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OMNIPAQUE
(iohexol) Injection
240 300 350

PHARMACY BULK PACKAGE–NOT FOR DIRECT INFUSION

Section I — Intrathecal
Section II — Intravascular
Section III — Oral/Body Cavity Use

350NOT FOR INTRATHECAL USE

Rx ONLY

DESCRIPTION

Iohexol,N,N´ - Bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)-acetamido]-2,4,6-triiodoisophthalamide, is a nonionic, water-soluble radiographic contrast medium with a molecular weight of 821.14 (iodine span 46.36%). In aqueous solution each triiodinated molecule remains undissociated. The chemical structure is:

OMNIPAQUE is provided as a sterile, pyrogen-free, colorless to pale-yellow solution, in Pharmacy Bulk Package, in the following iodine concentrations: 240, 300, and 350 mgI/mL. A Pharmacy Bulk Package is used to dispense multiple single doses, utilizing a suitable transfer device. OMNIPAQUE 240 contains 518 mg of iohexol equivalent to 240 mg of organic iodine per mL; OMNIPAQUE 300 contains 647 mg of iohexol equivalent to 300 mg of organic iodine per mL; and OMNIPAQUE 350 contains 755 mg of iohexol equivalent to 350 mg of organic iodine per mL. Each milliliter of iohexol solution contains 1.21 mg tromethamine and 0.1 mg edetate calcium disodium with the pH adjusted between 6.8 and 7.7 with hydrochloric acid or sodium hydroxide. All solutions are sterilized by autoclaving and contain no preservatives. Iohexol solution is sensitive to light and therefore should be protected from exposure.

The available concentrations have the following physical properties:

Concentration
(mgI/mL)
OsmolalityBy vapor-pressure osmometry.
(mOsm/kg water)
Osmolarity
(mOsm/L)
Absolute Viscosity
(cp)
Specific Gravity
20°C37°C37°C
2405203915.83.41.280
30067246511.86.31.349
35084454120.410.41.406

OMNIPAQUE 240, OMNIPAQUE 300, and OMNIPAQUE 350 have osmolalities from approximately 1.1 to 3.0 times that of plasma (285 mOsm/kg water) or cerebrospinal fluid (301 mOsm/kg water) as shown in the above table and are hypertonic under conditions of use.

SECTION I

CLINICAL PHARMACOLOGY—Intrathecal

Iohexol is absorbed from cerebrospinal fluid (CSF) into the bloodstream and is eliminated by renal excretion. No significant metabolism, deiodination, or biotransformation occurs.

The initial concentration and volume of the medium, in conjunction with appropriate patient manipulation and the volume of CSF into which the medium is placed, will determine the extent of the diagnostic contrast that can be achieved.

Following intrathecal injection in conventional radiography, OMNIPAQUE 240, and OMNIPAQUE 300 will continue to provide good diagnostic contrast for at least 30 minutes. Slow diffusion of iohexol takes place throughout the CSF with subsequent absorption into the bloodstream. Once in the systemic circulation, iohexol displays little tendency to bind to serum or plasma proteins. At approximately 1 hour following injection, contrast of diagnostic quality will no longer be available for conventional myelography. If computerized tomographic (CT) myelography is to follow, consideration should be given to a delay of several hours to allow the degree of contrast to decrease.

After administration into the lumbar subarachnoid space, computerized tomography shows the presence of contrast medium in the thoracic region in about 1 hour, in the cervical region in about 2 hours, and in the basal cisterns in 3 to 4 hours.

In patients with renal impairment, depending on the degree of impairment, prolonged plasma iohexol levels may be anticipated due to decreased renal elimination.

INDICATIONS AND USAGE—Intrathecal

OMNIPAQUE 240, and OMNIPAQUE 300 are indicated for intrathecal administration in adults including myelography (lumbar, thoracic, cervical, total columnar) and in contrast enhancement for computerized tomography (myelography, cisternography, ventriculography).

CONTRAINDICATIONS—Intrathecal

OMNIPAQUE should not be administered to patients with a known hypersensitivity to iohexol.

Myelography should not be performed in the presence of significant local or systemic infection where bacteremia is likely.

Intrathecal administration of corticosteroids with OMNIPAQUE is contraindicated.

Because of the possibility of overdosage, immediate repeat myelography in the event of technical failure is contraindicated (see DOSAGE AND ADMINISTRATION).

WARNINGS—General

PRECAUTIONS—General

Diagnostic procedures which involve the use of radiopaque diagnostic 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. (See ADVERSE REACTIONS.)

