Hypaque-76

Hypaque-76 is indicated for excretory urography, aortography, angiocardiography (ventriculography, pulmonary angiography, selective coronary arteriography), peripheral angiography (peripheral arteriography and peripheral venography), intravenous digital arteriography, contrast enhancement of computed tomographic head imaging, contrast enhancement of computed tomographic body imaging, selective renal arteriography, selective visceral arteriography, central venography, and renal venography.

In addition to the following generalCONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS, there are additional listings in these categories under the particular procedures.

Hypaque-76 has no absolute contraindications in its recommended uses (see general WARNINGS and PRECAUTIONS).

Do not use Hypaque-76 for myelography or for examination of dorsal cysts or sinuses which might communicate with the subarachnoid space. Even a small amount in the subarachnoid space may produce convulsions and result in fatality. (See also AORTOGRAPHY, Warnings.) Epidural injection is also contraindicated.

Hypaque-76 should not be injected directly into the carotid, vertebral, or spinal arteries.

Hypaque-76 is contraindicated in patients with a hypersensitivity to salts of diatrizoic acid.

Urography is contraindicated in patients with anuria.

Urography and large dose vascular procedures are contraindicated in dehydrated azotemic patients. (See also PRECAUTIONSGeneral.)

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.

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 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.

Excretory urography is potentially hazardous in patients with multiple myeloma. In some of those patients, therapeutically resistant anuria resulting in progressive uremia, renal failure, and eventually death has followed this procedure. 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 combination of both may be causative. The risk of excretory urography in myelomatous patients is not a contraindication to the procedure; however, they require special precautions. 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. Myeloma, which occurs most commonly in persons over age 40, should be considered before instituting urographic procedures.

Contrast media may promote sickling in individuals who are homozygous for sickle cell disease when the material is injected intravenously or intra-arterially.

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.

Recent reports of thyroid storm occurring following the intravascular use of iodinated radiopaque diagnostic 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 diatrizoate salts.

Contrast media administered for cardiac catheterization and angiocardiography may cause cellular injury to circulating lymphocytes. Chromosomal damage in humans includes inhibition of mitosis, increases in the number of micronuclei, and chromosome aberrations. The damages appear to be related to the contrast medium itself rather than to the x-ray radiation. It is to be noted that those agents have not been adequately tested in animal or laboratory systems.

Urography should be performed with caution in patients with severely impaired renal function and patients with combined renal and hepatic disease.

Subcutaneous extravasation causes transitory stinging, chiefly because of hypertonic cellulitis. If the volume extravasated is small, ill effects are very unlikely. However, if the extravasation is extensive, especially in poorly vascularized areas (e.g., dorsum of the foot or hand), and especially in the presence of vascular disease, skin slough may occur. Injection of sterile water to dilute or addition of spreading agents to speed absorption have not been successful and may aggravate the condition.

Selective spinal arteriography or arteriography of trunks providing spinal branches can cause mild to severe muscle spasm. However, serious neurologic sequelae, including permanent paralysis, could occur with even small doses of the 76 percent concentration.

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 FOLLOWING SECTIONS FOR INDIVIDUAL INDICATIONS AND USAGE CONTAIN CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, AND DOSAGE AND ADMINISTRATION SECTIONS RELATED TO THE SPECIFIC PROCEDURES. HOWEVER, IT SHOULD BE UNDERSTOOD THAT THE INFORMATION IN THE GENERAL SECTIONS IS ALSO LIKELY TO APPLY TO ALL OF THESE SPECIFIC USES.

Hydration: With the possible exception of urography, patients should be fully hydrated prior to the following procedures.

EXCRETORY UROGRAPHY

Diatrizoate salts are used in small, medium, and large dose urography. Visualization of the urinary tract can be achieved by either direct intravenous bolus injection, intravenous drip infusion, or incidentally following intra-arterial procedures. Visualization of the urinary tract is delayed in infants less than 1 month old, and in patients with urinary tract obstruction (see CLINICAL PHARMACOLOGY).

Hypaque-76 solution may be used for excretory urography in selected patients. It may be used when prior urography has failed to provide diagnostic contrast and for preliminary excretory tract study to detect obstruction in azotemic patients or to avoid retrograde instrumentation. It may also be used as a high dosage medium to intensify and prolong the nephrographic effect when the prime purpose is examination of the renal parenchyma, especially with tomography. When combined with the urea "washout" technique, Hypaque-76 provides the necessary increased pyelographic contrast and diuresis required for screening or special examination of patients with suspected renal hypertension.

Contraindication

Urography is contraindicated in patients with anuria.

