. It
should be noted that the absence of a reaction to the test dose
does not preclude the possibility of a reaction to the full diagnostic
dose. If the test dose causes an untoward response of any kind,
the necessity for continuing with the examination should be
carefully reevaluated and, if it is deemed essential, the examination
should be conducted with all possible caution. In rare instances
reactions to the test dose itself may be extremely severe;
therefore, close observation of the patient, and facilities for
emergency treatment, appear indicated.
Renal toxicity has been reported in a few patients with liver
dysfunction who were given oral cholecystographic agents
followed by urographic agents. Administration of RenoCal-76
(Diatrizoate Meglumine and Diatrizoate Sodium Injection USP)
should therefore be postponed in any patient with a known or suspected
hepatic or biliary disorder who has recently taken a
cholecystographic contrast agent.
Caution should be exercised with the use of radiopaque media in
severely debilitated patients and in those with marked
hypertension. The possibility of thrombosis should be borne in
mind when percutaneous techniques are employed.
Consideration must be given to the functional ability of the kidneys
before injecting this preparation.
Contrast agents may interfere with some chemical determinations
made on urine specimens; therefore, urine should be collected
before administration of the contrast medium or two or more days
The following precautions pertain to specific procedures:
Excretion urography and nephrotomography: Acute renal failure
has been reported in diabetic patients with diabetic nephropathy
and susceptible nondiabetic patients (often elderly with preexisting
renal disease) following urographic procedures. Therefore, careful
consideration should be given to the increased potential risk in
these patients prior to performing either procedure. In excretion
urography adequate visualization may be difficult or impossible to
attain in uremic patients or others with severely impaired renal
function (see CONTRAINDICATIONS). In nephrotomography,
although azotemia is not considered a contraindication, care is
required in patients with advanced renal failure. Preparatory partial
dehydration is not recommended in these patients, and their
urinary output should be observed for one to two days following
Aortography: Repeated intra-aortic injections may be hazardous.
Pediatric angiocardiography: Repeated injections may be
hazardous particularly in infants weighing less than 7 kg (see
Peripheral arteriography: Hypotension or moderate decreases in
blood pressure seem to occur frequently with intra-arterial
(brachial) injections; therefore, the blood pressure should be
monitored during the immediate ten minutes after injection; this
blood pressure change is transient and usually requires no
Selective coronary arteriography: It is recommended that the
procedure should not be performed for approximately four weeks
following the diagnosis of myocardial infarction. Mandatory
prerequisites to the procedure are experienced personnel, ECG
monitoring apparatus, and adequate facilities for immediate
resuscitation and cardioversion.
Intravenous digital subtraction angiography: The dose is usually
administered mechanically under high pressure; rupture of smaller
peripheral veins can occur. This may be avoided by using an
intravenous catheter threaded proximally beyond larger tributaries
or, in the case of the antecubital vein, into the superior vena cava;
the femoral vein is used sometimes. It may be desirable to
administer a test dose by manual injection prior to the diagnostic
dose to ensure that the catheter has been properly positioned.
Usage In Pregnancy
Safety for use during pregnancy has not been established;
therefore, this preparation should be used in pregnant patients
only when, in the judgment of the physician, its use is deemed
essential to the welfare of the patient.
Mild, moderate, and sometimes severe adverse reactions may
occur associated with the procedure and/or the contrast media.
Reactions known to occur with parenteral administration of
iodinated ionic contrast media (see the listing below) are possible
with a 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, severe and 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.
Nausea, vomiting, flushing, or a generalized feeling of warmth are
the reactions seen most frequently with intravascular injection.
Symptoms which may occur are chills, fever, sweating, headache,
dizziness, pallor, weakness, severe retching and choking,
wheezing, a rise or fall in blood pressure, facial or conjunctival
petechiae, urticaria, pruritus, rash, and other eruptions, edema,
cramps, tremors, itching, sneezing, lacrimation, etc. Antihistaminic
agents may be of benefit; rarely such reactions may be severe
enough to require discontinuation of dosage.
Although local tissue tolerance is usually good, there have been a
few reports of a burning or stinging sensation or numbness and of
venospasm or venous pain, and partial collapse of the injected
vein. Neutropenia or thrombophlebitis may occur.
Severe reactions which may require emergency measures may
take the form of a cardiovascular reaction characterized by
peripheral vasodilatation with resultant hypotension and reflex
tachycardia, dyspnea, agitation, confusion and cyanosis
progressing to unconsciousness. Or, the histamine-liberating effect
of these compounds may induce an allergic-like reaction which
may range in severity from rhinitis or angioneurotic edema to
laryngeal or bronchial spasm or anaphylactoid shock.