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). Dehydration in these patients seems to be enhanced by the osmotic diuretic action of contrast agents. Patients should be well hydrated prior to and following administration of any contrast medium, including iohexol. The possibility of a reaction, including serious, life-threatening, fatal, anaphylactoid, cardiovascular or central nervous system reactions, should always be considered (see ADVERSE REACTIONS). Therefore, it is of utmost importance that a course of action be carefully planned in advance for the immediate treatment of serious reactions, and that adequate and appropriate facilities and personnel be readily available in case of any reaction. The possibility of an idiosyncratic reaction in susceptible patients should always be considered (see ADVERSE REACTIONS). The susceptible population includes, but is not limited to, patients with a history of a previous reaction to contrast media, 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 media, 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 (see ADVERSE REACTIONS). Premedication with antihistamines or corticosteroids to avoid or minimize possible allergic reactions in such patients should be considered. Recent reports indicate that such pretreatment does not prevent serious life-threatening reactions, but may reduce both their incidence and severity.

In patients with severe renal insufficiency or failure, compensatory biliary excretion of the drug is anticipated to occur, with a slow clearance into the bile. Patients with hepatorenal insufficiency should not be examined unless the possibility of benefit clearly outweighs the additional risk.

Administration of contrast media should be performed by qualified personnel familiar with the procedure and appropriate patient management (see PATIENT MANAGEMENT). Sterile technique must be used with any spinal puncture.

If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.

Parenteral products should be inspected visually for particulate matter and discoloration prior to administration. If particulate matter or discoloration is present, do not use.

Repeat Procedures: If in the clinical judgment of the physician sequential or repeat examinations are required, a suitable interval of time between administrations should be observed to allow for normal clearance of the drug from the body (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY).

Pregnancy

ADVERSE REACTIONS—Intrathecal

The most frequently reported adverse reactions with OMNIPAQUE are headache, mild to moderate pain including backache, neckache and stiffness, nausea, and vomiting. These reactions usually occur 1 to 10 hours after injection, and almost all occur within 24 hours. They are usually mild to moderate in degree, lasting for a few hours, and usually disappearing within 24 hours. Rarely, headaches may be severe or persist for days. Headache is often accompanied by nausea and vomiting and tends to be more frequent and persistent in patients not optimally hydrated.

Transient alterations in vital signs may occur and their significance must be assessed on an individual basis. Those reactions reported in clinical studies with OMNIPAQUE are uled below in decreasing order of occurrence, based on clinical studies of 1531 patients.

Headaches: The most frequently occurring adverse reaction following myelography has been headache, with an incidence of approximately 18%. Headache may be caused by either a direct effect of the contrast medium or by CSF leakage at the dural puncture site. However, in managing the patient, it is considered more important to minimize intracranial entry of contrast medium by postural management than attempting to control possible CSF leakage (see PATIENT MANAGEMENT).

Pain: Mild to moderate pain including backache, neckache and stiffness, and neuralgia occurred following injection with an incidence of about 8%.

Nausea and Vomiting: Nausea was reported with an incidence of about 6%, and vomiting about 3% (see PATIENT MANAGEMENT). Maintaining normal hydration is very important. The use of phenothiazine antinauseants is not recommended. (See WARNINGS—General.) Reassurance to the patient that the nausea will clear usually is all that is required.

Dizziness: Transient dizziness was reported in about 2% of the patients.

Other Reactions: Other reactions occurring with an individual incidence of less than 0.1% included: feeling of heaviness, hypotension, hypertonia, sensation of heat, sweating, vertigo, loss of appetite, drowsiness, hypertension, photophobia, tinnitus, neuralgia, paresthesia, difficulty in micturition, and neurological changes. All were transient and mild with no clinical sequelae.

OVERDOSAGE

Clinical consequences of overdosage with OMNIPAQUE have not been reported. However, based on experience with other nonionic myelographic media, physicians should be alert to a potential increase in frequency and severity of CNS-mediated reactions. Even use of a recommended dose can produce effects tantamount to overdosage, if incorrect management of the patient during or immediately following the procedure permits inadvertent early intracranial entry of a large portion of the medium.

The intracisternal LD50 value of OMNIPAQUE (in grams of iodine per kilogram body weight) is greater than 2.0 in mice.

DOSAGE AND ADMINISTRATION — Intrathecal

The volume and concentration of OMNIPAQUE 240, or OMNIPAQUE 300 to be administered will depend on the degree and extent of contrast required in the area(s) under examination and on the equipment and technique employed.

OMNIPAQUE 240 at a concentration of 240 mgI/mL, or OMNIPAQUE 300 at a concentration of 300 mgI/mL is recommended for the examination of the lumbar, thoracic, and cervical regions in adults by lumbar or direct cervical injection and is slightly hypertonic to CSF.