Precautions

Although azotemia is not considered a contraindication, care is required in patients with advanced renal failure. The usual preparatory dehydration should be omitted, and urinary output should be observed for one to two days in these patients. Adequate visualization may be difficult or impossible to attain in patients with severely impaired renal and/or hepatic function. Use with extreme caution in patients with concomitant hepatorenal disease.

When Hypaque-76 is used with a urea "washout" procedure, the patient should also be observed for a few hours to detect signs of undue dehydration caused by increased diuresis induced by both the medium and the urea. Ingestion of water may be required for rehydration.

In myelomatosis, urography should only be performed with caution. If a weak protein-binding agent such as a diatrizoate is used for the procedure, it is essential to omit preparatory dehydration, administer fluids, and attempt to alkalinize the urine.

Preparatory Dehydration: Preparatory dehydration is dangerous in infants, young children, the elderly, and azotemic patients (especially those with polyuria, oliguria, diabetes, advanced vascular disease, or preexisting dehydration). The undesirable dehydration in these patients may be accentuated by the osmotic diuretic action of the medium.

Dehydration may improve image quality in patients with adequate renal function particularly if a low dose is used. Dehydration, however, will not improve contrast quality in patients with substantial renal insufficiencies and will increase risk of contrast induced renal damage. Dehydration in these patients is therefore contraindicated.

Adverse Reactions

Side effects following this relatively high dose urography are usually mild and transitory and do not appear to occur more frequently or severely than those induced by "standard dose" urography. Nausea, facial flushing, and emesis are not uncommon reactions. (See also ADVERSE REACTIONSGeneral.)

Dosage and Administration

The usual intravenous dose for adults is 20 mL, with a range of 20 mL to 40 mL. Children require less in proportion to weight: Under 6 months of age4 mL; 6 to 12 months6 mL; 1 to 2 years8 mL; 2 to 5 years10 mL; 5 to 7 years12 mL; 8 to 10 years14 mL; 11 to 15 years16 mL.

ANGIOGRAPHYGeneral

Diatrizoate salts are used for radiographic studies throughout the cardiovascular system.

Intravascular radiopaque diagnostic agents of high concentration are not recommended for cerebral or spinal angiography (see CONTRAINDICATIONSGeneral), and contrast agents with the lowest compatible viscosity and higher concentration of iodine (310 mg/mL to 480 mg/mL of bound iodine) must be used for angiocardiography. Contrast media approaching serum ionic content and osmolality have less potential for deleterious effects on the myocardium (see PRECAUTIONSGeneral, Drug Interactions).

Addition of chelating agents may contribute to toxicity in coronary angiography, and the sodium content of angiographic agents used in coronary arteriography is of crucial importance.

AORTOGRAPHY

Hypaque-76 solution may be injected by commonly accepted techniques, such as translumbar, retrograde catheter, retrograde pressure injection (by cannula) or antegrade (brachial) catheter, for examination of the aorta and its major branches.

During aortography by the translumbar technique, extreme care is advised to avoid inadvertent intrathecal injection since the injection of even small amounts (5 mL to 7 mL) of the contrast medium may cause convulsions, permanent sequelae, or fatality. Should the accident occur, the patient should be placed upright to confine the hyperbaric solution to a low level, anesthesia may be required to control convulsions, and if there is evidence of a large dose having been administered, a careful cerebrospinal fluid exchange-washout should be considered.

Pheochromocytoma: Administration of angiographic media to patients known or suspected to have pheochromocytoma can cause dangerous changes in blood pressure. A minimum dose should be injected. The blood pressure should be carefully monitored and measures for controlling major fluctuations should be available.

The presence of a vigorous pulsatile flow should be established before using a catheter or pressure injection technique. A small "pilot" dose (about 2 mL) should be administered to locate the exact site of needle or catheter tip to help prevent injection of the main dose into a branch of the aorta or intramurally. In the translumbar technique, severe pain during injection may indicate intramural placement and abdominal or back pain afterwards may indicate hemorrhage from the injection site. Following catheter procedures, gentle pressure hemostasis for 5 to 10 minutes is advised, followed by observation for 30 to 60 minutes and immobilization of the limb for several hours to prevent hemorrhage from the site of arterial puncture.

Under conditions of slowed aortic circulation there is an increased likelihood of aortography causing muscle spasm. Occasional serious neurologic complications, including paraplegia, have also been reported in patients with aortic-iliac or even femoral artery bed obstruction, abdominal compression, hypotension, hypertension, spinal anesthesia, injection of vasopressors to increase contrast, and low injection sites (L2-3). In these patients the concentration, dose, and number of repeat injections of the medium should be maintained at a minimum with appropriate intervals between injections. The position of the patient and catheter tip should be carefully evaluated.