Temporary renal shutdown or other nephropathy may occur.
Adverse reactions may sometimes occur as a consequence of the procedure for which the contrast agent is used. Adverse reactions
in excretion urography have included cardiac arrest, ventricular
fibrillation, anaphylaxis with severe asthmatic reaction, and
flushing due to generalized vasodilatation. Reactions following
higher doses for nephrotomography are usually mild and
transitory and do not appear to occur more frequently or severely
than those induced by doses for excretion urography. Nausea,
vomiting, flushing, or a generalized feeling of warmth are the
reactions seen most frequently. In aortography , the risks of
procedures include injury to the aorta and neighboring organs,
pleural puncture, renal damage including infarction and acute
tubular necrosis with oliguria and anuria, accidental selective filling
of the right renal artery during the translumbar procedure in the
presence of preexistent renal disease, retroperitoneal hemorrhage
from the translumbar approach, spinal cord injury and pathology
associated with syndrome of transverse myelitis, generalized
petechiae, and death following hypotension, arrhythmia, and
anaphylactoid reactions. Adverse reactions in pediatric
angiocardiography have included arrhythmia and death. Duringperipheral arteriography, complications have occurred including
hemorrhage from the puncture site, thrombosis of the vessel, and
brachial plexus palsy following axillary artery injections. Duringselective coronary arteriography and selective coronary
arteriography combined with left ventriculography, most patients
will have transient ECG changes. Transient arrhythmias may occur
infrequently. Ventricular fibrillation may result from manipulation
of the catheter during the procedure or administration of the
medium. Other reactions may include hypotension, chest pain, and
myocardial infarction. Transient elevation of CPK (creatine
phosphokinase) has occurred in approximately 30 percent of the
patients tested. Fatalities have been reported. Complications due to
the procedure include hemorrhage, thrombosis, pseudoaneurysms
at the puncture site, and dislodgment of arteriosclerotic plaques.
Dissection of the coronary vessels and transient sinus arrest have
Adverse reactions in selective renal arteriography include nausea,
vomiting, hypotension and hypertension. Post-arteriographic
changes in laboratory studies include transient elevations in BUN,
serum creatinine and glucose.
Complications due to the procedure during selective visceral
arteriography include hematomas, thrombosis, pseudoaneurysms
at injection site, and dislodgment of arteriosclerotic plaques. Other
reactions may include urticaria, hypotension, hypertension, and
insignificant changes in renal function and liver chemistry tests.
DOSAGE AND ADMINISTRATION
RenoCal-76 (Diatrizoate Meglumine and Diatrizoate Sodium
Injection USP) should be at body temperature when injected, and
may need to be warmed before use. Syringes should be rinsed as
soon as possible after injection to prevent freezing of the plunger.
Withdrawal of the contrast agent should be accomplished under
aseptic conditions with sterile needle and syringe.
Excretion Urography and Nephrotomography
Appropriate preparation of the patient is desirable for optimal
results. A laxative the night before the examination, a low residue
diet the day before, and low liquid intake for 12 hours prior to the
procedure may be used to clear the gastrointestinal tract and to
induce a partial dehydration which is believed to increase the
urinary concentration of the contrast medium. Enemas are to be
avoided to prevent rehydration.
Preparatory partial dehydration is not recommended in infants,
young children, the elderly, those with impaired renal function, or
azotemic patients (especially those with polyuria, oliguria,
diabetes, advanced vascular disease, or preexisting dehydration,
see PRECAUTIONS). The undesirable dehydration in these patients
may be accentuated by the osmotic diuretic action of the medium.
In uremic patients partial dehydration is not necessary and
maintenance of adequate fluid intake is particularly desirable.
The usual intravenous dose for patients aged 16 years or more is
20 mL, but 30 to 40 mL have been used. Children require less in
proportion to weight: Under 6 months of age–4 mL; 6 to 12
months–6 mL; 1 to 2 years–8 mL; 2 to 5 years–10 mL; 5 to 7
years–12 mL; 8 to 10 years–14 mL; 11 to 15 years–16 mL.
The preparation is given by intravenous injection. If flushing or
nausea occurs during administration, injection should be slowed
or briefly interrupted until the side effects have disappeared.
A scout film should be made before the contrast medium is
administered. To allow for individual variation, several films should
be exposed beginning approximately five minutes after injection. In
patients with renal dysfunction optimal visualization may be
delayed until 30 minutes or more after injection.