A total dose of 3060 mg iodine or a concentration of 300 mgI/mL should not be exceeded in adults in a single myelographic examination. This is based on clinical trial evaluation to date. As in all diagnostic procedures, the minimum volume and dose to produce adequate visualization should be used. Most procedures do not require either maximum dose or concentration.

Anesthesia is not necessary. Premedication sedatives or tranquilizers are usually not needed (see PRECAUTIONS). Patients should be well hydrated prior to and following contrast administration. Seizure-prone patients should be maintained on anticonvulsant medication.

Many radiopaque contrast agents are incompatible in vitro with some antihistamines and many other drugs; therefore, concurrent drugs should not be physically admixed with contrast agents.

Rate of Injection: To avoid excessive mixing with CSF and consequent dilution of contrast, injection should be made slowly over 1 to 2 minutes.

Depending on the estimated volume of contrast medium which may be required for the procedure a small amount of CSF may be removed to minimize distention of the subarachnoid spaces.

The lumbar or cervical puncture needle may be removed immediately following injection since it is not necessary to remove OMNIPAQUE after injection into the subarachnoid space.

Adults: The usual recommended total doses for use in lumbar, thoracic, cervical, and total columnar myelography in adults are 1.2 gI to 3.06 gI as follows:

ProcedureFormulationsConcentration
(mgI/mL)
Volume
(mL)
Dose
(gI)
Lumbar
Myelography
(via lumbar injection)
OMNIPAQUE 2402407-12.51.7-3.0
Thoracic
Myelography
(via lumbar injection)
OMNIPAQUE 240
OMNIPAQUE 300
240
300
6-12.5
6-10
1.7-3.0
1.8-3.0
Cervical
Myelography
(via lumbar injection)
OMNIPAQUE 240
OMNIPAQUE 300
240
300
6-12.5
6-10
1.4-3.0
1.8-3.0
Cervical
Myelography
(via C1-2 injection
OMNIPAQUE 240
OMNIPAQUE 300
240
300
6-12.5
4-10
1.4-3.0
1.2-3.0
Total Columnar
Myelography
(via lumbar injection
OMNIPAQUE 240
OMNIPAQUE 300
240
300
6-12.5
6-10
1.4-3.0
1.8-3.0

Refer to DIRECTIONS FOR PROPER USE OF OMNIPAQUE PHARMACY BULK PACKAGE section for instructions.

Parenteral products should be inspected visually for particulate matter or discoloration prior to administration. If particulate matter or discoloration is present, do not use.

Repeat Procedures: If in the clinical judgment of the physician sequential or repeat examinations are required, a suitable interval of time between administrations should be observed to allow for normal clearance of the drug from the body. An interval of at least 48 hours should be allowed before repeat examination; however, whenever possible, 5 to 7 days is recommended.

PATIENT MANAGEMENT—Intrathecal

Suggestions for Usual Patient Management

Good patient management should be exercised at all times to minimize the potential for procedurally related complications.

SECTION II

CLINICAL PHARMACOLOGY—Intravascular

Following intravascular injection, iohexol is distributed in the extracellular fluid compartment and is excreted unchanged by glomerular filtration. It will opacify those vessels in the path of flow of the contrast medium permitting radiographic visualization of the internal structures until significant hemodilution occurs.

Approximately 90% or more of the injected dose is excreted within the first 24 hours, with the peak urine concentrations occurring in the first hour after administration. Plasma and urine iohexol levels indicate that the iohexol body clearance is due primarily to renal clearance. An increase in the dose from 500 mgI/kg to 1500 mgI/kg does not significantly alter the clearance of the drug. The following pharmacokinetic values were observed following the intravenous administration of iohexol (between 500 mgI/kg to 1500 mgI/kg) to 16 adult human subjects: renal clearance—120 (86-162) mL/min; total body clearance—131 (98-165) mL/min; and volume of distribution—165 (108-219) mL/kg.

Renal accumulation is sufficiently rapid that the period of maximal opacification of the renal passages may begin as early as 1 minute after intravenous injection. Urograms become apparent in about 1 to 3 minutes with optimal contrast occurring between 5 to 15 minutes. In nephropathic conditions, particularly when excretory capacity has been altered, the rate of excretion may vary unpredictably, and opacification may be delayed after injection. Severe renal impairment may result in a lack of diagnostic opacification of the collecting system and, depending on the degree of renal impairment, prolonged plasma iohexol levels may be anticipated. In these patients, as well as in infants with immature kidneys, the route of excretion through the gallbladder and into the small intestine may increase.

Iohexol displays a low affinity for serum or plasma proteins and is poorly bound to serum albumin. No significant metabolism, deiodination or biotransformation occurs.

OMNIPAQUE probably crosses the placental barrier in humans by simple diffusion. It is not known to what extent iohexol is excreted in human milk.