The only adverse reaction expected is a mild burning or painful sensation on injection. Unusual reactions can occur, as in angiocardiography. An abrupt hypertensive episode can occur following entry of the medium into the renal artery in patients with pheochromocytoma. Mesenteric necrosis, acute pancreatitis, renal shutdown (usually transitory), and neurologic complications have been reported following inadvertent injection of a large part of the aortic dose into a branch of the aorta. Entry of the large aortic dose into the renal artery can cause, even in the absence of symptoms, albuminuria, cylindruria, hematuria, and an elevated BUN. Rapid and complete return of function usually follows.

Additional procedural reactions 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, and retroperitoneal hemorrhage from the translumbar approach.

Adult: The usual adult dose as a single injection is 15 mL to 40 mL, repeated if indicated, to a total of 160 mL.

Pediatric: The usual single pediatric dose ranges from 0.3 mL/kg to 0.9 mL/kg. The total dose should not exceed 1 mL/kg.

ANGIOCARDIOGRAPHY

Due to its physical characteristics (chiefly tonicity and viscosity) and the volume administered, Hypaque-76 may cause a number of transitory hemodynamic changes. When the medium is ejected from the left ventricle or introduced at the root of the ascending aorta, a brief (three seconds) hypertensive response is usually induced, followed immediately by a decrease in aortic and peripheral blood pressures below normal levels, lasting for at least two minutes. This hypotensive phase may be followed by a 15- to 20-minute period of fluctuating blood pressure.

Clinical doses (up to 1 mL per kg) injected into the vena cava or right heart outflow tract usually cause an irregular rise in right ventricular blood pressure, a slight increase in pulmonary artery blood pressure, and delayed signs of peripheral hypotension.

Other changes reported clinically include an increase in cardiac output and atrial pressure, a decrease in myocardial contractile force, and at the peak of postinjection hypotension, a marked rise in aortic and carotid blood flow, and elevation of central venous pressure. At dosage levels used in angiocardiography, the hematocrit and hemoglobin level may fall about 10 to 15 percent and serum osmolality may rise 10 to 12 percent. Blood carbon dioxide, pH, and BUN levels may fall. These changes commence immediately after injection, reach a maximum in two to five minutes, and return to normal values in 10 to 15 minutes. However, after the initial rise, plasma volume may decrease and continue to fall below control levels, even beyond 30 minutes, probably due to diuresis. If repeat injections are made in rapid succession these changes are likely to be more pronounced. (See also Dosage and Administration.) Hypaque-76 is not metabolized. It is eliminated unchanged, rapidly and completely in the urine by glomerular filtration.

Precautions

During administration of large doses of Hypaque-76 continuous monitoring of vital signs is desirable. Caution is advised in the administration of large doses to patients with incipient heart failure because of the possibility of aggravation of the preexisting condition. Hypotension should be corrected promptly since it may induce serious arrhythmias.

Because of the hemodynamic changes which may occur on injection into the right heart outflow tract, special care, especially regarding dosage, should be observed in patients with right ventricular failure, pulmonary hypertension, or obliterated pulmonary vascular beds.

Apnea, bradycardia and other arrhythmias, cerebral effects (lethargy and depression), and a tendency to acidosis are more likely to occur in cyanotic infants. It is desirable that vital signs be monitored on an intensive care basis afterwards to detect delayed adverse effects (arrhythmia, electrolyte and hemodynamic disturbances). Infants are more likely than adults to respond with convulsions, particularly after repeated injections. Unlike in the adult, the amount of the total dosage in young infants is of particular importance. (See Dosage and Administration.)

Adverse Reactions

See ADVERSE REACTIONSGeneral.

Dosage and Administration

The individual dose is determined by the size of the structure to be visualized, the anticipated degree of hemodilution, and valvular competence. Weight is a minor consideration in adults. The size of each individual dose is a more important consideration than the total dosage used. When large individual doses are administered, as for contrast in the cardiac chambers and thoracic aorta, it has been suggested that 20 minutes be permitted to elapse between each injection to allow for subsidence of hemodynamic disturbances.

Adult: The usual adult dose in a single injection is 45 mL, with a range of 40 mL to 50 mL. This may be repeated as necessary. However, when combined with selective coronary arteriography, the total dose should not exceed 225 mL.

Pediatric: The usual single pediatric dose is 0.2 mL/kg to 0.3 mL/kg. The total dose should not exceed 50 mL.

Adult: The usual single adult dose is 30 mL, with a range of 10 mL to 56 mL.