NOTE: In infants and children and in certain adults, the medium
may be injected intramuscularly. The suggested dose is the same
as the intravenous dose divided and given bilaterally in the gluteal
muscles. Radiographs should be taken at 20, 40, and 60 minutes
after the medium is injected.
Nephrotomography may be performed when prior urography has
failed to provide diagnostic information. At high dosage,
RenoCal-76 may be used to intensify and prolong the
nephrographic effect (especially with tomography) when the prime
purpose is examination of the renal parenchyma. For example, this
method may be employed in the preoperative differentiation of
renal masses and damage to the renal parenchyma such as that
caused by infarcts or infections.
The suggested dose is 100 mL administered by rapid bolus
intravenous injection or intravenous infusion. The usual time
interval for administration of the dose has ranged up to four
minutes for bolus injections and up to 15 minutes for infusions,
depending on the volume of the solution. During the period of
intense blush of the renal parenchyma (nephrographic phase),
tomographic “cuts” spaced 1 cm apart are obtained through the
entire thickness of both kidneys. The complete film series should
be exposed within 60 to 90 seconds following administration of
the dose for best results. The number of “cuts” (longitudinal) will
vary in individual cases.
RenoCal-76 injected into the aorta by the translumbar or
retrograde method of administration, permits radiographic
visualization of the aorta, its major branches and the abdominal
arteries. An incidental nephrogram is obtained as the contrast
medium travels through the renal vasculature, provided it has been
injected above the renal artery.
Patients should be prepared in a manner similar to that used for
intravenous urography. Premedication with a suitable barbiturate is
As in any form of surgery, certain hazards accompany
aortographic procedures (see ADVERSE REACTIONS).
For adults and children over 16 years of age, the usual dose is 15
to 40 mL as a single injection, repeated if indicated. Children
require less in proportion to weight. Doses up to a total of 160 mL
have been given safely.
Since the medium is given by rapid injection in this procedure,
patients should be watched for untoward reactions during the
injection. Unless general anesthesia is employed, patients should
be warned that they may feel some transient pain or burning
during the injection followed by a feeling of warmth immediately
A scout film should be made before the contrast agent is
administered. The first radiogram should be taken as the last few
mL of the contrast medium are being injected.
Angiocardiography, with RenoCal-76 (Diatrizoate Meglumine and
Diatrizoate Sodium Injection USP) may be performed by injection
into a large peripheral vein or by direct catheterization of the heart.
An excretory urogram can be obtained 10 to 15 minutes after
injection of the contrast medium since it is concentrated in and
eliminated by the kidneys.
Patients should be prepared in a manner similar to that used for
intravenous urography. Appropriate preanesthetic medication
should be given.
Clinical studies in man and related animal experiments, have
suggested that the hypertonicity of diatrizoate contrast agents
produces significant hemodynamic effects, especially in
right-sided injections. Large volumes of such agents cause a drop
in peripheral arterial and systemic pressures and cardiac output, a
rise in pulmonary arterial and right-heart pressures, bradycardia,
and regular ectopic beats. Resulting effects on peripheral arterial
and pulmonary arterial pressures are postulated to be due to
mechanical blockage of the pulmonary vascular bed and clumping
of red cells.
Hypertonic solutions cause a decrease in hematocrit in vitro and in vivo, and shrinkage of red blood cells.
It is suggested that hemodynamic changes be monitored and that
pressures considered abnormal under roentgenographic
conditions be allowed to return to a preangiographic level before
continuation of radiopaque injection; this usually takes 15 minutes.
The suggested single dose for children under five years of age is
10 to 20 mL, depending on the size of the child. For children 5 to
10 years of age, single doses of 20 to 30 mL are recommended.
Doses up to a total of 100 mL have been given safely.
Since the contrast medium is given by rapid injection, the patient
should be watched for untoward reactions during the injection.
Some patients not under general anesthesia may experience a
feeling of bodily warmth, tightness of the chest, and throbbing
headache. All these sensations are of short duration. Transient
nausea and vomiting may occur in some patients.
A preliminary control film should be made in the usual manner.
Appropriate preparation of the patient is indicated, including
suitable premedication. For visualization of an entire extremity, a
single dose of 20 to 40 mL is suggested; for the upper or lower
half of the extremity only, 10 to 20 mL is usually sufficient.
Injection is made into the femoral or subclavian artery by the
percutaneous or operative method. Because the contrast agent is
given by rapid injection, flushing of the skin may occur. Patients
not under general anesthesia may experience nausea and vomiting
or a transient feeling of warmth. Vascular spasm is not likely to
A scout film should be made routinely before administering the
contrast medium. Radiograms of the upper half of the extremity
are taken while the last few mL are being injected, followed by
radiograms of the lower half of the extremity a few seconds later.