Animal studies indicate that iohexol does not cross an intact blood-brain barrier to any significant extent following intravascular administration.

OMNIPAQUE enhances computed tomographic imaging through augmentation of radiographic efficiency. The degree of density enhancement is directly related to the iodine span in an administered dose; peak iodine blood levels occur immediately following rapid intravenous injection. Blood levels fall rapidly within 5 to 10 minutes and the vascular compartment half-life is approximately 20 minutes. This can be accounted for by the dilution in the vascular and extravascular fluid compartments which causes an initial sharp fall in plasma concentration. Equilibration with the extracellular compartments is reached in about ten minutes; thereafter, the fall becomes exponential.

The pharmacokinetics of iohexol in both normal and abnormal tissue have been shown to be variable. Contrast enhancement appears to be greatest immediately after bolus administration (15 seconds to 120 seconds). Thus, greatest enhancement may be detected by a series of consecutive two-to-three second scans performed within 30 to 90 seconds after injection (ie, dynamic computed tomographic imaging). Utilization of a continuous scanning technique (ie, dynamic CT scanning) may improve enhancement and diagnostic assessment of tumor and other lesions such as abscess, occasionally revealing unsuspected or more extensive disease. For example, a cyst may be distinguished from a vascularized solid lesion when precontrast and enhanced scans are compared; the nonperfused mass shows unchanged x-ray absorption (CT number). A vascularized lesion is characterized by an increase in CT number in the few minutes after a bolus of intravascular contrast agent; it may be malignant, benign, or normal tissue, but would probably not be a cyst, hematoma, or other nonvascular lesion.

Because unenhanced scanning may provide adequate diagnostic information in the individual patient, the decision to employ contrast enhancement, which may be associated with risk and increased radiation exposure, should be based upon a careful evaluation of clinical, other radiological, and unenhanced CT findings.

INDICATIONS AND USAGE, GENERAL—Intravascular

OMNIPAQUE 350 is indicated in adults for angiocardiography (ventriculography, selective coronary arteriography), aortography including studies of the aortic root, aortic arch, ascending aorta, abdominal aorta and its branches, contrast enhancement for computed tomographic head and body imaging, intravenous digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels, peripheral arteriography, and excretory urography.

OMNIPAQUE 350 is indicated in children for angiocardiography (ventriculography, pulmonary arteriography, and venography; studies of the collateral arteries and aortography, including the aortic root, aortic arch, ascending and descending aorta).

OMNIPAQUE 300 is indicated in adults for aortography including studies of the aortic arch, abdominal aorta and its branches, contrast enhancement for computed tomographic head and body imaging, cerebral arteriography, peripheral venography (phlebography), and excretory urography.

OMNIPAQUE 300 is indicated in children for angiocardiography (ventriculography), excretory urography, and contrast enhancement for computed tomographic head imaging.

OMNIPAQUE 240 is indicated in adults for contrast enhancement for computed tomographic head imaging and peripheral venography (phlebography).

OMNIPAQUE 240 is indicated in children for contrast enhancement for computed tomographic head imaging.

CONTRAINDICATIONS

OMNIPAQUE should not be administered to patients with a known hypersensitivity to iohexol.

WARNINGS—General

Nonionic iodinated contrast media inhibit blood coagulation, in vitro, less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing nonionic contrast media.

Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. Numerous factors, including length of procedure, catheter and syringe material, underlying disease state, and concomitant medications may contribute to the development of thromboembolic events. For these reasons, meticulous angiographic techniques are recommended including close attention to guidewire and catheter manipulation, use of manifold systems and/or three-way stopcocks, frequent catheter flushing with heparinized saline solutions and minimizing the length of the procedure. The use of plastic syringes in place of glass syringes has been reported to decrease but not eliminate the likelihood of in vitro clotting.

OMNIPAQUE should be used with extreme care in patients with severe functional disturbances of the liver and kidneys, severe thyrotoxicosis, or myelomatosis. Diabetics with a serum creatinine level above 3 mg/dL should not be examined unless the possible benefits of the examination clearly outweigh the additional risk. OMNIPAQUE is not recommended for use in patients with anuria.

Radiopaque contrast agents are potentially hazardous in patients with multiple myeloma or other paraproteinemia, particularly in those with therapeutically resistant anuria. Although neither the contrast agent nor dehydration has separately proven to be the cause of anuria in myeloma, it has been speculated that the combination of both may be causative factors. The risk in myelomatous patients is not a contraindication; however, special precautions are necessary. Partial dehydration in the preparation of these patients prior to injection is not recommended since this may predispose the patient to precipitation of the myeloma protein in the renal tubules. No form of therapy, including dialysis, has been successful in reversing the effect. Myeloma, which occurs most commonly in persons over age 40, should be considered before instituting intravascular administration of contrast agents.