Pediatric: The pediatric dose ranges from 0.3 mL/kg to 0.9 mL/kg. The total dose should not exceed 1 mL/kg.

Multiple Procedures

With continuing advances in radiologic techniques and the development of more sophisticated equipment as well as more versatile and reliable radiopaque media, it is possible to examine multiple vascular systems and target organs during a single radiographic examination of the patient.

Multiple procedures of selective angiography require multiple injections of the contrast medium into several specific target organs and result in a greater dosage. Large doses of Hypaque-76 were well tolerated in multiple injections and multiple procedures of angiography.

See general sections for Contraindications, Warnings, Precautions, Adverse Reactions, and Dosage and Administration recommendations as well as those sections pertinent to the specific procedures.

Adult: The maximum total dose for multiple procedures in adult use should not exceed 225 mL.

Pediatric: When multiple procedures are required in pediatric use, the total dose administered should be maintained below 4 mL/kg, or especially in young infants below 3 mL/kg.

Selective Coronary Arteriography

Adult: The usual single adult dose for right or left coronary arteriography is 8 mL (range 4 mL to 10 mL) repeated as required up to a total dose of 120 mL for coronary arteriography alone.

PERIPHERAL ANGIOGRAPHY

The use of Hypaque-76 is sometimes preferred over less concentrated media in selected cases for femoral and brachio-axillary arteriography in adults.

Pulsation should be present in the artery to be injected. In thromboangiitis obliterans, or ascending infection associated with severe ischemia, angiography should be performed with extreme caution, if at all.

Pain or a burning sensation with some spasm may occur, and is more marked in patients with arterial insufficiency. Therefore, the procedure is more satisfactorily performed under general or, for the lower extremity, spinal anesthesia.

Technical complications have included hemorrhage from the puncture site, and brachial plexus palsy following axillary artery injections.

Arterial thrombosis, displacement of arterial plaques, and ipsilateral venous thrombosis are very rare complications.

Arteriography (aorto-iliac runoff and peripheral)

Adult: The single adult dose for femoral arteriography varies from 20 mL to 40 mL, depending on the site of placement, i.e., aorta-iliac runoff, iliofemoral, femoral. For the upper limb, 20 mL to 40 mL is usually sufficient. These doses may be repeated up to three times.

VENOGRAPHY

Central Venography

Adult: For central venography (inferior or superior vena cava), the total adult dose is 40 mL to 50 mL, repeated up to two times.

Renal Venography

Adult: The usual single adult dose is 20 mL to 40 mL.

Peripheral Venography

Adult: The usual single adult dose is 40 mL with a range of 40 mL to 60 mL.

SELECTIVE RENAL ARTERIOGRAPHY

Adult: The usual single adult dose is 8 mL, repeated up to three times. The dose ranges from 5 mL to 10 mL.

SELECTIVE VISCERAL ARTERIOGRAPHY

Celiac Axis: The usual adult dose ranges from 30 mL to 40 mL with subselective arteriography of its branches, e.g., hepatic, usual dose of 25 mL with a range of 15 mL to 30 mL; mesenteric, usual dose of 30 mL with a range of 20 mL to 40 mL; splenic, usual dose of 20 mL with a range of 20 mL to 50 mL.

Superior Mesenteric: The usual single adult dose is 30 mL with a range of 20 mL to 40 mL. The maximum total dose should not exceed 175 mL.

INTRAVENOUS DIGITAL ARTERIOGRAPHY

Arteriograms of diagnostic quality can be obtained following the intravenous administration of Hypaque-76 employing digital subtraction and computer imaging enhancement equipment. The intravenous route of administration using these techniques has the advantage of being less invasive than the corresponding selective catheter placement of the medium. The dose is administered into a peripheral vein usually by mechanical injection although sometimes by rapid manual injection. The technique has been used most frequently to visualize the ventricles, the aorta and most of its larger branches including carotid, cerebral, vertebral, renal, celiac, mesenterics, and the major peripheral vessels of the limbs.

Since the dose is usually administered mechanically under high pressure, rupture of smaller peripheral veins has occurred. It has been suggested that this can 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. Sometimes the femoral vein is used.

The usual dose of Hypaque-76 per injection by the intravenous digital technique is 30 mL to 60 mL with a range of 0.5 mL/kg to 1 mL/kg administered as a bolus 7.5 mL/second to 30 mL/second using a pressure injector. The dose and rate of injection will depend primarily on the type of equipment and technique used, with first exposures made on calculated circulation time.

CONTRAST ENHANCEMENT OF COMPUTED TOMOGRAPHIC HEAD IMAGING

Injectable radiopaque contrast media may be used to refine diagnostic precision in areas of the brain which may not otherwise have been satisfactorily visualized.