Selective Renal Arteriography
The usual dose is 5 to 10 mL injected into either or both renal
arteries via femoral artery catheterization. This dose may be
repeated as necessary; doses up to 60 mL have been given.
Selective Visceral Arteriography
The usual dose is 30 to 50 mL injected into the appropriate
visceral artery (celiac axis and its branches, superior mesenteric
artery, or inferior mesenteric artery) via femoral artery
catheterization. This may be repeated as necessary. It is
recommended that the combined total dose not exceed 250 mL.
Selective Coronary Arteriography
The usual dose is 4 to 10 mL injected into a coronary artery. This
dose, repeated as necessary, may be administered into each
coronary artery; doses up to a total of 150 mL have been given.
Patients should be monitored continuously by ECG throughout the
Selective Coronary Arteriography Combined with Left
For left ventriculography the usual dose is 35 to 50 mL injected
into the left ventricle. This may be repeated as necessary. It is
recommended that the total dose for combined selective coronary
arteriography and left ventriculography not exceed 200 mL.
Intravenous Digital Subtraction Angiography (DSA)
Diagnostic-quality arteriograms can be obtained by intravenous
administration of RenoCal-76 (Diatrizoate Meglumine and
Diatrizoate Sodium Injection USP) and employment of digital
subtraction and computer imaging enhancement equipment. This
technique has the advantage of being less invasive than the
corresponding intra-arterial selective catheter placement
technique. The dose is administered into a peripheral vein by
mechanical pressure injection, although sometimes by rapid
manual injection (see PRECAUTIONS). This technique has been
used most frequently to visualize the ventricles, the aorta and
most of its larger branches including the carotid, coronary,
pulmonary, intracranial, ophthalmic, vertebral, renal, celiac,
mesenterics and the major peripheral arteries of the limbs, and for
visualization of graft patency.
The usual dose of RenoCal-76 (Diatrizoate Meglumine and
Diatrizoate Sodium Injection USP) per bolus injection ranges
between 30 and 60 mL (approx. 0.5 to 1 mL/kg) administered
intravenously at a rate of 7.5 to 30 mL per second. When
indicated, multiple bolus injections of RenoCal-76 (200 mL
maximum total volume) may be administered; dosage and rate of
injection are generally determined by considerations of age,
weight, renal function and arterial site to be studied, as well as by
type of equipment and technique to be used. First exposures are
made on the basis of calculated circulation time.
The suggested dose is 50 to 125 mL by intravenous
administration; scanning may be performed immediately after
completion of administration. Doses for children should be
proportionately less, depending on age and weight.
No special patient preparation is required for contrast
enhancement of CT brain scanning. However, it is advisable to
insure that patients are well hydrated prior to examination.
RenoCal-76 (Diatrizoate Meglumine and Diatrizoate Sodium
Injection USP) is available in packages of:
Twenty-five single dose 50 mL vials (NDC 0270-0860-20)
Ten single dose 100 mL bottles (NDC 0270-0860-30)
Ten single dose 150 mL bottles (NDC 0270-0860-40)
Ten single dose 200 mL bottles (NDC 0270-0860-50)
The preparation should be stored at 20-25°C (68-77°F) [See USP];
protected from light. If precipitation or solidification has occurred
due to storage in the cold, immerse the container in hot water and
shake intermittently to redissolve any solids. The product should
not be used if a precipitate does not dissolve.
Manufactured for Bracco Diagnostics Inc.
Princeton, NJ 08543
by SICOR Pharmaceuticals, Inc.
Irvine, CA 92618
Printed in USA
diatrizoate meglumine and diatrizoate sodium injection, solution
HUMAN PRESCRIPTION DRUG
Item Code (Source)
Route of Administration
Name (Active Moiety)
diatrizoate meglumine (diatrizoic acid)
660 MILLIGRAM In 1 MILLILITER
diatrizoate sodium (diatrizoic acid)
100 MILLIGRAM In 1 MILLILITER
edetate calcium disodium
0.1 MILLIGRAM In 1 MILLILITER
contains a VIAL, SINGLE-DOSE
This package is contained within the PACKAGE (0270-0860-20)
contains a BOTTLE, UNIT-DOSE
This package is contained within the PACKAGE (0270-0860-30)
contains a BOTTLE, UNIT-DOSE
This package is contained within the PACKAGE (0270-0860-40)
contains a BOTTLE, UNIT-DOSE
This package is contained within the PACKAGE (0270-0860-50)