Ionic contrast media, when injected intravenously or intra-arterially, may promote sickling in individuals who are homozygous for sickle cell disease.

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 patient's blood pressure should be assessed throughout the procedure and measures for the treatment of hypertensive crisis should be readily available.

Reports of thyroid storm following the use of iodinated, ionic radiopaque contrast media in patients with hyperthyroidism or with an autonomously functioning thyroid nodule suggest that this additional risk be evaluated in such patients before use of any contrast medium.

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

PRECAUTIONS—General

Diagnostic procedures which involve the use of radiopaque diagnostic 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 (see ADVERSE REACTIONS:Intravascular—General).

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), infants and small children. Dehydration in these patients seems to be enhanced by the osmotic diuretic action of urographic agents. It is believed that overnight fluid restriction prior to excretory urography generally does not provide better visualization in normal patients. Patients should be well hydrated prior to and following administration of any contrast medium, including iohexol.

Acute renal failure has been reported in diabetic patients with diabetic nephropathy and in susceptible nondiabetic patients (often elderly with preexisting renal disease) following excretory urography. Therefore, careful consideration of the potential risks should be given before performing this radiographic procedure in these patients.

Immediately following surgery, excretory urography should be used with caution in renal transplant recipients. The possibility of a reaction, including serious, life-threatening, fatal, anaphylactoid or cardiovascular reactions should always be considered (see ADVERSE REACTIONS: Intravascular—General). It is of utmost importance that a course of action be carefully planned in advance for immediate treatment of serious reactions, and that adequate and appropriate personnel be readily available in case of any reaction.

The possibility of an idiosyncratic reaction in susceptible patients should always be considered (see ADVERSE REACTIONS: Intravascular—General). The susceptible population includes, but is not limited to, patients with a history of a previous reaction to contrast media, 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 media, 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 (see ADVERSE REACTIONS: Intravascular—General). Premedication with antihistamines or corticosteroids to avoid or minimize possible allergic reactions in such patients should be considered and administered using separate syringes. Recent reports indicate that such pretreatment does not prevent serious life-threatening reactions, but may reduce both their incidence and severity.

Even though the osmolality of OMNIPAQUE 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.

General anesthesia may be indicated in the performance of some procedures in selected adult patients; however, a higher incidence of adverse reactions has been reported in these patients, and may be attributable to the inability of the patient to identify untoward symptoms, or to the hypotensive effect of anesthesia which can reduce cardiac output and increase the duration of exposure to the contrast agent.

Angiography should be avoided whenever possible in patients with homocystinuria, because of the risk of inducing thrombosis and embolism.

In angiographic procedures, the possibility of dislodging plaques or damaging or perforating the vessel wall should be borne in mind during the catheter manipulations and contrast medium injection. Test injections to ensure proper catheter placement are recommended.

Selective coronary arteriography should be performed only in those patients in whom the expected benefits outweigh the potential risk. The inherent risks of angiocardiography in patients with chronic pulmonary emphysema must be weighed against the necessity for performing this procedure.

If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.

Parenteral products should be inspected visually for particulate matter and discoloration prior to administration. If particulate matter or discoloration is present, do not use.

Pregnancy

ADVERSE REACTIONS: Intravascular—General

Adverse reactions following the use of OMNIPAQUE 240, OMNIPAQUE 300, and OMNIPAQUE 350 are usually of mild to moderate severity. However, serious, life-threatening and fatal reactions, mostly of cardiovascular origin, have been associated with the administration of iodine-containing contrast media, including OMNIPAQUE. The injection of contrast media is frequently associated with the sensation of warmth and pain, especially in peripheral angiography; pain and warmth are less frequent and less severe with OMNIPAQUE than with many contrast media.

Cardiovascular System: Arrhythmias including PVCs and PACs (2%), angina/chest pain (1%), and hypotension (0.7%). Others including cardiac failure, asystole, bradycardia, tachycardia, and vasovagal reaction were reported with an individual incidence of 0.3% or less. In controlled clinical trials involving 1485 patients, one fatality occurred. A cause and effect relationship between this death and iohexol has not been established.

Nervous System: Vertigo (including dizziness and lightheadedness) (0.5%), pain (3%), vision abnormalities (including blurred vision and photomas) (2%), headache (2%), and taste perversion (1%). Others including anxiety, fever, motor and speech dysfunction, convulsion, paresthesia, somnolence, stiff neck, hemiparesis, syncope, shivering, transient ischemic attack, cerebral infarction, and nystagmus were reported, with an individual incidence of 0.3% or less.