Tumors: Radiopaque diagnostic agents 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.

Nonneoplastic Conditions of the Brain: The use of Hypaque-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 Hypaque-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.

The suggested dose is 50 mL 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.

CONTRAST ENHANCEMENT OF COMPUTED TOMOGRAPHIC BODY IMAGING

Hypaque-76, brand of diatrizoate meglumine and diatrizoate sodium injection, may be used for enhancement of computed tomographic scans performed for detection and evaluation of lesions in the liver, pancreas, kidneys, aorta, mediastinum, abdominal cavity, pelvis, and retroperitoneal space.

Enhancement of computed tomography with Hypaque-76 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 the contrast agent. Therefore, utilization of a continuous scanning technique (dynamic CT scanning) may improve enhancement and diagnostic assessment of tumor and other lesions such as an abscess, occasionally revealing unsuspected or more extensive disease. For example, a cyst may be distinguished from a vascularized solid lesion when 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.

The suggested dose is 50 mL to 125 mL by rapid intravenous bolus administration; scanning may be performed immediately after completion of administration. Doses for children should be proportionately less, depending on age and weight.

Vials of 50 mL, rubber stoppered, box of 25 (NDC 0407-0776-04)

Calibrated bottles of 200 mL, rubber stoppered, with hangers, box of 10 (NDC 0407-0778-02)

Distributed by Amersham Health Inc.
Princeton, NJ 08540

Printed In USA

HNC-9D

Applies to diatrizoate: injectable powder for injection, injectable solution, oral powder for reconstitution, oral and rectal solution

General

The most frequently reported adverse reactions were vomiting, nausea, diarrhea, erythema, a sensation of pain, and a general feelings of warmth on intravascular administration.[Ref]

Cardiovascular

Common (1% to 10%) Transient disturbance in heart rate, blood pressure, disturbance in cardiac rhythm or function, cardiac arrest
Uncommon (0.1% to 1%): Thrombophlebitis, venous thrombosis
Rare (0.01% to 0.1%): Thromboembolic events, myocardial infarction
Very rare (less than 0.01%): Severe hypotension and collapse; circulatory failure; ventricular fibrillation
Frequency not reported: Tachycardia, shock, hypotension, hypertension, reflex tachycardia, cyanosis[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomit, diarrhea
Frequency not reported: Diarrhea (ceases as soon as the intestine has been emptied); existing enteritis or colitis may be temporarily exacerbated; in case of obstruction, the prolonged contact with bowel mucosa can lead to erosions and to bowel necrosis; intestinal perforation; abdominal pain; oral mucosal blistering[Ref]

Hypersensitivity

Common (1% to 10%): Anaphylactoid reactions (mild angioedema, conjunctivitis, coughing pruritus, rhinitis, sneezing, urticarial)[Ref]

Respiratory

Common (1% to 10%): Transient disturbances in respiratory rate, dyspnea, respiratory distress, cough
Rare (less than 0.1%): Respiratory arrest, pulmonary edema
Frequency not reported: Bronchospasm, medication aspiration, pulmonary edema following aspiration, aspiration pneumonia, sneezing, laryngeal spasm[Ref]

Endocrine

Uncommon (0.1% to 1%): Thyroid function tests indicative of hypothyroidism or transient thyroid suppression in adults and pediatric patients (including infants)
Frequency not reported: Hyperthyroidism[Ref]

Dermatologic

Rare (less than 0.1%): Toxic epidermal necrolysis, urticaria, rash, pruritus, erythema, face edema, mucocutaneous syndrome (e.g. Stevens-Johnson's or Lyell syndrome)
Frequency not reported: Sweating, mild angioedema[Ref]

Nervous system

Very rare (less than 0.01%): Convulsions, cerebral symptoms
Frequency not reported: Disturbances in consciousness, dizziness, headache, tremor, somnolence, transient paresis (vision or facial muscle paresis and epileptic fits), amnesia, photophobia, temporary states of agitation or confusion[Ref]

Genitourinary

Frequency not reported: Perforation of the urethra, genitourinary tract infections, oliguria, hematuria, anuria[Ref]

Local

Frequency not reported: Local pain, edema[Ref]

Metabolic

Frequency not reported: Fluid and electrolyte imbalance[Ref]

Ocular

Frequency not reported: Lacrimation, temporary blindness[Ref]

Other

Frequency not reported: Pyrexia, sweating, chills, blanching, weakness, gagging and feeling suffocated, gasping, edema, cramp, malaise[Ref]

Renal

Frequency not reported: Temporary renal failure[Ref]

Some side effects of Hypaque-76 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.