Respiratory System: Dyspnea, rhinitis, coughing, and laryngitis, with an individual incidence of 0.2% or less.

Gastrointestinal System: Nausea (2%) and vomiting (0.7%). Others including diarrhea, dyspepsia, cramp, and dry mouth were reported, with an individual incidence of less than 0.1%.

Skin and Appendages: Urticaria (0.3%), purpura (0.1%), abscess (0.1%), and pruritus (0.1%).

Individual adverse reactions which occurred to a significantly greater extent for a specific procedure are uled under that indication.

OVERDOSAGE

Overdosage may occur. The adverse effects of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular systems. The symptoms included: cyanosis, bradycardia, acidosis, pulmonary hemorrhage, convulsions, coma, and cardiac arrest. Treatment of an overdosage is directed toward the support of all vital functions, and prompt institution of symptomatic therapy.

The intravenous LD50 values of OMNIPAQUE (in grams of iodine per kilogram body weight) are 24.2 in mice and 15.0 in rats.

DOSAGE AND ADMINISTRATION — General

As with all radiopaque contrast agents, the lowest dose of OMNIPAQUE necessary to obtain adequate visualization should be used. A lower dose may reduce the possibility of an adverse reaction. Most procedures do not require use of either the maximum volume or the highest concentration of OMNIPAQUE. The combination of volume and concentration of OMNIPAQUE to be used should be carefully individualized accounting for factors such as age, body weight, size of the vessel and the rate of blood flow within the vessel. Other factors such as anticipated pathology, degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed should be considered.

Sterile technique must be used in all vascular injections involving contrast media.

Refer to DIRECTIONS FOR PROPER USE OF OMNIPAQUE PHARMACY BULK PACKAGE section for instructions.

If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.

It may be desirable that solutions of radiopaque diagnostic agents be used at body temperature when injected.

Parenteral products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Solutions of OMNIPAQUE should be used only if clear and within the normal colorless to pale yellow range. If particulate matter or discoloration is present, do not use.

INDIVIDUAL INDICATIONS AND USAGE

ANGIOCARDIOGRAPHY

AORTOGRAPHY AND SELECTIVE VISCERAL ARTERIOGRAPHY

OMNIPAQUE 300 at a concentration of 300 mgI/mL and OMNIPAQUE 350 at a concentration of 350 mgI/mL are indicated in adults for use in aortography and selective visceral arteriography including studies of the aortic arch, ascending aorta, and abdominal aorta and its branches (celiac, mesenteric, renal, hepatic and splenic arteries).

OMNIPAQUE 350 at a concentration of 350 mgI/mL is indicated in children for use in aortography including studies of the aortic root, aortic arch, ascending and descending aorta.

CEREBRAL ARTERIOGRAPHY

OMNIPAQUE 300 at a concentration of 300 mgI/mL is indicated in adults for use in cerebral arteriography. The degree of pain and flushing as the result of the use of OMNIPAQUE 300 in cerebral arteriography is less than that seen with comparable injections of many contrast media.

In cerebral arteriography, patients should be appropriately prepared consistent with existing or suspected disease states.

CONTRAST ENHANCED COMPUTED TOMOGRAPHY

OMNIPAQUE 240 at a concentration of 240 mgI/mL, OMNIPAQUE 300 at a concentration of 300 mgI/mL, and OMNIPAQUE 350 at a concentration of 350 mgI/mL are indicated in adults for use in intravenous contrast enhanced computed tomographic head and body imaging by rapid injection or infusion technique.

OMNIPAQUE 240 at a concentration of 240 mgI/mL and OMNIPAQUE 300 at a concentration of 300 mgI/mL are indicated in children for use in intravenous contrast enhanced computed tomographic head imaging by rapid bolus injection.

CT SCANNING OF THE HEAD

OMNIPAQUE may be used to redefine diagnostic precision in areas of the brain which may not otherwise have been satisfactorily visualized.

CT SCANNING OF THE BODY

OMNIPAQUE may be useful for enhancement of computed tomographic images for detection and evaluation of lesions in the liver, pancreas, kidneys, aorta, mediastinum, pelvis, abdominal cavity, and retroperitoneal space.

Enhancement of computed tomography with OMNIPAQUE may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone. In other cases, the contrast agent may allow visualization of lesions not seen with CT alone (ie, tumor extension) or may help to define suspicious lesions seen with unenhanced CT (ie, pancreatic cyst).

For information regarding the use of dilute oral plus intravenous OMNIPAQUE in CT of the abdomen, see INDIVIDUAL INDICATIONS AND USAGE—Oral Use.

DIGITAL SUBTRACTION ANGIOGRAPHY

PERIPHERAL ANGIOGRAPHY

OMNIPAQUE 300 at a concentration of 300 mgI/mL or OMNIPAQUE 350 at a concentration of 350 mgI/mL is indicated in adults for use in peripheral arteriography. OMNIPAQUE 240 at a concentration of 240 mgI/mL or OMNIPAQUE 300 at a concentration of 300 mgI/mL is indicated in adults for use in peripheral venography.

Sedative medication may be employed prior to use. Anesthesia is not considered necessary.

Patient discomfort during and immediately following injection is substantially less than that following injection of various other contrast media. Moderate to severe discomfort is very unusual.

EXCRETORY UROGRAPHY

OMNIPAQUE 300 at a concentration of 300 mgI/mL or OMNIPAQUE 350 at a concentration of 350 mgI/mL is indicated for use in adults in excretory urography to provide diagnostic contrast of the urinary tract.

OMNIPAQUE 300 at a concentration of 300 mgI/mL is indicated in children for excretory urography. (See Section III for information on voiding cystourethrography.)

For pharmacokinetics of excretion in adults, see CLINICAL PHARMACOLOGY—Intravascular.

Pediatrics

SECTION III

CLINICAL PHARMACOLOGY—Oral/Body Cavity Use

For most body cavities, the injected iohexol is absorbed into the surrounding tissue and eliminated by the kidneys and bowel as previously described in SECTION II, CLINICAL PHARMACOLOGY—Intravascular. Examinations of the uterus (hysterosalpingography) and bladder (voiding cystourethrography) involve the almost immediate drainage of contrast medium from the cavity upon conclusion of the radiographic procedure. Orally administered iohexol is very poorly absorbed from the normal gastrointestinal tract. Only 0.1 to 0.5 percent of the oral dose was excreted by the kidneys. This amount may increase in the presence of bowel perforation or bowel obstruction. Iohexol is well tolerated and readily absorbed if leakage into the peritoneal cavity occurs.

Visualization of the joint spaces, uterus, fallopian tubes, peritoneal herniations, pancreatic and bile ducts, and bladder can be accomplished by direct injection of contrast medium into the region to be studied. The use of appropriate iodine concentrations assures diagnostic density.

Orally administered OMNIPAQUE produces good visualization of the gastrointestinal tract. OMNIPAQUE is particularly useful when barium sulfate is contraindicated as in patients with suspected bowel perforation or those where aspiration of contrast medium is a possibility.

INDICATIONS AND USAGE, GENERAL—Oral/Body Cavity Use

OMNIPAQUE 240, OMNIPAQUE 300, and OMNIPAQUE 350 have osmolalities from approximately 1.6 to 3.0 times that of plasma (285 mOsm/kg water) and are hypertonic under conditions of use.

Adults: OMNIPAQUE 350 is indicated in adults for arthrography and oral pass-thru examination of the gastrointestinal tract.

OMNIPAQUE 300 is indicated in adults for arthrography and hysterosalpingography.

OMNIPAQUE 240 is indicated in adults for arthrography, endoscopic retrograde pancreatography and cholangiopancreatography, herniography, and hysterosalpingography.

OMNIPAQUE diluted to concentrations from 6 mgI/mL to 9 mgI/mL administered orally in conjunction with OMNIPAQUE 300 at a concentration of 300 mgI/mL administered intravenously is indicated in adults for contrast enhanced computed tomography of the abdomen.

Children: OMNIPAQUE 300 is indicated in children for examination of the gastrointestinal tract.

OMNIPAQUE 240 is indicated in children for examination of the gastrointestinal tract.

OMNIPAQUE diluted to concentrations from 50 mgI/mL to 100 mgI/mL is indicated in children for voiding cystourethrography.

OMNIPAQUE diluted to concentrations from 9 mgI/mL to 21 mgI/mL administered orally in conjunction with OMNIPAQUE 240 at a concentration of 240 mgI/mL or OMNIPAQUE 300 at a concentration of 300 mgI/mL administered intravenously are indicated in children for use in contrast enhanced computed tomography of the abdomen.

CONTRAINDICATIONS

OMNIPAQUE should not be administered to patients with a known hypersensitivity to iohexol.

WARNINGS—General

PRECAUTIONS—General

See SECTION II, PRECAUTIONS—General.

Orally administered hypertonic contrast media draw fluid into the intestines which, if severe enough, could result in hypovolemia. Likewise, in infants and young children, the occurrence of diarrhea may result in hypovolemia. Plasma fluid loss may be sufficient to cause a shock-like state which, if untreated, could be dangerous. This is especially pertinent to the elderly, cachectic patients of any age as well as infants and small children.

ADVERSE REACTIONS: Oral/Body Cavity Use—General

OVERDOSAGE

See also SECTION II, OVERDOSAGE.

The recommended dose of OMNIPAQUE 350 at a concentration of 350 mgI/mL for adult oral pass-thru examination of the gastrointestinal tract is 50 mL to 100 mL. In a Phase I study, 150 mL of OMNIPAQUE 350 was administered orally to 11 healthy male subjects. The incidence of diarrhea was 91% (10 of 11) and abdominal cramping was 27% (3 of 11). Despite all of these events being mild and transient the occurrences were more than double that seen at the recommended doses. It is apparent from this finding that larger volumes of hypertonic contrast media, like OMNIPAQUE, increase the osmotic load in the bowel which may result in greater fluid shifts.

DOSAGE AND ADMINISTRATION—General

INDIVIDUAL INDICATIONS AND USAGE

VOIDING CYSTOURETHROGRAPHY (VCU)

OMNIPAQUE diluted to concentrations from 50 mgI/mL to 100 mgI/mL is indicated in children for voiding cystourethrography. VCUs are often performed in conjunction with excretory urography.

ARTHROGRAPHY

OMNIPAQUE 240 at a concentration of 240 mgI/mL or OMNIPAQUE 300 at a concentration of 300 mgI/mL or OMNIPAQUE 350 at a concentration of 350 mgI/mL is indicated in radiography of the knee joint in adults, and OMNIPAQUE 240 at a concentration of 240 mgI/mL or OMNIPAQUE 300 at a concentration of 300 mgI/mL is indicated in radiography of the shoulder joint in adults, and OMNIPAQUE 300 at a concentration of 300 mgI/mL is indicated in radiography of the temporomandibular joint in adults. Arthrography may be helpful in the diagnosis of posttraumatic or degenerative joint diseases, synovial rupture, the visualization of communicating bursae or cysts, and in meniscography.

ENDOSCOPIC RETROGRADE PANCREATOGRAPHY (ERP)/ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP)

OMNIPAQUE 240 at a concentration of 240 mgI/mL is indicated in adults for use in ERP/ERCP.

HYSTEROSALPINGOGRAPHY

OMNIPAQUE 240 at a concentration of 240 mgI/mL or OMNIPAQUE 300 at a concentration of 300 mgI/mL is indicated in radiography of the internal group of adult female reproductive organs; ovaries, fallopian tubes, uterus, and vagina. Hysterosalpingography is utilized as a diagnostic and therapeutic modality in the treatment of infertility and other abnormal gynecological conditions.

HERNIOGRAPHY

OMNIPAQUE 240 at a concentration of 240 mgI/mL is indicated in adults for use in herniography.

DIRECTIONS FOR PROPER USE OF OMNIPAQUE PHARMACY BULK PACKAGE

  • The transfer of OMNIPAQUE (Iohexol Injection) from the Pharmacy Bulk Package is restricted to a suitable work area, such as a laminar flow hood.
  • The container closure may be penetrated only one time, utilizing a suitable transfer device and aseptic technique.
  • The withdrawal of container spans should be accomplished without delay. However, should this not be possible, a maximum time of 8 hours from initial closure entry is permitted to complete fluid transfer operations. The container should not be removed from the aseptic area during the entire 8 hour period.
  • The temperature of the container should not exceed 30°C, after the closure has been entered.

HOW SUPPLIED

OMNIPAQUE 240

  •  200 mL fill in 200 mL bottle with hanger, 240 mgI/mL, boxes of 10 Pharmacy Bulk Packages (NDC 0407-1412-16)

OMNIPAQUE 300

  •  200 mL fill in 200 mL bottle with hanger, 300 mgI/mL, boxes of 10 Pharmacy Bulk Packages (NDC 0407-1413-55)
  •  500 mL in +PLUSPAK™ (polymer bottle), boxes of 10 Pharmacy Bulk Packages (NDC 0407-1413-68)

OMNIPAQUE 350

  •  500 mL in +PLUSPAK™ (polymer bottle), boxes of 10 Pharmacy Bulk Packages (NDC 0407-1414-98)

SPECIAL HANDLING AND STORAGE FOR POLYMER BOTTLES ONLY.

DO NOT USE IF TAMPER-EVIDENT RING IS BROKEN OR MISSING.

Protect glass and polymer bottles of OMNIPAQUE from strong daylight and direct exposure to sunlight. Do not freeze. Omnipaque should be stored at controlled room temperature, 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Distributed by GE Healthcare Inc.
Princeton, NJ 08540

Manufactured by GE Healthcare Ireland
Cork, Ireland

Omnipaque is a trademark of GE Healthcare.
GE and the GE Monogram are trademarks of General Electric Company.

Rev September 2005
ONC-4F-CORK

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